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EudraCT User Manual (Public Website)

1. 54 7 5 14 Section J Ethics Committee Competent Authority esses eene eene nnne eese 59 8 SAVING RESTORING CHECKING AND PRINTING THE CT APPLICATION 0 221 4 4 62 9 1 62 9 2 SAVING THE C T APPLICA ANEN Hu E 62 6 2 1 Saing Care Dataser aS Va 64 8 3 RESTORING A SAVED CT APPLICATION ssccccccsssecccesesecccceussecceccuesecccesuusecceesuaeecceesuueecceesuueecceesaueecceesaneeeeees 64 6 3 1 Reloading a Saved Application where no CT Application is loaded in the 64 8 3 2 Reloading a Saved Application where CT Application is already loaded in the PC 65 9 4 CHECKING THE CT APPLICATION FOR DATA CONSISTENCY 410 0 0 0 00 0 2 0000000005500000002000000000 66 6 5 noted MONI FM DEED 67 8 5 1 Printing the CI Application T Orms a 67 8 5 2 Section K Check List of the Information Appended to the Application 0 67 8 6 PROBLEMS THAT MAY BE ENCOUNTERED 68 8 6 1 Loading the XML SCRE E M 68 8 6 2 EudraCT Number MATERIE 68 8 6 3 RT
2. 9 of 73 Doc id Eudra CT EUDRACT USER MANUAL PUBLIC WEBSITE 2 Complete the fields both of which are mandatory The e mail should be accurate so that the e mail containing the security code is sent to the correct recipient 3 When the fields have been correctly completed press the Get Security Code link and a confirmation screen will appear The e mail will arrive shortly afterwards depending on network traffic etc Get Security Code Success An e mail has been sent to martin gregaryaemesa eu nt with the details Fig 4 Get Security Code Success Screen 4 e mail address printed on this confirmation screen to be sure that it does not contain any typing errors If the e mail address is incorrect then the e mail cannot be delivered See section 5 4 2 Entering an invalid e mail format 5 Atthis point press Continue to return to the EudraCT Welcome Screen The e mail that contains the security code will be sent to the e mail address used in the request form 6 Open the e mail account used on the request from to find the e mail This will be from user EudraC Tl eudra org and with the subject Application for Security Code 7 Open the message to obtain the Security code Application for Security Code Message Plain Text Unicode UTF 8 File Edit Insert Format Tools Actions Help GeReply f Reply to All Forward 5 x
3. 7 5 3 Section A Trial Identification A Trial Identification EudraCT Number TEST 000016 30 Sponsor s Protocol Code Number Prot 123 Member 5tate Competent Authority MHRA These are the details for section A Trial Identification Enter details and use Save You can Copy Paste items of free text e g Protocol Title from a word processing file of the Protocol The Sponsor s Protocol Code Number must be that used to obtain the EudraCT Number Member State Competent Authority MHRA EudraCT Number rEsT 0000 16 30 Full title of the trial Test clinical trial application Sponsor s protocol code number Prot 123 Sponsor s protocol version E Sponsor s protocol date E 2004 o1 o3 Name or abbreviated title of the trial where rest available ISRCTN number if available Fig 26 A Trial Identification 1995 2004 EMEA Page 24 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE 1 The heading on this page will show the EudraCT Number of this application and the MSCA entered in the Initial Required Information screen The Sponsor s Protocol Code Number will updated based on the entries in the Trial Identification screen if the screen is refreshed following input 2 Complete the information on the form The EudraCT number cannot be changed but all other data fields are available for input It is even possible to change the MSCA at this stage so that a copy of this application could b
4. Biological Biotechnological information is complete click the Next link This will progress to the next logical screen As follows 11 If both the questions Is this a somatic cell medicinal product and Is this a gene therapy medicinal product were answered No then the IMP Identification Index screen will display 12 If either of these questions was answered Yes then the appropriate subsidiary screen will display to collect the additional information D4 IMP Identification Details Somatic Cell Therapy EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health This is a multi screen form use the navigation key to navigate to each of the screens Answer only if this is a Somatic Cell Therapy Product Answer all questions then use Next Origin of the somatic cells autologous allogeneic xenogeneic If xenogeneic specify the species of origin Type of cells Stem cells Differenciated cells If differenciated specify the type of cells e g keratinocytes fibroblasts chondrocytes Others If others specify the type of cells Gave amp Exit Back Next Cancel Fig 41 D4 IMP Identification Details Somatic Cell Therapy 8 When the screen D4 IMP Identification Details Somatic Cell Therapy displays complete the information and click the Next link This will progress to
5. These are the details for section B Identification of the Sponsor Enter details and use Save Use add sponsor to add a Sponsor Once you have entered the Sponsor details you can edit delete them You can also add details of the Legal Representative as required by Article 19 of Directive 2001 20 EC Deleting A Sponsor also deletes any associated Legal Representative add sponsor No Sponsors have been added for this application Application Menu Page Fig 29 B Sponsor Identification Index No entries 2 Click the link to add sponsor and the Sponsor Identification details screen appears 1995 2004 EMEA Page 26 of 73 CT EUDRACT USER MANUAL PUBLIC WEBSITE EUDI LES 3 Complete the information required on the form to describe the sponsor Select the sponsor s country from the list of all countries of the world and identify the status of the sponsor from the drop down list as either commercial or non commercial 4 If it is necessary for this sponsor to a legal representative in accordance with Article 19 of Directive 2001 20 EU then check the appropriate button 1995 2004 EMEA Page 27 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE 11 1 Sponsor Identification Details EudraCT Number TEST 000016 30 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority MHRA These the details for section B1 Sponsor Identification Detail
6. Browse to or enter the filename and use File path of saved XML file to load Browse Upload Cancel Fig 71 Load Application from File Confirmation no existing loaded application 1995 2004 EMEA Page 64 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE EU ae 3 Enter the filename by typing it in or browse to find it When the filename has been entered click the Upload link and the Load Application from File Success page will display Load Application from File Success EudraCT Number TEST 000016 30 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority MHRA Use Continue to continue Fig 72 Load Application from File Success 4 Click the Continue link and the Clinical Trial Application Menu will display with the reloaded Application available for review and or edit 8 3 2 Reloading a Saved Application where CT Application is already loaded in the 1 From the EudraCT Welcome page click the link Click here to load a saved Clinical Trial Application 2 CT Application has been worked on since the PC was started then the Load Application from File Confirmation screen will display to provide the option to use this current application before overwriting it with a new one from disc Load Application from File Confirmation EudraCT Number TEST D00022 26 Sponsor s Protocol Code Number Prot 1273 Member State Competent Authority Ministry
7. EudraCT Number should be sent Any valid e mail address is acceptable and need not be the requestor s e mail e Enter the security code sent earlier Enter here the EudraCT security code obtained by using the Get Security Code link This security must not have been used on another application and it must be less than 24 hours since it was issued Please select the Member States where it is anticipated that the trial will be run This is not mandatory information but completion will provide some advanced indication of likely Clinical Trial applications in each Member State The Member States selected will represent the best available information and may change However should this information change there is no requirement to notify any Member States of the changes 3 When the fields have been correctly completed you should press the Get EudraCT Number link and a confirmation screen will appear The e mail will arrive shortly afterwards depending on the speed of your local e mail servers Get EudracT Number Success An e mail has been sent to martin gregaryaemea eu nt with the details Fig 11 Get EudraCT Number Success Screen 4 Check the e mail address printed on this confirmation screen to be sure that it does not contain any typing errors If the e mail address is incorrect then the e mail cannot be delivered See section 5 4 2 Entering an invalid e mail format 5 Atthis point press Continue to return to the Eu
8. LES 8 5 Printing the CT Application The information collected in the CT Application includes details of the MS Competent Authority and the Ethics Committee related to the application The print options within the system will select the appropriate information and produce a complete paper version of the CT Application for either recipient In addition there is a separate document template for Section K Check List of The Information Appended to the Application Form 8 5 1 Printing the CT Application Forms 1 is recommended that before the CT Application forms are printed the data validation checks have been completed see section 8 4 Checking the CT Application for Data Consistency and that the full XML has been saved see section 8 2 Saving the CT Application 2 From the EudraCT Welcome page select the option Get Printable Copy This displays the Printable Copy menu Printable Copy EudraCT Number 2004 000061 35 Sponsor s Protocol Code Number wevvy Member State Competent Authority INFARMED Portugal NOTE These options download the PDF ta an disk Itis suggested the file is named with a pdf extension Download Current Form for MS Competent Authority Download Current Form for Ethics Committee Download Blank MS Competent Authority Form Download Blank Ethics Committee Form Cancel 3 Select the form that is required The current forms will produce the paper CT Applications for the MSCA and the
9. The process of loading the template selecting a MS and then adding the MS specific information can then be repeated for all Member States to which an application will be made 9 4 Other Options for Creating Templates The process described here for completing a template is the most straightforward However a CT Application that has a EudraCT Number which is a mandatory field and also can be loaded into the application The MSCA can then be changed and any data specific to the new MSCA can be updated to produce the completed CT Application for the second MSCA By paying proper attention to a file naming convention the XML files for the different MS can be saved separately and submitted correctly 1995 2004 EMEA Page 71 of 73 Doc id Eudra 7 EUDRACT UsER MANUAL PUBLIC WEBSITE 2 10 GLOSSARY OF TERMS CTF Central Technical Facility MSCA Member State Competent Authority MS Member State TMF Trial Monitoring Facility XML The data format of the saved CT Application Form information EC Ethics Committee 11 SUMMARY OF SYSTEM ERROR MESSAGES Mesage 5 Correction Ret or cancel or cancel Requestor s e mail Address and Get EudraCT or cancel 6 3 2 Number You have attempted to resubmit data Get Security Code Press Continue do not by using either the browser back Get EudraCT use the Browser Back 6 3 8 button or refresh option Number Button processing this request and Get E
10. add sponsor 1995 2004 EMEA Page 28 of 73 Doc id Eudra Cp EUDRACT USER MANUAL PUBLIC WEBSITE EUD134 v1 3 2 lfasponsor data should need to be changed then take the edit link and the page B1 Sponsor Identification Details will display with all the entered data for the selected sponsor which can then be changed by repeating steps 2 to 5 above information for a sponsor is not required it can be deleted by clicking the delete link for the selected sponsor NB This delete is immediate and final and there is no warning or verification screen 4 Ifa sponsor has a legal representative then take the link add legal rep and the Legal Representative Identification Details screen is displayed B2 Legal Representative Identification Details EudraCT Number TEST 000016 30 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority MHRA These are the details for section B2 Legal Representative Identification Details Enter details and use Save Mame of organisation Legal Co Street address Town city Post code Country UNITED KINGDOM Telephone number Fax number E mail address Contact person Given name Middle name Family name Fig 32 B2 Legal Representative Identification Details 7 Complete the information on the screen for the legal representative 8 Click the save button to return to the Sponsor Identification Index The index screen will show the
11. 6 3 2 Entering invalid e mail address nennen eese rnnt enean nnne nnns 16 6 3 3 DIT ITO HEU 17 6 3 4 Duplicate Sponsor s Protocol Code Number 17 6 3 5 Using an invalid security 18 6 3 6 Usine an expired SeCUrily 18 6 3 7 Using a security code more than eee nn nnn hnhnh hehe 45 19 6 3 8 VS osten eiue E A OO 19 6 3 9 Unexplained CET DES 20 7 COMPLETING THE APPLICATION 21 7 1 MN OT PION epoca cece ce Sete ra see feces 21 DATA CONVENTIONS WHEN COMPLETING THE CT APPLICATION 21 7 3 SAVING THE CT APPLICATION 22 7 4 NAVIGATING THE CT APPLICATION SYSTEM cccccssccsscssccscccscccsccssccssccsccsscesscescesscesscescesscesseescesscesseescessees 22
12. Ethics Committee The blank forms will produce empty CT Application templates that can be used as data entry sheets during the completion of the CT Application using EudraCT or may be completed by hand as CT Applications in their own right 8 5 2 Section Check List of the Information Appended to the Application Form The CT Application is required to contain a checklist of the documents that ill be submitted with the CT Application This checklist is provided as an MSWord template that can be down loaded from the EudraCT system 1 From the EudraCT Clinical Trial Application Menu select the option Section K The Section K Check List menu is displayed 1995 2004 EMEA Page 67 of 73 Doc id Eudra CT EUDRACT USER MANUAL PUBLIC WEBSITE D Aa K Check List Menu EudraCT Number 2004 123456 12 Sponsor s Protocol Code Number Member State Competent Authority Smithers Check List Menu instructions Section Form Word 2000 template Section K Form Word6 95 template Cancel 2 Select the MSWord format that is required and click the link The checklist will display as an active template with check boxes that are checked to indicate the documents that are included in the application to the MSCA and Ethics Committee 3 When the list has been completed it is saved to your PC or network in the same way as any other MSWord document The options to print a CT Application from for either the MSCA or the Ethics Commit
13. EudraCT Number EudraCT Number Step 1 The first stage in the process is to obtain an authenticated security code This security code will be sent to the e mail address specified by you the requestor an the form and is needed in order to complete the EudracT Number request The security code 15 valid for EudracT Number only and expires after 24 hours Apply for Security Code EudraCT Number Step 2 This is the main EudracT Number request that allows the requestor ta obtain EudracT Number that will provide the unique reference for the Clinical Trial The EudracT number will be sent to the e mail address specified by you the requestor an the form Apply for EudraCT Number Create Mew Clinical Trial Application Once you have the EudracT Number and wish to enter Clinical Trial Application details please press this link Click here to create a new Clinical Trial Application Load Saved Clinical Trial Application If you have saved the Clinical Trial amp pplication to disk and wish to load the details please press this link Click here to load a saved Clinical Trial Application Download CT Amendment Form If you would like an Amendment Form for your Application please press this link Download CT Amendment Form Download CT End of Trial Form If you would like an End of Trial Farm for your Application please press this link Download End of Trial Form Return to EudraCT Home Page Fig 2 EudraCT Welcome Page The Eu
14. From EudraCT eudra org Sent Fri 05 03 2004 16 25 Gregory Martin Subject Application for Security Code Nour security code is 12312823 This code will only be valid for 24 hours THIS IS AN AUTOMATED EMAIL PLEASE DO NOT REPLY AS EMAILS RECEIVED AT THIS ADDRESS WILL BE AUTOMATICALLY DELETED Fig 5 Security Code e mail 8 Make a note of the security code for use in your request for a Eudract number The security code can be also be selected and copied from the e mail for pasting into the EudraCT Number request form 1995 2004 EMEA Page 10 of 73 Doc id Eudra CT EUDRACT USER MANUAL PUBLIC WEBSITE 5 4 Problems that encountered 5 41 Not entering mandatory data The two fields on the Get Security Code Screen are mandatory If an entry is omitted then an appropriate error message will be displayed at the top of the form when the link Get Security Code is pressed Either or both of the warning messages shown on the following will be seen if the relevant fields are not completed Get Security Code Fields marked with must be completed en press the Cancel button which will return you to the main menu The Requestor Name is required The Requestor e mail is required Requestor Namen Requestor e mailf Get Security Code Cancel Fig 6 Get Security Code warning messages To correct the error either 1 Enter valid information in the
15. REQUESTING A EUDRACT SECURITY 1 1 6 9 5 41 Lg e b NOME 9 5 2 NAVIGATING THE EUDRACT NUMBER 5 8 0 4 000000 00 00000 re 9 5 3 THE PROCESS FOR OBTAINING SECURITY CODE scccseccsccsccscccnccccccssccsccscesscesccescesccesseascesscessescesseessenses 9 5 4 PROBLEMS THAT MAY BE 0011 10 11 5 4 1 Not entering mandatory 11 5 4 2 Entering an invalid e mail 11 2 4 3 IOUT OCCU IES Oum 11 2 4 4 USINE THCOTTECL KEYS 12 5 4 5 Lex Dramed DEODOSSDTE ests MEM Dea m Midi yu 6 REQUESTING A EUDRACI NUMBER 13 6 1 Ped ENT oe ee 13 6 2 THE PROCESS FOR OBTAINING A EUDRACT 4 00000000000 13 6 3 PROBLEMS THAT MAY BE ENCOUNTERED sccsccsscceccsccsccsccsscccescesceusesccsscescescescessesscsccscescessessescesscuscescessens 16 6 3 1 Not entering mandatory sravaveyncawsneswesietesionsvabeeesanenssenusieieassianndensvad tuapearsderesienieesunaes 16
16. See section 7 5 4 Save as XML 7 5 12 Section H Population of Trial Subjects 1 When the link H Population of Trial Subjects is taken the Population of Trial Subjects screen is displayed H Population of Trial Subjects EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health If there are no subjects under 18 it is sufficient to answer and then answer the questions on adults and elderly Complete each question then use Save Age span Are the trial subjects under 18 C C No If Yes please select from the following In utero yes No Preterm newborn infants up to gestational age lt 37 weeks Newborn 0 27 days Yes No C Yes C No Infant and toddler 28 days 23 months No Children 2 11years yes C No Adolescent 12 17 years yas No Adult 18 65 years No Elderly 265 years C Yes C No Gender Female C Yes C No Male C Yes No Fig 56a H Population of Trial Subjects screen 1 1995 2004 EMEA Page 52 of 73 CT EUDRACT USER MANUAL PUBLIC WEBSITE Poupulation of trial subjects Healthy volunteers C Yes No Patients C Yes No Specific vulnerable populations women of childbearing potential C Yes No pregnant women C Yes No nursing women C Yes No emergency situation C Yes No If Yes give details subjects incapable of
17. Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health Central Technical Facilities includes central laboratories and central ECG or image processing facilities Trial Monitoring Facilities involves CROs add investigator add central technical facility add trial monitoring facili TOR NN No Investigators have been added for this application Mo Central Technical Facilities have been added for this application Trial Monitoring Facilities have been added for this application Application Menu Page Fig 57 Proposed Sites Index no sites entered 2 Click the add investigator link and the Investigator Detail page will display Ii Investigator Details EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health Complete the Investigator Sites in this Member State only What is the role of this investigator Contact person Given name EN National coordinating investigator for a multicentre trial Middle name Other principal investigator for a multicentre trial Principal investigator for a single centre trial Family name Qualification MD Institution name Institution department name Street address Town city Post code Country Page 54 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE Fig 58 Investigator Details 3 Complete the information on the scree
18. Trial Identification F Sites Responsible for IMP Release B Sponsor Identification G General Information on the Trial C Applicant Identification H Population of Trial Subjects D Information on the IMPs I Proposed Sites in the Member State E Information on the Placebos J Ethics Committee MS Competent Authority Save as XML Get Printable Copy Validate Application Section K Welcome Page 1995 2004 EMEA Page 70 of 73 Eudra EUDRACT UsER MANUAL PUBLIC WEBSITE 2 The CT Application is then completed as described in the body of the document saving as an XML at frequent intervals When the CT information common to the trial has been completed then the final template can be saved as an XML file 9 3 Producing MS Specific CT Applications from a Template The template crated using the process described in section 9 2 Creating a new Template can be reloaded to the CT Application using the link from the Welcome page Click here to load a saved Clinical Trial Application The CT Application template data will load into the application Access Section A Trial Identification from the Application Menu and select the appropriate MSCA from the drop down list Save the CT Application as a new XML file with a new filename Add to the CT Application all the additional information that is specific to the application for the MS selected saving as an XML at frequent intervals The final CT Application will be MS specific
19. a from this location that the Full use File mH ome do method sayveFullD ata from 192 168 10 17 is named with What would you like to do with this file Open this file fram its current location Save this file to disk Always ask before opening this type of file Cancel More Info Fig 28 saving the XML 1995 2004 EMEA Page 25 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE EU s Save as XML EudraCT Number 2004 000061 35 Sponsor s Protocol Code Number wevvy Member State Competent Authority INFARMED Portugal You can choose c psted that the Full option is chosen E en Save 4s in the new Bri ml extension t History Fullbata1 xml gm Network P File name gt Save as XML Document Cancel EZ 3 Select an appropriate filename and folder and save the file Resave the XML file to this same filename and folder as the CT application form is developed to ensure that there is a permanent record of the CT application form 7 5 5 Section B Sponsor Identification 1 When the link B Sponsor Identification is taken the Sponsor Identification Index screen is displayed For a new CT Application this will show that there are no sponsors B Sponsor Identification Index EudraCT Number TEST 000016 30 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority MHRA
20. a security code 5 4 5 Unexplained processing errors There are situations that may cause the application to fail that are out of the control of the application environment When such a situation occurs the error screen will be displayed Press the OK link to return to the EudraCT Welcome screen To prevent further errors you should close the Internet browser restart it and re enter the EudraCT system from the main link on the Eudra home page See section 4 1 Access to the EudraCT System Such errors should be reported to the system administrators by e mail using the contact link on the EudraCT Welcome screen e There has been a technical error processing this request Please use the contact action in the Banner if you wish to report the problem You may need to restart your Browser if you encounter further problems Fig 9 EudraCT Technical Error Processing screen 1995 2004 EMEA Page 12 of 73 C T EUDRACT USER MANUAL PUBLIC WEBSITE 6 REQUESTING A EUDRACT NUMBER 6 1 Introduction Doc id EUD134 v1 3 This part of the system is used to obtain a EudraCT number for the Clinical Trial application A EudraCT Number is needed in order to make a successful Clinical Trial Application within Europe Once a EudraCT number has been issued it is to be used as the unique reference for the clinical trial throughout Europe and the use of more than one EudraCT number to describe the same Clinical Tria
21. details of the legal representative under those of the sponsor who they represent 9 From this screen the following options can be taken 5 If another sponsor is involved with the trial then repeat the option add sponsor 6 data should need to be changed then take the edit link and the page B1 Sponsor Identification Details will display with all the entered data for the selected sponsor which can then be changed by repeating steps 2 to 5 above 7 representative data should need to be changed then take the edit link and the page B2 Legal Representative Identification Details will display with all the entered data for the selected legal representative which can then be changed by repeating steps 7 and 8 above 8 Note When a sponsor has a legal representative there is no option to add an additional legal representative for that sponsor 1995 2004 EMEA Page 29 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE ED s Sponsor Identification Index EudraCT Number TEST 000016 30 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority MHRA These are the details for section B Identification of the Sponsor Enter details and use Save Use add sponsor to add Sponsor Once you have entered the Sponsor details you can edit or delete them You can also add details of the Legal Representative as required by Article 19 of Directive 2001 20 EC Deleting A Spons
22. giving consent personally If Yes specify C Yes No others C Yes C No If others specify the specific vulnerable populations The planned number of subjects to be included In the member state In the European Community In the whole clinical trial I Plans for treatment or care after the subject has ended the participation in the trial if it is different from the expected normal treatment of that condition H Save Cancel Fig 56b Population of Trial Subjects screen 2 2 Complete the information required on the form to describe the population of subjects included in the trial The large text boxes will scroll to show the information that has been added It is possible to copy and paste information into these boxes from other electronic documents 1995 2004 EMEA Page 53 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE 3 When details of the population of trial subjects have been added to the system click the link Application Main Menu to return to the CT Application Menu Then click the link Save as XML and resave the CT Application form to the local XML file See section 7 5 4 Save as XML 7 5 13 Section Proposed Sites in the Member State 1 When the link 1 Proposed Sites in the Member State is taken the Proposed Sites Index is displayed For a new CT Application this will show that no sites have been identified I Proposed Sites Index EudraCT Number TEST 000022 26
23. hosted on behalf of the European Commission http europa eu int EudracT Helpdesk email eudractifiemes eu int ta be supplied by IT operations EudraCT Helpdesk phone Tel 44 20 74 18 77 77 Fax 44 20 74 18 77 Queries on Web functionality to 2277777 7 Westferry Circus Canary Wharf London E14 4HB Fig 1 EudraCT Home Page The EudraCT Home page has the following links Access to EudraCT Application This is the link to the EudraCT system Click here for the EudraCT Welcome Page Access to EudraCT supporting documentation Click here for links to the CT Directive 2001 20 EC and subsidiary guidance documentation 1995 2004 EMEA 6 of 73 CT EUDRACT USER MANUAL PUBLIC WEBSITE EUDI LES FAQ This is provides a list of frequently asked questions Help This link provides on line access to this user manual Contact This link provides the facility to send an e mail to the system support group at 4 3 The EudraCT Welcome Page This is main index to the EudraCT system Welcome EudracT Number In order to provide a unique reference far clinical trials with at least one site in the Community each trial will be given a unique number the EudracT Number which must be included on all Clinical Trial applications within the Community and as needed on other documents relating to the trials e g SUSAR reports Steps 1 and 2 below access the forms that must be submitted in order to obtain
24. id EUD134 v1 3 7 Complete the information on the screen to describe the Central Technical Facility 8 When the information is complete click the Save link to return to Proposed Sites Index screen 1995 2004 EMEA Page 56 of 73 CT EUDRACT USER MANUAL PUBLIC WEBSITE ie a I Proposed Sites Index EudraCT Number 2004 123456 12 Sponsor s Protocol Code Number Member State Competent Authority Smithers Proposed Sites Index instructions add investigator add central technical facility add trial monitoring facility Investigators INi Name Investigator Name it delete Central Technical Facilities 1 Name it delete Trial Monitoring Facilities have been added this application Application Menu Page Fig 61 Proposed Sites Index one investigator and one 9 From this screen the following options can be taken 1 The options for investigators detailed in step 5 2 If another is included in the trial then repeat the option add central technical facility 3 If CTF data should need to be changed then take the edit link for the appropriate CTF and the page 13 Central technical Facility Details will display with all the entered data for the selected CTF which can then be changed by repeating steps 7 and 8 above 4 the information for a is not required it can be deleted by clicking the delete link fo
25. site and the Responsible Sites Identification Details page is displayed 1995 2004 EMEA Page 45 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE F Responsible Sites Identification Details EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health This is multi screen form use the navigation key Next to navigate to each of the screens IMP and Placebo responsibilities are on the next screen Site organisation name Manufacturing Co Street address 1 Town city 1 Post code Country UNITED KINGDOM x Has the site been authorised Yes No C As a manufacturer importer or both Both Manufacturer or importer authorisation number If no authorisation give the reasons Has the site been inspected by EU Yes No C authorities If Yes date of the last inspection 2002 10 Save amp Exit Next Cancel Fig 51 Responsible Sites Identification Details 3 Enter the information to describe the responsible site When the information is complete click the Next link to progress to the Responsible Sites Identification Details IMPs Placebos screen that lists the IMPs and placebos from which to select those that this site is responsible for releasing 4 Select the IMPs and or placebos that this site is responsible for releasing by checking the appropriate Yes radio button 1995 2004 EME
26. t E mail to which the EudraCT number will be sent Enter the security code sent earlier 7 Fig 13 Get number field warnings correct the error either 1 Enter valid information in the fields identified in the error message s and press the Get Security Code link to obtain a security code 2 Take the Cancel link to return to the EudraCT Welcome Screen and if a EudraCT Number is required take the appropriate link back to the Get EudraCT Number screen 6 3 2 Entering an invalid e mail address format The EudraCT system will check to ensure that the e mail address entered complies with the standard format If an e mail address with an incorrect format is entered the following error message will appear on the screen when the Get Security Code link is pressed 1995 2004 EMEA Page 16 of 73 Doc id Eudra CT EUDRACT USER MANUAL PUBLIC WEBSITE EUDI VES You have entered an invalid Requestor s e mail address Fig 14 Invalid e mail address format warning To correct the error either 1 Enter an e mail address with a valid format and press the Get Security Code link to obtain a security code 2 Take the Cancel link to return to the EudraCT Welcome Screen and if a security code is required take the appropriate link back to the Get Security Code screen 6 3 3 Not receiving the e mail There may be several reasons why the e mail does not arrive The mo
27. the CT information The system is designed with maximum flexibility and although this section will assume that each section is completed in order this is not necessary An application can be completed in several sessions adding changing or deleting information as required until the final application form has all the required information The final application form can then be printed in a version for the Member State Competent Authority and in a version for submission to the Ethics Committee The electronic version of the CT Application form can be saved and submitted with the paper application to the Member State Competent Authority for the MSCA to include in the central EudraCT database without any necessity to re key the information 7 2 Data Conventions when Completing the CT Application Form The on line web pages used to collect the CT Application form data use a variety of screen elements These are Single line free text Type into these fields up to the maximum allowed Entry restricted to the fields characters maximum length on input Can copy paste from other applications or electronic documents Multi line free text Type in these fields up to the maximum allowed Entry is not restricted at fields characters input but a warning is sent Can copy paste from other applications or when the form is saved and documents the data length must be reduced Dates Enter the date in the sequence year month day in Valid date format check
28. the link J 1 Ethic Committee to enter Ethics Committee information and the Ethics Committee screen displays 3 1 Ethics Committee EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health Complete the current status of the Ethics Committee Opinion at the time of submission to the 5 Competent Authority Ethics committee name Street address Town city Post code Country Date of submission vyyy mm dd What is the status of the Ethics Committee s m opinion If given specify the date of opinion z yyyy mm If given indicate whether favourable or not If not favourable give the reasons If not favourable give the eventual anticipated date of resubmission vyyy mm dd Gave Cancel Fig 65 J 1 Ethics Committee 1995 2004 EMEA Page 60 of 73 EUDRACT USER MANUAL PUBLIC WEBSITE EU a Eudra 3 Complete the information on the screen to describe the Ethics Committee to which the application will be made 4 When the information is complete click the Save link to return to Ethics Committee Competent Authority Information screen 5 Click the link J 2 MS Competent Authority to enter MSCA information and the MS Competent Authority screen displays 1 2 MS Competent Authority EudraCT Number TEST 000022 26 Sponsor s Protocol Code Nu
29. this screen Answer all questions then use Next Does the IMP contain an active substance of chemical origin biological biotechnological origin yeg C No No If to biological biotechnological origin specify the type of product Extractive yes Recombinant yes Vaccine yeg GMO Plasma derived products Others If others specify the type of product C Yes C Yes C Yes Is this IMP a somatic cell therapy medicinal product 7 yes C Yes C Yes gene therapy medical product radiopharmaceutical medicinal product immunological medicinal product such as vaccine allergen immune serum herbal medicinal product C Yes C Yes homeopathic medicinal product yes medicinal product containing genetically modified organisms C Yes If has the authorisation for contained use been granted yes is it pending yes another type of medicinal product If another type of medicinal product specify the type of medicinal product Save amp Exit e t e E C No C No C No C No C No C No No C No C No C No al Back Next Cancel Fig 40 D2 D3 IMP Identification Details Biological Biotechnological 1995 2004 EMEA Page 36 of 73 EUD134 v1 3 EUDRACT UsER MANUAL PUBLIC WEBSITE UD s Eudra 7 When the IMP Identification Details Type
30. 2 Click the link C1 Applicant to the MS Competent Authority and the Application to the MC Competent Authority screen is displayed 1995 2004 EMEA Page 30 of 73 Cp EUDRACT UsER MANUAL PUBLIC WEBSITE C1 Application to the MS Competent Authority EudraCT Number TEST 000016 30 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority MHRA These are the details for section C Applicant Identification Enter details and use Save This is the Applicant to the M5 Competent Authority Enter the details of the legal Applicant who will sign the form The Contact Name may be a different individual at the same Location Organisation The Phone Fax and E mail should be those of the Contact person The legal representative of the sponsor r Person or organisation name Lea al co of person to contact Given name of person to contact Middle name Mame of person to contact Family name Street address Town city Post code Country Telephone number Fax number E mail address Fig 35 C1 Application to the MS Competent Authority 3 Complete the information on the screen Select the appropriate applicant from the drop down list and the country of the applicant from the list of Member States 4 Click the Save link to return to the Applicant Identification Menu 5 Click the link C2 Applicant to the Ethics Committee and the Application
31. 2 IMP Identification details Active Substances 14 Complete the details on this page and click the Save link which will return to the IMP Identification Index page which will show that an active ingredient has been added to the IMP D IMP Identification Index EudraCT Number 5 000022 26 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority MHRA Click add ta start the first IMP or create another Once an IMP is added links for edit delete copy and add active substance are displayed far that IMP Use add active substance for all active substances in that IMP Complete all questions in Section D far each IMP but if mast of the answers are the same for any additional IMPisi e g 3 tablets af different strength then enter one IMP use the copy IMP function this screen then edit the relevant fields in the copy add IMP Tradename 1 Product A i add active substance Application Menu Page Fig 45 D IMP Identification Index One IMP added with one active substance 15 From this screen the following options can be taken 19 If another IMP is included in the trial then repeat the option add IMP 1995 2004 EMEA Page 40 of 73 Doc id Eudra CT EUDRACT USER MANUAL PUBLIC WEBSITE Eo A VIS 20 21 22 23 24 29 If IMP data should need to be changed then take the edit link and the page D1 D2 IMP
32. 42 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE Placebo Information Details EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health The follawing applies for one Placebo Repeat add placebo for each different Placebo PRnn is the IMP identity number shown in the D IMP Identification Index Select for all IMPs for which this is a Placebo and for the others Information is only preserved for IMPs which have a positive association to the Placebo Use to proceed Pharmaceutical form Coated tablet Route of administration Oral use r Which IMP 5 is it a placebo for PR Aspro If it is a placebo for this IMP is the Yes C No composition apart from the active substance 5 otherwise identical to the IMP being tested If composition is not identical specify the major ingredients Gave Cancel Fig 47 E Placebo Information Details 4 Click the Save link which will return to the Placebo Information Details page which will show that a placebo has been added to the trial E Placebo Information Index EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Praot 123 Member State Competent Authority MHRA If are using ar more Placebo IMPs use add placebo Complete for each different Placebo used add placebo Pharmaceutical form Capsule Route of admi
33. 7 4 1 Navigating the CT Application Form 2 7 4 2 Navi canne the Web PALES 23 7 5 THE PROCESS FOR COMPLETING A NEW 00 23 7 5 1 Accessing the CT Application 222222 0000000000000000050212 8 8 8 000000 0000000 81 5 23 75222 Starting the CT Application 24 5 nurus 24 7 5 4 RITTER 22 1995 2004 2 73 CT EUDRACT USER MANUAL PUBLIC WEBSITE 1 7 5 5 Secon B D pPonSor den CANON aiee siss 26 7 5 6 Section C Applicant arn nn esses ssa 30 Section D Information on 32 2 0 Section E Information on Placebos e ep ap RYE e VR epu ese Ve STE ES YES e ERO ehe ev UPR Su en 42 7 5 9 Adding Placebos without an eee eese tnn neis sies aene rises en rennes 44 7 5 10 Section Sites Responsible for IMP Release eene nnne 45 7 5 11 Section General Information on the 1 1 000000000004 000 nennen eene nnne nnn nnn nnns 46 7 5 12 Section Population of Trial Subjects esses 52 7 5 13 Section I Proposed Sites in the Member State
34. A CZECH REPUBLIC FINLAND GREECE IRELAND LIECHTENSTEIN MALTA POLAND SLOVENIA UNITED KINGDOM L1 EI EI EI PI PI ET P B CI Get EudraCT Number Fig 10 Get EudraCT Number Screen 1995 2004 EMEA Page 13 of 73 CT EUDRACT USER MANUAL PUBLIC WEBSITE LES 2 The requestor will complete all the mandatory fields which are marked with 7 e Requestor s Organisation Name Include in here the name of the organisation that the requestor works for If the requestor is not making the request on behalf of an organisation but on their own behalf then the Requestor s Organisation Name should be left blank but you should use the fields Requestor s Organisation Town City and Requestor s Organisation Country to enter your own Town or City and Country respectively Hequestor s Organisation Town City This is a mandatory field organisation Country This is a mandatory field Select the appropriate country from the drop down list of all the countries of the world Sponsors Protocol Code Number This is the Protocol Code Number for the clinical trial that will be linked to the EudraCT number obtained from this request It can be entered in the normal format used by the requestor s organisation Hequestor name Enter your name e E mail to which the EudraCT Number will be sent Enter the e mail address to which the
35. A Page 46 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE 11 Responsible Sites Identification Details 5 Placebos EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member 5tate Competent Authority The Ministry of Health Select the IMPs and or Placebos for which this site is responsible for the release Note that this screen lists all relevant IMPs and Placebos to enable you to select the relevant IMP s Placebo s The list is provided for reference and only a positive selection Yes saves the data Finished IMP PR2 Aspro Placebo Pharmaceutical form Coated tablet 1 s E Route of administration Oral use Back Save amp Exit Cancel Fig 52 F Responsible Sites Identification Details IMPs Placebos 5 When the IMPs and placebos that this site is responsible for have been selected click the Save amp Exit link to return to the Responsible Sites Identification Index F Index of Sites Responsible for IMP Release EudraCT Number 5 22 26 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority MHRA This records the Sites responsible for final OP Release for distribution to Investigators for the IMPs selected in the following screen s add responsible site Organisastian 1 delete Organisation 2 it delete Application Menu Page Fig 53 F Responsible Sites Identification Index two sites added 6 From thi
36. Design of the Trial are on the next screen Free text can be copy pasted from a ward processed copy of the Protocol but be brief as long copies of protocol text are not required Specify the medical condition free text ICD10 classification code MedDRA classification code Version Level Classification Is it a rare disease C Yes C No Main objective of the trial Secondary objectives of the trial Principal inclusion criteria list the most important max 5000 characters 1995 2004 EMEA Page 48 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE Doc id EUD134 v1 3 Fig 54a General Information on the Trial screen 1 Principal exclusion criteria list the most important max 5000 characters Primary end point s max 5000 characters Definition of the end of the trial Does the trial end with the last visit of the cy CN last subject x If justify the end of trial definition Initial estimate of the duration of the trial in the European Community Save amp Exit Next Cancel 3 Fig 54b General Information on the Trial screen 2 Complete the information required on the form to describe the trial The large text boxes will scroll to show the information that has been added It is possible to copy and paste information into these boxes from other electronic documents When the necessary information has been added click the Next link and the Gener
37. Eudra EUDRACT UsER MANUAL PUBLIC WEBSITE 1 1 EUDRACT UsER MANUAL PUBLIC WEBSITE Heference EUD134 Version 1 3 Date April 2004 1995 2004 EMEA Page 1 of 73 Eudra EUDRACT USER MANUAL PUBLIC WEBSITE NT CONTENTS 1 ABOUT THIS DOCUMENT 5 MR EC TES Ee eC RERO UE SCA T Sa e E 4 2 GSXNSIENOVIRVIIEVW n 92 92952595955021995090059099822091 9520390 a 2 9 0 008 90 5020 0 9 089 4 2 1 RM MEME EUM MI MIS EAS 4 2 1 1 IU qb TX 4 2 1 2 SOO NG LINEE EE EE EEN T EAE EEN 4 3S GETTINGSTARIFD eE EEEa 4 3 1 SYSTEM sATA ENNER EIE ENEE OKE NAE ORKAN 4 3 1 1 ETE E E E E S 4 1711 4 0 OIE uoces 4 3 1 3 PD a E E a E E E E E A E T T EE EA O 5 3 1 4 For printing the application forms 5 4 AWCCESSING THESYSTENDE sonion aa a as 6 4 1 ACCESS TO TIE FUDRACT SYSTEM crete atc es a 6 4 2 HONE PACE 4 T E A E 6 4 3 THE EUDRACT 0 000000000000 7 5
38. EudraCT number nor does it attempt to explain the CT process itself 2 SYSTEM OVERVIEW 2 1 General The system is divided into two basic parts The first part provides the facilities for obtaining a EudraCT Number for a Clinical Trial Application This is a two step process that first requires that a security code reference be obtained as a means of validating the EudraCT Number request The second part identifies some simple information about the requestor and the Sponsor s Protocol Code Number of the trial for which the EudraCT number is required There are two simple forms to collect the information required and the security code and EudraCT number will be returned by e mail The EudraCT number is used as the unique reference to a clinical trial on the CT application form The second major part of the EudraCT system is based on a set of web pages that will collect the information required to complete the CT application save the data to disc print paper copies for the Member State Competent Authorities MSCA and Ethics Committees EC and then make an electronic copy for despatch to the MSCA There are also facilities to download forms for The Request for Authorisation of a Substantial Amendment to a Clinical Trial and for the Declaration of the End of a Clinical Trial 2 1 1 Entering Data The system is based on web enabled request forms These collect the information required for the request of a security code EudraCT Number and the da
39. IMPs and active substances have been added to the system click the link Application Main Menu to return to the CT Application Menu Then click the link Save as XML and resave the CT Application form to the local XML file See section 7 5 4 Save as XML 1995 2004 EMEA Page 41 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE EU s 7 5 8 Section E Information on Placebos 1 When the link E Information on Placebos is taken the Placebo Information Index screen is displayed For a new CT Application this will show that there are no placebos Placebo Information Index EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health If you are using one or more Placebo IMPs use add placebo Complete for each different Placebo used add placebo No Placebos have been added for this application Application Menu Page Fig 46 E Placebo Information Index no placebos added 2 Click the link to add placebo and the Placebo Identification Details screen appears This screen will list all the IMPs entered for the trial so far There is a pair of Yes radio buttons by each IMP so that the IMPs that the placebo will replace can be selected 3 Enter the pharmaceutical form and route of administration for the placebo and then select the IMP or IMPs that this placebo will replace by setting the radio buttons 1995 2004 EMEA Page
40. Identification Details Status Description will display with all the entered data for the selected IMP which can then be changed by repeating steps 3 to 9 above If the information for an IMP is not required it can be deleted by clicking the delete link for the selected IMP NB This will delete any associated actives substances and the delete is immediate and final and there is no warning or verification screen If another very similar IMP is included in the trial then an existing IMP can be copied and the record edited to include the differences by repeating steps 3 to 9 above The details of the active substance can be by deleted by clicking with the delete link by the active substance NB this delete is immediate and final and there is no warning or verification Screen If existing active substance information should need to be changed then take the edit link for the active substance and the page IMP Identification Details Active Substances screen will appear Repeat step 14 above to change active substance data and click the link Save which will return to the IMP Identification Index page which will show that the active ingredient has been added to the IMP If another active substance is to be added to an existing IMP then click the link add active substance and when the screen IMP Identification Details Active Substances displays repeat step 14 above to add a new active substance 16 When details of the
41. PC or network and save the CT application frequently to ensure that work is not lost See section 7 5 4 Save as XML The system has a time out facility which will end any session if there is no activity for 30 minutes Any work not saved when the system times out will be lost 7 4 Navigating the CT Application System 7 41 Navigating the CT Application Form Navigation through the CT Application Form must be done by following the navigation buttons on the screens The sections of the CT Application Form are accessed via the Clinical Trial Application Menu which provides the main navigation through the system These sections may be selected in any sequence in order to complete the CT Application form and at any time a section can be saved and then returned to at a later date to add additional information as it becomes available or to edit existing data Clinical Trial Application Menu EudraCT Number TEST 000016 30 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority MHRA NOTE The system will timeout if there is a period of inactivity For this reason and to avoid accidental data loss you must Save as XML to your local computer other accessible drive at the start of the session and regularly thereafter This is because no data is stored by the EudraCT system except temporarily during the current session The Save button is used during data entry this does NOT store your information on disk
42. RING CHECKING AND PRINTING THE CT APPLICATION 8 1 Introduction This section describes the processes included in the CT Application system for saving electronic versions of the CT Application Form and restoring them for review and or edit In addition the processes for printing the final application form for submission to the Member State Competent Authorities and Ethics Committee is described 8 2 Saving the CT Application As explained in section 7 5 4 Save as XML the CT Application form should be saved regularly to avoid loss of data The options for saving the CT Application data are included on the Clinical Trial Application Menu 1 Navigate to the Clinical Trial Application Menu and click the link Save as XML The Save as XML menu will display with the following options 1 Full XML This option will save all the data entered on the application form as an XML file This is the option to be used throughout the CT Application preparation process to permanently save the entered information 2 Core Dataset XML This option will save only part of the total data entered in the Application form This partial data is sufficient to meet the minimum requirement for data to be held in the central EudraCT database maintained by the MS competent authorities within the Community Save as XML EudraCT Number TEST D00022 26 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority EOF You can choose
43. Sent Fri 12 03 2004 10 25 To Gregory Martin oe Subject Application For EudraCT Number Security Code 10983786 already used THIS IS AN AUTOMATED EMAIL PLEASE DO NOT REPLY AS EMAILS RECEIVED AT THIS ADDRESS WILL BE AUTOMATICALLY DELETED Fig 21 Duplicate security code e mail To correct this error 1 Take the Cancel link on the Get EudraCT Number page to return to the EudraCT Welcome screen and request a new security code to be used in a new EudraCT Number request 6 3 8 Using incorrect navigation keys The standard Internet browser keys should not be used to find forms that have been already been submitted If a page that has been submitted once is submitted a second time then the following error message will appear Resubmit Data Error You have attempted to resubmit data by using either the browser back button or refresh option Press Continue to continue do not use the Browser Back Button Fig 22 Resubmit Data Error Screen 1995 2004 EMEA Page 19 of 73 Eudra CT EUDRACT USER MANUAL PUBLIC WEBSITE EUDI LES This error is corrected by taking the Continue link which returns to the EudraCT Welcome screen From here the appropriate link can be used to obtain a security code If the browser back key is used to find an earlier screen used to submit a request for a EudraCT Number then on the resubmit of the screen there is likely to be additional revalidation of the submitted data which may
44. T 69 8 6 4 Text Box Allowable Length 69 8 6 5 Numeric Field Validation ZU ERE EP EP 69 9 USING THE CT APPLICATION FORM AS TEMPLATE 70 9 lcge Da esa T 70 9 2 CREATING 7 NEW TEMPLATE 70 9 3 PRODUCING MS SPECIFIC CT APPLICATIONS FROM A 71 9 4 OTHER OPTIONS FOR 5 2225255 71 10 5 72 11 SUMMARY OF SYSTEM ERROR MESSAGES eoe e eoa eo pee o pa Pao Reb aur Pee a a noa a a pea PE n a PPP Pa aene P Pa bean ne 72 1995 2004 EMEA Page 3 of 73 Eudra EUDRACT UsER MANUAL PUBLIC WEBSITE 1 1 ABOUT THIS DOCUMENT This document describes the public website used to make an application for a Clinical Trial It describes how the system can be used to obtain a EudraCT number and complete the Clinical Trial CT application form This document does not describe the underlying business processes required by the Sponsor or Requestor to manage the request for the
45. ain Text Unicode UTF 8 File Edit View Insert Format Tools Actions Help Co Reply f Reply to All Forward v x a E From Sent Fri 12 03 2004 12 48 Gregory Martin Su Subject Application For EudraCT Number Security Code 81310654 has expired You must apply for a new one THIS IS AN AUTOMATED EMAIL PLEASE DO NOT REPLY AS EMAILS RECEIVED AT THIS ADDRESS WILL BE AUTOMATICALLY DELETED Fig 19 Expired security code e mail 6 3 7 Using a security code more than once Security codes are only valid for one EudraCT Number request If the security code is used more than once then the following error will be received when the Get EudraCT Number link is taken The security code has already been used in a request for a EudraCT number Please check the security code and if necessary request a new one An e mail has been sent to e mail address with this information Fig 20 Duplicate security code error message E mail will be sent to the e mail address on the EudraCT Number request form so that there is a positive record that a EudraCT number has not been issued for the request Application for EudraCT Number Message Plain Text Unicode UTF 8 File Edit View Insert Format Tools Actions Help Go Reply f Reply to All Forward E gt amp 2 From EudraCT eudra org
46. al Information on the Trial Scope Type Design screen will display 1995 2004 EMEA Page 49 of 73 Doc id EUD134 v1 3 EUDRACT UsER MANUAL PUBLIC WEBSITE G General Information on Trial Scope Type Design EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health This 16 a multi screen form use the navigation key Next to navigate to each of the screens For the Trial phase the ICH definitions are used Therefore if a Product has Marketing Authorisation in the EU for this Indication Dose Form and Concentration use to Therapeutic Use Select Yes to one phase only select the best approximation and to the others Complete all questions then use Next Scope of the trial Diagnosis C Yes Pharmacodynamic C Yes C No Prophylaxis C Yes C No Bioequivalence C Yes C No Therapeutic C Yes Dose response C Yes No Safety C Yes No Pharmacogenomic C Yes C No Efficacy C Yes No Pharmacoeconomic C Yes C No Pharmacokinetic C Yos Others C Yes C No If others specify scope of the trial Trial type and phase Human pharmacology Phase I C Yes C No Therapeutic exploratory Phase II C Yes C No Therapeutic confirmatory Phase III C Yes No Therapeutic use Phase IV C No Bioequivalence study C Yes No First administration to humans C Yes No Other Yes C No If other speci
47. al use Save amp Exit Back Next Fig 39 D2 D3 IMP Identification Details Route of Administration 5 this screen one or many routes of administration may be selected Highlight the appropriate route of administration from the list on the left and click on the gt gt gt symbol This will add the route of administration to IMP and update the list on the right This procedure can be repeated to add additional routes of administration If a route of administration is to be removed from the list on the right then click on the route of administration to highlight it and then click the lt lt lt symbol to move the route of administration back to the list on the left 6 When the route of administration information is complete click the Next link to progress to the IMP Identification Details Type Biological Biotechnological 1995 2004 EMEA Page 35 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE Doc id D2 D3 IMP Identification Details Type Biological Biotechnological EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member 5tate Competent Authority The Ministry of Health This is a multi screen form use the navigation key Next to navigate to each of the screens Answer all questions or as applicable Further detailed questions on Somatic Cell Therapy or Gene Therapy Products only appear if you answer Yes to the relevant last questions on
48. ation form to the Member State Competent Authority may be sent containing only the minimum core dataset The process to prepare this XML file is the same as the steps above In general this save will be done following the preparation and save of the complete CT Application NB If the Core Dataset is saved to an XML file and then the CT Application system is exited without also saving the full CT Application data then any data in the CT Application that is not included in the Core Dataset will be lost 8 3 Restoring a Saved CT Application CT Application information is saved as XML files using the processes described in section 8 2 Saving the CT Application The stored files can be restored by clicking the option Click here to load a saved Clinical Trial Application on the EudraCT Welcome page The next sequence will depend on whether there is already CT Application being worked on 8 3 1 Reloading a Saved Application where no CT Application is loaded in the PC 1 From the EudraCT Welcome page click the link Click here to load a saved Clinical Trial Application 2 CT Application has been worked on since the PC was started then the Load Application from File Confirmation screen will display with a request for the filename to be loaded Load Application from File Confirmation Use Browse to locate the saved ML file that you would like to load This allows you to load an application which has been saved to disk
49. d enter routes of administration data use Save amp Exit Next Cancel Fig 38b D1 D2 IMP Identification Details Status Description page 2 1995 2004 EMEA Page 34 of 73 Cy EUDRACT USER MANUAL PUBLIC WEBSITE eae 3 Complete the information on the screen to describe the IMP NB If either of the questions that allow for the IMP to described only in terms of its active substance is selected then it will be necessary to create a dummy record to which the active substances may be attached The following entries represent an acceptable dummy record 4 When the information is complete click the Next link to progress to the routes of administration selection for this IMP D2 D3 IMP Identification Details Route of Administration EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member 5tate Competent Authority The Ministry of Health This is a multi screen form use the navigation key Next to navigate to each of the screens Select the Route s of Administration then use gt gt gt to add Use lt lt lt to remove any added in error Complete then use Select to add use Ctrl key for multiples Routes of administration for this IMP Auricular use Ophthalmic use noncurrent Buccal use nancurrent Cutaneous use Dental use Endocervical use Endosinusial use Endotracheopulmanary use Epidural use Extra amniotic use Gastroenter
50. d investigator site NB This delete is immediate and final and there is no warning or verification screen 6 Click the add central technical facility link and the Central Technical Facility Details page will display 1995 2004 EMEA Page 55 of 73 Eudra I3 Central Technical Facility Details Number 2004 123456 12 Sponsor s Protocol Code Number Member State Competent Authority Smithers Central Technical Facility Details instructions Central technical facility organisation name Central technical facility organisation department Street address Town city Post code Country Contact person Given name Middle name Family name Telephone number Enter the details of any duties subcontracted to this central technical facility in this trial Routine clinical pathology testing Yes Clinical chemistry Yes Clinical haematology Yes Clinical microbiology Yes Histopathology Yes Serology endocrinology Yes Analytical chemistry Yes ECG analysis review Yes Medical image analysis review X ray MRI yes ultrasound etc Primary surrogate endpoint test Yes Other Duties subcontracted Yes If Yes specify the other duties Fig 60 13 Central Technical Facility Details B LX OQ CODO OF CE EUDRACT UsER MANUAL PUBLIC WEBSITE DD Uu CK CY Doc
51. d then make a new request for a security code 1995 2004 EMEA Page 11 of 73 Doc id Eudra CT EUDRACT USER MANUAL PUBLIC WEBSITE 2 Wrongly typed e mail address You may have included an e mail address in the correct format but mistyped the name In this instance the e mail from the EudraCT system will be returned to EudraCT as undeliverable The EudraCT system cannot do any more in this instance and your e mail will not arrive You must make another request for a security code 3 E mail address of another recipient If you use another person s e mail and not your own then you will not receive the e mail in your mail account Either contact the other person to check that they have received the e mail with the security code or request a new security code to be sent your own e mail address 5 4 4 Using incorrect navigation keys The standard Internet browser keys should not be used to find forms that have been already been submitted If a page that has been submitted once is submitted a second time then the following error message will appear Resubmit Data Error You have attempted to resubmit data by using either the browser back button or refresh option Press Continue to continue do not use the Browser Back Button Fig 8 Resubmit Data Error Screen This error is corrected by taking the Continue link that returns to the EudraCT Welcome screen From here the appropriate link can be used to obtain
52. d when the Get EudraCT Number link is taken A EudraCT Number has already been issued for Protocol Code Number Prot 123 2004 Are you sure that you wish to proceed to generate another EudraCT number It is likely that a EudraCT number for this Protocol Code Number has already been issued to another individual within your organisation or another collaborator on this trial Please check whether you have duplicated this EudraCT number request for your clinical trial If you are absolutely sure that you wish to continue then click the Get EudraCT Number button below otherwise click the Cancel button Fig 15 Duplicate Sponsor s Protocol Code Message It is very unlikely that different sponsors will use the same Protocol Code Numbers for their trials However this may happen and within the Community it is the EudraCT Number that will provide the truly unique reference to the sponsor s trial If the system detects a duplicate sponsor protocol code number the system will warn the requestor and in this case the most likely explanation is that a EudraCT number has already been requested by someone from the same organisation or another collaborator in the trial The option is given to exit the system without creating a new EudraCT number so that checks within the organisation or trial collaborators can be completed 1995 2004 EMEA Page 17 of 73 Doc id Eudra CT EUDRACT USER MANUAL PUBLIC WEBSITE EUDI VES To deal with this warning e
53. delete link for the selected IMP NB This delete is immediate and final and there is no warning or verification Screen 17 If IMP data should need to be changed then take the edit link and the page D1 D2 IMP Identification Details Status Description will display with all the entered data for the selected IMP which can then be changed by repeating steps 3 to 9 above 18 If another very similar IMP is included in the trial then an existing IMP can be copied and the record edited to include the differences 13 To add an active substance click the add active substance link and the IMP Identification Details Active Substances screen will appear 1995 2004 EMEA Page 39 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE D2 IMP Identification Details Active Substances Complete all fields that currently apply to this Active Substance in this Product If you have IMPs with different concentrations of the Active Substance complete one full Section D IMP and Active Substance then copy the IMP and edit the concentration in the CAS Chemical Abstract Services Number Other Descriptive Name may be used for bialogical biotechnological Products thet do not have an INN or Proposed INN Approved INN Proposed INN CAS number Current sponsor code Other descriptive name Concentration unit Concentration type Concentration number only use both fields for range Save Cancel Fig 44 D
54. draCT Welcome Screen The e mail that contains the EudraCT Number will be sent to the e mail address used in the request form 6 Open this e mail account to find the e mail This will be from user EudraCT Qeudra org and with the subject Application for EudraCT Number 7 Open the message to obtain the EudraCT Number 1995 2004 EMEA Page 14 of 73 Doc id Eudra CT EUDRACT USER MANUAL PUBLIC WEBSITE elias ia Application for EudraCT Number Message Plain Text Unicode UTF 8 Eile Edit View Insert Format Tools Actions Help ff Replytoal efiFomad G BY X e w D From EudraCT eudra org Sent Wed 10 03 2004 12 51 To Gregory Martin Subject Application For EudraCT Number The EudraCT number 2004 000249 40 has been issued for your Sponsor s Protocol Code Number protocol 1245 THIS IS AN AUTOMATED EMAIL PLEASE DO NOT REPLY AS EMAILS RECEIVED AT THIS ADDRESS WILL BE AUTOMATICALLY DELETED Fig 12 EudraCT Number e mail This e mail also includes the Sponsor Protocol Code Number for this request 8 Savethis e mail It is the receipt of confirmation of EudraCT number required as one of the documents to be included in the request for the Clinical Trial 1995 2004 EMEA Page 15 of 73 CT EUDRACT USER MANUAL PUBLIC WEBSITE 6 3 Problems that may be encountered 6 3 1 Not entering mandatory data Most of the fields on the Get EudraCT Number screen a
55. draCT Welcome page has the following links into the EudraCT system Apply for Security Code If you require a security code in order to apply for a new EudraCT number please press this link 1995 2004 EMEA Page 7 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE 2 Apply for EudraCT Number Once you have the security code and wish to obtain a EudraCT Number please press this link Create New Clinical Trial Application Click here to open the main CT Application Menu Load Saved Clinical Trial Application Click here to re load a saved XML file or resume work on CT Application in the PC memory Download CT Amendment Form Click here to download an MSWord form template for a substantial amendment to a CT Download CT End of Trial Form Click here to download an MSWord form template for a declaration of the end of a CT EudraCT home page Click here to return to EudraCT home page 1995 2004 EMEA Page 8 of 73 Doc id Eudra CT EUDRACT USER MANUAL PUBLIC WEBSITE 5 REQUESTING A EUDRACT SECURITY CODE 5 1 Introduction A EudraCT Security code is needed in order to make a successful request for a EudraCT Number The security code will be valid for only 24 hours from the time is received and can be used for only request for a EudraCT Number It is therefore not good practice to obtain security codes too far in advance of the EudraCT number request that they are required for 5 2 Navigating the EudraCT Number syste
56. e XML file Save as XML EudraCT Number 2004 000061 35 Sponsor s Protocol Code Number wevvy Member State Competent Authority INFARMED Portugal You can choose to 2 Vas oc SCE that the Full XML option is chosen e Save in the new Bri Save in E Desktop e E ml extension fs My Documents History 2 xl Computer 23 Fr illata xml Fullbata1 xml Computer E Network El Save as XML Document E File name Fig 68b Saving the XML file screen 2 Doc id EUD134 v1 3 1995 2004 EMEA Page 63 of 73 Eudra CT EUDRACT USER MANUAL PUBLIC WEBSITE EUDL LES 5 Add the name to the Save screen and save the CT Application The default extension of the file is XML 6 XML file is saved for the same CT Application form more than once with the same name then on each save after the first the following warning will be displayed It will generally be correct to select Yes to overwrite the existing file so that the XML file saved is of the latest version of the CT Application form C Documents and SetkingsiaregorvYDeskkoptFullbaka xml already exists Do vau want to replace iE Fig 70 Save XML Warning 8 2 1 Saving the Core Dataset as XML The electronic submission of the CT Applic
57. e sent to a the group of MSCAs in whose MS the trial will run See section 9 Using the CT Application Form as a Template 3 Click the Save button to return to the CT Application Menu 7 5 4 Save as XML At this point is advisable to create an XML file for the collection of the information to be entered 1 Click the link Save as XML on the CT Application Menu The following dialogue box will open Save as XML EudraCT Number 5 000022 26 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority EOF You can choose to save all the data as XML or just the Core Dataset Itis suggested that the Full option is chosen as this incoroporates the Core Dataset MOTE These options download the SML inta new Browser window You then need to use Save in the new Browser window to store the xML an disk Itis suggested the file 15 named with ml extension Full XML Core Dataset XML Continue Fig 27 Save XML dialogue box 2 Click on the link Full XML The XML file will be downloaded for saving to your PC or network Ensure that the radio button Save file to disk is checked and click OK Save as XML EudraCT Number 2004 000061 35 Sponsor s Protocol Cade Number weww Member State Competent Authority INFARMED Portugal File Download X You can choose t option is chi NOTE These opt Save As in the ne extensiar fou have chosen ta download
58. ed the format YYYY MM DD when the form is saved Radio buttons The Yes No radio buttons operate in pairs No validation No radio button is selected when a page is first entered but make a selection either Yes by clicking each radio button Check boxes Select a required check box by clicking on it and No validation deselect a box by clicking it again No check box is selected when a page is first entered Drop down lists Select the appropriate item from the drop down lists No validation Lists will show a blank entry when the page is first entered Combination lists Used only for routes of administration Select items No validation required and move from general list to the current list Moving items on the current list back into the general list can make changes 1995 2004 EMEA Page 21 of 73 Doc id Eudra EUDRACT USER MANUAL PUBLIC WEBSITE 7 3 Saving the CT Application It is most important that all users of this application understand the meaning of the Save button on the web pages Pressing this button only saves data in the webpage This is NOT a permanent record and will be lost if the Internet browser is closed times out or the web connection is broken It is important to realise that the information entered into the web pages is held in the computer memory and MUST be saved locally to preserve the work It is therefore good practice to create an XML file on the local
59. entered then the following messages will appear when the Get EudraCT Number link is taken depending on the particular situation e The Security Code entered must be 8 digits e Unable to find security code Fig 17 Security Code Error Messages To correcting the error depends on the reason for the failure 1 the security code had been incorrectly typed then enter the correct code and take the Get EudraCT Number link 2 If security code is incorrect then press the Cancel link to return to the EudraCT Welcome page and apply for a new security code 6 3 6 Using an expired security Security codes are only valid for 24 hours after they have been issued If an expired security code is entered then the following messages will appear when the EudraCT Number link is taken The security code has expired An e mail has been sent to e mail address with this information Fig 18 Expired security code error message E mail will be sent to the e mail address on the EudraCT Number request form so that there is a positive record that a EudraCT number has not been issued for the request To correct the error 1 Press the Cancel link to return to the EudraCT Welcome page request a new security code and then start the request for the EudraCT Number again 1995 2004 EMEA Page 18 of 73 CT EUDRACT USER MANUAL PUBLIC WEBSITE EUDL LES Application for EudraC T Number Message Pl
60. f cells hematopoietic stem cells aj Save amp Exit Back Cancel FIO 4z D DZ IVIF aene Descriptor 9 Complete the details on this page and click the link Save amp Exit which will return to the IMP Identification Index page that will show that an IMP has been added 1995 2004 EMEA Page 38 of 73 EUDRACT USER MANUAL PUBLIC WEBSITE ED s D IMP Identification Index EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority MHRA Click add to start the first IMP or create another one Once an IMP is added links for edit delete copy and add active substance are displayed for that IMP Use add active substance for all active substances in that IMP Complete all questions in Section D for each IMP but if mast of the answers are the same for any additional IMFs e g 3 tablets of different strength then enter IMP use the copy IMP function on this screen then edit the relevant fields in the copy add IMP Tradename 1 7 Product i add active substance Application Menu Page Fig 43 D IMP Identification Index One IMP added 12 From this screen the following options can be taken 15 If another IMP is included in the trial then repeat the option add IMP 16 If the information for an IMP is not required it can be deleted by clicking the
61. f characters allowed in the text box If this error is encountered then the amount of text must be reduced to fit the text box 8 6 5 Numeric Field Validation There are a few numeric fields within the application There is a validation check that numeric data is added If aloha characters are include then the following message will display e The field oxxxxxxxxxxxxxxxxxxx must be a number There is also a check for positive numeric values in the population of trial subjects If a negative number is entered then the following message is displayed e he field xxxxxxxxxxxxxxx must be a positive number Where is the name of the numeric field that is being completed IN either case enter correct numeric data that is a positive value if that is appropriate 1995 2004 EMEA Page 69 of 73 EUDRACT USER MANUAL PUBLIC WEBSITE 0 UsiNG THE CT APPLICATION FORM AS A TEMPLATE 9 1 Introduction The system has been designed so that the CT Application may be created as a template for a multi centre trial that will run in several Member States The template can be developed to include all the CT information that will be identical irrespective of the Member State in which the CT will run This template application may then be completed for each of the MS in which the trial will be run by including the MS specific information 9 2 Creating a new Template The template is created using the normal applicati
62. fields identified in the error message s and press the Get Security Code link to obtain a security code 2 Take the Cancel link to return to the EudraCT Welcome Screen and if a security code is required take the appropriate link back to the Get Security Code screen 5 4 2 Entering an invalid e mail format The EudraCT system will check to ensure that the e mail address entered complies with the standard format If an e mail address with an incorrect format is entered the following error message will appear on the screen when the Get Security Code link is pressed You have entered an invalid Requestor s e mail address Fig 7 Invalid e mail address format warning To correct the error either 1 Enter an e mail address with a valid format and press the Get Security Code link to obtain a security code 2 Take the Cancel link to return to the EudraCT Welcome Screen and if a security code is required take the appropriate link back to the Get Security Code screen 5 4 3 Not receiving the e mail There may be several reasons why the e mail does not arrive The most commonly occurring are 1 Failure of the e mail system or communication links The e mail may have been sent to a correct e mail recipient but the mail servers are slow or the communications links may have failed The EudraCT system cannot help in this instance You may decide to wait to be sure that the e mail has not will not arrived an
63. for Health You currently have an application in progress If you select Load Application from File then this will be overwritten Use Load Application from File to discard your current application Use Use Current Application to continue with your current Application Load Application from File Use Current Application Cancel Fig 73 Load Application from File Confirmation with a CT application already loaded 3 Click the link Load Application from File and the Load Application from File Confirmation will display to request the name of the file to be loaded and the steps 3 and 4 in section 8 3 1 Reloading a Saved Application where no CT Application is loaded in the PC can be followed NB In this instance the CT Application that is already loaded will be overwritten by the new file so it is important to save the current application first if information is not to be lost 5 If the link use Current Application is clicked then the Clinical Trial Application Menu will display with the current Application available for review and or edit 1995 2004 EMEA Page 65 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE The system includes very few data or data consistency check whilst the CY Application form is being created However there is a function that runs to check the main inconsistencies that may occur in the form 1 Navigate to the Clinical Trial Application Menu and click
64. fy trial type and phase Fig 55a General Information on the Trial Scope design screen 1 1995 2004 EMEA Page 50 of 73 Eudra EUDRACT UsER MANUAL PUBLIC WEBSITE Design of the trial Randomised C Yes C No Controlled C Yes C No If controlled specify Open C Yes C No Single blind C Yes No Double blind C Yes C Parallel group C Yes No Cross over C Yes No Other C Yes C No If other specify the design of the trial Specify the comparator An Other medicinal product s C Yes No Placebo C Yes C No Other C Yes C No If other specify the comparator Single site see also Section I C Yes No Multiple sites see also Section I yes No Multiple Member States C Yes No Does the trial involve third countries C Yes No Maximum duration of treatment of a subject according to the protocol Maximal dose allowed Specify per day or total per day total Gave amp Exit Back Cancel Fig 55b G General Information on the Trial Scope Type design screen 2 1995 2004 EMEA Page 51 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE 4 Complete the information required on the form to describe the details of the trial 5 When details of the sites have been added to the system click the link Application Main Menu to return to the CT Application Menu Then click the link Save as XML and resave the CT Application form to the local XML file
65. has been saved as a local XML file See section 8 2 Saving the CT Application If the link Use Current Application is taken then the Clinical Trial Application Menu will display with the current CT Application loaded 1995 2004 EMEA Page 23 of 73 Doc id Eudra EUDRACT UsER MANUAL PUBLIC WEBSITE ia Initial Required Information This allows you to specify the initial required information far your Clinical Trial Application Enter your EudracT Number and Member State Competent Authority and use Member State Competent Authority EudracT Number Save Cancel Fig 25 CT Initial Required Information 3 Enter in this screen the EudraCT Number for the CT obtained from the system and select from the drop down list the Member State Competent Authority to whom the application is to be made The entry of a Member State Competent Authority is not mandatory at this point and this feature allows for a template CT application Form to be generated if required See section 9 Using the Application Form as a Template 4 Click on Save and the Clinical Trial Application Menu will appear See Fig 24 7 5 2 Starting the CT Application From the CT Application Menu the information required for making the CT Application is entered section by section It is recommended that the feature Save as XML 15 used at least after each section is completed or more frequently for the larger sections
66. he number exists The following error messages may be encountered e The EudraCT number that you have entered does not exist in the system 1995 2004 EMEA Page 68 of 73 Eudra EUDRACT UsER MANUAL PUBLIC WEBSITE Hid ae e EudraCT number entered does not match the format In either case a valid EudraCT Number that exists in the database must be entered 8 6 3 Date Validation Dates entered in the system are all in the format yyyy mm dd The format of dates is checked and also the correctness of the date The following messages will be seen e Date entered for xxxxxxxxxxxxx date is not in a valid date format e Date entered for xxxxxxxxxxxxx date is not a valid date Where is the name of the date that is being entered The first error occurs if the format yyyy mm dd is not adhered to and the second error will occur is an invalid date is entered i e more than 12 months or too may days for the month In either case a valid date in the correct format must be entered 8 6 4 Text Box Allowable Length Validation The scrolling text boxes in the system are all set with a maximum allowable number of characters If the length is exceeded the following message will appear You have exceeded the max length of nnn characters for Where is the name of the text field being entered and nnn is the number o
67. ication Index No IMPs added 2 Click the link to add IMP and the IMP Identification Details Status Description screen appears D1 D2 IMP Identification Details Status Description EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health This is a multi screen form use the navigation key Next to navigate to each of the screens Use Next at the foot of each screen to ensure completion of all questions in Section D NOTE If there is no clear Test IMP or Comparator in your study design indicate all IMPs as Test IMP Category Test IMP Has the IMP to be used in the trial a marketing authorisation in the Member Yes State concerned by this submission If Yes then Product Trade name Product holder name Product MA number Has the IMP to be used in the trial a marketing authorisation in another Member Yes No State from which it is sourced for this trial If Yes then Enter Member 5tate Fig 38a 01 D2 IMP Identification Details Status Description page 1 1995 2004 EMEA Page 33 of 73 CT EUDRACT USER MANUAL PUBLIC WEBSITE Product Trade x Product holder name Product MA number Has the IMP to be used in the trial a marketing authorisation in a third country C Yes No from which it is sourced for this trial If Yes then E
68. ired it can be deleted by clicking the delete link for the selected TMF NB This delete is immediate and final and there is no warning or verification screen 14 When details of the proposed trial sites have been added to the system click the link Application Main Menu to return to the CT Application Menu Then click the link Save as XML and resave the CT Application form to the local XML file See section 7 5 4 Save as XML 7 5 14 Section J Ethics Committee Competent Authority 1 When the link J Ethics Committee Competent Authority is taken the Ethics Committee Competent Authority Information screen is displayed The two options collect Ethics Committee information for inclusion on the printed request to the MS Competent Authority and MS Competent Authority Information for inclusion in the printed request to the Ethics Committee 1995 2004 EMEA Page 59 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE J Ethics Committee MS Competent Authority Information EudraCT Number 5 22 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health Enter the information regarding the Ethics Committee and the MS Competent Authority The appropriate details will be printed on the paper application form J 1 Ethics Committee J 2 M5 Competent Authority Application Menu Page Fig 64 J Ethics Committee Competent Authority Information 2 Click
69. is the IMP identity number shown in the D IMP Identification Index Select Yes for all IMPs for which this is a Placebo and for the others Information is only preserved for IMPs which have a positive association Yes the Placebo Use to proceed Pharmaceutical form Route of administration No IMPs have been added for this application Fig 49 E Placebo Information Details No IMPs Added 2 In this case it is best to add the IMPs at this stage in section D and then return to create the Placebo information 1995 2004 EMEA Page 44 of 73 EUDRACT USER MANUAL PUBLIC WEBSITE 7 5 10 Section Sites Responsible for IMP Release 1 When the link Sites responsible for IMP Release is taken the Responsible Sites Identification Index screen is displayed For a new CT Application this will show that there are no responsible sites included Index of Sites Responsible for IMP Release EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health This records the Sites responsible for final Release for distribution to Investigators for the IMPs selected Yes in the following screen s add responsible site No Responsible Sites have been added for this application Application Menu Page Fig 50 F Responsible Sites Identification Index no sites added 2 Click the link add responsible
70. it only preserves the information within your current application form A Trial Identification Sites Responsible for IMP Release B Sponsor Identification G General Information on the Trial C Applicant Identification H Population of Trial Subjects D Information on the IMPs I Proposed Sites in the Member State E Information on the Placebos J Ethics Committee Competent Authority Save as XML Get Printable Copy Validate Application Section K Welcome Page Fig 24 Clinical Trial Application Menu The CT Application Menu includes the following links Sections A to Links to the web pages designed to collect the CT information for each section of the CT Application form Section K Section K can be downloaded as a MS Word form template 1995 2004 EMEA Page 22 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE 2 Save as XML This allows the contents of the current CT Application to be saved on a local drive or network as an XML file Get Printable Copy This allows for the contents of the current CT Application to be printed fro submission to either the MSCA or Ethics Committee Validate Application This runs a data consistency check on the current application data and reports inconsistencies EudraCT Home This returns to the EudraCT Home Page See Fig 1 7 4 2 Navigating the Individual Web Pages The navigation through the individual pages should be by using the on screen navigation buttons Do n
71. ither 1 Press the cancel button which will return to the Welcome to Eudract screen The appropriate link can then be used to request a EudraCT Number 2 Press the Get EudraCT Number button In this instance the system will issue a EudraCT Number but the warning that you have used duplicate Sponsor s Protocol Code Number will be included in the e mail sent to the e mail address on the EudraCT Number request form Application for EudraCT Number Message Plain Text Unicode UTF 8 File Edit Insert Format Tools Actions Help all 4 amp e DS X From EudraCT eudra org Sent Fri 12 03 2004 10 43 To Gregory Martin C Subject Application For EudraCT Number The EudraCT number 2004 000271 34 has been issued for your Sponsor s Protocol Code Number Prot 123 2004 WARNING This Sponsor s Protocol Code Number has already been used for a clinical trial It is likely that a EudraCT number for this Protocol Code Number has already been issued to another individual within your organisation or another collaborator on this trial Please check whether you have duplicated this EudraCT number request for your clinical trial THIS 15 AN AUTOMATED EMAIL PLEASE DO NOT REPLY AS EMAILS RECEIVED AT THIS ADDRESS WILL BE AUTOMATICALLY DELETED Fig 16 Duplicate Sponsor s Protocol Code 6 3 5 Using an invalid security code If an invalid or expired security code is
72. l is prohibited 6 2 The Process for Obtaining a EudraCT Number To obtain a EudraCT Number use the following sequence 1 From the EudraCT Welcome Screen take the link Apply for EudraCT Number The following screen will appear Get EudraCT Number If vau are requesting the EudracT number as an individual then you may leave the Requestar s organisation name empty this case the system will copy your Requestar s into the Requestars organisation name You must include your contact details in the Requestor s organisation town city and Requestar s organisation country boxes When you have completed the form press the EudracT Number button and an e mail with a EudracT Number will be sent to the e mail address entered If you want to cancel this application far a EudracT number press the Cancel button which will take you back to the main menu Requestor s organisation name Requestor s organisation town city Requestor s organisation cauntry Sponsor s protocol cade number Requestor E mail to which the number will sent Enter the security code sent earlier Please select the Member States where it is anticipated that the trial will be run CYPRUS ESTONIA GERMANY ICELAND LATVIA LUXEMBOURG NORWAY SLOVAKIA SWEDEN BELGIUM DENMARK FRANCE HUNGARY ITALY LITHUANIA NETHERLANDS PORTUGAL SPAIN AUSTRI
73. lephone number Fax number E mail address Save Cancel Fig 36 C2 Application to the Ethics Committee 11 When details of the applicants have been added to the system click the link Application Main Menu to return to the CT Application Menu Then click the link Save as XML and resave the CT Application form to the local XML file See section 7 5 4 Save as XML 7 5 7 Section D Information on IMPs 1 When the link D Information on IMPs is taken the IMP Identification Index screen is displayed For new CT Application this will show that there are no IMPs 1995 2004 EMEA Page 32 of 73 EUDRACT USER MANUAL PUBLIC WEBSITE D IMP Identification Index EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health Click IMP to start the first IMP or create another one Once an IMP is added links for edit delete copy and add active substance are displayed for that IMP Use add active substance for all active substances in that IMP Complete all questions in Section D for each IMP but if most of the answers are the same for any additional IMP s e g 3 tablets of different strength then enter one IMP use the copy IMP function on this screen then edit the relevant fields in the copy add IMP No IMPs have been added for this application Application Menu Page Fig 37 D IMP Identif
74. lution 3 1 4 For printing the application forms The application forms require that Adobe Acrobat reader be installed on the PC This is freely available from Adobe and can be downloaded from their site www adobe com The data entry fields have pre determined lengths and it is not possible to enter data in excess of these Date fields are all of the format yyyy mm dd 1995 2004 EMEA Page 5 of 73 CT EUDRACT USER MANUAL PUBLIC WEBSITE 4 ACCESSING THE SYSTEM 4 1 Access to the EudraCT System The EudraCT system is accessed using a link from the EMEA public home page that has the address WWw emea eu int 4 2 The EudraCT Home Page When the link to EudraCT is taken the EudraCT home page will appear D European Clinical Trials Database Welcome to the Community Clinical Trial system EudracT is database of all clinical trials commencing in the Community from 1 May 2004 onwards It has been established in accordance with Directive AIIM IE ss er rans acer isis re dtes e access to the EudracT application in order to e get EudracT number e complete save and print an electronic version of the clinical trial application form Access to EudraCT Application for EudracT number and Clinical Trial Application Form Access to EudraCT supporting documentation Directives guidelines and user documentation E C 1995 2004 Application
75. m There are certain navigation principles applied to the system for obtaining a EudraCT Number In particular standard browser navigation buttons Forward and back should NOT be used e Only the navigation buttons on the EudraCT screens should be used The following Navigation keys are used in this part of the system Cancel This link will clear any data that you may have entered on a form and will return you to the EudraCT Welcome Page Get Security Code and Get EudraCT Number These links will submit the appropriate form for processing to obtain the security code or EudraCT number respectively Continue or OK These links are used on information and error message screens and will take you back to the EudraCT Welcome page 5 3 The Process for Obtaining a Security Code To obtain a security code use the following sequence 1 From the EudraCT Welcome Screen take the link Apply for Security Code The following screen will appear Get Security Code Fields marked with must be completed When vou have completed the form press the Get Security Code button and an e mail with a Security Code will be sent to the e mail address entered If you wish to cancel this application far a security code then press the Cancel button which will return vou to the main menu Requestor Requestor e mailf Get Security Code Cancel Fig 3 Get Security Code Screen 1995 2004 EMEA
76. mber Prot 134 Member State Competent Authority The Ministry of Health Complete the current status af the application to this 5 Competent Authority at the time of submission to the Ethics Committee MS Competent authority name Street address F Town city Post code Country Date of submission E vyyy mm dd What is the status of the MS Competent Authority s authorisation Date of authorisation C C vyyy mm dd If Given indicate whether accepted or No If not accepted give the reasons If not accepted give the eventual anticipated date of resubmission vyyy mm dd Fig 66 J 2 5 Competent Authority 6 Complete the information on the screen to describe the MS Competent Authority to which the application will be made 7 When the information is complete click the Save link to return to Ethics Committee Competent Authority Information screen 8 When details of the Ethics Committee and MSCA have been added to the system click the link Application Main Menu on the Ethics Committee Competent Authority Information screen to return to the CT Application Menu Then click the link Save as XML and resave the CT Application form to the local XML file See section 7 5 4 Save as XML 1995 2004 EMEA Page 61 of 73 Eudr EUDRACT UsER MANUAL PUBLIC WEBSITE Doc id EUD134 v1 3 8 SAVING RESTO
77. n to describe the investigator NB The name given must be that of the investigator and not a third party contact 4 When the information is complete click the Save link to return to Proposed Sites Index screen I Proposed Sites Index EudracT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 123 Member 5tate Competent Authority Ministry for Health Central Technical Facilities includes central laboratories and central ECG or image processing facilities Trial Monitoring Facilities invalves CROs add investigator add central technical facility add trial monitoring facility Investigators IN1 Name Investigator 1 Central Technical Facilities have been added for this application Trial Monitoring Facilities have been added for this application Application Menu Page Fig 59 Proposed Sites Index one investigator entered 5 From this screen the following options can be taken 1 If another investigator site is included in the trial then repeat the option add investigator 2 If investigator site data should need to be changed then take the edit link for the appropriate investigator site and the page 11 Investigator Details will display with all the entered data for the selected investigator which can then be changed by repeating steps 2 to 4 above information for an investigator site is not required it can be deleted by clicking the delete link for the selecte
78. nistration Oral use Application Menu Page Fig 48 E Placebo Information Index one placebo added 5 From this screen the following options can be taken If another placebo is included in the trial then repeat the option add placebo 1995 2004 EMEA Page 43 of 73 Eudra EUDRACT UsER MANUAL PUBLIC WEBSITE If placebo data should need to be changed then take the edit link and the page E Placebo Information Details will display with all the entered data for the selected placebo which can then be changed by repeating steps 3 and 4 above If the information for a placebo is not required it can be deleted by clicking the delete link for the selected placebo NB This delete is immediate and final and there is no warning or verification Screen When details of the placebos have been added to the system click the link Application Main Menu to return to the CT Application Menu Then click the link Save as XML and resave the CT Application form to the local XML file See section 7 5 4 Save as XML Adding Placebos without an IMP If an attempt is made to add a placebo before any IMP has been added then the following screen is displayed E Placebo Information Details EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health The following applies for one Placebo Repeat add placebo for each different Placebo The PRnn
79. nter third country For situations where IMP to be used in the CT has a in 5 concerned but the protocol allows that any brand of the IMP with a MA in that MS be administered to the trial subjects However it is not possible to clearly identify the IMP s in advance of the start of the trial In the protocol treatment is defined only by active substance If Yes then ensure that D2 Active Substance section of the form is completed C Yes C No In the protocol treatment regimens allow different combinations of marketed products to be used according to local clinical practice at some or all investigator sites the If Yes then ensure that D2 Active C Yes Substance section of the form is completed The products to be administered are defined as belonging to an ATC group If Yes give ATC group Level 3 or more to the level that can defined of the applicable authorised code in the ATC code field in D2 C Yes C No Other If Yes then please specify C Yes C No Has the use of the IMP been previously authorised in a clinical trial conducted by the sponsor in the Community Yes C No Has the IMP been designated in this indication as an orphan drug in the C Yes Community If Yes give the orphan drug designation number Product name Product code code Reserved for future use no entry required Pharmaceutical form To save this an
80. on From the Welcome screen the option Click here to create a new Clinical Trial Application and the 2lnitial required Information Screen is displayed Initial Required Information This allows you to specify the initial required information for your Clinical Trial Application Enter the EudracT Number obtained for this protocol and the Member State Competent Authority and use Save which will then take you to the main Clinical Trial Application menu If vau want ta create general set of data for a multi state trial you can leave the Autharity field blank at this stage Member State Competent Authority EudraCT Number Save Cancel Enter the EudraCT Number for the CT Application and press Save The Clinical Trial Application Menu will display without a MSCA selected Clinical Trial Application Menu EudraCT Number 2004 000061 35 Sponsor s Protocol Code Number Member State Competent Authority MOTE The system will timeout if there is a period of inactivity For this reason and to avoid accidental data lass you must Save as XML to your local computer for other accessible drive at the start of the session and regularly thereafter This 15 because no data is stored by the EudracT system except temporarily during the current session The Save button is used during data entry this does MOT store your information an disk it only preserves the information within your current application farm 4
81. or also deletes any associated Legal Representative add sponsor Pharmaco delete Legal Rep Legal delete Application Menu Page Fig 33 B Sponsor Identification Index Sponsor and Legal Representative added 10 When all sponsor and any required legal representatives have been added to the system click the link Application Main Menu to return to the CT Application Menu Then click the link Save as XML and resave the CT Application form to the local XML file See section 7 5 4 Save as XML 7 5 6 Section C Applicant Identification 1 When the link C Applicant Identification is taken the Applicant Identification Menu screen is displayed which include two options 9 C1 Application to the MC Competent Authority This link displays a form to collect or edit the details of the MSCA applicant 10 C2 Application to the Ethics Committee This link displays a form to collect or edit the details of the Ethics Committee applicant C Applicant Identification Menu EudraCT Number TEST 000016 30 Sponsor s Protocol Code Number Prot 123 Member 5tate Competent Authority MHRA Complete the details of the Applicants to both the MS Competent Authority and the Ethics Committee The appropriate information will be printed on each Application C1 Application to the M5 Competent Authority C2 Application to the Ethics Committee Application Menu Page Fig 34 C Applicant Identification Menu
82. ot use the standard Internet browser buttons This will cause errors and lost data The navigation buttons within the pages of the CT Application form system are shown below Save This will save the contents of the current webpage but is NOT a permanent save to an XML file Cancel This button will clear the current web page and return to the CT Application Menu Page Next Multi page forms have this button to navigate to the next page Save and Exit This will save the contents of the current web page and return to the CT Application Menu This option exists on multi page forms to skip the next button Back Used on multi page forms to return to a previous page Application Menu Page This is a direct link back to the Clinical Trial Application Menu page 7 5 The Process for Completing a New CT Application 7 5 1 Accessing the CT Application Menu 1 From the EudraCT homepage Fig 1 take the link Access to EudraCT Application This will open the EudraCT Welcome page 2 From the EudraCT Welcome Page Fig 2 take the link Create New Clinical Trial Application and the Initial Required Information screen is displayed NB If a CT Application has already been started then the link Create New Clinical Trial Application will provide the option to Create New Application or to Use Current Application If a new application is started then the current application which is only in the computer memory will be lost unless it
83. r the selected CTF NB This delete is immediate and final and there is no warning or verification Screen 10 Click the add trial monitoring facility link and the Trial Monitoring Facility Details page will display 1995 2004 EMEA Page 57 of 73 Eudra CT EUDRACT USER MANUAL PUBLIC WEBSITE ie a I4 Trial Monitoring Facility Details EudraCT Number 2004 123456 12 Sponsor s Protocol Code Number Member State Competent Authority Smithers Central Technical Facility Details instructions Trial monitoring facility organisation name Fme Name 5900 facility organisation Documentation Street address Town city Post code Country Contact person Given name Middle name Family name Telephone number Enter the details of any duties functions subcontracted to this trial monitoring facility in this trial All tasks of the sponsor Yes Monitoring 7 Yes 9 Data management Yes E data capture Yes IVR5 treatment randomisation Y es 7 7 Medical writing SUSAR reporting T es Y es 3 0 Regulatory e g preparation of applications Yes and Ethics Committee Quality assurance auditing 7 T es Investigator recruitment Yes 90 0 2 Other Duties subcontracted Yes If Yes specify the other duties Save Cancel Fig 62 14 Trial Monitoring Facility Details 11 Complete the information on the sc
84. re mandatory If an entry is omitted then an appropriate error message will be displayed at the top of the form when the link Get EudraCT Number is pressed Any combination of the following warning messages may appear depending on which fields have not been correctly completed Get EudraCT Number fields marked with must be completed in all requests If vau are requesting the EudracT number as an individual then you may leave the Requestar s organisation name empty this case the system will copy your Requestor s name into the Reguestor s organisation You must include your contact details in the Requestor s organisation town city and Requestor s organisation country boxes When you have completed the farm press the EudracT Number button and an e mail with a EudracT Number willbe sent to the e mail address entered If you want to cancel this application far EudracT number press the Cancel button which will take you back to the main menu The Requestor s organisation town city is required The Requestor s organisation country is required The Sponsor s protocol code number is required The Requestor name is required The E mail to which the EudraCT number will be sent is required The Security Code is required Requestor s organisation name Requestor s organisation town city Requestor s organisation country Sponsor s protocol code number Requestor name
85. reen to describe the Trial Monitoring Facility TMF 12 When the information is complete click the Save link to return to Proposed Sites Index screen 1995 2004 EMEA Page 58 of 73 CT EUDRACT USER MANUAL PUBLIC WEBSITE Proposed Sites Index EudraCT Number 2004 123456 12 Sponsor s Protocol Code Number Member State Competent Authority Smithers Proposed Sites Index instructions add investigator add central technical facility add trial monitoring facility Investigators INi Investigator Central Technical Facilities CTF1 it delete Trial Monitoring Facilities TMF1 Name TMO Name it delete Application Menu Page Fig 63 Proposed Sites Index one investigator one CTF and one TMF added 13 From this screen the following options can be taken 1 The options for adding editing and deleting investigators described in step 5 2 options for adding editing and deleting Central Technical Facilities described in step 9 If another TMF is included in the trial then repeat the option add trial monitoring facility 4 f TMF data should need to be changed then take the edit link for the appropriate TMF and the page 14 Trial Monitoring Facility Details will display with all the entered data for the selected TMF which can then be changed by repeating steps 11 and 12 above 5 information for a TMF is not requ
86. result in duplicate Sponsor s Protocol Code Number warnings which should be dealt with in accordance with section 6 3 4 Duplicate Sponsor s Protocol Code Number 6 3 9 Unexplained processing errors There are situations that may cause the application to fail that are out of the control of the application environment When such a situation occurs the error screen will be displayed Press the OK link to return to the EudraCT Welcome screen To prevent further errors exit your Internet browser restart it and re enter the EudraCT system from the main link on the Eudra home page See section 4 1 Access to the EudraCT oystem Such errors should be reported to the system administrators by e mail using the contact link on the EudraCT Welcome screen There has been a technical error processing this request Please use the contact action in the Banner if you wish to repart the problem You may need to restart your Browser if you encounter further problems Fig 23 EudraCT Technical Error Processing screen 1995 2004 EMEA Page 20 of 73 Eudra EUDRACT UsER MANUAL PUBLIC WEBSITE 2 7 COMPLETING THE CT APPLICATION FORM 7 1 Introduction This section of the document describes the system for completing an electronic version of the Clinical Trial Application form CT Application Form that is used in all Member States of the Community The CT Application Form system is designed using Internet web pages to collect
87. s Enter details and use Save Name of organisation PharmaCo Street address Town city Post code Country UNITED KINGDOM e Telephone number Fax number E mail address Contact person Given name Middle name Family name Status of the sponsor Commercial Reserved for future use no answer required yes C Do you need to enter details of a legal Yes No C representative in accordance with Article 19 of Directive 2001 20 EU Save Cancel Fig 30 B1 Sponsor Identification Details 5 Click the save button to return to the Sponsor Identification Index B Sponsor Identification Index EudraCT Number TEST 000016 30 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority MHRA These are the details for section B Identification of the Sponsor Enter details and use Save Use add sponsor to add a Sponsor Once you have entered the Sponsor details you can edit or delete them You can also add details of the Legal Representative as required by Article 19 of Directive 2001 20 EC Deleting Sponsor also deletes any associated Legal Representative add sponsor LIEN C EE SP2 Name Pharma Co edit delete add legal Application Menu Page Fig 31 B1 Sponsor Identification Details Sponsor added 6 From this screen the following options can be taken 1 If another sponsor is involved with the trial then repeat the option
88. s been sent to e mail address with this information The security code has expired An e mail has been sent to e mail adaress with this information The XML file that you have tried to load does not conform to the EudraCT XML schema Unexpected element http eudract ClinicalTrialApplication xsd Date entered for xxxxxxxxxxxxx date is not a valid date You have exceeded the max length of Application sections nnn characters for A D E F G J text box The field xxxxxxxxxxxxx must be a number The field must bea Application section G Enter positive number positive number 1995 2004 EMEA EUDRACT UsER MANUAL PUBLIC WEBSITE Doc id EUD134 v1 3 Correction a the screen instructions Get EudraCT number Get EudraCT number Follow the screen instructions Get EudraCT number Obtain a new security code and make a new request for a EudraCT number Check that the XML file is correct If the load operation fails Load XML consistently then refer tot eh the EudraCT Help desk The EudraCT number that you have Application section A Enter correct Eudract 8 6 2 entered does not exist in the system Number EudraCT number entered does not Application section A Enter correct Eudract 8 6 2 match the format Number Date entered for xxxxxxxxxxxxx da
89. s screen the following options can be taken If another site is included in the trial then repeat the option add responsible site If responsible site data should need to be changed then take the edit link for the appropriate site and the page F Responsible Sites Identification Details will display with all the entered data for the selected site which can then be changed by repeating steps 2 to 5 above 1995 2004 EMEA Page 47 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE io as If the information for a site is not required it can be deleted by clicking the delete link for the selected site NB This delete is immediate and final and there is no warning or verification screen 7 When details of the sites have been added to the system click the link Application Main Menu to return to the CT Application Menu Then click the link Save as XML and resave the CT Application form to the local XML file See section 7 5 4 Save as XML 7 5 11 Section G General Information on the Trial 1 When the link G General Information on the Trial is taken the General Information on the Trial screen is displayed G General Information on Trial EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member 5tate Competent Authority The Ministry of Health This is a multi screen form use the navigation key Next to navigate to each of the screens Scope Type and
90. st commonly occurring are 1 Failure of the e mail system or communication links The e mail may have been sent to a correct e mail recipient but the mail servers are slow or the communications links may have failed The EudraCT system cannot help in this instance You may decide to wait to be sure that the e mail has not will not arrived and then make a new request for a security code 2 Wrongly typed e mail address You may have included an e mail address in the correct format but mistyped the name In this instance the e mail from the EudraCT system will be returned to EudraCT as undeliverable The EudraCT system cannot do any more in this instance and your e mail will not arrive You must make another request for a security code 3 E mail address of another recipient If you use another person s e mail and not your own then you will not receive the e mail in your mail account Either contact the other person to check that they have received the e mail with the security code or request a new security code to be sent your own e mail address 6 3 4 Duplicate Sponsor s Protocol Code Number The EudraCT system will check that the Sponsor s Protocol Code Number submitted on the form is unique within the EudraCT database It is very unlikely that different sponsors will use the same Protocol Code Numbers for their trials However it may be that the submitted Sponsor s protocol Code Number already exists and then a warning message is displaye
91. ta required for a CT application form The system has been designed to be as flexible as possible in order to meet the varying requirements of each Member State For this reason there are very few mandatory data items so it is necessary for all users to carefully check the printed CT Application forms for data consistency 2 1 2 Saving and Printing For obtaining a security code or EudraCT number the data entered on the web pages can be saved by saving the web page The information returned as e mails can be saved and printed from within the e mail system The CT Application form is saved locally as an XML file and can be printed as the application to the MSCA or as the application to the Ethics Committee 3 GETTING STARTED 3 1 System Requirements 3 1 1 E mail requirement To operate the system you will need to have a current e mail account and have software on your PC that enables you to receive e mails 3 1 2 Browser requirement The system operates most effectively using Microsoft Internet Explorer v5 and above 1995 2004 EMEA Page 4 of 73 Eudra EUDRACT UsER MANUAL PUBLIC WEBSITE 2 3 1 3 PC specification There is no special set up required Your PC should ideally be set to use Internet Explorer v5 or higher and the screens are best viewed at a screen resolution of 1024x768 All pages that are larger than the screen view will scroll so that all the information on a page can be viewed at any screen reso
92. te Application sections Enter correct data format is not in a valid date format J Application sections Enter a valid date J Reduce the amount 8 6 4 information added in the Ai section Enter only valid numeric 8 6 5 data in the field Page 73 of 73
93. tee exist on the Clinical Trial Application Menu 8 6 Problems that May be Encountered 8 6 1 Loading the XML Schema There are validation checks on the XML schema when a CT Application XML file is loaded into the system If the schema of the XML does not conform to the EudraCT schema then an error message will result e The XML file that you have tried to load does not conform to the EudraCT XML schema Unexpected element http eudract ClinicalTrialApplication xsd Where is the element name that caused the problem The XML loaded is possibly created with a superseded version of the XML schema but the error can be caused by directly editing the XML outside the EudraCT system There are also checks for a valid EudraCT Number and MSCA If these are incorrect then the following messages will display EudraCT number in the file that you have loaded does not exist the system The MS Competent Authority in the file that you have loaded does not exist in the system These kinds of errors are almost certainly created by editing the XML file outside EudraCT This editing is possible but has inherent dangers if not completed accurately In either case the XML file needs to be changed to contain a valid EudraCT Number and or MSCA in order to load 8 6 2 EudraCT Number validation Two validations are performed on EudraCT numbers a format check and a check that t
94. the link Validate Application The validation routine will run for the current application and produce a screen report of inconsistencies Validate Application Results EudraCT Number TEST O00022 26 Sponsor s Protocol Code Number Prot 123 Member State Competent Authority Ministry for Health This is the list of inconsistencies found in your application Please go back and correct the Inconsistencies before submission Sponsors SP1 Sponsor with required Legal Representative has Legal Representative IMPs Member State Marketing Authorisation Status is Yes and Product details are not completed PR1 Orphan Drug Status is and Orphan Drug Designation Number is not completed PR1 Routes of Administration Placebos PL1 No Related IMP Responsible Sites Responsible Sites General Trial Information General Trial Information Entered Population of Trial Subjects Under Eighteen is but you have selected groups under 18 years of age Proposed Sites Central Technical Facility Information added Trial Monitoring Facility Information added Fig 74 Validate Data Results 2 Use the standard web browser print options to print this results screen The data inconsistencies can be investigated and corrected 3 Click the OK link to return to the Clinical Trial Application Menu 1995 2004 EMEA Page 66 of 73 CT EUDRACT USER MANUAL PUBLIC WEBSITE
95. the next logical screen as follows 13 If the question Is this a gene therapy medicinal project was answered No then the IMP Identification Index screen will display 14 If this question was answered Yes the screen IMP Identification Details Gene Therapy Description will display 1995 2004 EMEA Page 37 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE ED s 05 02 IMP Identification Details Gene Therapy Description EudraCT Number TEST 000022 26 Sponsor s Protocol Code Number Prot 134 Member State Competent Authority The Ministry of Health This is a multi screen form use the navigation keys Next and Back to navigate between the screens Answer only if this is a Gene Therapy Product Answer all questions then use Next Gene 5 of interest x zl Is this in vivo gene therapy No Is this vivo gene therapy Type of cells hematopoietic stem cells Nucleic acid e g plasmid C Yes C No If nucleic acid specify if naked complexed No If viral vector specify adenovirus m retrovirus AAV If others specify the type of gene transfer m product Does the IMP contain genetically modified cells C Yes C No If specify the origin of the cells autologous 7 Yes No allogeneic yes No xenogeneic yas No If xenogeneic specify the species of origin Type o
96. to save all the data as xML or just the Core Dataset Itis suggested that the Full xML option is chosen as this incoroporates the Core Dataset NOTE These options download the XML into a new Browser window You then need ta use File Save Asin the new Browser window to store the xML disk Itis suggested the file is named with extension Full XML Core Dataset XML Continue Fig 67 Clinical Trial Application Menu 2 Click either link on the Save as XML menu and the XML file requested will be downloaded and the File Download dialogue will appear 3 Leave the radio button Save this file to disk checked and press 1995 2004 EMEA Page 62 of 73 EUDRACT UsER MANUAL PUBLIC WEBSITE Save as XML EudraCT Number 2004 000061 35 Sponsor s Protocol Code Number wevvw Member State Competent Authority INFARMED Portugal File Download X You can choose t that the Full xML option is chi NOTE These opt Save 4s in the ne ml extensior have chosen to download from this location use File mlHame do methad 2saveFullD ata fram 192 168 10 17 is named with What would you like to do with this file Open this file from its current location Save this file to disk Always ask before opening this of file Cancel Info Fig 68a Saving the XML file screen 1 4 Choose an appropriate folder and filename and save th
97. to the Ethics Committee screen is displayed 6 Complete the information on the screen Select the appropriate applicant from the drop down list and the country of the applicant from the list of Member States 7 Click the Save link to return to the Applicant Identification Menu 8 At this point if any of the applicant information added should require change then information can be accessed using the same links C1 Application to the MC Competent Authority and C2 Applicant to the Ethics Committee and changed made and then saved 1995 2004 EMEA Page 31 of 73 EUDRACT USER MANUAL PUBLIC WEBSITE UD a C2 Application to the Ethics Committee EudraCT Number TEST 000016 30 Sponsor s Protocol Code Number Prot 123 Member 5tate Competent Authority MHRA These are the details for section C Applicant Identification Enter details and use Save This is the Applicant to the Ethics Committee Enter the details of the legal Applicant who will sign the form The Contact Name may be a different individual at the same Location Organisation The Phone Fax and E mail should be those of the Contact person The legal representative of the sponsor Person or organisation name Legal Co Name of person to contact Given name Name of person to contact Middle name Name of person to contact Family name 0 Street address Town city Post code Country UNITED KINGDOM E Te
98. udraCT your Browser 6 3 9 Number town city is required mandatory information is required mandatory information is required mandatory information mandatory information number will be sent is required mandatory information mandatory information The Security Code entered must be 8 Get EudraCT number An incorrect security code 6 3 5 digits has been used Check the security code provided from the e mail and request a new code if required Unable to find security code Get EudraCT number An incorrect security code 6 3 5 has been used Check the security code provided from the e mail and request a new code if required 1995 2004 EMEA Page 72 of 73 1 EUbmACTUSERMANUAL PUBLIC WEBSITE Message Eudract Number has already been issued for Protocol Code Number Protocol Code Number Are you sure that you wish to proceed to generate another EudraCT Number It is likely that a EudraCT Number has already been issued to another individual within your organisation or another collaborator on this trial Please Check whether you have duplicated this EudraCT number request for your clinical trial If you are absolutely sure that you wish to continue then click the Get EudraCT Number button below otherwise click the Cancel button The security code has already been used in a request for a EudraCT number Please check the security code and if necessary request a new one An e mail ha

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