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User Manual for ToetsingOnline

1. 10 5 Using queries in the search form User manual portal ToetsingOnline Version May 2010 English 1 Registration 1 1 Single registration for use of the portal To gain access to the portal ToetsingOnline you must first register After successful registration you can create edit and manage a file within the portal Go to https toetsingonline ccmo nl click on the button English in the black toolbar at the top of the page and select Register as a new user The registration window opens and shows you how to register CCMO Researchers Ethics committees Public CCMO Register Documentation FAQ Nederlands Registration is needed to access the ToetsingOnline portal Select an action Register as new user Log in to ToetsingOnline Important ToetsingOnline uses popup screens Refer to the documentation paragraph 3 3 for more information on popups Note If you have problems logging in you may have entered a wrong username password combination Delete all fields on the next attempt Contact CCMO for help logging in tel 31 70 340 67 00 e mail admin ccmo nl Forgot your password Click here to receive a new password Forgot you user name Click here to receive your user name Certain information must be supplied in the registration window such as name and address When registering choose a user name After you have completed registration you will receive an e mail with a temporary password Clicking o
2. Choose your preferred language For displaying pages Choose 9 Allowed Sites Popups Seji You can specify which web sites are allowed to open popup windows Type the exact address of the site you want to allow and then click Allow Address of web site pd Allow Status Remove Site Remove All Sites Close User manual portal ToetsingOnline page 19 Version May 2010 English Google toolbar To allow pop ups just click Toolbar s Pop up blocker button The button s icon should change from Pop ups blocked to Pop ups allowed Once you allow pop ups on a specific website Pop up blocker adds the website to an Allowed sites whitelist lf you experience problems with pop up windows with other programmes contact the CCMO 4 4 Editing a submitted ABR form New version You can edit your submitted ABR form during the review process on your own initiative or at the request of the ethics committee by creating a new version To do so select the option New version in your toolbar at the top of the ABR form Your Original answers will be transported into the new version Close Print Hewversion Help A new version of the ABR is created which contains all your original answers The form retains the same file number though the version number increases by one Not all questions can be edited in a new version of an ABR form Some questions are blocked For more information see 4 5 Blocking of answ
3. File details File number NL23 Coordinator EC Local registration number Applicant A Mast Date review Title in English Result review Ethics committee TC Amsterdam Expected start date 04 11 2008 Competent authority Centrale Commissie Mensgebonden Onderzoek Expected end date 01 10 2010 CCMOQO Status r File File ma Reviews B Forms Review EC B1 ABR Form Decrees EC 01 smoking and heart disease active Submitted 10 Sep 2008 02 smoking and heart disease Submitted 10 Sep 2008 B5 EvudraCtT files Sm Adverse reactions event test Eudract 08 Oct 2008 E SUSAR Review CA Archive Ea User access amp overview amp Manage Local registration number and the coordinator of the ethics committee If you select the option File details the full overview of the file information is displayed At the bottom of this file details screen you can see which notifications alerts have been sent by mail 4 9 Status file lf the ethics committee actively uses ToetsingOnline the file is given a status after completion of the digital review A digital research file can have one of the following different types of status Not started A file is given this status if the review is positive and the ethics committee has not yet received a definite start and end date Current A file is given this status if the review is positive and the ethics committee has received a definite start date Ende
4. and select the file you Po antto add You must select a Dutch EvudraCT XML file Afterwards click on the Add file button to upload itto ToetsingOnline User manual portal ToetsingOnline page 10 Version May 2010 English Clicking on the button Browse Bladeren allows you to select the location where your EudraCT AF is saved After selecting your EudraCT AF it is added to your file and after submission of your ABR form it is automatically forwarded to the CBG for registration in the European EudraCT databank lt is only possible to attach XML files The title and name of the document is used only for your own registration In order for the CBG to process your file efficiently it is necessary that you indicate whether your XML file concerns a primary submission correction or amendment After selecting Add file your file is displayed You can delete this file at a later date and replace it with another XML file Close Save amp Close CCMO Documentation FAQ EudraCT details Creation date ofthis version 43 04 2010 Title of the AML attachment test Name applicant A Mast Remarks please state 1stregistration correction amendement Add Remove Dutch EudratT XML file The added file is 1 file 10 KB amp Testxml 10 Kb You need to remove the current uploaded file before you can add another one Click on the Remove button first B1 Does the research conce
5. Short title Local registration no Type of review Coordinator EC Remarks status review Finalizing timeline start date timeline dd mm yyyy sent on dd mm yyyy Desired reaction by dd mm yyyy Received on dd mm yyyy Lenath of timeline status timeline Date end timeline Remaining period in days Duration of the review Log met wijzigingen 25 02 2010 De vorige status was dossier volledig ontvangen 01 01 2010 NL31425 000 10 Eerste beoordeling coor opme vermoek wijzigingen aanvullen onderzoeksdossier Timeline is stopped 01 01 2010 26 02 2010 01 03 2010 60 days ll Suspended 17 04 2010 3 days Ethics Committee 57 days total no of days 103 days 25 02 2010 tc000 heeft deze beoordeling aangemaakt You can view the following information in the review window File number Short title Local registration number Type of review The following types of reviews can be made User manual portal ToetsingOnline Coordinator ethics committee First review Review amendment Review of adverse reaction Review of progress report Review of end report Other types of reviews Contact person or room within the ethics committee or competent authority Remarks Status review A review can have the following types of status Version May 2010 English page 27 complete file received placed on the meeting agenda with the date of the meeting request to change add to the research file stating
6. the research subject has recovered Using the Report follow up option gives the form a higher version number ES File Serious adverse events Ca Reviews Review Ec AE001 09 25525 i Decrees EC 02 worsening Concept Ee Review CA 01 1 dyspnoe leidttot ah stilstand Ter Kennisgeving Aangenomen Sa Adverse reactions event SUSAR SAE 7 22 Printing a submitted report form Once you have submitted the report form you can print it if you so wish To do so select the Print option in the black toolbar which will start the print functionality of your internet browser 7 23 Review by the MREC After you have submitted a SUSAR or SAE an e mail is automatically sent to the MREC The MREC will review the SUSAR or SAE a File Serious adverse reactions La Reviews Review EC SU001 09 25525 gt Decrees EC 02 uitbreiding uitslag Open bijlage Took Notice Of 01 06 2010 01 uitslag Open bijlage Took Notice Of 01 06 2010 Review CA AE001 09 25525 Adverse reactions event 02 worsening Concept 4 13 2010 E SUSAR 01 dyspnoe leidttot ah stilstand Took Notice Of 01 06 2010 tay SAE ES Archive La User access amp Overview gt Manage User manual portal ToetsingOnline page 40 Version May 2010 English 8 Access rights 8 1 Introduction As owner of a file you can authorise others to access your file For example you can authorise others to view your ABR form or give access rights to report SUSARs and SA
7. Other Full title of the research Short title of the research or acronym Note the search result is displayed at the bottom of the search form To view the result you must scroll downward Here you can select which ABR form you wish to view by clicking on Display selected documents or if only one document is displayed by clicking on the hyperlink in the title The ABR forms displayed appear in a new browser window and are shown one after the other User manual portal ToetsingOnline Version May 2010 English page 54 You can easily print an ABR form by using the print functionality of your internet browser Close Print New version Help Fi Form for E review and registration ABR form version September 2009 Research file ABR number 31425 Status Definitief Version 01 Status per 25 01 2010 Year 10 Filenumber NL31425 000 10 After reading the content of the form you can close it by clicking on Close in the black toolbar or the cross on the browser page You can start a new advanced search by clicking on the button Clear fields or New search CCMO Register eS Dutch Nederlands English Engels Method Keyword Dossier number Toets ingOnline EudraCT number Advanced Clear Fields New search File number ToetsingOnline EudraCT number fs Review commits Se cre date C Decree Select Once you have selected New search a search form start w
8. The page that opens is where you can change you language of choice by either clicking on the Nederlands or English button followed by Save changes ae Pd E mail max 1 a mast ccmo ni Voorkeurtaal Preferred language O Nederlands English New password as Repeat new password Po Your password will be changed only when you fillin a new password Leave the password fi Save changes Once you have altered the language settings ToetsingOnline will open in the chosen language You can always change the language again if you wish The printed version of the questions on the ABR form for the accredited MREC is in Dutch Whether you can answer all of the ABR questions in English depends on the MREC responsible for reviewing you file 1 4 Have you forgotten your user name or password Have you forgotten your user name or password On the web page https toetsingonline ccmo nl is a link which you can use to request your user name and a new password Would you like to alter your information Contact the CCMO at tel 31 70 340 67 00 e mail admin ccmo nl User manual portal ToetsingOnline page 4 Version May 2010 English 2 Portal 2 1 Personal portal window After logging in to ToetsingOnline you will enter your personal page Your contact details as supplied during registration can be found there Welcome A Mast Username mast Company CCMO E mail a mast ccma nl Address Parnassusple
9. You then fill in the user code of the user to be authorised and click on Search The name of the user will appear on your screen In the right hand menu you can set access rights for unblinded viewing of SUSARs and SAEs Both you and the authorised user will then recieve an e mail which contains information on the access rights set for sections of the file Other access 9 Read access C Report SUSAR and SAE CIB Forms Oe Safety information i e SUSAR SAE M View SUSAR and SAE reports unblinded see details on blinded reports CIP Decrees i Cl View SUSAR and SAE reports blinded see overview of blinded reports only Select all Deselect all Click on Save to enforce the selected access for this user on this file If you have chosen the option View SUSAR and SAE unblinded see details on blinded reports then the authorised user will be able to see all SUSARs and SAEs in overviews plus the attachments and the SUSARs and SAEs reported by others The user can also print these SUSARs and SAEs The file owner can make follow ups to his her own SUSARs and SAEs and can create new SUSARs and SAEs The authorised user will see the following in the overview User manual portal ToetsingOnline page 48 Version May 2010 English Edit account settings Concept ABR New submissions Allreviews Current research Allfiles Active files Shared files Archive File Title Acces rights for section Other NL31425 000 1
10. an ethics committee l1 Save this form before selecting the review committee which will reach the decree based on the Medical Research Involving Human Subjects Act i save Committee wv User manual portal ToetsingOnline page 14 Version May 2010 English Before the pull down menu opens the programme goes through the answers you have supplied Which ethics committees which will be displayed in the pull down menu depends on the answers given to the questions You can then choose an ethics committee There are three lists of ethics committees from which you can choose ethics committees which are competent to review non medicinal product research those which are competent to review all research which falls under the Medical Research Involving Human Subjects Act WMO including those with medicinal products and the CCMO If you edit the ABR form after selecting an ethics committee then it is possible that you will be requested to select an ethics committee again after submitting the form This is due to the programme once again going through all your supplied answers after submitting the form You can edit your choice of ethics committee at a later date as long as you have not yet submitted your ABR form After submission it is no longer possible to change the ethics committee see also 4 5 Blocking of questions in the ABR form User manual portal ToetsingOnline page 15 Version May 2010 English 4 Submitting an ABR form and d
11. be opened viewed printed and closed User manual portal ToetsingOnline page 50 Version May 2010 English 9 Transferring a digital file 9 1 Changing the submitter If the submitter or contact person of a research proposal temporarily changes during the review or the course of the study then you can let the CCMO know by mail at admin ccmo nl To transfer a research file the following information is required in the mail transfer request the NL number of the file s concerned user name of the old user user name of the new user The new submitter contact person must of course be registered in ToetsingOnline permission from the old user for the transfer to take place This can be arranged by asking the old user to send the transfer request After the transfer has taken place the information is no longer visible in the overview of the old user If the contact person has authorised users to view certain sections of his her file then these access rights remain unaltered for the authorised user s 10 Trial register 10 1 Introduction The aim of the CCMO trial reigster is to contribute to the transparancy of research on human subjects in the Netherlands As of the 1st of November 2009 every ABR form is partially public The core information from the ABR form is automatically entered in the public CCMO register at the moment that the MREC has reviewed the research file including the signed ABR form and has sent
12. click on Overview in the left menu User access amp file File Ca Reviews l B Forms Review EC B1 ABR Form Decrees EC 01 C2A titel active Submitted 25 Jan 2010 i 02 C2A titel Concept 12 May 2010 i Review CA B5 EudraCT files Ea Adverse reactions event test Eudratct 01 Jan 2010 E SUSAR P Decisions o Pia Primaire besluiten SAE test 041 Apr 2010 E Archive test 06 Apr 2010 Ea User access Overview Manage Here you can see the name of the user the user code and the access rights delegated bebruiker bebruikerscode Leesrechten Ovenge rechten Dr L Duinen g27554 Sectie H In the example above you have given user Dr L Duinen read access to section B of the file Section B contains the ABR form and any EudraCT forms in the case of research with medicinal products The authorised user can find your file under the tab Shared files User manual portal ToetsingOnline page 44 Version May 2010 English 8 5 Retracting reading access to a concept ABR form You can retract access rights which a user has to your concept ABR form To do so open the ABR form concerned click on Set access rights and type in the user code of the authorised user The name of the authorised user is displayed for you to check You can then deselect the option Read access to this ABR form and then Save The read access rights of the authorised user are now deleted 8 6 Setting read access for secti
13. dec a N 8 UCI E E rh cheat A E E E EE T taut qibass A a EE 9 PUDICAN nN Ol MON MallOn sisean a E 9 Compulsory addition of the EudraCT AF in research with medicinal products 9 Importing answers from your EudraCT AF in research with medicinal products 12 Supplying details Of participating centres ce ccccceececsseeeeceeeeeseeeeeeseeeeesaaeeessaeeeesaeees 12 SAVING DETOGICANIY areren aE a a a OES 13 GIOSING an ABR TOLM reee a aa 13 Opening editing an existing concept ABR fOr cccccsseecceeeeeeeeeceeeeeeeseeeeeeseaaeeees 13 PHANG a concep ABR TONM smorio on E 14 Deleting ine ABR TOM eere a a chute Muck omaateeaet es 14 Selecing anmes ComMINe Guss coined eee 14 Submitting an ABR form and digital fil ccceeseeseeeeeeeseeeeeeseeeseeenseeseeenaeeseeeneees 16 SUDMANO AT ABR TOLM rer a a ieee 16 PARUNG oe A raedate note ancnan osx cNme pane ee Co natk anata tne tiiameteenna 17 Problems with POP UP WINKOWS ccccceccccseeeeceeeeeeceeeeeeaeeceeceeeeeeueeesaueeeeseeeeesseeeessass 18 Editing a submitted ABR form New version ccsecccsseeceeeeeceeeeeseeeeseeeeseeesseeeeaaees 20 Blocking of QUESTIONS in the ABR TOM wisitiiest vetted sivahsiensiviae dares tuna ince wieen 20 PAMMCN GIN CIM sates aceite cB iat beh a ie seactceaawaa eauseeneadeeebaaehooenate 21 SAUS ABR TOMM cea E a 21 Recea An a E E E utmmetnnia 22 SAUSE R neues ites savegaiaueuha nanan mane elandaaapaatan 24 Digitale re
14. delete it You can however make a follow up report see also 7 21 Editing a submitted SAE form follow up 7 20 The coding of a submitted SAE form After you have submitted the report form and have closed it you will find all of the reports under the link SAEs A red cross or red exclamation mark may be displayed at the left of the report number This is a reference to question B6 and gives an indication of the gravity of the effects A red cross refers to an adverse reaction which is life threatening or can be fatal a red exclamation mark indicates that the adverse reaction can have consequences for the safety of the research subject participating in the research question A6 Next to the report number is a column containing information on whether the suspected adverse reaction has occurred in the study concerned the symptoms the status of the report form concept submitted took notice of and the status date 7 21 Editing a submitted SAE form follow up You can edit or add to an SAE report by clicking on the button Report follow up after opening the report form User manual portal ToetsingOnline page 39 Version May 2010 English After you have edited or added to the information in the report form you can save and submit the form A pop up field appears in which you can give the reason for the report follow up An example of a reason could be that there is additional information on the progress of the event for example
15. form together with your research file to the ethics committee selected in the ABR form You can print the ABR form after submission is complete Clicking on the Submif button in the ABR form automatically opens the print version of the ABR form in a new screen You can then print the ABR form by selecting the print functionality of your internet browser Note If the printed form is not displayed it is possible that it is being blocked by a pop up blocker see 4 3 Problems with pop up windows You can also print the ABR form at a later date by opening the ABR form and selecting the Print option in the toolbar at the top of the ABR form Close Print Make amendement Help Doing so opens a print version of the ABR form in a new window You can then print the ABR form by using the print functionality of your internet browser User manual portal ToetsingOnline page 17 Version May 2010 English You can print your concept ABR form by using the print functionality of your internet browser Doing so makes a print of your screen see also 3 13 Printing a concept ABR form Only the ABR form which is displayed in the read only mode is suitable for this as this displays all of the answers on your screen Selecting the Edif option sets the ABR form to edit mode which can result in some of the long answers not fitting in the input fields and flowing over onto the page Note A print of the screen in which you are fillin
16. form All previously created report forms are stored in the SAE menu of your research file Certain information is displayed in the window the version number the file number of the research protocol concerned and the status of the form for example concept submitted or took notice of m File Serious adverse events Reviews l Review EC AE002 10 31425 Decrees EC concept z Concept AE001 10 31425 pile 03 1 Double vison Took Notice Of 14 04 2010 Ga Adverse reactions event g2 Trouble vision submitted 24 03 2010 Ee SUSAR i H losse conncectie Submitted 01 03 2010 SAE Archive fm User access overview Manage You can select an existing SAE form after which the form opens in the read only mode Selecting the Edi option allows you to edit and or add to the information You can find the Edit option in the toolbar at the top of the report form Close Edit Delete Submit Help SAE form Report number AE002 10 31425 Status Concept Version concept Status per File number NL31425 000 10 Review date Reporter A Mast Date last modification 13 04 2010 7 17 Printing an SAE report form You can print a concept report form by using the print functionality of your internet browser This makes the so called print screen User manual portal ToetsingOnline page 38 Version May 2010 English Only the report form in the read only mode is suitable for printing as this displays all of the answers
17. modules and there are plans for further future development For more information on the development of ToetsingOnline go to the CCMO website at www ccmo nl Questions and suggestions which could lead to improvement of the portal ToetsingOnline or this manual are welcome Contact the CCMO at tel 070 340 6700 or e mail us at admin ccmo nl User manual portal ToetsingOnline Version May 2010 English Table of contents le 1 1 1 2 1 3 1 4 2 2 1 2 2 3 3 1 3 2 3 3 3 4 3 5 3 6 3 3 8 3 9 3 10 3 11 3 12 3 13 3 14 3 15 4 1 4 2 4 3 4 4 4 5 4 6 4 7 4 8 4 9 5 5 1 5 2 6 6 1 6 2 FLO GIS UA U lO Me secreeestescesncntee aa a a a aAa 1 Single registration for use Of the Portal cccceecccceseeceeeseeeeeeeseeeeeesseeeeeesseeeeeesaaeeeess 1 Alterno Present inio rmat ases E AO 2 Changing the language settings cccccccseeccceceseeceseeeeeeeeeeeeeeesseeeeeeeseeaeeeseeeeeeessaeeeees 3 Have you forgotten your user NAME OF PASSWOM cece eeeeee ee eeeeeeeeeeeeeeeeeeeeeaaeeeeeeeeeaes 4 POFTA acta aictctd ceiscted ols Giad deat a cies delsCanieosbendeeamect a 5 Personal DOMAl WINGOW isaaserrusuiceccinsovtstconaetc hes aussanneeruaubieuieteweRioeebtohaitbedetadsaasneadtins 5 Navigation Dal ersen E a ee eer eee ee ee ene 6 New CONGEDE ABR FOrM aicina a a aS aaa 7 IPO UIC HOMeS a 7 NEWABR TONT oieee a a a a casi amsatateet 7 S510 fee ee ene eee ee 7 PA A HOMINT TO OID Al asirna nes ae Neceeeatei
18. on the main screen of ToetsingOnline For further detailed information please consult the manual which can be found on the website This is a generated e mail please do not reply Save this e mail for your own administration The authorised user sees your ABR form after logging in with his her own information in the tab Concept ABR on the welcome page An icon is displayed at the end of the ABR form and view so that it is clear for the authorised user that this is not his her own ABR form but a form which he she has been given read access for The authorised user can open the ABR form as well as view print and close the form However the authorised user cannot edit the file User manual portal ToetsingOnline page 43 Version May 2010 English Edit account settings Concept ABR New submissions Allreviews Currentresearch Allfiles Active files Sharedfiles Archive ABR no Title Created Changed 32339 14 Apr 2010 14 Apr 2010 JAAA 14 Apr 2010 14 Apr 2010 32323 read only test 13 Apr 2010 14 Apr 2010 You can submit an ABR form as owner of the form if all of the questions have been answered see chapter 4 1 After submitting the ABR form the user given access rights to the concept ABR form is automatically given access to the file The authorised user is given read access to section B Submitting the ABR form creates a file in ToetsingOnline You can check what access rights you have in the file To do so
19. set the rights both you and the authorised user receive an e mail containing information on the access rights given for sections of the file The owner of the file can view all set access rights in the file under the menu Authorise users overview The authorised user can view the access rights given in the tab Shared files in the welcome page of ToetsingOnline The file overview looks as following User manual portal ToetsingOnline page 47 Version May 2010 English File Overview access rights by others Ca Reviews l Gebruiker Gebruikerscode Leesrechten Overige rechten Review EC Dr L Duinen 27554 Sectie B Melden SUSAR en SAE Inzien SUSAR en SAE ongeblindeerd iS Decrees EC Dr U Paars o04446 Inzien SUSAR en SAE geblindeerd If you have selected the option Report SUSAR and SAE then the authorised user will only see the SUSARs and SAEs submitted by him her in the overviews as well as the attachments of these SUSARs and SAEs The file owner can also view these SUSARs and SAEs The owner cannot make follow ups to these SUSARs and SAEs the authorised user however can The file owner can however make new SUSARs and SAEs 8 9 Authorisation for full access to SUSARs en SAEs You can authorise users to view reports of adverse reactions which occur during your study You can set these access right in the file itself To do so open the file and click on Manage in the left hand menu see also chapter 8 6
20. somatic cell therapy vaccine research GMOs see explanation as described in the Medical Research Involving Human Subjects Act Dutch abbreviation WMO yes Ono Add EudraCT B1a Do you wish to import information form your EudraCT XML file O yes no Digital submission of the completed EudraCT AF to the ethics committee and or competent authority is compulsory in the case of research with medicinal products on one of the research fields listed in the figure shown above at question B1 Your digital EudraCT form is sent directly to the Medicine Evaluation Board College Beoordeling van Geneesmidelen CBG as soon as your ABR form has been submitted The CBG then ensures that your EudraCT AF is registered in the EudraCT databank Note importing answers is not the same as attaching the EudraCT Application Form see 3 8 Importing answers from your EudraCT Application Form in research with medicinal products Importing is not compulsory However attaching the EudraCT Application Form in research with medicinal products at question B1 is compulsory Clicking on the button Add EudraCT opens a window which allows you to upload your EudraCT Close Save amp Close CCMO Documentation FAQ r ij Ey of Wea EudraCT details Creation date of this version fo Name applicant A Mast Remarks please state 1st registration correction amendement Add Remove Dutch EudraCT AML file Click Browse or Bladeren
21. the decision to the CCMO The information which is made public is marked in the online ABR form with a globe symbol 10 2 Consulting the trial register The CCMO trial register can be consulted by clicking on CCMO register in the black toolbar at the top of the page The trial register can be consulted after logging in to ToetsingOnline but can also be consulted via the general website of the CCMO User manual portal ToetsingOnline page 51 Version May 2010 English De Centrale Commissie Mensgebonden Onderzoek CCMO Researchers Ethics committees Public CCMO Register Documentation FAQ Nederlands The search form is opened in a separate browser window such as displayed below CCMO Register Language Taal Dutch Nederlands English Engels Method Keyword Dossier number ToetsingOnline EudraCT number Advanced Koyo 7 po 10 3 The limited search method The search form contains a number of search options The standard language is Dutch and the search method is set to search by keyword You can however choose between Dutch or English You can also change the search method to search by keyword file number ToetsingOnline or EudraCT number You can also perform an advanced search For more information see chapter 10 4 If you choose to search in Dutch as you wish to find all studies carried out on for example lyme then you type in lyme as keyword and then click on Search A
22. the date sent desired reaction date and date reaction is received being processed by the executive board review research file retracted stating date review positive stating date review negative stating date not WMO research or research on embryos stating date A review by the competent authority is not given the status positive review and negative review but rather the status no objection and objection both with the date stated Any previous status and therefore the progress of the review can be found in the review log Log met wijzigingen 25 02 2010 De vorige status was dossier volledig ontvangen 01 01 2010 25 02 2010 tc000 heeft deze beoordeling aangemaakt Date start timeline The date on which the review is started and the review timeline begins Length of the timeline The total number of days that the legal timeline consists of If the timeline is extended then this is visible Status timeline the timeline can have one of the following types of status current suspended completed the timeline can be suspended if the ethics committee has additional questions regarding your file or has requested you change certain information Date end timeline The date on which the valid timeline ends Days left till end of timeline The number of days left for the review Duration of the review The total duration from submission till review total duration is displayed here incl
23. 0 C2b titel Inzien SUSAR en SAE ongeblindeerd 8 10 Giving access to view blinded SUSARs and SAEs in the overview You can authorise users to view blinded the adverse reactions which occur during your study These access rights are set in the file itself To do so open the file and click on Manage in the left hand menu see also chapter 8 6 You then fill in the user code of the user to be authorised and click on Search The name of the user concerned appears on your screen You can set access rights for blinded viewing of SUSARs and SAEs in the right hand menu Other access Read access CIB Forms CI Report SUSAR and SAE CIL Safety information i e SUSAR SAE C View SUSAR and SAE reports unblinded see details on blinded reports CIP Decrees M View SUSAR and SAE reports blinded see overview of blinded reports only Select all Deselect all Click on Save to enforce the selected access for this user on this file If you have chosen the option View SUSAR and SAE blinded see overview of blinded reports only the authorised user will only be able to view an overview of the SUSARs and SAEs reported in that study The SUSARs SAEs and the attachments themselves cannot be opened by the user See the figure below ia File serious adverse reactions Reviews Review EC SU002 10 33004 a U001 10 33004 oa 02 Uremie 01 stijging Na K Kreat AE001 10 33004 02 p I Co slang verkeerd gemonteerd 01
24. CCESS rights cecccccsseeceeeceeeeeeeceeeceeseeeeeeesseaeeeeseeeeseessaeeeess 42 Giving others access rights to read your ABR fOr ccccccceceeeeeeeeeeeeeeeeaeeeeeeeaaees 42 Retracting reading access to a concept ABR fOr cccceccceeceeeeeceeseeeeseeeseeeeaeess 45 Setting read access for Sections Of the file eee ccecseseeeeeeeseeeeseeeeeeseeeeeeeeeaees 45 Retracting reading access to a file 20 cee ceecccesceceeeeeceeeceeceseueeceseecaeseneeenneessasessaess 47 Authorising others to be able to report adverse reactions cccccceecceeeeeeeeeeeseeeeeaes 47 Authorisation for full access to SUSARS en SAES cccceeeeeeeeseeeeeeeeeeeeeseeeeeeeeaaaeeees 48 Giving access to view blinded SUSARs and SAEs in the overview 0cccceeeee 49 Giving access rights to report adverse reactions and to view OVEIVIEWG 6608 50 Transferring a digital TNC oissocsecstecavoretsadecewiencecanieel nedtinctalecestiseateataseteteleswetedalaceusnieed 51 GNaNGING ANE SUDOM CN scied nected setae tor ience O EE oie auld EE 51 TERRA EC OUS UCN eas iewce stares be cid ceseeers a a a a Eea 51 NOG CUO apaises sea EE E E ES E Ea E 51 Consulting the tial regIStE cdz c4 ccc sc ecccsesscaesiuecdlascecucdocaeeacsance gqevedzeseisadaeecntaetsenctaced 51 The limited seade h MeNOd eeeemnee teeters rennet a E AE E A 52 User manual portal ToetsingOnline Version May 2010 English 10 4 The advanced search method
25. Es Access rights can only be given to registered users of ToetsingOnline Every registered user has a user code see chapter 8 2 8 2 User code Every registered user of ToetsingOnline has a user code Your user code is displayed on the right hand side of the toolbar at the top of your welcome page A Mast 89dfid Your user code is also displayed in your registration information The registration information is displayed by selecting Edit account settings on the welcome page Welcome A Mast Username mast E mail Phone r Fax Username User code Lastname Family name prepositions Company type Medical Devices industry User manual portal ToetsingOnline page 41 Version May 2010 English The user code of a user who is to be given access rights to your file is necessary to be able to delegate these rights This user should inform you of his her user code 8 3 Overview of types of access rights The following types of access rights can be given e Read concept ABR form e Read sections of file e Report SUSARs and SAEs e View SUSARs and SAEs e View blinded overview of SUSARs and SAEs 8 4 Giving others access rights to read your ABR form You can create a new ABR form by clicking on the link Make new file see chapter 3 2 After saving and closing the concept ABR form it is possible to set access for others to read this concept To do so open the ABR form again and select Set access
26. Research file Files given a negative review are also transferred to the archive For more information on digital registration of reviews go to chapter 5 Digital registration of reviews Took notice of After the ethics committee has notified receipt of an amendment which can be submitted after completion of the primary submission the ABR form is given the status Took notice of 4 8 Research file Once an ABR form has been submitted a research file is automatically created The file number is displayed in the ABR form The file number consists of the ABR number the chronological number of the selected ethics committee and the year in which the ABR form is submitted The number is preceded by the letters NL Research file ABR number 31425 Status Definitief Version 01 status per 25 01 2010 Year 10 Filenumber NL31425 000 10 The file number is then displayed in the various tabs of your personal portal window User manual portal ToetsingOnline page 22 Version May 2010 English dit account settings Concept ABR New submissions Allreviews Current research Allfiles Active files Sharedfiles Archive File number EudraCT number Local regno Title Ethics c NL31425 000 10 5795665435355 76889 C2b titel COMO Onderz You can open the file by clicking on the file number If the ethics committee and in the case of research with medicinal products also the competent authority have began the review process then this can be v
27. User Manual for ToetsingOnline Internet portal for the submission review registration and publication of medical research Version May 2010 Central Committee on Research Involving Human Subjects Summary The internet portal ToetsingOnline allows submitters of medical research proposals to create a digital research file containing the ABR form and the EudraCT Application Form You can submit your research file to the corresponding ethics committee and in the case of research with medicinal products to the competent authority It is presently still required that you also submit your file in hard copy to the Medical Review Ethics Committee MREC As of the 1 of January 2008 digital submission of your file to the competent authority is compulsory The ethics committee and when applicable the competent authority can then begin a digital review of your file It is possible for you to follow the review process and the timelines attached via the portal As a submitter you manage your own various research files on your personal page within the portal You only have to register once to manage several files As a submitter you can also authorise other users to be able to view your file Access rights can also be given to allow authorised users to report adverse reactions which occur during the course of the study The internet portal ToetsingOnline can be found at htips toetsingonline ccmo nl The portal is developed in
28. a new ABR form by clicking on the link New file By doing so you create a file and in that file the ABR form You can attach any future documents and forms to this file Each new ABR form is given a unique ABR number Research file ABR number 23807 Version concept You can hold your ABR form in concept for as long as is necessary After closing the concept ABR form you can find it in the tab view Concept ABR Edit account settings Concept ABR Newsubmissions Allreviews Current research Allfiles Active files Shared files Archive see also 3 12 Opening editing an existing ABR form Only after the ABR form has been submitted is a file number created see also 4 1 Submitting an ABR form 3 3 Sections The ABR form consists of a number of sections A to L You can select all sections simultaneously or you can choose a single or a number of chosen sections After selecting the desired sections click on Show selected sections after which the selected sections will be displayed In this way you can open and close the different sections of the ABR form whilst filling in the necessary information User manual portal ToetsingOnline page 7 Version May 2010 English Select the section you wish to edit Select all Deselect all 1B Administrative E C Research LJD Human subjects LIE Benefits and disavantages of participation LIF Information and privacy G Financial matters Ll Submission a
29. ative review by the ethics committee and or competent authority or which have had their review retracted User manual portal ToetsingOnline page 5 Version May 2010 English Important the files are only shown in the correct view if the ethics committee works with ToetsingOnline In all other cases your file will remain in the view New submissions 2 2 Navigation bar At the top of your personal page you can find a navigation bar This is a black toolbar containing various options This bar can be found at the top of every form and views of the portal Important use the options in the navigation bar and not in your internet browser De Centrale Commissie Mensgebonden Onderzoek Logout New file CCMO CCMO Register Documentation FAQ User manual portal ToetsingOnline page 6 Version May 2010 English 3 New concept ABR form 3 1 Introduction In the ToetsingOnline portal you can create and manage research files The ABR form and the EudraCT Application Form together form the research file see also 3 7 Compulsory addition of the EudraCT Application Form in research with medicinal products The ethics committee and for research with medicinal products also the competent authority can create a review in your research file see also 5 1 Review by ethics committee and or competent authority The ethics committee also manages the general file information see also 4 8 Research file 3 2 New ABR form You can create
30. ay 2010 English All fields marked with an asterisk are mandatory i Username mast User code 69df5d Lastname Family name prepositions Company type Company Company name Department Internal address Address Pastcode and city Phone Fax E mail max 1 a mast ccmo nl Voorkeurtaal Preferred language Nederlands English New password Loo Repeat new password Pe Your password will be changed only when you fill in a new password Leave the password fields blank to Save changes If you would rather have a different user name then you have to register again Any files and or concept ABR forms can be transported into your new account by the CCMO See 9 1 Changing submitter Note are you planning on managing another file It is possible to set access to your file for other users However editing your account settings is not the right way to go about this See how you can set access rights for another user under chapter 8 1 3 Changing the language settings ToetsingOnline is bilingual You can choose between Dutch or English language settings ToetsingOnline is automatically opened in Dutch You can change the language settings by logging in and clicking on Edit account settings User manual portal ToetsingOnline page 3 Version May 2010 English Welcome A Mast Username mast E mail amasi Phone OFO Fax Edit account settings
31. ayed in the Documents window and the originally reviewed ABR form is transferred to the archive within your file see also 4 7 Status ABR form A negatively reviewed amendment ABR form is deactivated and transferred to the archive In such a case your original ABR form with a positive review remains active and unedited User manual portal ToetsingOnline page 30 Version May 2010 English After the amendment has been reviewed you can then make a new amendment to the ABR form 6 3 Amendments to research proposals submitted before the 1st of March 2006 Research proposals submitted before the 1 of March 2006 still make use of the old ABR form You can still request your old form at the CCMO The ABR form in ToetsingOnline is only for research proposals submitted after the 1 of March 2006 It is not possible to register amendments to research proposals which were submitted before this date in ToetsingOnline User manual portal ToetsingOnline page 31 Version May 2010 English 7 Reporting adverse reactions events 7 1 Introduction lt is possible to report suspicions of serious adverse reactions SUSARs in ToetsingOnline by filling in a SUSAR report form Serious adverse events SAEs can be reported by filling in the SAE form in ToetsingOnline If the adverse reaction is already mentioned in the existing product information then you can state this in the annual safety report unless the gravity of the reaction makes im
32. compulsory However adding the EudraCT Application Form in research with medicinal products at question B1 is compulsory B1 Does the research concern a trial with medicinal products including gene therapy somatic cell therapy vaccine research GMOs see explanation as described in the Medical Research Involving Human Subjects Act Dutch abbreviation WMO yes Ono Add EudraCT B1a Do you wish to import information form your EudraCT XML file 9 O yes no 3 9 Supplying details of participating centres In the ABR form you can supply information on which centres are participating in the research You must fill in a separate form per centre Selecting the option Add centre opens the form Centre information CS In which centre s including general practices in the Netherlands will the research be conducted Type for each centre the number of human subjec main investigator name independent physician e Centre Human subjects Main investigator Independent physician 3 Antonius Ziekenhuis Sneek 565 test test The centre concerned is displayed at C9 in the ABR form once the form has been saved User manual portal ToetsingOnline page 12 Version May 2010 English You can alter the information by clicking on the hyperlink of the participating centre which opens the form You can delete the centre by clicking on the red cross Centre information Centre type Universal Medical Centre is Centre name Number
33. d A file is given this status if the review is positive and the ethics committee has received an end date A file with this status is transferred to the archive Suspended A file is given this status if the ethics committee has indicated that the research is Suspended in the file details Ended early User manual portal ToetsingOnline page 24 Version May 2010 English A file is given this status if the ethics committee has registered in the file details that the research has ended early A file with this status is transferred to the archive File details Status suspended Ended early File Number NL31425 000 10 Coordinator Ethics Committee Applicant A Mast Date review Result review Title in Dutch C2b titel Ethics committee COMO Centrale Commissie Mensgebonden Onderzoek Den Haag Competent Authority Minister van Volksgezondheid Welzijn en Sport Expected start date 02 02 2010 Final start date Expected end date 02 03 2010 Final end date Company MucoVax Depanment ToetsingOnline Address of applicant Parnassusplein 10 2511 VX Local registration no Type of research Name executor Remarks User manual portal ToetsingOnline page 25 Version May 2010 English 5 Digitale registration of reviews 5 1 Review by ethics committee and or competent authority After the ABR form is submitted see also 4 1 Submitting an ABR form you must also submit the complete research file in hard copy to the ethics committe
34. d such as the version number the file number of the file concerned the status of the form this can be either concept or submitted and the date of the review by the ethics committee or the competent authority File Serious adverse reactions La Reviews Review EC S U006 10 31425 Decrees EC concept t Concept E Review CA U005 10 31425 areas concept x Concept Adverse reactions event U004 10 31425 E SUSAR 03 test Open bijlage Submitted 15 04 2010 02 EA test Open bijlage Took Notice Of 14 04 2010 ly SAE 01 x Open bijlage Took Notice Of 14 04 2010 E gt Archive U003 10 31425 S oaas follow up Open bijlage Took Notice Of 14 04 2010 01 Test Open bijlage Took Notice Of 14 04 2010 E Overview U002 10 31425 01 Restless legs Open bijlage Took Notice Of 14 04 2010 Manage Bios U001 10 31425 Select an existing concept report form opens it in the read only mode If you wish to edit or add to the form select Edif You can find the Edit option in the toolbar at the top of the report form User manual portal ToetsingOnline page 34 Version May 2010 English Ee File SUSARs Om Reviews a Review EC U002 10 31425 Decrees EC concept SU001 10 31425 Review CA 04 yg headache Ga Adverse reactions event SUSAR SAE amp Archive fm User access S Overview Manage Close Edit Delete Submit SUSAR form based on ICH E2B Report number U002 10 31425 Status Concept Version c
35. e NL flenumber of the study NL31425 000 10 7 3 Attaching PDF file of report in Eudravigilance database If the report of the adverse reaction is already entered in the Eudravigilance database then you can attach this file CIOMS form in pdf form Clicking on the option Browse Bladerer opens the window where you can select your documents Clicking on the option Add file displays the selected file If you have selected the wrong document clicking on the Delete User manual portal ToetsingOnline page 33 Version May 2010 English option will delete it After the document has been uploaded all you have to do is fill in the displayed sections of the form 7 4 Saving periodically It is advised that you save your SUSAR report form periodically This prevents information being lost if your internet connection were to suddenly disconnect or unexpected errors were to occur You can find the Save option in the toolbar at the top of the SUSAR report form and at the end of every section 7 5 Closing the SUSAR form You can close the SUSAR report form by clicking on the Close option in the toolbar at the top of the form If you have not yet saved the report form you can select Save amp close under the button Save 7 6 Opening editing a concept SUSAR form All previously created report forms can be found in your research file under the menu SUSAR In the window certain file details are displaye
36. e selected in the ABR form If the research is with medicinal products then all documents must be submitted digitally in PDF format to the competent authority For more information on digital submission see our website www ccmo nl Once the complete set of documents have been received in hard copy the ethics committee and when applicable the competent authority can start the review process in the portal The ethics committee you have selected in the ABR form and in the case of research with medicinal products the competent authority have access read only access to your digital research file and can document the review These reviews are added to your digital file see also 4 8 Research file It is possible for you to view the reviews You can open a review directly by selecting it in the Current reviews window in your personal portal window You can also select the review from your research file under the link Review EC je m a File Review Ethics Committee of Reviews ese Type of review Primairy review Review EC Coordinator i Decrees EC Status Request for more information or change Time lines iew CA l Review LA number of days 56 Ca Adverse reactions event start 15 04 2009 E SUSAR decree date amp SAE jr Archive Ga User access Overview Manage Afterwards the review window opens User manual portal ToetsingOnline page 26 Version May 2010 English Review by Ethics Committee File number
37. er to sections of your file To do so open the file concerned click on Manage in the left hand menu and type in the user code of the authorised user The name of the authorised user appears for you to check You then deselect the box at for example B forms and P decrees and click on Save The access rights of the authorised user for that file are now deleted 8 8 Authorising others to be able to report adverse reactions You can authorise users to report adverse reactions which occur during your study You can set these rights in the file concerned To do so open the file and click on Manage in the left hand menu see also chapter 8 6 You then fill in the user code of the user to be authorised and click on Search The name of the user will appear on the screen In the right hand menu you can set rights for reporting or viewing SUSARs and SAEs If you wish to give the user access rights to be able to report SUSARs and SAEs for the study concerned then select the box Report SUSAR and SAE in the right hand menu Other access 9 Read access CIB Forms Report SUSAR and SAE Oe Safety information i e SUSAR SAE C View SUSAR and SAE reports unblinded see details on blinded reports CIP Decrees C View SUSAR and SAE reports blinded see overview of blinded reports only Select all Deselect all l l l Click on Save to enforce the selected access for this user on this file After you have
38. ers on the ABR form You can once again submit the edited version and print it for sending to the ethics committee see for more information 4 1 Submitting an ABR form and 4 2 Printing The original ABR form is saved Only ABR forms with submitted status van be used to make a new version ABR form version September 2009 Research file ABR number 31425 Status concept Version 03 Status per 15 04 7010 Year 10 Filenumber NL31425 000 10 Reason for Version new site 4 5 Blocking of questions in the ABR form Once you have selected an ethics committee and submitted your ABR form the answers on the form are checked After this check has taken place it is established to which ethics committee s you should submit your research proposal and whether it should be submitted to the competent authority The legal timeline is also established This validation only happens once User manual portal ToetsingOnline page 20 Version May 2010 English It is for this reason not possible to edit the following questions as of version 2 of the ABR form Question B1 Does it concern research with medicinal products including gene therapy somatic cell therapy GMOs see further explanation as mentioned in the Medical Research Involving Human Subjects Act WMO Question C10 Does it concern research with options humans reproductive cells remaining embryos foetuses in utero Certain subquestions of question C16 cannot be selected as of v
39. ersion 2 This concerns the following subquestions C16b Vaccine 16d Product as described in the Dutch Opium Act in pharmaceutical preparation for the treatment of addicted subjects C16e Somatic cell therapy C16f GMOs C16g Gene therapy 16h Xeno cell therapy research C16i Interference RNA C 16j Anti sense oligonucleotide research If these subquestions are already selected in version 1 then they can be edited The questions C14 intervention observational D6 category human subject and E1 is is not therapeutic may be edited However if editing these questions results in another ethics committee having to be selected from MREC to CCMO or vice versa then the form cannot be submitted The form contains information on the blocking of questions If you wish to change one or more of the above mentioned questions contact the CCMO 4 6 Amendment It is not possible to make an amendment to an ABR form which has not yet been reviewed An ABR form must have the status reviewed positive or took notice of before you can make an amendment see also 6 1 Making an amendment to an ABR form If you wish to edit the submitted ABR form during the review process you must make a new version see also 4 4 Editing a submitted ABR form New version 4 7 Status ABR form An ABR form can have the following different kinds of status Concept A new ABR form is automatically given the statu
40. for others in the black toolbar Close Edit Delete Submit Setaccess for others Help Note you can only set access for others for your concept ABR form if the form is in the so called read only mode That is to say you have not yet clicked on the Edi function If you have selected the Edit option the Set access for others button is no longer visible A window opens where you fill in the user code of the user who is to be given access rights Save Cancel Documentation FAQ Set access for others on this concept ABR form ABR number 32323 Title test User code Name je 42 ersion May 2010 English After filling in the user code you then click on Search after which the name of the user to be given access will appear on the screen Set access for others on this concept ABR form ABR number 32323 Title test User code Name Access Read access on this ABR form Click on Save to enforce the selected access for this user on this concept ABR form Access to this form will be propagated to the complete file after submittal of the concept Select Read access to this ABR form and Save in the black toolbar to set access for this user Afterwards both you and the authorised user will receive an e mail with the access rights given You are authorised to access ABR form ABR form 32323 on ToetsingOnline The form is located on the tab Concept ABR
41. form has been saved After submission the following information is added to the ABR number the reference number of the selected ethics committee and the year in which submission took place These numbers are preceded by the letters NL This number is the complete file number The ABR form is also given a version number User manual portal ToetsingOnline page 16 Version May 2010 English Research file ABR number 31425 Status Definitief Version 01 status per 25 01 2010 Year 10 Filenumber NL31425 000 10 In the example given above the number 207 refers to the ethics committee and 07 is the year 2007 After submitting the ABR form it is not possible to edit or delete it You can however make a new version see also 4 4 Editing a submitted ABR form new version After submission is complete the research file is created see also 4 8 Research file After you have submitted your ABR form you will receive a message informing you of the legislation which applies to your research proposal and which ethics committee you have selected in the ABR form and therefore where your research proposal must be submitted The mail also informs you of the competent authority where you may have to submit your research proposal and what the review timeline is for the ethics committee and the competent authority in the case of submission being required 4 2 Printing After submitting your ABR form you are required to send a signed printed version of the
42. g in the ABR form is not suitable as a print version and therefore cannot be used for submission to the ethics committee 4 3 Problems with pop up windows The ABR print form is opened in a separate browser window This window is viewed as a pop up window Some internet browsers and toolbars such as Google and Yahoo automatically prevent pop up windows being displayed if these browsers have been installed with the standard settings If one of these programmes prevents the ToetsingOnline pop up windows then you will experience problems printing the ABR form If you have problems with pop up windows the programme settings have to be altered Internet browser Until now problems with the blocking of pop ups have only been experienced with the internet browser Mozilla Firefox To change the settings in Mozilla Firefox so that pop ups windows are accepted do the following Go to Extra and select Options In the options window select Content and then Exceptions next to Block popup windows There you can add the website https toetsingonline ccmo nl User manual portal ToetsingOnline page 18 Version May 2010 English cl ae wo g General Tabs Content Applications Privacy Security Block popup windows Exceptions Load images automatically Exceptions Enable JavaScript Advanced Fonts amp Colours Default Font Times New Roman v Size 16 A Advanced Colours Languages
43. gistration Of reviews ccccscseeseceeseeeeeeeeenseeeeseeeeaeeeeaseeeesesoeseeeoanensanesonaes 26 Review by ethics committee and or competent Authority cccceceeeeeeeeeeeeeeeeeeeeees 26 Stating the decision of the ABR fOrM cccccseecceceeseeeeeeeeeceesaaeeeeeseeeesesseaaeeeesaaeees 29 AmM ndmenlS wos oie accreted ee eee ere 30 Making an amendment to an ABR form ccccsececseeeceeeecceseeceececeeecseseecsesessueeesaess 30 Editing a submitted amendment to the ABR fOrm ceccccceeececeeeeeeaeeeeeseeeeesaaeeeseees 30 User manual portal ToetsingOnline Version May 2010 English 6 3 7 1 7 2 7 3 7 4 T9 7 6 7 1 7 8 r9 7 10 7 11 7 12 TAS 7 14 7 19 7 16 LNT 7 18 7 19 7 20 7 21 7 22 7 23 8 1 8 2 8 3 8 4 8 5 8 6 8 8 8 8 9 8 10 8 11 9 9 1 10 10 1 10 2 10 3 Amendments to research proposals submitted before the 1st of March 2006 31 Reporting adverse reactiOnS CVeIts ccccesssescesseeeeenseecesseeeenseesoeseeneenseesenseesonss 32 MrOdUC ON ernari nE E ETE A E 32 NEW SUSAR COO eian e E A A E T 32 Attaching PDF file of report in Eudravigilance database cccccsecceeeceeeeeeeeeeeeeees 33 SAVING Periodical ac eccdanscasnetedYeancnasicabatencaactendecandoceacactue asta A O uectanceunidente ihe 34 Closing the SUSAR OM eraren a a a tt teen ia 34 Opening editing a concept SUSAR fOr n saannnnnonnnnonnnnnonunnnnnrrerernnenesrnrresrnrres
44. he field File number ToetsingOnline including the letters NL CCMO Register Language Taal Dutch Nederlands English Engels Method O Keyword Dossier number ToetsingOnline EudraCT number Advanced File number ToetsingOnline ni161 Query FIELD DossierNummer CONTAINS nl161 1 document found C NL161 National Tick bites study The previous search method can also be carried out with the EudraCT number User manual portal ToetsingOnline page 53 Version May 2010 English 10 4 The advanced search method The Advanced search method gives the opportunity to make use of more than one search options simultaneously It is for example possible to search for all positively reviewed ABR forms per MREC CCMO Register Language Taal Dutch Nederlands English Engels Method Keyword Dossier number ToetsingOnline EudraCT number Advanced File number ToetsingOnline EudraCT number Review committee Select yl Decree date Select DD MM YYYY Decree Select a Is the protocol also registered in another yes public trial register Ono clear Name applicant or contact person for the review committee Type organisation or company Select bi Name organisation or company Other Surname applicant or contact person Sponsor of the research Type company or institute Select v Name company or institute
45. iewed by selecting either the review in the overview screen or the review in the file itself see also 5 1 Review by the ethics committee and or competent authority Concept ABR New submissions Allreviews Current research Allfiles Active files Sharedfiles Archive File number Title Type of review ECICA Ethics Committee Remaining period NL31425 000 10 C2b titel Eerste beoordeling EC CCMO Centrale Commissie 3 days Mensgebonden Onderzoek Den Haag Your research file consists of the following components File The ABR forms are displayed here and in when applicable the EudraCT AF Review ethics committee Here you can find the review s of the ethics committee Decisions ethics committee Here you can find the decisions of the ethics committee uploaded as pdf files Review competent authority Here you can find the review s by the competent authority CA Adverse reactions events Here you can report adverse reaction events which occur during your research See chapter 7 Progress end report This option is not yet in use It will be possible in the near future to upload your progress reports and end reports here Archive Here you can find your deactivated ABR forms Certain file details are displayed at the top of the screen Some of these details are transferred from the ABR form The other details can be filled in by the ethics committee User manual portal ToetsingOnline page 23 Version May 2010 English
46. igital file 4 1 Submitting an ABR form You can submit the ABR form once you have completed all questions and you are ready to submit your research proposal together with the ABR form to the ethics committee To do so click on the option Submit in the toolbar at the top of the ABR form Close Save Delete Submit Help Once you have selected this option a validation process takes place That is to say the system controls whether all the necessary questions have been answered Windows Internet Explorer Errors occured while validating the Form Please correct the Form where stated in red Please note the marked errors will only disappear after saving or submitting the Form again The ABR form is only given the submitted status if no errors are found during the validation process If a compulsory question has not been filled in then the section concerned is opened and the question is marked with red text stating that the question has not been answered correctly E3 Will human subjects require hospitalisation in the context of the research yes the hospitalisation stay in the institute will be extended because ofthe research yes the hospitalisation stay in the institute is required for the research Ono You must select an option Note The red marked text remains after you have correctly filled in the question concerned This only disappears after the validation process has been successful or the ABR
47. imple and can be done by using the printing functionality of your internet browser This creates the so called print screen This is only possible if the ABR form is opened in the read only mode as this is the only way to display all the answers on the screen If you select the Edit option and in doing so change the form into the edit mode it is possible that some longer answers no longer fit in the input fields and will flow over the space supplied If the text is not displayed on the full page you can alter the page settings to landscape This can be done in the page settings of your internet browser After submitting the ABR form you can print the official version see 4 2 Printing Note A print of the screen in which you are filling in your ABR form is not suitable as a print version and can therefore not be used for submission to the ethics committee 3 14 Deleting the ABR form A concept ABR form can be deleted by selecting the Delete option in the toolbar at the top of the ABR form The ABR form is then deleted forever An ABR form which has the status submitted cannot be deleted 3 15 Selecting an ethics committee It is required that you supply information on which ethics committee you plan to submit to your research proposal to Selecting the option Select ethics committee opens a pull down menu where you can select the ethics committee concerned Note it is required you save your ABR form before selecting
48. in 10 Phone O70 Postcode and city 2511 VX Fax Country Nederland Edit account settings Concept ABR New submissions All reviews Current research Allfiles Activefiles Shared files Archive The page consists of a number of tabs views Concept ABR Here you can find your concept ABR form as long as it has not yet been submitted All information on concept ABR forms can be found under 3 2 New ABR form New submissions Here you can find your file as submitted to the ethics committee and or competent authority though which have not yet entered the reviewing process All reviews Here you can find your files which are currently being reviewed by the ethics committee and or competent authority The files are sorted by file number Current research Here you can find your file which has been registered by the ethics committee as having a definite starting date All files Here you can find all files which are categorised in the other views It is also possible in this view to search by EudraCT number and local MREC registration numbers Active files Here you can find all files which have been categorised in the other views except the files which have been placed in the archive Shared files Here you can find the files which other users have been given access rights to Archive Here you can find all files concerning research studies which have ended definitively and research proposals which have been given a neg
49. indow appears where you can once again select Advanced User manual portal ToetsingOnline page 55 Version May 2010 English 10 5 Using queries in the search form The search form contains a field in which queries are displayed Your search Is displayed in this field For example in the query field in the figure below you can see that a search was carried out on bewegingstherapie Keyword Query Field Bewegingth beweging Execute query If you have experience in working with queries then you can use the query field to perform a search The query can be given in the query field according to the standard query rules In this way you can narrow your search After entering the search click on Execute query after which the search result will appear at the bottom of the page The example given below resulted in all studies being found in which both methotrexaat as psoriasis are contained in the ABR form Keyword Query METHOTREXAAT AND PSORIASIS User manual portal ToetsingOnline page 56 Version May 2010 English
50. ing in the research question A6 Next to the report number is a column containing information on whether the suspected adverse reaction has occurred in the study concerned the symptoms the status of the report form concept submitted took notice of and the status date Ca Reviews gt Review EC U002 10 31425 amp Decrees EC concept 5 ess ee r U001 10 31425 REVIEW Ly 04 ag 1 headache Submitted ca Adverse reactions event SUSAR SAE Archive Ca User access amp Overview Manage User manual portal ToetsingOnline page 36 Version May 2010 English 7 12 Editing a submitted SUSAR form follow up You can edit or add to a SUSAR report by clicking on the button Report follow up after opening the report form Close Print Report follow up Help SUSAR form based on ICH E2B Report number U001 10 31425 status Definitief Version 01 status per 01 03 2010 File number NL31425 000 10 Date review Reporter A Mast Final date 01 03 2010 10 55 13 A pop up field appears in which you can give the reason for the report follow up An example of a reason could be that there is additional information on the progress of the event for example the research subject has recovered Using the Report follow up option gives the form a higher version number After you have edited or added to the information in the report form you can save and submit the form 7 13 New SAE report SAEs must be repo
51. ion P decrees then the user selected by you who is to be given read access can view ABR forms EudraCT forms section B and the decrees of the ethics committee and the thereby uploaded decrees section P The overview will look as following Overzicht gemachtigde gebruikers Gebruiker Gebruikerscode Leesrechten Overige rechten Dr U Duinen 949480 Sectie B P After you have set access rights the authorised user will receive an e mail which contains information on the access rights given for the file The authorised user can find your file in the tab Shared files as well as an indication of which sections of the files he she has been given read access to Welcome Dr L Duinen Jser name duinen Company Flevoziekenht Department B1 internal address B1 mail a mast ccmo nl Address jansstraat hone 034334 Postcode and city 2134 aX 056565 Country Nederland dit account settings Concept ABR New submissions Allreviews Current research Allfiles Activefiles Shared files Archive File Title Acces rights for section Other NL31425 000 10 C2b titel B P User manual portal ToetsingOnline page 46 Version May 2010 English Overvew per section Section gives read access to B Forms ABR EudraCT L Safety information SUSAR en SAE SUSAR SAE P Decrees Reviews uploaded decrees The other sections are not yet in use 8 7 Retracting reading access to a file You can retract the access rights of an authorised us
52. ll studies which meet this search requirement are displayed with the NL number and the title of the study The number of documents that meet the search requirement is displayed at the top of the result list with a query field containing code This you can ignore if you are not used to working with queries After selecting the study s you wish to view click on Show selected documents which will open the ABR form concerned The ABR forms displayed appear in a new browser window and are displayed one after the other User manual portal ToetsingOnline page 52 Version May 2010 English CCMO Register Language Taal Dutch Nederlands English Engels Method Keyword Dossier number ToetsingOnline EudraCT number Advanced Keyword lyme Query lyme Execute query Show selected documents Deselect all 1 document found NL161 National Tick bites study Show selected documents Deselect all After reading the content of the form you can close it by clicking on Close in the black toolbar or by clicking on the cross on the browser page Searching in English will result in the sections of the form which are in English being displayed as well as the titles of the studies found You can also search the trial register on file number in the same way as in ToetsingOnline If you already know the file number then choose the search method File number ToetsingOnline and type in the number in t
53. m a tial with medicinal products including gene therapy somatic Medical Research Involving Human Subjects Act Dutch abbreviation WMO 4 yes Ono Add EudratT The EudracT XML file was added successfully lt is also possible to add newer versions of your EudraCT AF to your research file via the link Add EudraC T Doing so allows you to add an extra EudraCT file to your research file Close Edit CCMO Documentation FAQ User manual portal ToetsingOnline page 11 Version May 2010 English You can also replace your present form To do so click on the link to the EudraCT file in your research file under Documents You can also add an edited EudraCT file to a new version of your ABR form 3 8 Importing answers from your EudraCT AF in research with medicinal products If you have filled in the EudraCT Application Form it is possible to import certain answers into your ABR form At Section B at the beginning of the ABR form you can indicate whether you wish to import answers from your EudraCT AF The questions concerned are marked with an EU symbol Bi The answers can still be edited once imported After importing the answer to question B1a is once again set to no However this does not affect the review of the form Note importing answers is not the same as attaching the EudraCT Application Form see 3 7 Compulsory addition of the EudraCT Application Form in research with medicinal products Importing is not
54. mediate reporting necessary To report the adverse event use the SAE form in ToetsingOnline see chapter 7 13 The SUSAR report form makes a distinction between reports already accepted in the Eudravigilance databank hittp eudravigilance emea europa eu and reports not reported in this databank SUSARs already reported to the EMEA Eudravigilance databank do not have to be reported again to the competent authority and the CBG as they have direct access to the Eudravigilance databank In this case only the questions A1 to A7 B1 B5 and B6 of the SUSAR report form should be filled in and can be attached as a pdf to the report All other SUSARs must be reported by completely filling in the SUSAR report form After the form has been submitted an xml file is generated which is sent to LAREB The LAREB ensures that your report is entered in the Eudravigilance databank The LAREB employees may contact you for additional information If this leads to changes to the SUSAR report form you will be requested to make a new version of the SUSAR report form in ToetsingOnline Note Reporting to the CBG and competent authority is no longer necessary if you have reported the SUSAR in ToetsingOnline Every medical research carries the risk of serious advent events SAEs These can also be reported in ToetsingOnline see chapter 7 13 7 2 New SUSAR report To report a new SUSAR log in to ToetsingOnline and open the concerned file number The page Re
55. n the link in the e mail will take you to an internet page where you can change the temporary password in a chosen password Your chosen user name and password will be the information you use to log into ToetsingOnline after registration is completed The link in the e mail is purely for altering your password Once you have altered your password you can log in directly to https toetsingonline ccmo nl If you do not receive the e mail with the link for altering your password contact the CCMO lt is possible to create more than one file and therefore more ABR forms under the same user name There is no need to register repeatedly every time you wish to create a new file The information you supply for your registration is automatically entered in each ABR form that you create It is however possible to alter this information on the ABR form User manual portal ToetsingOnline page 1 Version May 2010 English 1 2 Altering present information If you wish to alter your information after registration then you can do so on the registration page The registration page can be accessed by logging into ToetsingOnline and selecting Edit account settings at the top of the page You can edit all information except your user name Welcome A Mast User name mast E mail a mast ccmo nl Phone Fax Edit account settings Concept ABR Newsubmissions Allreviews Currentresearch All files User manual portal ToetsingOnline page 2 Version M
56. nd review LJ J Additional remarks LIK Summary LIL Sianature L History show selected sections The sections which are displayed at the top of the ABR form can also be used as hyperlinks Clicking on the underlined text allows you to navigate to that particular section It is also possible to pull down the sections in the ABR form by clicking on the blue triangle displayed before each section This option only works in Internet Explorer YB Section Administrative A link go to top is displayed at the end of section Clicking on this link takes you back to the selection list Go to top Save 3 4 ABR form toolbar A toolbar is displayed at the top of the ABR form which contains a number of options The options displayed depends on the status of the ABR form Opening a concept ABR form which has previously been saved opens the form in read only mode You can alter the ABR form by selecting the Edit option Close Edit Delete Submit Setaccessforothers Help User manual portal ToetsingOnline page 8 Version May 2010 English Selecting the Edif option also alters the options in the tool bar Close Save Delete Submit Help The Save and Help options serve as pull down menus Close Save Delete Submit Documentation ABR form version Septer a 3 5 Help A list of frequently asked questions FAQ is displayed in the black toolbar which serves as further assistance t
57. nly given the status submitted if no errors are found during the validation process If a compulsory question has not been filled in the section concerned is opened and the question concerned is marked with red text telling you that the question has not been completely answered Note Once you have properly filled in the question the red text remains displayed The text only disappears after the validation process has been successful or you save the report form After successful submission of the report form the form can no longer be edited or deleted However you can still make a follow up report see also 7 12 Editing a submitted SUSAR form follow up 7 10 Printing a submitted report form Once you have submitted the report form you can print it if you so wish To do so select the Print option in the black toolbar which will start the print functionality of your internet browser 7 11 The coding of the submitted SUSAR form Once you have successfully submitted your report form and have closed it all reports can be found under the link SUSAR A red cross or red exclamation mark may be displayed at the left of the report number This is a reference to question B6 and gives an indication of the gravity of the effects A red cross refers to an adverse reaction which is life threatening or can be fatal a red exclamation mark indicates that the adverse reaction can have consequences for the safety of the research subject participat
58. nnerenene 34 Panting a Concept FE DOM TON Usccstccncieccese secntnhivicnauntmatectatennieiaientarneiactudeucehadectiedeaa phe 35 Deleng A VOOM TOR ated cianeraahevainencsameliennclannctia A A E 35 SuUDMIttinG a SUSAR TON seencoteuece neseeniesscduedausiaushenseusinavsenaheeedianedteusseouneensr ustedes 36 Printing a SUBMITTER report TON icsretescztcecondts edccurdosearohcsicets ante deeaelecembeedsecedecdousicedesle 36 The coding of the submitted SUSAR fOrM cccccceeececeeeeeeeeeeeeeeeeseeeeeeseeeeeeeeeaeeees 36 Editing a submitted SUSAR form fOllOW UDP cccceceeeeeeeeeeeeeeeeseeeeeeeeeeeeeeseaeeeeeeas 37 NOW SAE COON reaa E EE EE se ducdudecees 37 PeROGICAIV SAVING ail SAE ORM reeniri a a a seme 37 closmg ani SAE TEDO TON kerren ena TE EE EREA 38 Opening editing a concept SAE TONM seserian ena ATE Ea ETTE EEE 38 PMB Gall SAVE report NOU eonia E tauren acs 38 DElETING an SAE report TONM sesser aieea ER RE SpA EEEE 39 SuUDMNG An SAE TOM aeaa E mecadtenevuntenmusereseaceebacnadelanetacas 39 Thecoding of a submitted SAE TOrM iscsi a 39 Editing a submitted SAE form follow up cccccccseececceceeeeeeeeceeeesseueeesseeeeeaeeeessaes 39 Printing a Submitted report form cceeeeccsseeeeceeeeeceececseesecceuseecsueeessegeesseueeeseeeessags 40 Review pE MRE G sire S 40 PACCOSS TIGIS irrena a a aa aE 41 MOGUCOM cernar E OE E N 41 USE COTO sence ere a cae ese T Ree eee eee ee eee ee 41 Overview of types Of A
59. o this user manual Form for medical ethical review and reg Help texts can be found at a number of questions in the ABR form You can open these help texts by clicking on the question mark symbol H displayed at the end of the question 3 6 Publication of information As of the 1st of November 2009 certain information from each ABR form is made public The questions concerned are marked with a globe symbol The core information from the ABR form are automatically entered in the CCMO public register after the CCMO has received and processed the review by the ethics committee For more information on the publication of information see hitp www ccmo nl 3 7 Compulsory addition of the EudraCT AF in research with medicinal products In the case of research with medicinal products including gene therapy somatic cell therapy and GMOs see further information at question B1 the EudraCT Application Form must also be submitted to the ethics committee and the competent authority as well as the ABR form You can find the form at htip eudract emea europa eu More information on this subject can be found at http Awww ccmo nl We advise filling in the EudraCT AF first before you fill in the ABR form as it is only possible to submit the ABR form after the EudraCT AF has been attached User manual portal ToetsingOnline page 9 Version May 2010 English B1 Does the research concern a trial with medicinal products including gene therapy
60. of human subjects 3 10 Saving periodically lt is advised you save your ABR form periodically This prevents the loss of information if your internet connection were to suddenly disconnect or if an unexpected error were to occur Note It is also required you save the ABR form before selecting an ethics committee The Save option can be found in the toolbar at the top of the ABR form and at the end of each section There is an additional Save button at Add centre and Select ethics committee Go to top ave 3 11 Closing an ABR form You can close the ABR form by clicking on the option Close in the toolbar at the top of the ABR form or if you have not yet saved your ABR form by clicking on Save amp Close found under the Save button Close Ves Delete Submit Deblock info Form Tole a a tt wand registration ABR form version September 2009 3 12 Opening editing an existing concept ABR form All previously created ABR forms can be found in your personal page under the view Concept ABR Selecting an existing ABR form opens it in the read only mode Selecting the User manual portal ToetsingOnline page 13 Version May 2010 English Edit option allows you to edit and or add information The Edif option can be found in the toolbar at the top of the ABR form Close Edit Delete Submit Help 3 13 Printing a concept ABR form Printing a concept ABR form is s
61. on the screen Selecting the Edif option places the form in the edit mode which can result in some long answers not fitting in to the input fields and flowing over on to the page If the text is not displayed on the full page then you can change the page settings to landscape To do so use the page settings of your internet browser After you have submitted the report form you can print the official version see also 7 10 Printing the submitted report form 7 18 Deleting an SAE report form A report form with the status concept can be deleted by selecting the Delete option in the toolbar at the top of the report form The report form is then deleted forever A report form with the status submitted cannot be deleted 7 19 Submitting an SAE form You can submit the report form after all questions have been answered To do so click the option Submit in the toolbar at the top of the report form The report form is only given the status submitted if no errors are found during the validation process If a compulsory question has not been answered then the section concerned opens and the question concerned is marked with red text stating that the question has not been completely answered Note after the questions has been answered properly the red text remains displayed It only disappears after the validation process is successful or you have saved the report form After submitting the form you can not edit or
62. oncept status per File number NL314275 000 10 Date review Reporter A Mast Modification date 30 03 2010 7 7 Printing a concept report form You can print a concept report form by using the print functionality of your internet browser Doing so makes the so called print screen Only the report form in the read only mode is suitable for printing as this displays all of the answers in the screen Selecting the Edi option places the form in the edit mode and it is then possible that some of the long answers will not fit in the input fields and will flow over onto the page If the text is not displayed on the full page then you change the page settings to landscape to print Use the page settings of your internet browser to change the page view After you have submitted the report form you can print the official print version see also 7 10 Printing a submitted report form 7 8 Deleting a report form A report form which has the status concept can be deleted by selecting the Delete option in the toolbar at the top of the report form The report form is then deleted forever A report form with the status submitted cannot be deleted User manual portal ToetsingOnline page 35 Version May 2010 English 7 9 Submitting a SUSAR form You can submit the report form once you have filled in all compulsory questions To do so select the option Submit in the toolbar at the top of the report form The report form is o
63. ons of the file You can set read access for your file from within the file concerned To do so open the file and click on Manage in the menu on the left 6 File File Reviews z9 B Forms Review EC B1 ABR Form Decrees EC 01 C2A titel active Submitted 25 Jan 2010 02 C2A titel Concept 12 May 2010 6 See B5 EudraCT files Gm Adverse reactions event test EudraCt 01 Jan 2010 E SUSAR cs aa Pia Primaire besluiten SAE test 01 Apr 2010 Archive test 06 Apr 2010 Ca User access amp Overview gt Manage A window opens where you fill in the user code of the user to be authorised Authorise other users for this file File number NWL31425 000 10 Title C2b titel Local registration number User code Name After entering the user code select Search and the name of the user to be authorised will appear on your screen On the left hand side of the menu you can set read access for sections of your file User manual portal ToetsingOnline page 45 Version May 2010 English Read access Sp ancees W FB Forms Ll Report SUSAR and SAE CIL Safe ty information Le SUSARISAE C View SUSAR and SAE re ports unblinded see details on blinded reports CIP De we es Cl view SUSAR and SAE reports blinded see overview of blinded reports only Select all Deselect all Click on Save to enforce the selected access for this user on this file If you choose Section B forms and Sect
64. rted to the reviewing ethics committee accredited MREC or CCMO To report a new SAE log in to ToetsingOnline and open the file by clicking on the file number Then select the option Adverse reactions events in the list of links on the left Then select then the Create option in the black toolbar at the top of the page and subsequently the pull down menu Create SAE If you select the option Adverse reactions event it is also possible to select SAE in the same overview menu You then select Create SAE in the toolbar Each new report is given a unique report number which is preceded by the letters AE The number consists of the report number followed by the year in which the form is filled in and the first give digits of the file number 7 14 Periodically saving an SAE form lt is advised to save the SAE report form periodically This prevents the loss of information is the internet connection were to suddenly disconnect or an unexpected error were to occur You can find the Save option in the toolbar at the top of the SAE report form and at the end of every section User manual portal ToetsingOnline page 37 Version May 2010 English 7 15 Closing an SAE report form You can close the SAE report form by selecting the C ose option in the toolbar at the top of the form or if you have not saved the form by selecting Save amp close under the Save button 7 16 Opening editing a concept SAE
65. s Concept A concept ABR form can be User manual portal ToetsingOnline page 21 Version May 2010 English added to edited or deleted You can find your concept ABR form in the Concept ABR window More information on concept ABR forms van be found in chapter 3 New concept ABR form Submitted You can submit a concept ABR form when you are ready to submit your research proposal to the ethics committee A submitted ABR form can no longer be edited or deleted You can however make a new version More information on submitting ABR forms can be found at chapter 4 Submitting an ABR form and digital file Deactivated If you have submitted a new version of an amendment of an ABR form to the ethics committee then it is possible that they activate the new version or amendment Only the active version of the ABR form is displayed in the Documents window New versions and amendments van be found in the window New edited documents Deactivated ABR forms van be found in the Archive window A positively reviewed ABR form is automatically active and any other versions of the form are deactivated Reviewed After the ethics committee has reached a decision regarding the review of your form it is given the status reviewed with the date of the decision Positively reviewed ABR forms are automatically activated Negatively reviewed ABR forms are deactivated and placed in the archive of the file see also 4 8
66. s for a previously reviewed ABR form then you can create an amendment in your ABR form Only ABR forms with the status Reviewed Positive or Took notice of and which are therefore active can be amended see also 4 7 Status ABR form To make an amendment open the present active ABR form and select the option Make amendment in the toolbar at the top of the ABR form Close Print Make amendement Help You will then be asked to give a reason for making the amendment A new version of the ABR form is made and all your original answers are retained This amended ABR form is given a higher version number and can be saved periodically as a concept see also 3 11 Closing an ABR form A concept ABR form can be printed see also 3 13 Printing a concept ABR form and submitted see 4 1 Submitting an ABR form It is possible to delete a concept ABR form see also 3 14 Deleting the ABR form however a submitted form cannot be deleted Not all questions can be edited in an amendment Some are blocked See 4 5 Blocking of questions on the ABR form 6 2 Editing a submitted amendment to the ABR form You can only make one amendment at a time For any changes to this amendment during the review process you can make a version of the submitted amendment ABR form see also 4 4 Editing a submitted ABR form New version After the ethics committee has positively reviewed the amendment or higher version the amendment ABR form is displ
67. search file will open Next select the option Adverse reactions event in the left navigation window Then select the option Make in the black toolbar and select Create SUSAR User manual portal ToetsingOnline page 32 Version May 2010 English File details File number NL25 Coordinator EC Local registration number Applicant A Mast Date review 06 03 2009 Title in English Result review Besluit Positief Ethics committee TC Breda Final start date 01 02 2010 Competent authority Expected end date 31 12 2011 Status Lopend SUSARs Ca Reviews Review EC U001 09 25525 SF Decrees EC 02 uitbreiding uitslag Open bijlage Took Notice Of 01 06 2010 E Review CA O41 uitslag Open bijlage Took Notice Of 01 06 2010 Gm Adverse reactions event SUSAR gt SAE i Archive Gm User access Overview amp Manage In the SUSAR window select the option Create SUSAR in the black toolbar Close Create SUSAR Help Each new report is given a unique report number which is preceded by the letters SU The number consists of the report number followed by the year in which the form is created and the first five digits of the file number Close Edit Delete Submit SUSAR form based on ICH E2B Report number U002 10 31425 Status Concept Version concept Status per File number NL31425 000 10 Date review Reporter A Mast Modification date 30 03 2010 A Section Administrative A1 Whatis the ToetsingOnlin
68. uding the number of days it took the ethics committee or competent authority to complete the review When the ethics committee requests additional information the timeline is suspended When the timeline is suspended a difference occurs between both these numbers User manual portal ToetsingOnline page 28 Version May 2010 English 5 2 Stating the decision of the ABR form After completion of the review the status of the reviewed ABR form is altered The ABR form can have one of the following types of status Reviewed Positive Reviewed Negative Took notice of Retracted Not WMO research or research on embryos An ABR form with the status Reviewed Negative Retracted or Not WMO research or research on embryos is automatically deactivated together with any versions and transferred to the file archive The ABR form which has been given the status Reviewed positive or Took notice of is automatically active and transferred to Documents Any other versions are deactivated and transferred to the file archive see also 4 7 Status ABR form and 4 8 Research file User manual portal ToetsingOnline page 29 Version May 2010 English 6 Amendments 6 1 Making an amendment to an ABR form After the first review has been completed you can submit amendments to the ethics committee and in the case of research with medicinal products to the competent authority lf an amendment has consequence
69. w O2 slang verkeerd gemonteerd Archive Note a combination of blinded and unblinded viewing access to SUSARs and SAEs is not possible User manual portal ToetsingOnline page 49 Version May 2010 English 8 11 Giving access rights to report adverse reactions and to view overviews You can authorise users to report adverse reactions and to view these reactions and those reported by other users in an overview These access rights can be set in the file itself To do so open the file and click on Manage in the left hand menu see also chapter 8 6 You then fill in the user code of the user to be authorised and click on Search The name of the user will appear in the screen You can set access rights for reporting SUSARs and SAEs in the right hand menu by clicking on the option View SUSAR and SAE unblinded see details on blinded reports Other access 6 Report SUSAR and SAE View SUSAR and SAE reports unblinded see details on blinded reports View SUSAR and SAE reports blinded see overview of blinded reports only Click on Save to enforce the selected access for this user on this file If you have chosen the option Report SUSAR and SAE in combination with the option View SUSAR and SAE unblinded see details on blinded reports then the authorised user will be able to report SUSARs and SAEs and view the SUSARs and SAEs reported in the study The SUSARs SAEs and the attachments can also

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