TrialDriver Visual Data Management for Global Clinical Trials
Contents
1. 999 006 NOT REGISTERED 999 007 NOT REGISTERED 999 008 NOT REGISTERED Supplementary Documents 999 009 NOT REGISTERED 999 010 NOT REGISTERED 999 011 NOT REGISTERED 999 012 NOT REGISTERED Enter CRF Data CRF data updated Connection Server RRRSRRBERIAE A Selecting a Subject for Data Entry Select one of your registered or enrolled subjects from the subject list and double click it or click the Enter CRF Data link Don t forget e A SCREENING subject will only have the CRF screening visit e An ENROLLED subject will have the entire CRF book lf TrialDriver E CRF 3 5 6 2 connected to study TD 103 LOCAL as user davidshepherd using server TD103_LOCAL 192 168 178 9 7 iol x Fie Extras Help FI Exit this Stud TrialDriver E CRF Electronic Investigator Forms for Global Clinical Trials TD 103 LOCAL Database Q View Study Website TrialDriver Reference Study Hybrid EDC PAPER v Email Study Management David Shepherd 99 Princeton Esthetic Dermatology Refresh List ae Help and Instructions Please select one of your assigned subjects to register and or enter CRF data Subject 1 initials Status Phase Registered Pages Todo Ready submit Sov QueesSSOCOC CSCSC C S S S S S Y 99 001 gt REGISTERED SCREENING 2012 09 21 16 0 0 0 99 002 gt ENROLLED TREATMENT 2012 09 29 36 2 6 o 99 003 NOT REGISTERED 7 s004 NOT REGISTERED Click this link to perform data2. match Once the monitor has verified an E CRF page that page is completely locked and its data cannot be modified not even if a reason for change is given If a page must be modified the monitor must revoke the verification which then enables the page again After the change has been made the verification process must be repeated A V icon next to a page indicates that SDV has been completed for that page No further changes can be made lj TrialDriver E CRF 2 9 0 2 connected to study TD 101 as user monitor using server TD101ET gcplink3 net MONITORING Screening Visit Patient Information i IPAGEO3 1 Prior and Concurre i i I PAGEO4 Birth Control Informati i L MPAGEOS Lesion Count i pue WM PAGEOS6 Erythema Assessment pee E PAGE0O7 Inclusion Criteria i PAGES Exclusion Criteria i i IPAGEOS Exclusion Criteria co Labs and Pregnancy T i i IPAGE10 i ap 1 Comments 2 Comments lt lt i heJ PAGEL 4 TREATMENT Treatment visit io be PAGE12 Patient information i buu MPAGE13 New or Changed Adve pee MPAGE14 New or changed Conc i i PAGE15 Lesion Count i er MPAGE16 Erythema Assessment i pee MPAGE17 Chromameter Measur i au MPAGE18 Chromameter Measur MPAGE19 Chromameter Measur kl PAGE2O 1 Comments GENDSTUDY End of
3. 0 DAVID SUBMIT 06 007 PAGE15 1 PAGE VERSION 1 2010 04 09T20 54 59 DAVID SUBMIT 06 007 PAGE16 1 PAGE VERSION 2 2010 04 09T20 54 59 DAVID RFC 06 007 PAGE16 1 RFC sss 2010 04 09T20 54 59 DAVID CHANGE 06 007 PAGE16 1 FIELD TTSCORE 0 8 CHANGED TO 9 2010 04 09T20 56 23 DAVID SUBMIT 06 007 PAGE16 1 PAGE VERSION 3 x Copy to Clipboard a ea E CIR SSA eee CLOSE Print Blank CRF Choose this option to display a PDF of the entire CRF The PDF will not contain any subject data Supplementary Documents Supplemental Documentation Choose this option to display a list of supplemental MEDWATCH3500 FDA Medwatch SAE Report Form documentation associated with this study Theseare a cpt tel ee ee etet hi pele arate teal TD 101 PROTOCOL Study Protocol for study TD 101 PDFs which pertain to the study but are not part of the CRF proper Select a document and click the OPEN button to display it in the PDF viewer from where it may be saved or printed Select a document and click OPEN to view and or print a document OPEN Cancel
4. 99 005 NOT REGISTERED 99 006 NOT REGISTERED 1 1 99 007 NOT REGISTERED e nt ry fo r a S u bj e ct S u bj e ct 99 008 NOT REGISTERED EON auld pace dace or double click the subject list entry 99 010 NOT REGISTERED 99 011 NOT REGISTERED 99 012 NOT REGISTERED 99 013 NOT REGISTERED 99 014 NOT REGISTERED 99 015 NOT REGISTERED 99 016 NOT REGISTERED S Enter CRF Data Logged in to study TD 103 LOCAL as user davidshepherd Connection Server Macame 14m h Navigating the E CRF main Screen The E CRF screen is divided into 3 main areas TrialDriver E CRF User Manual v3 5 gt At left is the CRF Table of Contents TOC Click an entry in this list to display the corresponding CRF page Beneath the TOC are controls which allow to create repeating pages and sections create PDFs and submit CRF data gt In the middle is the image of the CRF page overlaid with interactive data input fields Page Zoom controls are at top gt At right is Data Entry Assistance panel and the Reason for Change box which enables data re entry for pages which have already been submitted lf TrialDriver E CRF 3 5 6 2 connected to study TD 103 LOCAL as user davidshepherd using server TD103_LOCAL 192 168 178 9 File Extras Help Man Pma v beccrnton GQSCREENING i PAGEO01 CRF Table of EPAGEOO2 HE PAGE003 Contents Erana i pempaceoos i pem PpAaceoo6 i pem pace
5. All toe fie Eaa ne a Aion ee button ii 2 Ameriqon Indian E Alaskan Native X Orher Pedy R iew CRA Queries B Wiew Source Documents rE Scan Upload Documents gt CRF Sign Off 4 PR if Finally click the Sign Off button Any 4 CRF Sign Off L ee ee ee ee remaining pages and visits will be marked Oy eee Bee tery wee ryan oe bl k d b itt d t D t O gyscREENING Empty pages require confirmation before sign off ank ana submitte o Vata For any items which are not done E D CYCLE 1 Empty pages require confirmation before sign off Management The CRF will be locked j your confirmation is required Place a ae O CYCLE 2 Empty pages require confirmation before sign off checkmark on the relevant item or o i from fu rther cha nges i click Confirm All Click Refresh if ni m CYCLE 3 All pages ready for sign off CRF section will be m you update CRF data E O FINAL Empty pages require confirmation before sign off sign off and tock cnr F o ADY Empty pages rendre confemanen pebre soro waj Legend OK for Sign Off E Confirmation required K Cannot Sign Off TrialDriver E CRF User Manua f 2 C V3 9 s Creating PDFs You can create PDFs of the CRF pages at any time These can then be saved to your local disk printed or emailed PDFs are created which display the data you have entered Click the PDF button in the Page Controls area This will bring up a dialog which allows you to determine Y which pages shou
6. Informed Consent EP2012 Demographics 99 1002_ D S_ 20SEP2012 Pregnancy Test e g y S EDC Page is ready for submission gt K gt Informed Consent Informed Consent signed prior to any study related procedure Jno Xhres Date amp Time of Informed Consent 29SEP2012 a Demographics Race E iii im PAPEN ak one Native H only ial Asien or Ponie Islander lo American Indion BB Alaskan Native Xi omer ety BRITISH Date of Birth 20JAN1977 DD MMM YYYY Gender K Male A Female Please complete below Ethnicity A Hispanic or Latina K Mot Hispanic or Latino gt Pregnancy Test Is patient of childbearing potential Kvo Bws Bo Bes Ba Ld Leos Lwc wv NOTE If the pregnancy test is positive the subject cannot be enrolled in this study Was a pregnancy test performed Pregnancy Test Result 15 x Close this CRF Data Entry Assistance Data Entry Instructions Warnings Reason For Change Show Hide Detail Windows Navigating the E CRF visit Summaries Clicking on a Visit item in the E CRF Table of Contents displays a Visit Summary TrialDriver E CRF User Manual v3 5 gt The list display the page name page status submission and SDV details and the page description gt Some visits but not all are allowed to be marked Not Done in this case extra controls will appear on the visit summary sheet if a subject terminates early this can be useful to mark a
7. ON 2010 03 10T15 05 54 DAVID CHANGE 06 007 PAGE112 1 FIELD COVAL 1 CHANGED TO SDFSDFA t h t b A t 2010 03 10T15 05 54 DAVID CHANGE 06 007 PAGE112 1 FIELD COINIT 1 0 CHANGED TO 1 e C u r re n S u J e C 2010 03 10T15 05 54 DAVID CHANGE 06 007 PAGE112 1 FIELD CODTC 1 CHANGED TO 031010 u A 7 2010 03 10T15 07 00 DAVID SUBMIT 06 007 PAGE11 1 PAGE VERSION 3 Choose Co py to Clipboa rd to CO py the list InN a com ma 2010 03 10T15 07 00 DAVID RFC 06 007 PAGE11 1 RFC ddd 2010 03 10T15 07 00 DAVID CHANGE 06 007 PAGE11 1 FIELD COREF 2 CHANGED TO 3 d s it d f t it b f d H s t E 2010 03 10T15 07 00 DAVID CHANGE 06 007 PAGE112 1 FIELD COINIT 2 0 CHANGED TO 1 e m e O r m a s u a e O r O a n g n O XCe 2010 03 10T15 07 00 DAVID CHANGE 06 007 PAGE11 1 FIELD CODTC 2 CHANGED TO 031010 2010 03 11T10 51 28 MONITOR VERIFY 06 007 PAGE11 1 MONITOR 2010 03 11 08 10 Double click any list entry to hype rlink to the associated data 2010 03 11710 52 01 MONITOR VERIFY 06 007 PAGE11 2 MONITOR 2010 03 11 08 12 2010 03 117T11 14 48 DAVID SUBMIT 06 007 PAGE11 2 PAGE VERSION 1 fj d if bl 2010 03 11T11 14 49 DAVID SUBMIT 06 007 PAGE20 1 PAGE VERSION 2 ie l a p p ICa e 2010 03 11T11 14 49 DAVID RFC 06 007 PAGE202 1 RFC sdaffs 2010 03 11T11 14 49 DAVID CHANGE 06 007 PAGE2021 FIELD COINIT 1 0 CHANGED TO 1 2010 04 09T20 49 18 DAVID SUBMIT 06 007 PAGE16 1 PAGE VERSION 1 2010 04 09T20 53 4
8. Study i E PAGE21 End of Study GQUNSCHEDULED 1 Unscheduled visit i i PAGES1 Information i i IPAGES2 New or Changed Adve i BM PAGES3 New or changed Conc UNSCHEDULED 2 Unscheduled visit i bili DAGEO1 Information E Legend E Invalid data Unverified H Validated Ready V Verified E Submitted REPEAT PAGE Repeat the selected CRF page REPEAT SECTION Repeat the selected study section OPTIONAL SECTION Add an optional section to the CRF Ox A CLOSE PDF SUBMIT Subject 06 007 PAGE02 Investigator Number Patient Number Potient Initials Does the patient have ony relevant history in the following systems For each system place on X to indicate YES or NO When YES is selected enter the system CODE number below followed by a description of the diagnosis or procedure 01 Skin 02 Central Nervous System 03 Ophthalmologic O4 Ears Nose ond Throat 05 Respiratory 06 Gastrointestinal TrialDnver Reference Study Screening Visit Medical History amp Concurrent Conditions if page intentiona liy lett blank E K the bor 07 Hepatic 06 Cardiovascular 09 Renal 10 Genitourinary 11 Mesculoskoletal 12 Hematologic X 14 Alcohol Drug abuse 15 Tetrocyclines allergy l sae Diagnosis and or Procedure DEPRESSION i O sore THROAT isisidCd THROAT CRF data updated A green bar a
9. TrialDriver Visual Data Management for Global Clinical Trials Electronic Investigator Forms E CRFs for on site data entry and global data transmission User Guide Version 3 5 www trialdriver com The Basics TrialDriver E CRF User Manual v3 5 TrialDriver E CRF were conceived to leverage the experience that clinical investigators and monitors already have with paper CRFs The on screen metaphor of a paper based CRF book is maintained throughout Data is entered into interactive CRF fields and is validated at every keystroke color coding displays the validation status Data is entered and saved continuously online When ready it is submitted to the study database in a batch mode PDF printouts of CRF pages patient CRF books and blank CRFs are all available on demand Source Document Verification can be performed remotely online or on site against printed copies of the electronic forms in the same way as in any other paper based study Full 21CFR11 compliant audit trails are maintained locally and on the central study server CRF Table of contents CRF Page Controls Ip TrialDriver E CRF 2 9 0 2 connected to study TD 101 as user david using server TD101ET gcplink3 net File Extras Help E Lal td z Save Page x Close this CRE Subject 06 007 PAGEO1 GQSCREEN Screening Visit i i PAGEO Patient Information i PAGEO2 1 Medical History i IPAGEO3 1 Prior and Concu i i PAGEOS Birth Cont
10. ZO 1 Comments J J ENDSTUDY End of Study Some studies may contain optional or unscheduled PAGE 1 End of Study sections which do not automatically appear in the 4 PAUNSCHEDULED i Unscheduled visit subject CRF To include such a section click the _ BPAGES1 Inkoamation OPTIONAL SECTION button This will open a BIPAGES92 New or Changed Ad F selection list containing all such sections which are Legend defined for the current study r TEA f Invalid data Unverit Validated Ready W Verified 21x B Submitted Please select the optional section ees E a you wish to include in this CRF Repeat O T eil et Repeat the selected CRF page C REPEAT SECTION Repeat the selected study section UNSCHEDULED Unscheduled visit ontrols OPTIONAL SECTION Add an optional section to the CRF Optional Sections Dialog TrialDriver E CRF User Manual v3 5 Submitting Data to the Study Server How to submit data When all the fields on a page are displayed in GREEN this means that the page is ready to be submitted to the study server Click the SUBMIT button at bottom right to initiate the data submission process There is no necessity to submit pages one at a time all pages which are ready for submission will be submitted at once A dialog is displayed which tracks the progress of the data submission at the end a message is displayed Data successfully submitted If an error message is displa
11. as SCREENING otherwise the subject status will be ENROLLED To complete enrollment for a Screening subject click the Enroll this Subject link Register subject 06 0038 Enter 3 characters for subject initials lf TrialDriver E CRF 3 5 6 2 connected to study TD 103 LOCAL as user davidshepherd using server TD103_LOCAL 192 168 178 9 File Extras Help Use a dash if initial is unknown TrialDriver E CRF Electronic Investigator Forms for Global Clinical Trials Sy bj ect Initi a ls TD 103 LOCAL Database Q View Study Website re TrialDriver Reference Study Hybrid EDC PAPER email Study Management David Shepherd 99 Princeton Esthetic Dermatology Refresh List ay Help and Instructions 99 001 gt REGISTERED SCREENING 2012 09 21 16 16 0 o o 99 002 DS gt ENROLLED TREATMENT 2012 09 29 36 28 2 6 18 99 003 NOT REGISTERED 99 004 NOT REGISTERED 99 005 NOT REGISTERED 99 006 NOT REGISTERED 99 007 NOT REGISTERED 99 008 NOT REGISTERED 99 009 NOT REGISTERED 99 010 NOT REGISTERED 99 011 NOT REGISTERED 99 012 NOT REGISTERED 99 013 NOT REGISTERED 99 014 NOT REGISTERED 99 015 NOT REGISTERED 99 016 NOT REGISTERED Click this link to register a subject or double click an unregistered subject A amp Register this Subect Logged in to study TD 103 LOCAL as user davidshepherd Connectio
12. atology Refresh List Z Help and Instrug ons Subject 1D Initials status Phase Registered Pages ToDo Ready submit sov Queries nn TrialDri TrialDriver Reference Study TD 102 99 001 XYZ gt REGISTERED SCREENING 2012 09 21 16 16 o o o Z ria river 99 002 D S gt ENROLLED TREATMENT 2012 09 29 36 28 2 6 3 CNEAS 2 AWAITING RESPONSE Reference Study 99 003 NOT REGISTERED Date of Sreening 99 004 NOT REGISTERED Informed Consent Saas i EU EET E EE F Demographics 20 S A of Cc ie 39 006 NOT REGISTERED nE s aH oer 99 007 NOT REGISTERED Pregnancy Test 99 009 NOT REGISTERED 99 010 NOT REGISTERED gt Informed Consent Informed Consent signed prior to any study related knara iz NO Xess il al PRN TE ee E Open the View Queries window by clicking Date amp Time of Informed Consent 2 9SEP2012 the button beneath the CRF image gt Demographics Do MMM YYYY A White E African American Chadt one Notive Howalian only A Asien or Poi islander BB American Indien E Alaskon Native Kow BRETISH Queries are listed in the left hand panel Select a query to view the query text Double Click a query to navigate the CRF to the queried item View CRA Queries B View Source Documents E Scan Upload Documents a CRF Sign Off 4 DOUBLE CLICK A LIST ENTRY TO NAVIGATE TO THE CRF ITEM QUERY TEXT FROM CRA DAVIDSHEPHERD Text Enter y
13. ble transdermal or injectable cortrocepive i lili PAGE20 1 Comments LI EA oe i Meeogamous e p partner FY GIENDSTUDY End of Study Abstinence Sis anaa bela o72610 MPAGE21 End of Study Other please specity below GUNSCHEDULED 1 Unscheduled visit lmPAGES Information Satya i PAGE92 New or Changed Ad x Legend E Invalid data Unverified k B Validated Ready V Verified I Submitted REPEAT PAGE Repeat the selected CRF page 4 REPEAT SECTION Repeat the selected study se OPTIONAL SECTION Add an optional section to t E x Use the SUBMIT i button to start data Eb m transmission Loading reference image PAGE04 SUBMIT Source Doc Verification Connection Server McDan A TrialDriver E CRF User Manual v3 5 Submitting Data to the Study Server after data are submitted During data transmission a dialog is displayed indicating the progress When the transmission is complete a message is displayed which allows you to choose to create a PDF of the submitted pages This PDF can then be printed and the hard copies stored in the subject dossier For reference the CRF page is imprinted with the date and time of transmission Choose OK is you do not require a PDF at this point you can create the PDF later if you wish om ple Mote ony clinically significand results in adka History sample colle All Items submitted i Click PRINT to print paperhardco
14. bove the page indicates SDV completed 13 Endocrine Lymphatic X 18 i aali Place a check mark here to indicate that a page is verified Save Page X Close this CRF Data Entry Assistance Source Doc Verification Help and Instructio SITE MONITORS ONLY Note Once a page has been marked as verified no further changes can be made to that page If the page data needs to be modified first remove the SDV checkmark then have the investigator make the Subject 06 007 paceo2 _ SDV by MONITOR on 2010 07 on beii bd sv 30 08 58 TnalDnv or Reference Shady Page 2 k 4 gt screening Vise Medical History amp Concurrent Conditions 072610 Tb we erway d ore vale YES o WO oceunphoe d te digs o proceden m S NO ix 13 indsessn ympbsx rw oikani Pistary ie ho bellowing sre for arh seam ple on T v the saen CODE nantes bion bilowed by K mrd hern Spit 18 Cashews WA Abella dua D fatretieseg 9 ena 15 araoc allergy O fers Never and The nat V Ger desiony XI ii Ote depelienyy E gem U Bausesrstri ix 1 Syrena intone E Icar NAaniio A2 D RF User Manua V3 9 J Miscellaneous Options Some miscellaneous options are available under the menu option Extras These are View Audit Trail ae eee aes Select this option to display a list of all logged operations for toctime username OPERATI
15. en provided to you by the data management team Based on the user name you provide you will be presented with a list of studies to which you have access IMPORTANT The TrialDriver E CRF client requires internet access at all times LOGIN TO E CRF ioi xi TrialDriver E CRF Electronic Investigator Forms for Global Clinical Trials 1 Enter your assigned user name then First enter your username then select a study and enter your password User Name davidshephera 2 Select the study Online help is Studies available in all awa with which you screens where you cry TD 103 LOCAL TD 103 Reference Study want to work then see this message Test Study Connection Password LOGIN 3 Enter your password and click the LOGIN button Connection Server tdconnect info h Logged out of study If this box is green then your internet connection is good Registering and Enrolling Study Subjects TrialDriver E CRFs can include CRF books for multiple subjects The subjects are pre configured by data management and are presented in a list At first all subjects are marked as NOT REGISTERED Select a subject in the list and click the Register this Subject link This will display a dialog in which you will enter the initials of the subject you are registering If the study design calls for a screening procedure to be undertaken the subject status after registration will appear in the list
16. ght ee WOU A O Screening Visit Patient Information Initials K the bacit poge inte Beea by bhi bork Race x Cosim T Asian Ethnicity K Hispani JE Non bisponic Data Entry Assistance Data Entry Assistance Panel aL Boa a Hawaiian ot Perili Idender E Notive Aerin Oo Mive Alade O Other specily Enter the weight of the subject O LO REVISE DATA EJI Source Doc Verification Connection Server GIEEEE Phare mik al applicable dhackboos with ae X Interactive Data Entry Fields Getting Started TrialDriver E CRFs are stored on a central study server which are accessed using the TrialDriver E CRF client application Before starting work with a TrialDriver E CRF you need the following gt The TrialDriver E CRF client application must be installed on a PC running Windows XP Vista or 7 gt The PC should have a broadband internet connection Note If behind a Firewall port 3306 should be open gt The PC can optionally be attached to a printer if E CRF pages will be printed and stored in the patient files Broadband Internet Connection PO n Standard PC with e Microsoft Windows XP Vista 7 e TrialDriver E CRF Client Application t 4 Printer Logging in to the E CRF TrialDriver E CRFs are password protected When you launch the E CRF application via the desktop icon the first screen will ask you to provide your username and password which will have be
17. gned Was the patient given a copy of the completed Informed Consent form Date of informed consent E a al Fh Yes E a t IX ves m The missing data codes are listed in the data assistance area They are NI No Information NA Not Applicable UNK Unknown ND Not Done Enter the code text into a text box or click the button for the appropriate code al Data Entry Assistance TrialDriver E CRF User Manual v3 5 Entering Data into the E CRF Partial Dates Sometimes you will not be able to provide complete dates gt If you know the year but the day and or month are missing Enter two dashes for the missing parts gt If the date is completely unknown Leave the field blank or enter UNK Entering Data into the E CRF Repeating Pages and Sections Some pages in a CRF are designated as repeating pages Such pages are typically logging pages such as Medical History Concomitant Medications and so on If you need more entries than will fit on a single page 1 Select the page you are interested in from the Table of Contents 2 Click the REPEAT PAGE button Similarly some studies may have complete sections visits which repeat an indeterminate number of times To create a new repeating section 1 Select any page in the section you are interested in 2 Click the REPEAT SECTION button a Proc Lo g kelh Ua N ELE Mle ds en MPAGE1S Chromameter Meas E PAGE
18. ile Monogamous relationship with ste Abstinence Other please specify below in a gt Source Doc Verification Connection Server SRE The Birth Control Information was incorrec a paanan Optionally you can enter a Query ID if the data is being changed because of a data query Enter the Reason For Change here then Click the REVISE DATA button to re enable the page TrialDriver E CRF User Manual v3 5 Dealing with Data Queries Data Management may issue queries against data you have submitted The TrialDriver E CRF client allows you to view the Data Clarification Forms DCF online and to respond appropriately to them The sequence of operations is gt The presence of a query is indicated by a flag in your subjects list gt Open the CRF and click the View Queries button to see the queries list gt Review each query in turn Decide if you will make changes to the data gt If YES make the data changes If NO enter a brief comment Finally click the Return This Query button TrialDriver E CRF Active queries are flagged in the subjects list Electronic Investigator Forms for Global Clinical Trials O pen th e su bject CR F to Vi ew th e q ue ries TD 103 LOCAL Database Q ue cnis Websit TrialDriver Reference Study Hybrid EDC PAPER B Email Study Management 99 002 SCREENING PAGE001 i CG t Eg sexe Pace David Shepherd 99 Princeton Esthetic Derm
19. ld be printed PDF Your options are to create a PDF containing Create PDF gt Only the current page Create a PDF from selected CRF page gt All pages in the current section a mse pages Select the pages which should appear in the PDF and click OK gt Selected Pages mark the pages a You can save the PDF print it or mail it once it is created you require in the list at right soba gt All pages Current Page Only Additionally you can elect to include Current Visit Only Screening Visit only those pages which have been submitted to the Study Server Leaving this option unchecked will also include empty pages Treatment visit End of Study End of Study QUNSCHEDULED 1 Unscheduled visit QUNSCHEDULED 2 Unscheduled visit QUNSCHEDULED 3 Unscheduled visit Selected Pages All Pages The PDF will be displayed in an embedded PDF Reader window Transmitted Pages Only Click the Close this Window link to return to the interactive CRF CANCEL lrialDriver E CR Source Document Verification For study monitors and CRAs Study monitors can perform Source Document Verification SDV on TrialDriver E CRFs Monitors are provided with special login credentials which prevents them from entering data into the E CRF but enables an SDV mode so that they may provide an indication that they have compared the data in the E CRF with those in the source documents and have found them to
20. ll visit pages Not Done in one operation Click a Visit item in the Table of Contents to display the summary sheet If the visit is allowed to be Not Done extra controls appear on the summary sheet __ MPAGeoo1 MPaceoo2 BPAGEOO3 BPAGEO04 BIPAGEOOS BPAGEO0S Subject 999 001 ABC VISITO3 PHASE1 WEEK1 VISITO3 SCREENING Informed consent D Eligibility Inclusion Eligibility Exclusion Eligibility Exclusion Eligibility Exclusion Eligibility Exclusion 1 Medical History 1 Concomitant Me Vital Signs Phys Ex Labs Pregnancy Te SCID CT Axis I SCIO CT Axis II MADRS CGI QIDS SR CPFQ SFI HAM D28 1 HAM D2s 2 C SSRS 1 C SSRS 2 PHASE1 WEEK1 9 pages If this visit was not done check the box and click the Update Visit button All pages will be marked intentionally blank and the page set ready for transmission E PAGE040 E PAGE041 E PAGE042 NOT READY NOT READY NOT READY Subject 999 001 ABC VISITO PSCREPNITNGG VISITO SCREENING 25 pages pave Sus Submission ven Sov besoretion E E PAGEOOL PAGEOO2 E PAGEOOS E PAGEOO4 E PAGEOOS E PAGEODS E PAGEOO7 E PAGEOOS E PAGEOOS E PAGEOLO Visit Not Done ee FF FY FEF EF S SUBMITTED READY NOT READY NOT READY NOT READY NOT READY NOT READY NOT READY SUBMITTED NOT READY 2011 01 11 11 36 1 2011 01 11 11 31 1 Vital Signs Med Di
21. mation W PAGEO2 1 Medical History feo MPAGEO3 1 Prior and Concu TrialDriver Reference Study i PAGEOS Birth Control Infor Screening Visit oO Other specily GJENDsTUDY End of Study ae 072611 Me PAGE21 End of Study UNSCHEDULED 1 Unscheduled visit i fv MBPAGES1 Information o pe PAGE9S2 New or Changed Ad ik PAGE93 New or changed Co Vital Signs ra Canc oocn cs fat ab ta 2 ill bi a Body Temperature W Invalid data Unverified Blood Pressure sitting 1 Validated Ready V Verified E Submitted Puke rote REPEAT PAGE Repeat the selected CRF page ew ts REPEAT SECTION Repeat the selected study section OPTIONAL SECTION Add an optional section to the CRF Weight 150 b a i ut CLOSE SUBMIT Loaded E CRF for subject 06 007 il PAGEOS Lesion Count j BM PAGEOS Erythema Assessm Patient Information i BBPAGEO7 Inclusion Criteria il PAGEOS Exclusion Criteria L MPAGEOS Exclusion Criteria je MPAGE10 Labs and Pregnanc s MPAce11 V 1 Comments Oo Ba be PAGE11 V 2 Comments E A TREATMENT Treatment visit 1 Nee i E PAGEL Patient information PAGEL New or Changed Ad l Etheicity DE repose E mentini i MPAGEI4 New or changed Co PAGES Lesion Count f ic PAGES Erythema Assessm i _ PAGE17 Chromameter Meas Informed Consent Signed x Yes E ib H N PAGEIS Chromame
22. n Server RRSSRRBEEIRFGNN 14m A The Study Main Page After successfully logging in to the study you are presented with a list of your subjects Four additional links provide access to study resources View Study Website opens a web page dedicated to study management Email Study Management opens your email program CRF Source Documents provides access to the source documents for this study which you can print and fill in prior to entering the data in the E CRF Supplementary Documents provides a list of miscellaneous documents which you can print Ip TrialDriver E CRF 3 0 2 1 connected to study EB1010 301 TESTING as user david using server EB1010 301_TEST gcplink2 net oO x File Extras Help Exit this Stud TrialDriver E CRF Electronic Investigator Forms for Global Clinical Trials EB1010 301 TESTING Database A Double Blind Paroxetine and Placebo Controlled Study of 50 mg day and 100 mg day of EB 1010 among Outpatients with Major Depressive Disorder Who have Responded Inadequately to Prior Selective Serotonin Reuptake Inhibitors Dr David Shepherd 999 Testing Site David O pen Study Website Refresh List o Help and Instructions Q View Study Website Email Study Management g Email Study Management 999 002 ENROLLED 2010 12 20T12 42 40 172 172 999 003 NOT REGISTERED Al CRF Source Documents 999 004 NOT REGISTERED gan 999 005 NOT REGISTERED Supplementary Documents CRF Source Documents
23. oo7 io be PAGE00S cycue 1 i be PAGE009 i ePAGE010 i MEPAGEO11 i f MIPAGEO12 kw PAGEO13 cyce 2 i MPAGEOOS i i MIPAGEO1O i PAGEO11 i f MIPAGEO12 i E PAGE013 A cyce 3 i bePAaGE009 i be PAGE010 i e PAGEO11 i f MIPAGEO12 i im B PAGE013 FINAaL Legend Icon Legends lt a Submitted REPEAT CRF PAGE Repeat the selected CRF page Repeat the selected CRF section CRF Controls gt App Controls Add an optional CRF section Screening ICF Demographics Inclusion Criteria Exclusion Criteria El 1 Medical History 2 Medical History Phys Exam Vital Signs Blood Chemistry CBC Urinalysis Coagulation Perf Status Imaging Treatment Cycle 1 1 Phys Exam Vital Blood chemistry CBC Urinalysis UPT Perf Status Imaging Study Drug administr Treatment Cycle 2 1 Phys Exam Vital Blood chemistry CBC Urinalysis UPT Perf Status Imaging Study Drug administr X Treatment Cycle 3 1 Phys Exam Vital Blood chemistry CBC Urinalysis UPT Perf Status Imaging Study Drug administr Final Visit or early t hd Unverified V Verified a PDF SUBMIT H ha Save Page REFERENCE STUDY CRF 1 0 Tri ID ivi R fe Stud TD 102 TrialDriver Reference Study Sereening Subjea 1D Date of Screening
24. our response to the query in the right PAGEOO1 1 SCREENING 1 ee eee ees Oe Pee ak en oe hand panel Or just click the checkbox to PAGE004 1 SCREENING 1 MHDIAG i Issued to site Please indic indicate that you have made data changes QUERY RESPONSE FROM SITE DAVIDSHEPHERD Finally click the Return this Query button Investigator Sign Off gt When a subject CRF is completed the investigator is requested to sign off on that CRF gt Not all users are allowed to sign off this is a permission set in the user profile gt Some users are allowed to sign and unsign some may only unsign but not sign gt When part or all of the E CRF are signed off the pages are locked to prevent further changes The signature must be revoked unsigned in order to make further changes Click the CRF Sign Off button EE E 3 k fo ere beneath the CRF image to l open the Sign Off window m REFERENCE STUDY CRF 1 0 TrialDriver Reference Study TD 102 TrialDriver Informed Consent Demographics Pregnancy Test An overview of the Sign Off status of the CRE is displayed gt Informed Consent Informed Consent signed prior t ftudy related procedure Specifically the Investigator is asked to confirm that any empty pages and visits Date amp Time ot Into are intentionally blank Place a checkmark next to items requiring gt Demographics S Roce Wie E tir esis confirmation or click the Confirm
25. pies 9 fu rug Sere File the paper copies in the subject dossier sample calle pana Vest Result Leos ug Hot hop hen 1 Fee gt Close this window Ti ote oO A Al Zameen el 4 Click OK in the dialog to create a PDF of the pages which were Sog submitted Ea S emee d ue em eg peter nd mde matte of n ek we Z2ven 3 gt h o o To print use the Acrobat Toolbar Button above TrialDriver E CRF User Manual v3 5 Submitting Data to the Study Server How to re submit updated page data After a page has been submitted it is locked and no further data entry is allowed on it All the fields are GREY indicating their Read Only status The only exception to this rule concerns logging pages which are expected to be updated periodically If you must revise data on a locked page do the following gt Select the page in the Table of Contents gt Enter a Reason for Change in the Data Assistance panel gt Click the REVISE DATA button The Page will be reactivated and you can change data The page must now be re submitted Birth control information Check ALL that apply If female of child bearing potential EJ LLL Not applicable male or post men IUD Diaphragm with spermicide Depo Provera Norplant Oral contraceptive with condoms Condom with spermicide gel or foa Implantable transdermal or inject Surgically ster
26. rol Infor i IPAGEOS Lesion Count pee MPAGEO6 Erythema Assessm i IPAGEO7 Inclusion Criteria fe MPAGEOS Exclusion Criteria i i l PAGEOS Exclusion Criteria i jo MPAGE10O Labs and Pregnanc pue MPAGE11 V 1 Comments i kw lMPAGE11 V 2 Comments GQTREATMENT Treatment visit i be PAGE12 Patient information i IPAGE13 New or Changed Ad fon MPAGE14 New or changed Co i IPAGE1S Lesion Count e WPAaGE16 Erythema Assessm i an MPAGE17 Chromameter Meas i fn MPAGE1S Chromameter Meas i pee MPAGE19 Chromameter Meas i ill PAGE20 1 Comments G JeNDsTuDy End of Study i E PAGE21 End of Study E GQUNSCHEDULED 1 Unscheduled visit j PAGE91 Information i NEPAGES2 New or Changed Ad ee ee Legend W Invalid data Unverified Validated Ready V Verified E Submitted REPEAT PAGE Repeat the selected CRF page REPEAT SECTION Repeat the selected study section OPTIONAL SECTION Add an optional section to the CRF A CLOSE PDF SUBMIT CRF data updated TrialDriver Reference Study Irestigator Number Patient None Demographics ane ESE Sex K Nele oO Ferndle Informed Consent Informed Consent Signed x es Wes the patient given o copy of the 7 completed Informed Comsent form x Yes Date of informed consent Vital Signs Body Temperature Blood Pressure sitting Puke rote Respiratory rate Wei
27. spensation MADRS CGI QIDS SR Save Page i H sexe Pace Informed consent De Eligibility Inclusion Eligibility Exclusion 1 Eligibility Exclusion 2 Eligibility Exclusion 3 Eligibility Exclusion 4 Medical History Concomitant Medications Vital Signs Phys Ex Labs Pregnancy Test Double Click a page item to navigate to that page If a visit has been marked Not Done a red cross appears next to the visit name e J PAGE153 J PAGE154 J PAGE155 IJ PAGE156 j ee m M PHASE2 WEEK6 ET Vital Signs Med Di Lab samples Pregna ECG Physical Exam Entering Data into the E CRF basics gt Click in an interactive data field to activate it The active field is colored YELLOW gt GREEN colored fields contain valid data RED colored fields are invalid gt GREY colored fields are Read Only TrialDriver E CRF User Manual v3 5 gt Use the TAB and BACK TAB key to jump from one data field to the next or previous one gt Data are entered into TEXT fields and CHECKBOX fields NOTE Page data are saved to the study server whenever you change page or exit the E CRF If you want to save data more frequently click the Save Page link lj TrialDriver E CRF 2 9 0 2 connected to study TD 101 as user david using server TD101ET gcplink3_net x Close this CRF Screening Visit p MPPAGEO1L Patient Infor
28. ter Meas ba P Wes the patient given of the MPAGE19 Chromameter Meas ceanglan iad anad tanner aa x Yes I i lll PAGE20 1 Comments Please maik all applicable checkbooes with ae X WJJ Data Entry Assistance Mark one box to indicate the race of the subject If other enter text in the appropriate 1 Caucasian 2 Asian 5 Native American 6 Native Alaskan 9 Other race Connection Server O geplinki net A Entering Data into the E CRF Checkboxes and Checksets gt There are two types of data entry field Text Entry and Checkbox Entry gt There are two flavors of checkbox Single checkboxes and sets of checkboxes checksets gt To check or uncheck a box with the mouse just click in it gt To check a box using the keyboard For a single checkbox the SPACE key will toggle the box on or off For a set of checkboxes checkset hitting the number key displayed next to the box will activate that box Y1 5 A single erence Study Page checkbox can be toggled by g Visit Time ts L OOO clicking in it or by pressing the ormation SPACE key ionally left blank _ Race x Covcosion E Asian E Black j Hawaiian or Pacific Islander 4 a Native American a Notive Alaskan l Other specify Ethnicity x Hispanic A box in a checkset can be activated by clicking in it or by pressing the key corresponding to the number printed ne
29. xt to the box l o Non hispanic YI eference Study Page ng Visit n Time 24hrs Mi formation n 1000 Dote TH ntionally left blank E Race X Caucasian LI Asian IX Black LI Hawaiian or Pocific Islander L Notive American L Native Alaskan L Other specify ii Wie Ethnicity x Hispanic L Non hispanic Only a single box in a checkset may be active If multiple boxes have been clicked the checkset is displayed in RED color indicating invalid data Entering Data into the E CRF Missing Data TrialDriver E CRF User Manual v3 5 If a field is empty and displayed in RED this means that the field may not be empty If however you have no data for this field then you must indicate this by choosing one of the codes which indicate missing data There are four such codes which are listed in the Data Entry Assistance area at the right of the screen Enter the code into a text entry box or if the field in question is a checkbox click the appropriate button in the assistance area Informed Consent Signed Was the patient given a copy of the completed Informed Consent form Date of informed consent This field is displayed in RED because it may not be left empty So long as any field on a page is red that page cannot be submitted to the study server If no data is available for the field enter one of the missing data codes into the box which will turn the field green Informed Consent Si
30. yed please communicate this to the data management team lj TrialDriver E CRF 2 9 0 2 connected to study TD 101 as user david using server TD101ET gcplink3 net z z gt r Subject 06 007 PAGE04 _ l Save Page E Close this CRF Pages wh ich are QSCREEN Screening Visit z o a i J Data Entry Assistance rea d y to be E MPAGEO1 Patient Information a i JPAGEO2 1 Medical History v1 5 M PAGED3 1 Prior and Concu TrialDriver Reference Study submitted to the 7 oger ANAR esi aaia p MPAGEOS Lesion Count St u d y Se rver h ave a i MPAGEOS Erythema Assessm marl Birth Control i NEPAGEO7 Inclusion Criteria liii YE LLOW Icon int h e be PAGEOS Exclusion Criteria Initials DDD j MPAceoS Exclusion Criteria Table of Contents Lmpacero Labs and Pregnanc Birth control information MPAGE11 V 1 Comments oe a Hf female of child bearing potential whet methods of birth control are currently being used ITREATMENT Treatment visit ee iaaa ia H PAGE12 Patient information H PAGE13 New or Changed Ad epplicable mela or post menopessel for at least 2 years B PAGE14 New or changed Co x i Diophrogm with sparmidde rv BBPAGE1S Lesion Count Dego P 5 MPAGE1I6 Erythema Assessm _ Morpho i MBPAGE17 Chromameter Meas L Oral contraceptive with condoms je MPAGE18 Chromameter Meas fal Condom with spermkide gal or foam i MPPAGE19 Chromameter Meas C tmplera
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