eSource Data and ePRO

1. 0(4 )NSIGHTS m &IRST 1UARTER %LECTRONIC 3OURCE $ATA #DkMDC @MC (MSDQOQDSDC AX KNA@K 1DFTK@SNQX TSGNQHSHDR 3VN QDBDMS QDFTK@SNQX OTAKHB@SHNMR @CCQDRR SGD SNOHB NE DKDBSQNMHB RNTQBD C@S@ HM BKHMHB@K HMUDRSHF@SHNMR r ?$WODBS@SHNMR ENQ $KDBSQNMHB 2NTQBD #@S@ @MC #@S@ 3Q@MRBQHADC SN $KDBSQNMHB #@S@ NKKDBSHNM 3NNKR HM KHMHB@K 3QH@KRI @KRN JMNVM @R SGD kM@K $, 1DlDBSHNM /@ODQ V@R OTAKHRGDC HM 2DOSDLADQ ã @MC SGD r %# CQ@ES ?THC@MBD ENQ (MCTRSQX $KDBSQNMHB 2NTQBD #NBTLDMS@SHNM HM KHMHB@K (MUDRSHF@SHNMRII V@R OTAKHRGDC HM )@MT@QX 6GHKD SGD UHDVR @QD RKHFGSKX CHEEDQDMS

2. SGDRD CNBTLDMSR OQNUHCD BK@QHSX BNMBDQMHMF SGD DWODBS@SHNMR NE QDFTK@SNQX @TSGNQHSHDR QDF@QCHMF DKDBSQNMHB RNTQBD C@S@ #(2 KHMHB@K #@S@ (MSDQBG@MFD 2S@MC@QCR NMRNQSHTL CNBTLDMS DMSHSKDC ?+DUDQ@FHMF SGD #(2 2S@MC@QCR SN %@BHKHS@SD SGD TRD NE $KDBSQNMHB 2NTQBD #@S@ VHSGHM KHMHB@K 3QH@KRIII V@R HRRTDC HM -NUDLADQ 3GHR CNBTLDMS OQDRDMSDC UHDVR NE @ O@MDK NE HMCTRSQX @MC QDFTK@SNQX LDLADQR @MC CDUDKNODC @ RDS NE TRDQ QDPTHQDLDMSR ENQ RNTQBD C@S@

3. HQQDRODBSHUD NE SGD LDCH@ NQ SDBGMNKNFX TRDC SN GNKC SGD C@S@ 3GD $, 1DlDBSHNM /@ODQ DWSDMCR SGHR #(2 BNMBDOS @MC OQNUHCDR @ BNMSDWST@K EQ@LDVNQJ ENQ SGD TRD NE DKDBSQNMHB RNTQBD @MC O@ODQ RNTQBD H D C@S@ SQ@MRBQHADC EQNL O@ODQ RNTQBD CNBTLDMSR SN 1% R HM BKHMHB@K SQH@KR 3GD %# THC@MBD BNLOKDLDMSR DWHRSHMF FTHC@MBD @MC QDFTK@SHNM VHSG SGD HMSDMS SN ?OQNLNSD SGD B@OSTQD NE RNTQBD C@S@ HM DKDBSQNMHB ENQL 3GD ENKKNVHMF @QSHBKD DWOKNQDR SGD SNOHB NE DKDBSQNMHB RNTQBD C@S@ @MC HCDMSHkDR RNLD JDX BNMBDOSR SG@S @QD BNLLNM @MC RDDLHMFKX @FQDDC TONM VHSGHM SGDRD OTAKHB@SHNMR #ONTENTS 4HE )MPORTANCE OF 3OURCE P 2EGULATORY %XPECTATIONS FOR P 'OOD 1UALITY $ATA $EkNING 3OURCE

4. 3OURCE $ATA

5. P 3OURCE $OCUMENT … 1NC 3GNQDKK #HQDBSNQ

6. 0T@KHSX ,@M@FDLDMS NLOKH@MBD 3EVEN +EY #OMMON )SSUES P AROUND 3OURCE /'3 NQONQ@SHNM %DAQT@QX

7. #ONCLUSIONS P

8. %LECTRONIC 3OURCE $ATA #DkMDC @MC (MSDQOQDSDC AX KNA@K 1DFTK@SNQX TSGNQHSHDR 4HE )MPORTANCE OF 3OURCE )F YOU HAVE EVER HAD THE GOOD FORTUNE TO TAKE WATER FROM THE PLACE 0(4 WAS FOUNDED ON A SIMILAR PURITY PRINCIPLE THE @PUREST DATA WHERE IT LITERALLY @SPRINGS FORTH FROM THE GROUND

9. YOU KNOW WHAT A OBTAINABLE DURING A CLINICAL INVESTIGATION COMES FROM CAPTURING REFRESHING EXPERIENCE THAT CAN BE 3EVERAL HIKING TRAILS IN THE 53 PATIENT REPORTED OUTCOMES DIRECTLY AT THE POINT OF EXPERIENCE m NOT FEATURE A NATURAL SPRING TO kLL UP A CANTEEN 4RYING TO CAPTURE THE kLTERED THROUGH LATER RECALL

10. TRANSCRIBED FROM A PAPER RECORD

11. TASTE OF WATER FRESH FROM THE GROUND WHEN YOU RETURN HOME CAN OR INTERPRETED BY A CLINICIAN 3UCH E3OURCE METHODS CAN YIELD BE A CHALLENGE 3OME OF THE BOTTLED WATER THAT WE CONSUME TODAY DATA OF HIGH QUALITY THAT REVEAL THE IMPACT OF DRUGS

12. THERAPIES OR IS ACTUALLY PURIkED AND PROCESSED TAP WATER

13. TAKEN FROM MUNICIPAL DEVICES ON THE PATIENT S HEALTH AND QUALITY OF LIFE 'UIDANCES WATER SUPPLIESIV $! REGULATIONS AROUND BOTTLED WATER EVEN FROM THE $! AND %-! ALONG WITH #$)3# DEkNITIONS SUPPORT USE SPECIFY THAT

14. IN ORDER TO PROPERLY BE CALLED OF ELECTRONIC SOURCE METHODS SUCH @SPRING WATER

15. THE BOTTLED WATER MUST BE AS E02/ ELECTRONIC PATIENT REPORTED FROM A NATURALLY EMANATING SOURCE

16. NOT OUTCOME DURING CLINICAL INVESTIGATIONS

17. PULLED

18. PUMPED OR PROCESSED FROM OUT OF OTTLED 7ATER AND SPECIFY PRINCIPLES TO ENSURE THAT THE GROUNDV 7HAT S THE gSOURCEu IS PROPERLY IDENTIkED AND THAT THE E3OURCE RECORDS ARE TRUSTWORTHY THE 3OURCE

19. $EkNING 3OURCE

20. 3OURCE $ATA

21. 3OURCE $OCUMENT %NGLISH LANGUAGE DEkNITIONS OF RNTQBD ARE CONSISTENT WITH THE CONCEPT AS USED BY CLINICAL RESEARCHERS /XFORD %NGLISH $ICTIONARY $EkNITION OF 3OURCE ! WORK

22. ETC

23. SUPPLYING INFORMATION OR EVIDENCE ESP OF AN ORIGINAL OR PRIMARY CHARACTER AS TO SOME FACT

24. EVENT

25. OR SERIES OF THESEVI )N CLINICAL RESEARCH TRIALS

26. THE TERM QMSPAC IS USED TO IDENTIFY THE RECORDS AND THE DATA THAT PROVIDE THE INFORMATION TO BE ANALYZED IN A TRIAL 4HIS IS NOT NECESSARILY THE kRST INSTANCE OF RECORDING A CERTAIN ELEMENT OF DATA SUCH AS A BIRTH DATE WHICH WOULD BE ON THE BIRTH RECORD THIS MAY INSTEAD COME FROM THE PATIENT S MEDICAL CHART OR FROM AN INTERVIEW WITH THE PATIENT OR SOME OTHER QMSPAC 3URPRISINGLY

27. ONLY #$)3# DEkNES QMSPACä THE $! DOCUMENT AND THE %-! 2ElECTION 0APER DEkNE QMSPAC B?R? AND QMSPAC BMASKCLR 4HE #$)3# DEkNITION CAPTURES HOW THE WORD QMSPAC MAKES B?R? DIFFER FROM QMSPAC B?R? #$)3# $EkNITION OF 3OURCE 4HE SPECIkC PERMANENT RECORD S UPON WHICH A USER WILL RELY FOR THE RECONSTRUCTION AND EVALUATION OF A CLINICAL INVESTIGATIONVII #$)3# ALSO NOTES THAT THE WORD SOURCE IS @3OMETIMES USED AS SHORTHAND FOR SOURCE DOCUMENTS ANDOR SOURCE DATAVIII 2EGULATORY %XPECTATIONS FOR 'OOD 1UALITY $ATA $! #OMMISSIONER $R -ARGARET (AMBURG

28. IN HER KEYNOTE SPEECH )N THE INTRODUCTION

29. THE $! DRAFT GUIDANCE SETS FORTH THE AT $)! IN *UNE

30. SPOKE ABOUT THE $! FOCUS ON ADVANCING INTENT TO @PROMOTE THE CAPTURE OF SOURCE DATA IN ELECTRONIC REGULATORY SCIENCE AND ENSURING THE SAFETY OF PATIENTS IN TRIALS

31. FORM 4HE 'UIDANCE WILL NOT REPLACE ANY PREVIOUS GUIDANCE OR AS WELL AS THE SAFETY OF APPROVED DRUGS

32. DEVICES AND THERAPIES REGULATION

33. BUT WAS INTENDED TO COMPLEMENT EXISTING GUIDANCE !S PART OF THIS EFFORT

34. SHE MENTIONED THAT A FOUNDATION OF AND REGULATION

35. INCLUDING THE %LECTRONIC 2ECORDS AND %LECTRONIC GOOD QUALITY DATA WILL NEED TO BE OBTAINED FOR RESEARCHERS 3IGNATURES RULE 53 #2 e

36. NLOTSDQHYDC 2XRSDLR 4RDC AND REGULATORS AS A BASIS FOR DECISION MAKING !S NOTEDIX

37. THE HM KHMHB@K (MUDRSHF@SHNMRX 53 $! -AY @MC DMDQ@K CAPTURE OF 02/ PATIENT REPORTED OUTCOME DATA IN PAPER FORM /QHMBHOKDR NE 2NESV@QD 5@KHC@SHNMXI 53 $! *ANUARY IS FRAUGHT WITH A NUMBER OF CHALLENGES

38. INCLUDING DUPLICATE DATA

39. TRANSCRIPTION ERRORS

40. NON CONTEMPORANEOUS ENTRY

41. MISSING !S MENTIONED EARLIER

42. THE %-! RElECTION PAPER SEEKS TO PROVIDE DATA AND INCOMPLETE DATA )N THC@MBD ENQ (MCTRSQX $KDBSQNMHB A CONTEXTUAL FRAMEWORK FOR THE USE OF ELECTRONIC SOURCE AND 2NTQBD #NBTLDMS@SHNM HM KHMHB@K (MUDRSHF@SHNMR

43. THE $! FURTHER PAPER SOURCE IE TRANSCRIBED IN CLINICAL TRIALS 2ATHER THAN BUILDS UPON AN EXISTING REGULATORY FRAMEWORK FOR THE CAPTURE

44. SPECIkCALLY ENCOURAGE THE USE OF ELECTRONIC SOURCE

45. THE PAPER PROCESSING

46. TRANSMISSION AND STORAGE OF ELECTRONIC DATA IN NOTES THAT MANY CLINICAL INVESTIGATIONS ARE USING ELECTRONIC CLINICAL TRIALS 4HIS COMES SEVERAL MONTHS AFTER THE %-! S '#0 SOURCE

47. YET LITTLE REGULATORY FRAMEWORK EXISTS TO ENSURE THAT THE 'OOD #LINICAL 0RACTICE )NSPECTORS 7ORKING 'ROUP POSTED THEIR ELECTRONIC SOURCE DATA MEETS THE REQUIREMENTS FOR '#0 IN THE %5 kNAL VERSION OF A 1DlDBSHNM O@ODQ NM $WODBS@SHNMR ENQ $KDBSQNMHB %UROPEAN 5NION 4O PROVIDE A FRAMEWORK FOR ELECTRONIC SOURCE 2NTQBD #@S@ AND #@S@ 3Q@MRBQHADC SN $KDBSQNMHB #@S@ NKKDBSHNM DATA

48. THE '#0 )NSPECTORS 7ORKING 'ROUP CHOSE TO ADOPT 3NNKR HM KHMHB@K 3QH@KR 7HILE THE TWO DOCUMENTS COVER SIMILAR THE PRINCIPLES SET FORTH BY #$)3# IN XII TOPICS

49. THE FOCUS AND OBJECTIVE OF EACH DOCUMENT IS DIFFERENT

50. 3EVEN 2ECOMMENDATIONS FOR 3PONSORS !BOUT %LECTRONIC 3OURCE

51. FROM OUR !NALYSIS OF THE $! $RAFT 'UIDANCE AND %-! 3OURCE 0APER 0UT IT IN THE 0ROTOCOL 4HERE SHOULD BE INFORMATION IN THE PROTOCOL DESCRIBING WHO WILL BE THE CREATORS OF THE DATA

52. WHAT DATA WILL BE GATHERED AND WHEN WILL IT BE GATHERED ! DATAlOW DIAGRAM CAN GREATLY ASSIST IN THE UNDERSTANDING OF ALL THE DIFFERENT TYPES OF DATA THAT ARE TO BE GATHERED AND HOW THEY WILL EVENTUALLY MAKE IT INTO THE E#2 ELECTRONIC #ASE 2EPORT ORM

53. WHETHER PAPER OR ELECTRONIC SOURCE !NY DEVICES OR SOFTWARE USED SHOULD BE LISTED IN THE PROTOCOL AS WELL #APTURE IT %LECTRONICALLY )T IS CONSIDERED BEST PRACTICE TO NOT USE PAPER SOURCE WHEN ELECTRONIC DATA CAPTURE IS USED IN A CLINICAL INVESTIGATIONXIII 7HEN PAPER IS THE SOURCE

54. THERE SHOULD BE CLEAR QUALITY CONTROL STEPS AS IDENTIkED IN THE PROTOCOL TO ENSURE THAT ERRORS ARE MINIMIZED !NY PAPER SOURCE SHOULD BE MAINTAINED IN THE kLES OF THE INVESTIGATOR ACCORDING TO APPLICABLE RETENTION REQUIREMENTS

55. WHICH ADDS TO THE TIME AND COST BURDEN TO THE SITE 7HILE BOTH PAPERS SUGGEST THE DEVELOPMENT OF ADEQUATE CONTROLS

56. THE $! 'UIDANCE GOES AS FAR AS TO STATE g$! RECOMMENDS THAT CLINICAL DATA BE ENTERED ELECTRONICALLY BY STUDY SITE PERSONNEL AT THE TIME OF THE SUBJECT VISIT TO AVOID TRANSCRIPTION FROM UNNECESSARY PAPER RECORDSXIVu %NTER THE $ATA IN 2EAL 4IME #ONTEMPORANEOUS ENTRY OF DATA IS AN ESSENTIAL COMPONENT OF DATA QUALITY 4HE DELAY BETWEEN OBSERVING AND RECORDING SHOULD BE MINIMIZED

57. ESPECIALLY IN THE CASE OF OUTCOME MEASURES WHICH CAN BE SUBJECT TO RECALL BIAS )T IS HELPFUL TO DOCUMENT THE RECALL PERIOD AS PART OF THE PROTOCOL 3YSTEMS WHICH COLLECT ELECTRONIC DATA SHOULD RECORD THE TIME OF ENTRY AS WELL AS THE TIME OF OBSERVATION OR EVENT !S SEEN IN WARNING LETTERSXV

58. EXACT ENTRY OF TIME POINTS INCLUDING DOSING IS IMPORTANT OBJECTIVE EVIDENCE ENSURING THAT PATIENT CARE IS APPROPRIATE AND DONE PER PROTOCOL 3UPPORT -AINTENANCE OF $ATA UNDER THE !UTHORITY OF THE )NVESTIGATOR OTH DOCUMENTS POINT OUT THAT THE INVESTIGATOR IS RESPONSIBLE FOR MAINTAINING CONTROL OF SOURCE DATA OR A CERTIkED COPY FROM THE POINT OF COLLECTION THROUGHOUT THE LIFECYCLE OF THE DATA 7HAT DOES CONTROL MEAN IN THE CONTEXT OF SOURCE DATA 3OME DATA RELATED TASKS MAY BE DELEGATED TO THIRD PARTIES OTHER THAN THE SPONSOR XVI

59. BUT THE INVESTIGATOR IS gULTIMATELY RESPONSIBLE FOR THE QUALITYu OF ALL SOURCE DATA !NY CHANGES TO SOURCE DATA SHOULD BE DONE WITH THE KNOWLEDGE AND CONSENT OF THE INVESTIGATOR %VEN IF THE DATA ARE STORED ON A COMPUTERIZED SYSTEM AT A THIRD PARTY

60. THE SPONSOR AND INVESTIGATOR SHOULD BE ABLE TO DEMONSTRATE TO REGULATORY AUTHORITIES THAT THE INVESTIGATOR AND AUTHORIZED SITE STAFF HAD ACCESS AND ABILITY TO gMAINTAINu THE SOURCE DATA AT ALL TIMES

61. AND THAT THE SPONSOR COULD NOT UNILATERALLY DO SO

62. 3EVEN 2ECOMMENDATIONS FOR 3PONSORS !BOUT %LECTRONIC 3OURCE

63. FROM OUR !NALYSIS OF THE $! $RAFT 'UIDANCE AND %-! 3OURCE 0APER

64. CONTINUED )NCLUDE !LL #HANGES IN AN !UDIT 4RAIL OF THE E3OURCE $OCUMENT 4HE CONTENT NECESSARY TO BE PART OF AN AUDIT TRAIL FOR ELECTRONIC RECORDS IS SET FORTH IN #2 4HE $! DRAFT @'UIDANCE FOR )NDUSTRY %LECTRONIC 3OURCE $OCUMENTATION IN #LINICAL )NVESTIGATIONS GIVES SOME FURTHER SUGGESTIONS FOR THE META DATA AUDIT TRAIL FOR E3OURCE RECORDS )N KEEPING WITH EXISTING RULES ON ELECTRONIC RECORDS

65. ALL MODIkCATIONS TO SOURCE DATA MUST HAVE AN AUDIT TRAIL 4HE AUDIT TRAIL MUST BE INEXTRICABLY LINKED TO THE DATA AND MUST NOT OBSCURE THE ORIGINAL DATA )N GENERAL

66. SYSTEMS SHOULD BE DESIGNED SO THAT SOURCE DATA IS NEVER DELETED

67. EVEN IF IT IS NOT GOING TO BE INCLUDED IN ANALYSIS DATASETS 4HE ORIGINAL OBSERVATIONS OF THE PATIENT OR CLINICAL STAFF SHOULD BE PRESERVED IN THE kLES OF THE INVESTIGATOR $OCUMENT THE 3OURCES OF $ATA AND %NSURE !CCESS #ONTROLS ARE !DEQUATE 4HE SOURCE OF ANY DATA SHOULD BE CLEAR

68. WHETHER THE SOURCE RECORD IS CAPTURED FROM A PATIENT ON AN ELECTRONIC DEVICE

69. ENTERED BY CLINICAL STAFF INTO AN %LECTRONIC $ATA #APTURE SYSTEM OR PART OF THE MEDICAL RECORD IN AN %(2 SYSTEM 4HIS WILL ALLOW FOR REGULATORY INSPECTION OF THE PROCESSES PROTECTING SOURCE DOCUMENTS AND DATA !LL SOURCE DATA

70. SUCH AS VALUES FROM CENTRAL LABORATORIES OR 02/ ENTRIES FROM PATIENTS

71. SHOULD BE REVIEWABLE DURING THE TRIAL BY THE INVESTIGATOR

72. REGULATORY INSPECTORS OR THOSE WHO CREATED THE DATA 0ERFORM 2ISK !SSESSMENTS WHEN USING %LECTRONIC (EALTH 2ECORDS AS E3OURCE 3YSTEMS THAT CONTAIN %(2 S MAY BE USED FOR MANY PURPOSES

73. INCLUDING REPORTING CONCOMITANT MEDICATIONS

74. DOCUMENTING PRE EXISTING CONDITIONS OR IDENTIFYING POTENTIAL SUBJECTS (OWEVER

75. INSTITUTIONAL %(2 SYSTEMS MAY EMPLOY CONTROLS AND STANDARDS THAT DIFFER FROM THOSE EXPECTED FOR CLINICAL TRIALS 7HEN SUCH RECORDS ARE USED

76. IT SHOULD BE CLEAR FROM TRIAL DOCUMENTS THAT THE SPONSOR HAS EVALUATED THE RISKS AND PREPARED MITIGATIONS 4HE DATA PROTECTION REQUIREMENTS FOR SUCH SYSTEMS SHOULD BE CONSIDERED AND BALANCED WITH THE VALUE OF THE INFORMATION RETRIEVED

77. 2ElECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DATA AND I #ONCLUSIONS DATA TRANSCRIBED TO ELECTRONIC DATA COLLECTION TOOLS IN CLINICAL TRIALS

78. WWWEMEAEUROPAEUDOCSEN?'DOCUMENT7#PDF *ANUARY 4HESE DOCUMENTS FURTHER CLARIFY THE EXPECTATIONS OF REGULATORY HTTPWWWFDAGOVDOWNLOADS$RUGS II 'UIDANCE#OMPLIANCE2EGULATORY)NFORMATION'UIDANCES5#-PDF AUTHORITIES REGARDING ELECTRONIC SOURCE DATA

79. AND DESCRIBE A GROUP OF HTTPWWWCDISCORGSTUFFCONTENTMGRkLESFECAFDFCAACBBDFA III HIGH LEVEL PRINCIPLES

80. WHICH

81. WHEN THEY ARE ADHERED TO

82. PROVIDE A GOOD DFDDMISCDOCSESDIPDF BASIS FOR THE ACCEPTABILITY OF SOURCE DATA IV @OTTLED 7ATER 0URE $RINK OR 0URE (YPE %RIK $ /LSON !PRIL V 53 #2 e A VI 7HILE THEY EXPLORE THE TOPIC OF E3OURCE INDEPENDENTLY

83. THEY COME TO 3OURCE

84. N E

85. 4HE /XFORD %NGLISH $ICTIONARY ND ED /%$ VI SIMILAR CONCLUSIONS OTH DOCUMENTS SHOW AN INTENTION TO SUPPORT /NLINE /XFORD 5NIVERSITY 0RESS .OVEMBER HTTPWWWOEDCOM VIEWDICTIONARYENTRY%NTRY .OTE 4HE ETYMOLOGY OF THE EXPANDED USE OF ELECTRONIC SOURCE DATA IN CLINICAL TRIALS )F PROPERLY WORD @SOURCE IS TAKEN FROM OLD RENCH FOR THE ORIGIN OF A SPRING OR STREAM OF WATER DEPLOYED WITHIN THE GUIDANCE GIVEN FROM THESE DOCUMENTS

86. SYSTEMS WITH ELECTRONIC SOURCE SHOULD PROVIDE GOOD QUALITY DATA TO SUPPORT THE VII #$)3# 'LOSSARY 6

87. GOALS OF SPONSORS AND REGULATORY AUTHORITIES HTTPWWWCDISCORGSTUFFCONTENTMGRkLES VIII BEFEBFFAFCAADEEMISCCDISC??GLOSSARYPDF %QUIVALENCE OF %LECTRONIC AND 0APER AND 0ENCIL !DMINISTRATION OF IX 0ATIENT 2EPORTED /UTCOME -EASURES ! -ETA !NALYTIC 2EVIEW

88. 'WALTNEY

89. #*

90. 3HIELDS !,

91. 3HIFFMAN 3 6ALUE IN (EALTH -AR !PR ./4% #OMPUTERIZED 3YSTEMS 5SED )N #LINICAL )NVESTIGATIONS 'UIDANCE

92. X %XPECTATIONS FOR %LECTRONIC 3OURCE $ATA AND $ATA WWWFDAGOV/(2-3$/#+%43FRD GDL0$ *ANUARY 4RANSCRIBED TO %LECTRONIC $ATA #OLLECTION 4OOLS IN XI 'ENERAL 0RINCIPLES OF 3OFTWARE 6ALIDATION

93. HTTPWWWFDAGOV #LINICAL 4RIALS IS A kNAL RELEASE FROM THE %-! MEDICALDEVICESDEVICEREGULATIONANDGUIDANCEGUIDANCEDOCUMENTS UCMHTM *ANUARY 4HE $! DRAFT 'UIDANCE FOR )NDUSTRY %LECTRONIC #$)3# E 3OURCE 3TANDARD 2EQUIREMENTS #$)3# #LINICAL $ATA )NTERCHANGE XII 3TANDARDS #ONSORTIUM 6ERSION .OVEMBER 3OURCE $OCUMENTATION IN #LINICAL )NVESTIGATIONS 'OOD #LINICAL $ATA -ANAGEMENT 0RACTICE

94. 3OCIETY FOR #LINICAL $ATA XIII IS OPEN FOR PUBLIC COMMENT UNTIL !PRIL

95. -ANAGEMENT

96. $ECEMBER #OMMENTS CAN BE MADE AT HTTPWWWREGULATIONS XIV ,INES

97. 'UIDANCE FOR )NDUSTRY %LECTRONIC 3OURCE $OCUMENTATION IN #LINICAL )NVESTIGATIONS $2!4 '5)$!.#% GOV $OCKET .O $! $ XV 53 $! TO )#/. #LINICAL 2ESEARCH )NC .OVEMBER

98. kNDING A I

99. RETRIEVED FROM HTTPWWWFDAGOV)#%#)%NFORCEMENT!CTIONS 7ARNING,ETTERSUCMHTM XVI 4ASKS MAY BE DELEGATED TO A THIRD PARTY

100. SUCH AS A TECHNICAL SERVICE PROVIDER 4HERE SHOULD BE A FORMAL DOCUMENT AS PART OF THE TRIAL THAT SETS OUT WHAT TASKS WILL BE EXECUTED BY THE THIRD PARTY

101. TYPICALLY DONE AS PART OF A CONTRACTUAL AGREEMENT 53 (%!$15!24%23 %52/0%!. (%!$15!24%23 0(4 #ORPORATION 0(4 #ORPORATION 3·RL WWWPHTCORPCOM 2UTHERFORD !VENUE

102. CHEMIN ,OUIS (UBERT #OPYRIGHT Ú 0(4 #ORPORATION OSTON

103. -! 53! 0ETIT ,ANCY

104. 'ENEVA

105. 3WITZERLAND 2EV 4OLL REE 0HONE

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