0(4 )NSIGHTS m &IRST 1UARTER                                                 %LECTRONIC 3OURCE $ATA                       ...
SGDRD CNBTLDMSR OQNUHCD BK@QHSX BNMBDQMHMF SGD DWODBS@SHNMR NE QDFTK@SNQX@TSGNQHSHDR QDF@QCHMF DKDBSQNMHB RNTQBD C@S@ #(2 ...
HQQDRODBSHUD NE SGD LDCH@ NQ SDBGMNKNFX TRDC SN GNKC SGD C@S@ 3GD $, 1DlDBSHNM /@ODQ DWSDMCR SGHR#(2 BNMBDOS @MC OQNUHCDR ...
3OURCE $ATA
P  3OURCE $OCUMENT                                                                        … 1NC 3GNQDKK                   ...
0T@KHSX ,@M@FDLDMS   NLOKH@MBD  3EVEN +EY #OMMON )SSUES         P  AROUND 3OURCE                                          ...
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eSource Data and ePRO

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Electronic Source (eSource) Data: Defined and Interpreted by Global Regulatory Authorities

Two recent regulatory publications from FDA and EMA address the topic of electronic source data in clinical investigations.

While the views are slightly different, these documents provide clarity concerning the expectations of regulatory authorities regarding electronic source data.

This Issue explores the topic of electronic source data and identifies some key concepts that are common (and seemingly agreed upon) within these publications.

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eSource Data and ePRO

  1. 1. 0(4 )NSIGHTS m &IRST 1UARTER %LECTRONIC 3OURCE $ATA #DkMDC @MC (MSDQOQDSDC AX KNA@K 1DFTK@SNQX TSGNQHSHDR3VN QDBDMS QDFTK@SNQX OTAKHB@SHNMR @CCQDRR SGD SNOHB NE DKDBSQNMHB RNTQBD C@S@HM BKHMHB@K HMUDRSHF@SHNMR r ?$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. 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 CNBTLDMSOQDRDMSDC UHDVR NE @ O@MDK NE HMCTRSQX @MC QDFTK@SNQX LDLADQR @MC CDUDKNODC @ RDS NE TRDQ QDPTHQDLDMSR ENQRNTQBD C@S@
  3. 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 HD C@S@SQ@MRBQHADC EQNL O@ODQ RNTQBD CNBTLDMSR SN 1% R HM BKHMHB@K SQH@KR 3GD %# THC@MBD BNLOKDLDMSR DWHRSHMFFTHC@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. 4. 3OURCE $ATA
  5. 5. P 3OURCE $OCUMENT … 1NC 3GNQDKK #HQDBSNQ
  6. 6. 0T@KHSX ,@M@FDLDMS NLOKH@MBD 3EVEN +EY #OMMON )SSUES P AROUND 3OURCE /3 NQONQ@SHNM %DAQT@QX
  7. 7. #ONCLUSIONS P
  8. 8. %LECTRONIC 3OURCE $ATA #DkMDC @MC (MSDQOQDSDC AX KNA@K 1DFTK@SNQX TSGNQHSHDR4HE )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 DATAWHERE IT LITERALLY @SPRINGS FORTH FROM THE GROUND
  9. 9. YOU KNOW WHAT A OBTAINABLE DURING A CLINICAL INVESTIGATION COMES FROM CAPTURINGREFRESHING EXPERIENCE THAT CAN BE 3EVERAL HIKING TRAILS IN THE 53 PATIENT REPORTED OUTCOMES DIRECTLY AT THE POINT OF EXPERIENCE m NOTFEATURE A NATURAL SPRING TO kLL UP A CANTEEN 4RYING TO CAPTURE THE kLTERED THROUGH LATER RECALL
  10. 10. TRANSCRIBED FROM A PAPER RECORD
  11. 11. TASTE OF WATER FRESH FROM THE GROUND WHEN YOU RETURN HOME CAN OR INTERPRETED BY A CLINICIAN 3UCH E3OURCE METHODS CAN YIELDBE A CHALLENGE 3OME OF THE BOTTLED WATER THAT WE CONSUME TODAY DATA OF HIGH QUALITY THAT REVEAL THE IMPACT OF DRUGS
  12. 12. THERAPIES ORIS ACTUALLY PURIkED AND PROCESSED TAP WATER
  13. 13. TAKEN FROM MUNICIPAL DEVICES ON THE PATIENT S HEALTH AND QUALITY OF LIFE UIDANCESWATER SUPPLIESIV $! REGULATIONS AROUND BOTTLED WATER EVEN FROM THE $! AND %-! ALONG WITH #$)3# DEkNITIONS SUPPORT USESPECIFY THAT
  14. 14. IN ORDER TO PROPERLY BE CALLED OF ELECTRONIC SOURCE METHODS SUCH@SPRING WATER
  15. 15. THE BOTTLED WATER MUST BE AS E02/ ELECTRONIC PATIENT REPORTEDFROM A NATURALLY EMANATING SOURCE
  16. 16. NOT OUTCOME DURING CLINICAL INVESTIGATIONS
  17. 17. PULLED
  18. 18. PUMPED OR PROCESSED FROM OUT OF OTTLED 7ATER AND SPECIFY PRINCIPLES TO ENSURE THATTHE GROUNDV 7HAT S THE gSOURCEu IS PROPERLY IDENTIkED AND THAT THE E3OURCE RECORDS ARE TRUSTWORTHY THE 3OURCE
  19. 19. $EkNING 3OURCE
  20. 20. 3OURCE $ATA
  21. 21. 3OURCE $OCUMENT%NGLISH LANGUAGE DEkNITIONS OF RNTQBD ARE CONSISTENT WITH THE CONCEPT AS USEDBY CLINICAL RESEARCHERS /XFORD %NGLISH $ICTIONARY $EkNITION OF 3OURCE ! WORK
  22. 22. ETC
  23. 23. SUPPLYING INFORMATION OR EVIDENCE ESP OF AN ORIGINAL OR PRIMARY CHARACTER AS TO SOME FACT
  24. 24. EVENT
  25. 25. OR SERIES OF THESEVI)N CLINICAL RESEARCH TRIALS
  26. 26. THE TERM QMSPAC IS USED TO IDENTIFY THE RECORDS AND THE DATA THAT PROVIDE THE INFORMATION TO BE ANALYZED IN ATRIAL 4HIS IS NOT NECESSARILY THE kRST INSTANCE OF RECORDING A CERTAIN ELEMENT OF DATA SUCH AS A BIRTH DATE WHICH WOULD BE ON THE BIRTHRECORD THIS MAY INSTEAD COME FROM THE PATIENT S MEDICAL CHART OR FROM AN INTERVIEW WITH THE PATIENT OR SOME OTHER QMSPAC3URPRISINGLY
  27. 27. ONLY #$)3# DEkNES QMSPACä THE $! DOCUMENT AND THE %-! 2ElECTION 0APER DEkNE QMSPAC B?R? AND QMSPAC BMASKCLR4HE #$)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 DATAVIII2EGULATORY %XPECTATIONS FOR OOD 1UALITY $ATA$! #OMMISSIONER $R -ARGARET (AMBURG
  28. 28. IN HER KEYNOTE SPEECH )N THE INTRODUCTION
  29. 29. THE $! DRAFT GUIDANCE SETS FORTH THEAT $)! IN *UNE
  30. 30. SPOKE ABOUT THE $! FOCUS ON ADVANCING INTENT TO @PROMOTE THE CAPTURE OF SOURCE DATA IN ELECTRONICREGULATORY SCIENCE AND ENSURING THE SAFETY OF PATIENTS IN TRIALS
  31. 31. FORM 4HE UIDANCE WILL NOT REPLACE ANY PREVIOUS GUIDANCE ORAS WELL AS THE SAFETY OF APPROVED DRUGS
  32. 32. DEVICES AND THERAPIES REGULATION
  33. 33. BUT WAS INTENDED TO COMPLEMENT EXISTING GUIDANCE!S PART OF THIS EFFORT
  34. 34. SHE MENTIONED THAT A FOUNDATION OF AND REGULATION
  35. 35. INCLUDING THE %LECTRONIC 2ECORDS AND %LECTRONICGOOD QUALITY DATA WILL NEED TO BE OBTAINED FOR RESEARCHERS 3IGNATURES RULE 53 #2 e
  36. 36. NLOTSDQHYDC 2XRSDLR 4RDCAND REGULATORS AS A BASIS FOR DECISION MAKING !S NOTEDIX
  37. 37. THE HM KHMHB@K (MUDRSHF@SHNMRX 53 $! -AY @MC DMDQ@KCAPTURE 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. 38. INCLUDING DUPLICATEDATA
  39. 39. TRANSCRIPTION ERRORS
  40. 40. NONCONTEMPORANEOUS ENTRY
  41. 41. MISSING !S MENTIONED EARLIER
  42. 42. THE %-! RElECTION PAPER SEEKS TO PROVIDEDATA AND INCOMPLETE DATA )N THC@MBD ENQ (MCTRSQX $KDBSQNMHB A CONTEXTUAL FRAMEWORK FOR THE USE OF ELECTRONIC SOURCE AND2NTQBD #NBTLDMS@SHNM HM KHMHB@K (MUDRSHF@SHNMR
  43. 43. THE $! FURTHER PAPER SOURCE IE TRANSCRIBED IN CLINICAL TRIALS 2ATHER THANBUILDS UPON AN EXISTING REGULATORY FRAMEWORK FOR THE CAPTURE
  44. 44. SPECIkCALLY ENCOURAGE THE USE OF ELECTRONIC SOURCE
  45. 45. THE PAPERPROCESSING
  46. 46. TRANSMISSION AND STORAGE OF ELECTRONIC DATA IN NOTES THAT MANY CLINICAL INVESTIGATIONS ARE USING ELECTRONICCLINICAL TRIALS 4HIS COMES SEVERAL MONTHS AFTER THE %-! S #0 SOURCE
  47. 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 %5kNAL VERSION OF A 1DlDBSHNM O@ODQ NM $WODBS@SHNMR ENQ $KDBSQNMHB %UROPEAN 5NION 4O PROVIDE A FRAMEWORK FOR ELECTRONIC SOURCE2NTQBD #@S@ AND #@S@ 3Q@MRBQHADC SN $KDBSQNMHB #@S@ NKKDBSHNM DATA
  48. 48. THE #0 )NSPECTORS 7ORKING ROUP CHOSE TO ADOPT3NNKR HM KHMHB@K 3QH@KR 7HILE THE TWO DOCUMENTS COVER SIMILAR THE PRINCIPLES SET FORTH BY #$)3# IN XIITOPICS
  49. 49. THE FOCUS AND OBJECTIVE OF EACH DOCUMENT IS DIFFERENT
  50. 50. 3EVEN 2ECOMMENDATIONS FOR 3PONSORS !BOUT %LECTRONIC 3OURCE
  51. 51. FROM OUR !NALYSIS OF THE $! $RAFT UIDANCE AND %-! 3OURCE 0APER 0UT IT IN THE 0ROTOCOL4HERE SHOULD BE INFORMATION IN THE PROTOCOL DESCRIBING WHO WILL BE THE CREATORS OF THE DATA
  52. 52. WHAT DATA WILL BE GATHERED AND WHENWILL IT BE GATHERED ! DATAlOW DIAGRAM CAN GREATLY ASSIST IN THE UNDERSTANDING OF ALL THE DIFFERENT TYPES OF DATA THAT ARE TO BEGATHERED AND HOW THEY WILL EVENTUALLY MAKE IT INTO THE E#2 ELECTRONIC #ASE 2EPORT ORM
  53. 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 7HENPAPER IS THE SOURCE
  54. 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. 55. WHICH ADDSTO THE TIME AND COST BURDEN TO THE SITE 7HILE BOTH PAPERS SUGGEST THE DEVELOPMENT OF ADEQUATE CONTROLS
  56. 56. THE $! UIDANCE GOESAS FAR AS TO STATE g$! RECOMMENDS THAT CLINICAL DATA BE ENTERED ELECTRONICALLY BY STUDY SITE PERSONNEL AT THE TIME OF THE SUBJECTVISIT 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 SHOULDBE MINIMIZED
  57. 57. ESPECIALLY IN THE CASE OF OUTCOME MEASURES WHICH CAN BE SUBJECT TO RECALL BIAS )T IS HELPFUL TO DOCUMENT THERECALL PERIOD AS PART OF THE PROTOCOL 3YSTEMS WHICH COLLECT ELECTRONIC DATA SHOULD RECORD THE TIME OF ENTRY AS WELL AS THE TIME OFOBSERVATION OR EVENT !S SEEN IN WARNING LETTERSXV
  58. 58. EXACT ENTRY OF TIME POINTS INCLUDING DOSING IS IMPORTANT OBJECTIVE EVIDENCEENSURING THAT PATIENT CARE IS APPROPRIATE AND DONE PER PROTOCOL 3UPPORT -AINTENANCE OF $ATA UNDER THE !UTHORITY OF THE )NVESTIGATOROTH DOCUMENTS POINT OUT THAT THE INVESTIGATOR IS RESPONSIBLE FOR MAINTAINING CONTROL OF SOURCE DATA OR A CERTIkED COPY FROMTHE POINT OF COLLECTION THROUGHOUT THE LIFECYCLE OF THE DATA 7HAT DOES CONTROL MEAN IN THE CONTEXT OF SOURCE DATA 3OME DATARELATED TASKS MAY BE DELEGATED TO THIRD PARTIES OTHER THAN THE SPONSOR XVI
  59. 59. BUT THE INVESTIGATOR IS gULTIMATELY RESPONSIBLE FOR THEQUALITYu OF ALL SOURCE DATA !NY CHANGES TO SOURCE DATA SHOULD BE DONE WITH THE KNOWLEDGE AND CONSENT OF THE INVESTIGATOR %VENIF THE DATA ARE STORED ON A COMPUTERIZED SYSTEM AT A THIRD PARTY
  60. 60. THE SPONSOR AND INVESTIGATOR SHOULD BE ABLE TO DEMONSTRATE TOREGULATORY AUTHORITIES THAT THE INVESTIGATOR AND AUTHORIZED SITE STAFF HAD ACCESS AND ABILITY TO gMAINTAINu THE SOURCE DATA AT ALLTIMES
  61. 61. AND THAT THE SPONSOR COULD NOT UNILATERALLY DO SO
  62. 62. 3EVEN 2ECOMMENDATIONS FOR 3PONSORS !BOUT %LECTRONIC 3OURCE
  63. 63. FROM OUR !NALYSIS OF THE $! $RAFT UIDANCE AND %-! 3OURCE 0APER
  64. 64. CONTINUED )NCLUDE !LL #HANGES IN AN !UDIT 4RAIL OF THE E3OURCE $OCUMENT4HE 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 AUDITTRAIL FOR E3OURCE RECORDS )N KEEPING WITH EXISTING RULES ON ELECTRONIC RECORDS
  65. 65. ALL MODIkCATIONS TO SOURCE DATA MUST HAVE ANAUDIT TRAIL 4HE AUDIT TRAIL MUST BE INEXTRICABLY LINKED TO THE DATA AND MUST NOT OBSCURE THE ORIGINAL DATA )N GENERAL
  66. 66. SYSTEMSSHOULD BE DESIGNED SO THAT SOURCE DATA IS NEVER DELETED
  67. 67. EVEN IF IT IS NOT GOING TO BE INCLUDED IN ANALYSIS DATASETS 4HEORIGINAL 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 !DEQUATE4HE SOURCE OF ANY DATA SHOULD BE CLEAR
  68. 68. WHETHER THE SOURCE RECORD IS CAPTURED FROM A PATIENT ON AN ELECTRONIC DEVICE
  69. 69. ENTEREDBY CLINICAL STAFF INTO AN %LECTRONIC $ATA #APTURE SYSTEM OR PART OF THE MEDICAL RECORD IN AN %(2 SYSTEM 4HIS WILL ALLOW FORREGULATORY INSPECTION OF THE PROCESSES PROTECTING SOURCE DOCUMENTS AND DATA !LL SOURCE DATA
  70. 70. SUCH AS VALUES FROM CENTRALLABORATORIES OR 02/ ENTRIES FROM PATIENTS
  71. 71. SHOULD BE REVIEWABLE DURING THE TRIAL BY THE INVESTIGATOR
  72. 72. REGULATORY INSPECTORS ORTHOSE WHO CREATED THE DATA 0ERFORM 2ISK !SSESSMENTS WHEN USING %LECTRONIC (EALTH 2ECORDS AS E3OURCE3YSTEMS THAT CONTAIN %(2 S MAY BE USED FOR MANY PURPOSES
  73. 73. INCLUDING REPORTING CONCOMITANT MEDICATIONS
  74. 74. DOCUMENTINGPREEXISTING CONDITIONS OR IDENTIFYING POTENTIAL SUBJECTS (OWEVER
  75. 75. INSTITUTIONAL %(2 SYSTEMS MAY EMPLOY CONTROLS ANDSTANDARDS THAT DIFFER FROM THOSE EXPECTED FOR CLINICAL TRIALS 7HEN SUCH RECORDS ARE USED
  76. 76. IT SHOULD BE CLEAR FROM TRIALDOCUMENTS THAT THE SPONSOR HAS EVALUATED THE RISKS AND PREPAREDMITIGATIONS 4HE DATA PROTECTION REQUIREMENTS FOR SUCH SYSTEMS SHOULDBE CONSIDERED AND BALANCED WITH THE VALUE OF THE INFORMATION RETRIEVED
  77. 77. 2ElECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DATA AND I #ONCLUSIONS DATA TRANSCRIBED TO ELECTRONIC DATA COLLECTION TOOLS IN CLINICAL TRIALS
  78. 78. WWWEMEAEUROPAEUDOCSEN?DOCUMENT7#PDF *ANUARY 4HESE DOCUMENTS FURTHER CLARIFY THE EXPECTATIONS OF REGULATORY HTTPWWWFDAGOVDOWNLOADS$RUGS II UIDANCE#OMPLIANCE2EGULATORY)NFORMATIONUIDANCES5#-PDF AUTHORITIES REGARDING ELECTRONIC SOURCE DATA
  79. 79. AND DESCRIBE A GROUP OF HTTPWWWCDISCORGSTUFFCONTENTMGRkLESFECAFDFCAACBBDFA III HIGHLEVEL PRINCIPLES
  80. 80. WHICH
  81. 81. WHEN THEY ARE ADHERED TO
  82. 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. 83. THEY COME TO 3OURCE
  84. 84. N E
  85. 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. 86. SYSTEMS WITH ELECTRONIC SOURCE SHOULD PROVIDE GOOD QUALITY DATA TO SUPPORT THE VII #$)3# LOSSARY 6
  87. 87. GOALS OF SPONSORS AND REGULATORY AUTHORITIES HTTPWWWCDISCORGSTUFFCONTENTMGRkLES VIII BEFEBFFAFCAADEEMISCCDISC??GLOSSARYPDF %QUIVALENCE OF %LECTRONIC AND 0APERAND0ENCIL !DMINISTRATION OF IX 0ATIENT2EPORTED /UTCOME -EASURES ! -ETA!NALYTIC 2EVIEW
  88. 88. WALTNEY
  89. 89. #*
  90. 90. 3HIELDS !,
  91. 91. 3HIFFMAN 3 6ALUE IN (EALTH -AR!PR ./4% #OMPUTERIZED 3YSTEMS 5SED )N #LINICAL )NVESTIGATIONS UIDANCE
  92. 92. X %XPECTATIONS FOR %LECTRONIC 3OURCE $ATA AND $ATA WWWFDAGOV/(2-3$/#+%43FRDGDL0$ *ANUARY 4RANSCRIBED TO %LECTRONIC $ATA #OLLECTION 4OOLS IN XI ENERAL 0RINCIPLES OF 3OFTWARE 6ALIDATION
  93. 93. HTTPWWWFDAGOV #LINICAL 4RIALS IS A kNAL RELEASE FROM THE %-! MEDICALDEVICESDEVICEREGULATIONANDGUIDANCEGUIDANCEDOCUMENTS UCMHTM *ANUARY 4HE $! DRAFT UIDANCE FOR )NDUSTRY %LECTRONIC #$)3# E3OURCE 3TANDARD 2EQUIREMENTS #$)3# #LINICAL $ATA )NTERCHANGE XII 3TANDARDS #ONSORTIUM 6ERSION .OVEMBER 3OURCE $OCUMENTATION IN #LINICAL )NVESTIGATIONS OOD #LINICAL $ATA -ANAGEMENT 0RACTICE
  94. 94. 3OCIETY FOR #LINICAL $ATA XIII IS OPEN FOR PUBLIC COMMENT UNTIL !PRIL
  95. 95. -ANAGEMENT
  96. 96. $ECEMBER #OMMENTS CAN BE MADE AT HTTPWWWREGULATIONS XIV ,INES
  97. 97. UIDANCE FOR )NDUSTRY %LECTRONIC 3OURCE $OCUMENTATION IN #LINICAL )NVESTIGATIONS $2!4 5)$!.#% GOV $OCKET .O $!$ XV 53 $! TO )#/. #LINICAL 2ESEARCH )NC .OVEMBER
  98. 98. kNDING A I
  99. 99. RETRIEVED FROM HTTPWWWFDAGOV)#%#)%NFORCEMENT!CTIONS 7ARNING,ETTERSUCMHTM XVI 4ASKS MAY BE DELEGATED TO A THIRD PARTY
  100. 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. 101. TYPICALLY DONE AS PART OF A CONTRACTUAL AGREEMENT53 (%!$15!24%23 %52/0%!. (%!$15!24%230(4 #ORPORATION 0(4 #ORPORATION 3·RL WWWPHTCORPCOM 2UTHERFORD !VENUE
  102. 102. CHEMIN ,OUIS(UBERT #OPYRIGHT Ú 0(4 #ORPORATIONOSTON
  103. 103. -! 53! 0ETIT,ANCY
  104. 104. ENEVA
  105. 105. 3WITZERLAND 2EV 4OLLREE 0HONE

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