Audit trail

Clicking the Log link in the left-hand sidebar displays the audit trail. The audit trail is a plain text file which can be copied and pasted into a local text file if required. This log records all significant events and changes to the data including:

  • Data entry and editing of forms
  • Creation and adding messages to queries
  • Creation and editing of contacts
  • Randomisations
  • Movement of blocks within code and rescue lists
  • Unblinding

An example extract from a log is shown below. The items shown in each row of the log are (from left to right):

  • IP address of the user who initiated the event
  • Name and user ID of the user
  • URL
  • Server date and time (including GMT offset)
  • Notice level - usually this will be “INFO (6)”
  • Message

Where applicable, the message contains information on the data before and after the event. Some events might generate several related messages - such as an explanatory note

"Edited form Eligibility Criteria Check At Recruitment for Patient SDN01"

plus a change in the data:

"Row in crfBaselineEligibilityCriteria for: {"id" : "1"}, changed From: {"updated" : "2009-10-22 17:45:47","reasonForEdit":null ..."

Example extract

100.2.3.4 "Simon Admin (ID 2)" "/Trialname/crf/reviewadd/BaselineEligibilityCriteria/1" [2009-10-22T17:45:47+01:00] INFO (6): Row inserted to crfBaselineEligibilityCriteria: {"id":null,"patientId" : "1","userId" : "1","lastUserId" : "1","created" : "2009-10-22 17:45:47","updated" : "2009-10-22 17:45:47","reasonForEdit":null,"notes":null,"diagnosisOfIpfOrNsip" : "No","rhcMeanPap" : "Yes","ageRange" : "No","unstableUnderlyingLungDisease":null,"anySeriousComorbidity":null,"systolicBp":null,"clinicallyOvertIschaemicHeartDisease":null,"unableToPerform6MinuteWalkTest":null,"receivingExcludedMedications":null,"plannedSurgicalInterventionInStudyPeriod":null,"chronicLiverDisease":null,"endStageRenalDisease":null,"pregnantOrSuspectedPregnancy":null,"emphysemaPredominantOnHrct":null,"writtenInformedConsent":null,"dateWrittenInformedConsentGiven" : "10\/08\/2008","validationStatus":null,"validationNotes":null}
100.2.3.4 "Simon Admin (ID 2)" "/Trialname/crf/reviewadd/BaselineEligibilityCriteria/1" [2009-10-22T17:45:47+01:00] INFO (6): Added form Eligibility Criteria Check At Recruitment for Patient SDN01
100.2.3.4 "Simon Admin (ID 2)" "/Trialname/crf/reviewedit/BaselineEligibilityCriteria/1" [2009-10-22T17:48:40+01:00] INFO (6): Row in crfBaselineEligibilityCriteria for: {"id" : "1"}, changed From: {"updated" : "2009-10-22 17:45:47","reasonForEdit":null,"unstableUnderlyingLungDisease":null,"anySeriousComorbidity":null,"systolicBp":null}, To: {"updated" : "2009-10-22 17:48:40","reasonForEdit" : "Adding some more answers","unstableUnderlyingLungDisease" : "No","anySeriousComorbidity" : "Yes","systolicBp" : "No"}
100.2.3.4 "Simon Admin (ID 2)" "/Trialname/crf/reviewedit/BaselineEligibilityCriteria/1" [2009-10-22T17:48:40+01:00] INFO (6): Edited form Eligibility Criteria Check At Recruitment for Patient SDN01
100.2.3.4 "Simon Admin (ID 2)" "/Trialname/contact/add/Individual" [2009-08-13T10:37:45+01:00] INFO (6): Row inserted to contact: {"id":null}
1.2.3.4 "Simon Admin (ID 2)" "/Trialname/contact/add/Individual" [2009-08-13T10:37:45+01:00] INFO (6): Row inserted to individual: {"id" : "52","title":null,"lastName" : "Kinnear","firstName" : "James","jobTitle" : "Layman","responsibility":null,"notes":null,"type" : "individual","qualifications":null,"regNo":null,"cv" : "0","cvDate":null,"delegationLogReceived" : "0","delegationLogReceivedDate":null}
100.2.3.4 "Simon Admin (ID 2)" "/Trialname/contact/add/Individual" [2009-08-13T10:37:45+01:00] INFO (6): Added contact James Kinnear
Page updated 29 Oct 2014