Sealed Envelope | Audit trail

Clicking the Log link in the top menu bar displays the audit trail. The most recent 100 lines are shown by default; click the ‘Show all’ button to see the entire log. The audit trail is a plain text file which can be downloaded if required using the Download button. The 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 sites
Randomisations
Movement of blocks within code lists
Unblinding
Downloads from the system such as reports in CSV format, CRF data, code list and the audit trail itself

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" : "2015-10-22 17:45:47","reasonForEdit":null ..."

Example extract

100.2.3.4 "Simon Admin (ID 2)" "/redpill/trialname/crf/reviewadd/BaselineEligibilityCriteria/1" [2015-10-22T17:45:47+01:00] INFO (6): Row inserted to crfBaselineEligibilityCriteria: {"id":null,"patientId" : "1","userId" : "1","lastUserId" : "1","created" : "2015-10-22 17:45:47","updated" : "2015-10-22 17:45:47","reasonForEdit":null,"notes":null,"diagnosisOfIpfOrNsip" : "No","rhcMeanPap" : "Yes","ageRange" : "No","dateWrittenInformedConsentGiven" : "10\/08\/2008","validationStatus":null,"validationNotes":null}
100.2.3.4 "Simon Admin (ID 2)" "/redpill/trialname/crf/reviewadd/BaselineEligibilityCriteria/1" [2015-10-22T17:45:47+01:00] INFO (6): Added form Eligibility Criteria Check At Recruitment for Patient SDN01
100.2.3.4 "Simon Admin (ID 2)" "/redpill/trialname/crf/reviewedit/BaselineEligibilityCriteria/1" [2015-10-22T17:48:40+01:00] INFO (6): Row in crfBaselineEligibilityCriteria for: {"id" : "1"}, changed From: {"updated" : "2015-10-22 17:45:47","reasonForEdit":null,"unstableUnderlyingLungDisease":null,"anySeriousComorbidity":null,"systolicBp":null}, To: {"updated" : "2015-10-22 17:48:40","reasonForEdit" : "Adding some more answers","unstableUnderlyingLungDisease" : "No","anySeriousComorbidity" : "Yes","systolicBp" : "No"}
100.2.3.4 "Simon Admin (ID 2)" "/redpill/trialname/crf/reviewedit/BaselineEligibilityCriteria/1" [2015-10-22T17:48:40+01:00] INFO (6): Edited form Eligibility Criteria Check At Recruitment for Patient SDN01
100.2.3.4 "Simon Admin (ID 2)" "/redpill/trialname/contact/add/Individual" [2015-08-13T10:37:45+01:00] INFO (6): Row inserted to contact: {"id":null}
1.2.3.4 "Simon Admin (ID 2)" "/redpill/trialname/contact/add/Individual" [2015-08-13T10:37:45+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)" "/redpill/trialname/contact/add/Individual" [2015-08-13T10:37:45+01:00] INFO (6): Added contact James Kinnear