Summary
This report is intended to track audits made to a study library for change control purposes.
All audits captured via the CRF Design > Study Library component should be captured in this report.
Report Logic
Report all audit history for each of the following categories:
Metadata
Study Events
Forms
Item Group References
Item Groups
Item References
Items
Code Lists
Measurement Units
Methods
If no audit history is present, do not report anything.
Report name should be: Study Library Audits_“study name”_“date of generation”
Report Outputs
This report contains all available audit records for CRF Study Library artifacts. This report does not contain any artifacts for clinical data or the usage of these forms.
Study Metadata
Study Events
Forms
ItemGroup Refs
ItemGroups
Item Refs
Items
CodeLists
Measurement Units
Methods
Report Limitations
Studies from older ClinSpark versions will have less audit records
Over time the number of design audits ClinSpark produces has significantly increased. Studies which were designed on earlier versions of ClinSpark will not have complete audit trails. Studies designed on in current ClinSpark releases will contain audits for all standard Study Library artifacts.
No audits will exist for deleted Study Library elements
ClinSpark will not allow deletion of Study Library elements once Clinical Data has been collected against them. However during the design phase, it is possible to delete elements and no audit record will be created. The focus of audits is to ensure a complete audit record for Clinical Data and study elements used for this collection.
Example Report
Report Walkthrough
INSERT VIDEO HERE