Study Library Audits (Report)

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.

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Study Metadata

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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

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Report Walkthrough