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Introduction
Users update the CP workflow, events, label formats, etc., based on their requirements. The audit trail on the CP overview page does not give you detailed information on what was changed, why it was changed, etc.
The Meeting regulatory compliance like 21 CFR Part 11 compliance requires tracking all the , CAP, or ISO requires reviewing changes done to the collection protocol, getting the changes peer-reviewed, and publishing them. To overcome the security issues, OpenSpecimen allows you to track the changes made in CP attributes, label settings, events, specimen requirements, workflows, consents, and so on.
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a protocol before publishing them. Starting v9.0, OpenSpecimen supports creating draft mode Collection Protocols before it is published for usage.
Note: Participant & specimens can be created when a CP is in Draft mode. A watermark is displayed on pages to highlight the CP’s current status.
Enable CP Revisions
By default, the CP revision setting is disabled.
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1. Log in as a Super Admin. 2. Navigate to 'Settings':  3. Search for ‘CP Revisions' in the ‘Biospecimen’ module and 'Enable’ it:  |
Notifications
CP PI and coordinators are notified via email whenever a CP is moved to draft or published mode.
The reviewers and publisher are notified via email when the CP is published.
Draft Mode
Once the ‘CP Revisions' setting is enabled and you make any changes to the Whenever you edit a CP, the CP goes into 'Draft’ mode:. A watermark “Draft” is displayed on all the pages.
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1. Click on the 'Publish' button:  2. Enter the details (Summary of Changes, Reason, Reviewers) and click on 'Publish':  |
Revisions Details
When A new tab “Revisions” is displayed when you enable the setting, a new tab, 'Revisions', is added to all the CPs:.
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If you navigate to the revisions tab, it will display all details like when the CP was published, who published it, reviewers, etc.:  To view the revision details, click on the eye icon:   |
Download Revision
Whenever any revision is made to the CP, you You can download the CP definition for that specific a revision by clicking on the download icon beside it:
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