Introduction

Meeting regulatory compliance like 21 CFR Part 11, CAP, or ISO requires reviewing changes done to 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.

Video

Enable CP Revisions

By default, the CP revision is disabled.

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

Whenever you edit a CP, the CP goes into 'Draft’ mode. A watermark “Draft” is displayed on all the pages.

The CP remains in the ‘Draft' mode until it’s published.
The draft nature of the CP is visible in all the CP-related data entry pages. This ensures that the users know that they are doing data entry for a draft CP.

Publish

You can publish the CP once the changes made to the CP are peer-reviewed.

1. Click on the 'Publish' button:

2. Enter the details (Summary of Changes, Reason, Reviewers) and click on 'Publish':

Revisions Details

A new tab “Revisions” is displayed when you enable the setting.

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

You can download the CP definition for a revision by clicking on the download icon beside it:

CP Revisions (v9.0)