Procedure Review Process (CRA)
Procedure Review is the built-in communication channel between sites and monitors. Each procedure (aka CRF) can go through multiple submission cycles and is finally closed by the monitor once all data is reviewed.
In this article
- Procedure Review Workflow
- Status Descriptions
- Status Counts
- Queries on Reviewed Procedures
Procedure Review Workflow
The following steps make up the procedure review workflow:
1. Site user enters data and/or uploads source.
2. Site user submits the procedure for review using the Review button.
Note: When submitting for review, a comment is optional.
3. Once the site user submits the procedure for review, the status of the procedure is updated to Submitted and data entry is locked.
Note: It can be unlocked by a site user for additional data entry as long as the procedure is in the Submitted status.
4. Monitor reviews the procedure. Using the Review button, they can either
- Close and mark the procedure as Reviewed Complete.
- Close and mark the procedure as Review Not Required, Not Done.
- If appropriate, close and mark the procedure as Reviewed with a reason.
- In the 2022.12 release, monitors can now issue queries on form and field level with the new query workflow in place of Review Comment. To issue a query, click on New Form-Level Query button on the form, or New Query button on any field in the form.
5. If a query is issued, the procedure is unlocked for data entry and the site can make appropriate updates and re-submit the procedure for review.
Note: After a procedure is marked as Reviewed, a monitor can re-open the procedure at any time, by updating the status to Review Comment, if further data entry updates are required.
Queries on Reviewed Procedures
If a Data Manager issues a query to a procedure marked as Reviewed, the procedure will be automatically unlock for data entry. If data entry is updated, the procedure must be re-submitted for CRA Review. If the query is answered (and data entry updates are not made) the procedure does not need to be resubmitted.
Status Descriptions
A procedure/CRF for a visit that has been started will always have one of the following Review statuses:
- Open - Automatically set when a visit is started
- Review Comment - Procedure has been reviewed by the monitor and is sent back to the site with a comment/question
- Submitted - Procedure data entry is complete and is awaiting review by the monitor
- Reviewed - Procedure data entry has been reviewed by the monitor
Review Status Counts
The current count of procedures grouped by review status is displayed and rolled up from subject visits, to subjects, and finally to the site level under the column labeled Review Status. Status counts are displayed in the format "a / b / c / d" where...
- a = procedures with status of Open
- b = procedures with status of Review Comment
- c = procedures with status of Submitted
- d = procedures with status of Reviewed
