Guidelines: Requests for approval

The sponsor can choose whether or not to use the approval system, and to what degree it should be used for each study. Example: A sponsor could decide to use approvals only for rollbacks.
On the Configurations page, you can adjust the approval level if it is too high or too low. Example: The sponsor might decrease the level of approvals for a date of birth change from two to one, or might change the approval role for a specific field from study manager to field monitor.
The roles that can approve a request are set at the time the request is first received. If the approval role for a type of request is later changed, the previous role must still approve any requests that were assigned to that role before the change. Example: If the approver for rollbacks is set as the study manager at the time of a request but is later changed to field monitor, the study manager must approve the earlier request.
Out-of-window and out-of-age approvals require one level of approval. For all other requests, you can set up none, one level, or two levels of approval.
The approval permissions for out-of-window and out-of-age permissions are set through the permissions settings during study design.
You can approve or reject any request that is assigned your role, but:
- You cannot approve a request that you made.
- You cannot perform both first- and second-level approvals on the same request.
- Only one user needs to approve or reject first-level or second-level requests, regardless of how many roles are authorized to approve the request.
You must provide a comment for each request that you reject. This comment documents the reasons for your decision, and can also provide guidance on further action (which is especially important when the request is rejected). You do not have to provide comments for approved requests.