Approvals and change requests
How owners approve EnaResearch studies or request changes, how PIs change dates, data scope and retention after approval, and who is notified by email.
- Admin panel
No study collects data without an owner's approval. After approval, the PI can still edit descriptive fields freely, but larger date shifts, data scope changes and retention changes go back to an owner as a change request. Every decision is recorded in the study's history and the audit log.
Required role
- Owner to approve, request changes, approve or reject change requests.
- The study's PI to submit, withdraw and request changes.
Approve a study (owner)
When a study is submitted, owners receive an email and see Awaiting your approval on Overview and a banner on Studies. Click Show, or filter the list with Awaiting my approval.
Click Review on the row (or Review approval in the row menu). The review window summarizes the protocol; Open the full protocol shows everything.
Choose Approve, or Request changes and write What needs to change. A note is optional when approving and required when requesting changes. The note is added to the timeline and sent to the PI.
After your decision, the next waiting item opens (Next). On approval the study becomes Scheduled until its start date, or starts at once if it was set to start on approval; recruitment opens either way.
If you are the study's PI and approve your own study, the approval is flagged as self-approved in the history.
Change a study after approval (PI)
| Change | How it applies |
|---|---|
| Title, protocol no, description, internal note | Actions → Edit study; applies immediately |
| Date shifts of up to 30 days in total from the approved dates | Actions → Change dates or protocol; applies immediately |
| Longer date shifts | Change request; owner approval |
| Data scope: measurement types, sources, data before participation, late data window, clinical record scope, eligibility criteria | Change request; owner approval |
| Retention period (shorter or longer) | Actions → Change retention; always owner approval |
A reason is always required and is recorded in the history and the audit log. A study can have only one pending change request at a time; until it is approved, the current values apply. The start date cannot change once the study has started. The PI can Withdraw request while it is pending.
A retention change can be requested even after the study has ended, as long as its data has not been deleted yet.
Decide a change request (owner)
Change requests appear under Awaiting my approval with the label Change request. Open Review change request, read the requested values and the reason, then choose Approve request or Reject (a reason is required to reject). An approved request is applied at once.
Email notifications
EnaResearch sends lifecycle emails: submissions and change requests go to owners, decisions go to the PI. There are no phone (push) notifications. If an email cannot be delivered, the action still completes.
Related articles
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