Using Spec Approvals
Spec Approvals let an External Vendor Study Spec Designer send a specification for formal, in-app approval before it's published, with a full audit trail of who approved it, when, and on what version.
Spec Approvals currently supports External Vendor study specifications only.
Requesting Approval for a Specification
Open the specification and click Publish Draft from the Actions menu.
In the Publish Draft? dialog, turn on the Request approvals toggle.
Click Set up request. The Approval request panel opens.
Fill in the request Subject (required), Message (optional), Due date (optional), and Approvers (required) - select one or more users with access to the data package.
Click Send request.
The specification moves into “in-review” and can't be edited until the request is completed or voided.
While a Specification Is In Review
Once a request is sent, the specification header shows an In-review badge and the spec becomes read-only. Spec Chat stays available so the team can keep discussing the content.
Anyone with access to the specification can open the Approval request panel to see the Subject, Message, Due date, and the list of Approvers with their status:
Pending - the approver hasn't responded yet
Approved - the approver has signed off
If you're an approver and the request is still pending, you'll see Approve and Reject buttons next to your name.
A Spec Designer with access to the data package and who can edit study specs can cancel the request at any time by clicking Void request at the bottom of the panel, then confirming Void the approval request?. Voiding returns the specification to an editable draft.
Approving or Rejecting a Request
To approve:
Click Approve next to your name in the Approval request panel.
In the Reason for approving dialog, select a reason from the dropdown: I approve this document, I have reviewed this document, I am the author of this document, or Other (enter your own reason under Please specify).
Click Approve, then complete the Electronic Approval authentication step to confirm your identity.
To reject:
Click Reject next to your name.
In the Reject specification? dialog, enter a Reason for rejecting (required).
Click Reject.
Rejecting a request cancels it and returns the specification to an editable draft. This action can't be undone - the author will need to send a new request after making changes.
After All Approvers Sign
Once every approver has approved the request, the specification is published, and a finalized approval PDF is generated, listing the study, data package, version, publish date and time, and each approver's name, title, reason, and date.
The Versions tab notes Published with Approvals in the Published Reason column for that version.
Publishing a new draft from an approved version starts a new approval cycle. Approval history isn't carried forward to the new draft, but it stays visible on the previously approved version.
Viewing Approval Requests and History
Go to Metadata > Spec Approvals to see every approval request across your specifications, with columns for Data Package, Study, Project, Version, Status, Creation Date, Requested By, and Actions.
Depending on the status, the Actions column lets you:
View spec - open the read-only specification (In review)
Download PDF - download the finalized approval PDF (Approved)
View details - see the rejection reason (Rejected)