What are the nine archival rights and how should I assign them?
The following Oracle InForm CRF Submit archival rights can be added to Oracle InForm rights groups in Oracle InForm User Management Tool:
- Generate Archives—Generate archival PDFs based on the user's Oracle InForm account configuration.
- Administer Archives—Configure Oracle InForm CRF Submit. The CRFAdmin is the only rights group that can do this.
- Delete Archives—Delete a request. Users can only delete their own requests.
- View All Completed Archives—(For sponsor users) See all completed requests, including those generated by other users.
- Manage Templates—Create, edit, and use Oracle InForm CRF Submit request templates.
- Share Archive with Sites—Sponsor users with this right can share PDFs with Site users. Site users with Archives access will be able to log into Oracle InForm and download the PDFs.
- Confirm Archives Download—Although it is typical for those who can sign CRFs and casebooks are the same people that can accept/confirm they have received the PDFs, this right allows site users to download requests without the right to generate requests.
- View Download Confirmation—View a report showing which sites have accepted their PDF archives.
- Download for eTMF—Make the PDF output available where someone with the eTMF right can access it. An eTMF download allows an InForm user with the eTMF right to retrieve it and load it into an electronic trial master file (eTMF) system. If you choose this right, you cannot select any other archival rights.
How these rights interact
If you choose the Download for eTMF right, you cannot select any other archival rights.
Typical rights assignments
The table below shows the nine rights and the rights groups to which they are typically assigned.
| Oracle InForm CRF Submit Right | CRC | PI | Sub-I | CRA | CDM | Project Manager | Medical Monitor | View Only | CRF Admin | CRF Unblinded |
|---|---|---|---|---|---|---|---|---|---|---|
|
Generate Archives |
X |
X |
X |
X |
X |
X |
-- |
-- |
X |
X |
| Administer Archives |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
X |
-- |
| Delete Archives |
X |
X |
X |
X |
X |
X |
-- |
-- |
X |
X |
| View All Completed Archives |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
X |
| Manage Templates |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
X |
-- |
| Share Archives with Sites |
-- |
-- |
-- |
-- |
X |
-- |
-- |
-- |
X |
X |
| Confirm Archives Download |
-- |
X |
X |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
| View Download Confirmation |
-- |
-- |
-- |
-- |
X |
X |
-- |
-- |
X |
X |
Parent topic: Rights management