SUMMARY
In Release 2.18.4 of Disclose, the attachments functionality for a study has been enhanced to enable a user to modify the attachment type of an existing attachment. Modifying an attachment type for a study will version the attachment, retain business approval where appropriate and create an audit trail of the changes.
How to modify an attachment type:
Navigate to the attachment you wish to update under Study -> Attachments and click on the drop-down arrow in the Attachment Name field. Click Edit Properties.
Select the updated attachment type from the drop-down, click Save.
3. Optional: Users can view the change to the attachments in the attachment version history, or in the PRF version history (screenshot below) if the attachment is a public attachment:
Re-approving an updated attachment type:
Modifying an attachment type for a study retains previously obtained business approval. However, if a user deems it necessary for the attachment to be re-approved, a manual attachment compliance event can be created to route the changes for approval.
Navigate to the Study -> Compliance screen, click Check Out.
Click Add on the Compliance Events ribbon to add a Manual Compliance event:
Complete the required fields. Select the attachment associated with the type update in the "Attachments". Provide a Due Date that reflects the timing of when the changes need to be approved; click Save.
If necessary, cancel existing In Progress or Pending Compliance Events that have higher priority to enable the newly created manual event to start.
Help related questions:
As a user I don't have the ability to modify an attachment type:
Please confirm that the user is assigned to a role that has "Edit Attachment" Permission assigned in his/her user profile.
For Administrators: To verify permissions assigned to a role, navigate to Administration -> Roles, click on the related role. Observe if the role as "Edit Attachment" permissions:
I've modified the attachment type of an attachment for my study in Disclose and I don't see the changes on CTgov or my company website.
Changing the attachment type does not automatically trigger a submission to ClinicalTrials.gov or Company website. A user is require to re-export the attachment type update.
Upon attempting to update an attachment type, I am receiving an error that the attachment has already been uploaded.
Only one attachment per attachment type can be uploaded per study with the exception of the attachment type "Attachment". If there are multiple documents to be uploaded, please user the type "Attachment"
Upon attempting to update an attachment type, I am receiving an error that the a workflow is 'In Progress'.
An attachment type can not be updated if there is an existing, in progress, Attachment Compliance maintenance event. To proceed, please reach out to the study manager and request that they cancel the existing event to enable the change to be applied. Once complete, please follow the instructions above to initiate a new Attachment Compliance event.