Recalling a CDA

When appropriate, you can recall a CDA document that was sent to a study site within the CDA workflow and recall a CDA submitted by a study site user or by an Oracle Site Select user on the study site’s behalf.

Permissions on which CDA documents, if any, you can recall follow your CDA-assigned permission(s); no additional permission is required to recall a CDA. For example, if you have the Negotiation for assigned CDA/Document submissions only permission, you can recall only those CDAs that are in the scope of that permission.

Site users who have authenticated into Oracle Site Select LITE via a username/password can delete their last uploaded CDA by navigating to the Document library tab in Oracle Site Select LITE. This includes CDAs they uploaded as well as those uploaded on their behalf.

When you view the Document approvals area on either the Requires site resubmission or Approved tab, you'll see a Recall action button in the Document History modal. The Recall button is available only for the most recent document. By design, the Recall button is not available on a Final Approved document that was auto-completed by a document found in a site's document library.

If you click Recall, a confirmation modal displays that shows the outcome of the Recall action (e.g., "The document workflow will be reverted to Pending review"). If appropriate for the document, additional warning text may display. For example, "You are about to recall the document submitted to the site for review. This will remove the document from the site's document library and active document task. It will also revert the document workflow back to Requires approval. If the site has already downloaded the document, this feature will not remove that download from their system."

If you recall the document:

• The document link is removed from the Oracle Site Select LITE document library and the Oracle Site Select LITE action task bar
• The CDA workflow is reverted back to the Oracle Site Select user (e.g., the document submission is "undone")
• Comments associated with the document are removed
• No email notification is sent to the Oracle Site Select user or site users

If you request a resubmission from a site, but do not upload a document, and you then want to recall that "submission," the recall action will revert the action of requesting a resubmission, but it will not impact a document submission.

• There is no document link to remove from the Oracle Site Select LITE document library nor the Oracle Site Select LITE action task bar
• The CDA workflow is reverted back to the Oracle Site Select user
• The audit log is updated to reflect the recall
• No email notification is sent to any Oracle Site Select or Oracle Site Select LITE user
• The comments associated with the submission are removed

• Recall a CDA