Managing protocols

You'll need to specify key protocol information in Oracle Site Select, such as the study name and study number, IRB/EC type, countries, and therapeutic area. Then upload the protocol in Microsoft Word or Adobe Acrobat (PDF) format and run a workflow to drive the process required to deliver the document to sites.

Just like confidentiality documents, you can:

• Define multiple workflows so that different protocol documents, such as the full protocol or a synopsis, can be delivered to various sites
• Designate a default protocol document to automatically assign to all workflows
• Manage multiple versions of protocols so that sites receive the latest protocol version

If a protocol changes, you can upload a new version. On the "Manage protocol documents" page, click the "Protocol version history" section to expand the section and view previous protocol versions. You can view or download the protocol file or click "X" to remove the file.

If you choose to remove a protocol document, Oracle Site Select will detect if the document is in use by sites, and you'll have the choice to preserve or restart the workflow.

• Upload a study protocol to a workflow