1. Information for CRO and Sponsor Users
  2. Document Management

10 Document Management

Study administrators, protocol and CDA managers, and email managers can use this section to learn how to manage documents in Oracle Site Select so study sites can view, download, and complete document related workflow tasks.

  • Managing CDAs and confidentiality statements
    Some study workflows require supporting documents, like a CDA or confidentiality statement. You can upload CDAs and confidentiality statement documents into Oracle Site Select and share them with sites at the appropriate time (as specified in your workflows).
  • Managing CDA submissions and approvals
    If you have the appropriate document review privileges, you can view every round of a CDA's review cycle on the manage menu's Document Approvals page.
  • Signing CDAs digitally with Adobe Sign integration
    Oracle Site Select offers CFR Part 11-compliant digital signature for the CDA workflow through optional subscription to Adobe Sign. Your Oracle Project Manager will provide subscription details.
  • 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.
  • 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.
  • Managing generic documents
    Generic Document is a specific workflow task available in the Task Library when you create or modify a workflow under Site workflow configuration.
  • Document Library
    The Document Library feature allows for document reuse and automates the completion of workflow tasks using stored library documents associated to study site, investigator, or institution.
  • Document workflow task audit
    Site grid users can download an audit file containing document workflow completion details.