RPEMeetingNotesArchive

• 12/12/08
  • Discussed Detailed Proposal
• 12/19/08
  • Discussed RPE Use Case Graphic
• 01/09/09
  • Discussed RPE Flow Diagram
  • Transactions from Protocol Manager to Protocol Executor when the study changes
    • AmendProtocolDefinition
  • Studies should be versioned
    • Added to Flow Diagram
  • Check study version transaction
    • Is there a todo here?
  • Add enter patient in study transaction (responses: ACK ENTER, ACK ENROLL, ACK INFORM CONSENT). This would happen before the patient is enrolled into a study.
    • Added to Flow Diagram: UpdateProtocolState (XML Message to EnterPatientRequest/ScreenPatientRequest?)
  • Add Prerequisites/Dependencies
    • (patient ran through inclusion/exclusion criteria, patient signed inform consent, labs, documented signed inform consent, screening etc.)
    • Need to define these in more detail
  • Patients get “screen failed” may or may not be entered into EDC
    • This will be a response from the UpdateProtocolState(EnrollPatientRequest) transaction with instructions on next steps (define next steps)
  • List before/after of enroll
    • No idea what i was trying to accomplish here
  • Changed Enroll Patient to EnrollPatientRequest
    • Added to Flow Diagram
  • Determined that only the "UpdateProtocolManager(EnrollProtocolRequest)" Transaction would be worked for the next publication of RPE.
    • Currently the focus as well as documenting the other items involved in the RPE use case