RPEMeetingNotesArchive

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• 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
• 01/16/09
  • Agenda
    • Review RPE wiki
    • Define input/output data elements needed for the UpdateProtocolManager(EnrollPatientRequest) transaction
      • Work will be needed form the EDC side in order to define these data elements
    • Discuss XML standards to be used for message parameter supplied in the UpdateProtocolManager transaction
      • Choosing an XML standard cannot happen until we have defined the data elements needed for the transaction
      • Need to also think about other data elements needed for the other options for this "UpdateProtocolManager" transaction
  • Define the difference between Protocol and Protocol State.
    • ProtocolDefinition
    • ProtocolInstance/ProtocolState
    • From the Trial Design Model (TDM) - 1.2 Separation of Concerns: Trial Design vs. Trial Execution?
    • Three have been proposed...will add to agenda for next meeting
      1. ProtocolDocument – aka ProtocolDoc
      2. ProtocolDesign – aka ProtocolDesign
      3. ProtocolDefinition – aka ProtocolDef
    • New name for UpdateProtocolManager based on this decision?
  • Add AmendProtocol transaction from ProtocolManager to ProtocolExecutor
    • Added an AmendProtocolDefinition transaction to the RPE Flow Diagram
  • Add EnterPatient/PatientInScreening transaction
    • Added an UpdateProtocolState(EnterPatientRequest/ScreenPatientRequest) transaction to the RPE Flow Diagram
  • Add FreezePatient transaction
    • Added an AlertProtocolState(FreezePatient, Unfreeze/Thaw, LockPatient/SignOffOnPatient, Unlock) transaction to the RPE Flow Diagram
  • Add LockPatient/SignOffOnPatient transaction
    • patient is done
    • Added an AlertProtocolState(FreezePatient, Unfreeze/Thaw, LockPatient/SignOffOnPatient, Unlock) transaction to the RPE Flow Diagram
  • Add Unfreeze/Thaw transaction
    • Added an AlertProtocolState(FreezePatient, Unfreeze/Thaw, LockPatient/SignOffOnPatient, Unlock) transaction to the RPE Flow Diagram
  • Add UnLock transaction
    • big issue...more auditable
    • Added an AlertProtocolState(FreezePatient, Unfreeze/Thaw, LockPatient/SignOffOnPatient, Unlock) transaction to the RPE Flow Diagram
  • Discussed the need to clarify why we chose to do the one transaction "UpdateProtocolManager(EnrollProtocolRequest)"
    • Seems to be one of the most needed?
    • The content used for the ProtocolDef will come from the Trial Design Model (TDM), which is not complete
    • The "UpdateProtocolManager(EnrollProtocolRequest)" transaction doesn't need the entire ProtocolDef to be functional, just an identifier for the ProtocolDef

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