RPEClosedIssues
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Closed issues are being tracked in meeting notes in green
- How to deal with protocols amendments taken during the study?
- Provided the AmendProtocolDef transaction
- How does RPE relate to RFD. Is RPE essentially a content profile using RFD infrastructure? Or does RFD create new RFD-like transactions.
- RPE is a set of transactions that allow communication between a ProtocolManager and a ProtocolExecutor relating to the ProtocolDef. RFD is a communication mechanism that will be referenced and used within RPE
- How much automation of protocol events is within grasp? How to executable tasks get conveyed to the Protocol Executor (Enabler? Enactor?)
- We have taken a look at as much automation as possible with the RPE profile. We will focus on the UpdateProtocolExeStep transaction, specifically for the EnrollPatientRequest message
- The executable tasks get conveyed to the ProtocolExecutor via the CDISC Trial Design Model standard
- Find a correct place for (Actions before Protocol Executor agrees to participate - approval from IRB, Form5272 for investigator, training, contract, site signs NDA with pharma company.
- These should become dependencies for the AgreeToParticipateProtocolDef transaction
- Change "Enroll in Protocol" transaction to be "Agrees to Participate".
- changed in profile and RPE Flow Diagram
- Remove "Review CRFs for data capture and data entry" from Use Case Graphic
- Removed, but not using that Graphic currently for workflow
- Add transactions for
- Study changes, schedule is updated, version each study, check study version transaction
- AmendProtocolDef
- Protocol Manager Submit Alert to Protocol Executor
- AlertProtocolState
- Schedule visits transaction (needs to be a seperate transaction after EnrollPatient)
- UpdateProtocolExeStep(PatientScheduled)
- Study changes, schedule is updated, version each study, check study version transaction