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

01/23/09

• RPE wiki changes?
  • Reviewed changes from last meeting
• 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
  • Looked good, Robert to look them over
• 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
    1. ProtocolDocument – aka ProtocolDoc
    2. ProtocolDesign – aka ProtocolDesign
    3. ProtocolDefinition – aka ProtocolDef
  • New name for UpdateProtocolManager based on this decision?
  • Will use ProtocolDef to define the Protocol Document being created by eClinical and maintained by the ProtocolManager (Updated the RPE Flow Diagram)
  • Will use UpdateProtocolExeStep to define the transaction that allows the ProtocolExecutor to update the ProtocolManager when the Execution Step has taken place (Updated the RPE Flow Diagram)
  • Added ProtocolDef and ProtocolState to the Glossary
• Glossary needs some attention
  • Added ProtocolDef and ProtocolState to the Glossary
• Update transactions to reflect new transactions from 01/16 meeting
  • Updated the transactions to reflect previous discussions and the RPE Flow Diagram
  • Is it alright to put a link to the Trial Design Model document on the wiki?
  • Uploaded the TDM document per Diane Wold
• Open/Closed issues needs work?
  • Cleaned it up a little...Open/Closed issues will mostly work from the meeting notes
• Review input/output data elements needed for the UpdateProtocolManager(EnrollPatientRequest) transaction
  • Work will be needed form the eClinical side in order to define these data elements
  • What data is needed from the EHR to successfully Enroll a subject into EDC for a study
  • What data is available from the EDC to store within the EHR
• [To be done after the input/output data elements are defined] 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
• Add UpdateProtocolState(SubjectComplete) transaction
• Introduce BRIDG (Biomedical Research Integrated Domain Group) as a standard to use with RPE
  • Think of it in the same way as a content profile (CRD) for the transmission mechanism (RFD)
  • caBIG
• What needs to be done before 01/26/09-01/27/09 face-to-face?
  • Discuss the wiki and Supplement Template-V7.1.doc IHE Supplement Template
  • per Jason Colquitt: As a reminder the Word Template Supplement Template-V7.1.doc IHE Supplement Template is expected to be the document by which all profiles are working toward. If you could have your partially complete profile in this format for next week, this would make a consistent presentation, and would make review of the profiles easier.

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