Retrieve Protocol for Execution

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Introduction

This is a draft of the Retrieve Protocol for Execution Profile (RPE) supplement to the Quality, Research, and Public Health (QRPH) Technical Framework. This draft is a work in progress, not the official supplement or profile.

Profile Abstract

The Retrieve Protocol for Execution Profile (RPE) provides an automated mechanism for EHR to retreive a complex set of clinical research instructions (or a protocol) from an EDC system to execute within the EHR.

  • RFD scenario teams:
    • Sponsors: Pfizer, Lilly, Novartis, Genzyme
    • EHRs: Greenway, Cerner, Allscripts, Epic
    • eClinical: Outcome Sciences, Nextrials, Phoenix Data Systems
  • Proposal Editor: Landen Bain (CDISC)
  • Profile Editors:
    • Daemon Whittenburg (Greenway Medical Technologies)
    • Diane Wold (Glaxo Smith Klein - Chair of CDISC’s Trial Design Team )
  • Dan Levy (Outcome Sciences)
  • Robert Barr (NexTrials)
  • Chris Connor (Phoenix Data Systems / Bio-Imaging Technologies)
  • Jane Griffin (Cerner)
  • Jaime Lucove (AllScripts)
  • Lisa Chatterjee (DIFZ, chair of CDISC’s Protocol Representation team)
  • David Handelsman (SAS)
  • Mark Arratoon (GE Healthcare)
  • Jan Kratky (SAS)
  • Josh Painter (Intel)

Meeting Notes

RPE Meeting Notes Archive 

  Upcoming meeting dates (every Friday starting on 4/10)
  Meeting time 1-2pm (est)

  USA toll (preferred): 	857.207.4197
  USA toll free: 	888.643.3083
  UK toll (preferred): 	0203 024 9429
  UK freefone: 	0808 101 2760
  Participant passcode: 	71999358 then #
  NOTE:  If you have free long distance, please use the toll number rather than the toll free


04/24/09

  • We are working on transitioning meetings from GSK to IHE...(Continue to use GSK numbers above until I confirm the IHE webex being set up)
  • QRPH Tech May 4-6 Face to Face Agenda
    • What do we need to submit for public comment (May 18th deadline)?
      • Daemon to get with Jason Colquitt
    • Need to do work on volume I and start volume II
      • .xsd
      • .wsdl
      • .bpel
  • Review XML Schema Definitions (xsd) for each actor
  • Discuss standards to be used for the messages being passed between actors
    • Jason Rock - HL7v3 Study Design, Study Participation, Subject Data discussion update
    • HL7v3 Study Design(would be used within ProtocolDefManager)
      • Directly overlapped with ODM
      • Contains eligibility criteria
      • Contains workflow
      • Can handle "if in treatmentA here are activities for treatmentA"
    • HL7v3 Study Participation(would be used within ProtocolStateManager)
      • Contains elements for Subject
      • Contains elements for Investigators
      • Contains elements for Sites
      • Handles subjects in which sites
      • Handles IRB approval
      • Describes who are the patients in the study
    • Subject Data (would be used within ProtocolStateManager)
      • Contains the data within study
      • Contains data elements for scheduling
      • The Care Record from the HL7 Care Provision was used
      • Contains the target of activities
      • The difference with Care Record is
        • In a Care Record message the role is patient
        • In Subject Data is subject
    • HL7v3 Clinical Research Filtered Query Service (possibly used later for querying)
    • TDM experts to discuss the benefits of using TDM and how it relates to the HL7 Study Design message
      • How will using TDM be affected by the FDA using HL7v3 by 2012?
      • TDM can be used for ProtocolDef, but not state management...
        • At minimum will need to look at using HL7v3 Study Participation and Subject Data for the state messages...
      • TDM inclusion/exclusion defined by using ODM condition definition construct
    • I believe one of the choices of TDM or HL7v3 Study Design are sufficient and we shouldn't have to discuss BRIDG?
  • Discuss PIX/PDQ to be used for all associated IDs to represent the patient
  • Change name of UpdateProtocolExeStep to ExecuteProtocolStep?
  • ProtocolStateManager needs RetrieveProtocolDef transaction from ProtocolDefManager
  • There is no current model within TDM to place RFD information for each visit?
    • Should there be a seperate actor to manage the relationship between an RFD formID and a visit contained within the TDM?
    • Supply context information of RFD forms to be used?
    • Use ODM extension to place the RFD definition within the TDM
  • Add detailed diagrams explaining different scenarios for the different transactions
    • This is to clarify the questions that have been brought up in writing this profile
  • Add additional use cases, such as the Cancer Registry's use case?
    • Get Cancer Registry's Use Case

Open Issues

Open issues are being tracked in the meeting notes in red

  • Similar issues are addressed in the Performance Measurement Data Element Structured for EHR Extraction white paper. What relation does RPE have with quality initiatives?

Closed Issues

RPE Closed Issues

Risks

  • Cross-system work flow integration is a relatively new area for IHE.
  • The EHR's risk encountering the clinical research regulatory environment 21 CFR part 11.
  • Coming up with a way for the EHR to be able to handle and manage changes to the Protocol Definition

Summary

Many health care sites supplement their core patient care activities by participating in clinical trials. Currently, the tasks required for clinical research participation are served by systems entirely separate from the site's EHR. The ITI profile Retrieve Form for Data-capture (RFD), along with its complementary content profile Clinical Research Data-capture, have set a path towards integrating site-based clinical research work flow into the task manager of an electronic health record. This new profile, Retrieve Protocol for Execution, expands the scope of work flow integration between clinical research and EHR systems.

CDISC's Protocol Representation team intends to develop a standard protocol document, derived from the BRIDG, a RIM-linked data model. This protocol representation includes the Trial Design Model a standard structure for representing the planned sequence of events and the treatment plan of a trial. This planned sequence of events includes many tasks that could be executed by an EHR's work flow engine. The 'schedule of activities' section of the trial design includes clinical trial activities such as interventions (e.g., administering drug, surgery) and study administrative activities (e.g,. obtaining informed consent, distributing clinical trial material & diaries, randomization) as well as assessments. The time is ripe to insert these executable work flow tasks into the EHR for execution within the site's normal way of doing business.

State of systems before RPE
State of systems after RPE

The Problem

Research protocols are complex instruction sets that guide the conduct of trials. A subset of the protocol pertains to the activities of the healthcare provider site that participates in the trial. This instruction set specifies the data to be captured, tests to be ordered, inclusion and exclusion criteria for subjects, number and type of visits, etc. These instructions currently reside in hard copy binders which provide guidance for study coordinators at research sites. What is desired is a way to insert protocol instructions into an EHR for automatic completion.

Glossary

Clinical Trial Protocol
The ICH (International Conference on Harmonization) GCP (Good Clinical Practice) defines a Clinical Trail Protocol to be "a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in other documents referenced in the protocol (such as an Investigator's Brochure)."
ProtocolDef
The protocol documentation created by an eClinical Research sponsor that describes a clinical research study. The ProtocolDef will be maintained by the ProtocolManager.
ProtocolState
The protocol state at the point in which a patient is involved in a clinical study.

Volume I

Dependencies

  • patient inclusion/exclusion criteria
  • patient signed inform consent
  • labs
  • documented signed inform consent
  • screening

Overview

Detailed Proposal

Scope

Example

Use Case - Investigational New Drug Clinical Trial

In the uses cases below, we describe the before and after effects of implementing the Retrieve Protocol for Execution profile.

  • The setting for the clinical trial use case is a physicians’ practice where patient care is delivered side-by-side with clinical research.
  • The site, Holbin Medical Group, is a multi-site physician practice, employing over 100 physicians in a variety of specialties.
  • Holbin’s CEO encourages the physicians to participate as site investigators for pharmaceutical-sponsored clinical trials.

Before Retrieve Protocol for Execution

Preconditions
  1. A Clinical Research Protocol is defined by a clinical trials expert.
  2. Holbin provides support for clinical research activities in the form of a Research Department of twelve dedicated study coordinators, mostly RNs, along with clerical and data-entry support personnel.
  3. Holbin Medical Group uses an Electronic Health Record (EHR) and a number of sponsor-provided Electronic Data Capture (EDC) systems for documenting clinical trial activities.
Use Case
  1. Clinical Research Site's Involvement
    1. Holbin’s involvement in a clinical study begins when the Research Department receives a request for proposal (RFP) from PharmaGen, a biopharma research sponsor.
    2. A Study Coordinator, Patricia Zone, RN, evaluates the RFP for business viability and clinical appropriateness, provides the requested documentation back to the sponsor, and agrees to participate
  2. Approved as a site for PharmaGen #1234 trial
    1. After being approved as a site for the PharmaGen #1234 trial, the site Holbin Medical Group provides the required regulatory documentation to the sponsor
    2. The physician identified as the Principal Investigator and other study personnel receive protocol-specific training from the sponsor, including training in use of the SynerGen EDC system.
  3. During the trial set-up period, Patricia takes a number of steps that require interaction with the EHR. At this juncture, searches are at an aggregate level
    1. Ensures that the appropriate system security is in place for this protocol;
    2. Recruits patients to participate as subjects according to inclusion and exclusion criteria described in the study protocol;
    3. Creates a visit type for 1234 patient visits;
    4. Reviews CRFs for data capture and data entry;
    5. Pre-orders labs and other assessments;
    6. Performs all the attendant financial tasks.
  4. Following set up, Patricia contacts Corey Jones, a patient at Holbin, about participating in the trial, and Corey agrees to participate as a subject. A number of tasks deal with this individual patient
    1. Register Corey in the EHR as a subject in trial #1234, using the EHR’s patient index.
    2. She also registers Corey as a subject in the EDC system.
    3. She schedules Corey’s study visits using the EHR scheduling module, and flags the visits as pertaining to the trial #1234.
    4. Initiates clinical trial care and trial-specific documentation.
Postconditions
Holbin Medical Group uses an Electronic Health Record (EHR) and the SynerGen EDC Electronic Data Capture (EDC) system to document the PharmaGen #1234 trial activities.

After Retrieve Protocol for Execution

Precondition
  1. A Clinical Research Protocol is defined by a clinical trials expert.
Use Case
  1. Clinical Research Site's Involvement
    1. ProtocolExecutor uses the RetrieveProtocolList transaction to obtain a list of protocols from the Protocol Manager
    2. ProtocolExecutor uses the AgreesToParticipate transaction to notify ProtocolManager that the site agrees to participate in the study
    3. ProtocolExecutor uses the RetrieveProtocol transaction to obtain the specific protocol from the ProtocolManager
  2. Approved as a site for PharmaGen #1234 trial
    1. ProtocolManager uses the SubmitProtocolApproval transaction to the ProtocolExecutor for a specific protocol
    2. ProtocolExecutor uses the SubmitRegulatoryDocumentation transaction to submit required regulatory documentation to the ProtocolManager
  3. Trial Setup
    1. ProtocolExecutor uses the UpdateProtocolManager (patient identified) transaction to let the ProtocolManager know that patients have been identified
  4. Patient Involvement
    1. ProtocolExecutro uses the UpdateProtocolManager (request enroll patient) transaction to attempt to enroll the patient into the study
    2. ProtocolExecutor uses the UpdateProtocolManager (schedule patient study visits) transaction to update the ProtocolManager that the study visits have been scheduled
Postcondition
Holbin Medical Group uses an Electronic Health Record (EHR) to document the PharmaGen #1234 trial activities using RFD.


Process/Flow

The flow of transactions between the Actors (ProtocolDefManager, ProtocolExecutor and ProtocolStateManager

Actors/Transaction

Actors

  • Protocol Definition Manager
    • An entity that manages clinical research protocol definitions.
    • An example would be an EDC vendor that wishes to allow access to the list of clinical research protocol definitions contained within the EDC system.
  • Protocol Executor
    • An entity wanting to access clinical research protocol definitions from an entity that manages clinical research protocol definitions.
    • An example would be an EHR vendor that wants to participate in clinical studies by accessing clinical research protocol definitions.
  • Protocol State Manager
    • An entity wanting to receive clinical research data from a supplying entity
    • An example would be an EDC vendor wanting to consume data from an EHR

Transactions

  • RetreiveProtocolDef
    • Used to allow a ProtocolExecutor to retrieve an instance of a ProtocolDef for a particular study from a ProtocolDefManager
    • Can be used by a site attempting to pull down a ProtocolDef once they have finalized all Prerequisites/Dependencies to execute this transaction
  • EnterPatientRequest
    • prereq: patient has signed consent, meets pre-screening eligibility criteria before consent
    • parameters: a structure to allow for multiple patients to be entered
  • PatientSCreeningVisitsScheduled
    • prereq: patient entered
  • RecordPatientScreeningVisit
    • prereq: patient entered
  • EnrollPatientRequest
    • prereq: screening complete, meets screening eligibility criteria
    • reasons for failure: screen failed, study put on hold, enrollment complete
  • PatientStudyVisitisScheduled
  • RecordPatientStudyVisit
        • usage:
          • ProtocolExecutor needs to alert ProtocolManager that patient doesn't want to be a part of the study from ProtocolExecutor
          • An RFD form to withdraw the patient from study can also be used
  • AmendProtocolDef
  • AlertProtocolState
Retrieve Protocol for Execution Actors and Transactions
Actor Transaction Option Section
Protocol Executor RetrieveProtocolDef R ?
AgreeToParticipateInProtocolDef R ?
SubmitProtocolDefApproval R ?
SubmitProtocolDefRegulatoryDocumenation R ?
UpdateProtocolExeStep R ?
AlertProtocolState R ?
AlertProtocolDef R ?
Protocol Manager RetrieveProtocolDef R ?
AgreeToParticipateInProtocolDef R ?
SubmitProtocolDefApproval R ?
SubmitProtocolDefRegulatoryDocumenation R ?
UpdateProtocolExeStep R ?
AlertProtocolState R ?
AlertProtocolDef R ?

Volume II

Retrieve Protocol for Execution Content

Standards

Interaction Diagrams

Resources



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