Retrieve Protocol for Execution

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.

• RFD scenario teams:
  • Sponsors: Pfizer, Lilly, Novartis, Genzyme
  • EHRs: Cerner, Allscripts, Greenway, Epic
  • eClinical: Outcome Sciences, Nextrials, IPL
• Proposal Editor: Landen Bain, CDISC
• Profile Editor: Diane Wold, Glaxo Smith Klein; Peter Villiers, SAS; Daemon Whittenburg, Greenway Medical
• Lisa Chatterjee, DIFZ, chair of CDISC’s Protocol Representation team
• Diane Wold, GSK, chair of CDISC’s Trial Design team
• Peter Villiers, SAS, developer of ODM extensions to express Schedule of Activities
• Daemon Whittenburg, Greenway Medical
• Dan Levy, Outcome Sciences
• Jane Griffin, Cerner
• Amar Das, Stanford Professor

Meeting Minutes

• 12/12 - Discussed Detailed Proposal
• 12/19 - Discussed RPE Use Case Graphic

Open Issues

• Similar issues are addressed in the Performance Measurement Data Element Structured for EHR Extraction white paper. What relation does RPE have with quality initiatives?
• How to deal with protocols amendments taken during the study?
• How does RPE relate to RFD. Is RPE essentially a content profile using RFD infrastructure? Or does RFD create new RFD-like transactions.
• How much automation of protocol events is within grasp? How to executable tasks get conveyed to the Protocol Executor (Enabler? Enactor?)
• Retrieved from "http://wiki.ihe.net/index.php?title=Detailed_Proposal"

Risks

• Cross-system workflow integration is a relatively new area for IHE.
• The EHRs risk encountering the clinical research regulatory environment 21 CFR part 11.

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.

Volume I

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.

Before Retrieve Protocol for Execution

Preconditions

1. A Clinical Research Protocol is defined by a clinical trials expert.
2. The setting for the clinical trial use case is a physicians’ practice where patient care is delivered side-by-side with clinical research.
3. The site, Holbin Medical Group, is a multi-site physician practice, employing over 100 physicians in a variety of specialties.
4. Holbin’s CEO encourages the physicians to participate as site investigators for pharmaceutical-sponsored clinical trials; 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.
5. 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

1. Approved as a site for PharmaGen #1234 trial
   1. After being approved as a site for the PharmaGen #1234 trial, the site Holbin Medical Gruop 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.

1. 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.

1. 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

A Clinical Research Protocol is defined by a clinical trials expert.

Use Case

1. Clinical Research Site's Involvement
2. Approved as a site for PharmaGen #1234 trial
3. Trial Setup
4. Patient Involvement

Postcondition

Actor Definitions

Protocol Executor

Rceives the protocol instruction and executes it

Protocol Manager

Manages a collection of protocols

Transaction Definitions

Publish Protocol

Retrieve Protocol List

Enroll in Protocol

Retreive Protocol

Submit Protocol Documentation (maybe use Enroll in Protocol)

Submit Approval

Retrieve Approval

Submit Regulatory Documentation

Enroll Patient

Volume II

Retrieve Protocol for Execution Content

Standards

Interaction Diagrams

Resources

• RPEUseCaseGraphic.jpg
• RPEUseCaseGraphic.ppt

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