Retrieve Protocol for Execution

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Introduction

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

Meeting Minutes

Open Issues

Closed Issues

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.

Glossary

Volume I

Dependencies

Overview

Scope

Example

Use Case

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

Before Care Management

Preconditions
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
Postconditions

After Care Management

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

Actors/Transaction

Process/Flow

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



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