Difference between revisions of "Detailed Proposal"

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==3. Key Use Case: Investigational New Drug Clinical Trial==
 
==3. Key Use Case: Investigational New Drug Clinical Trial==
  
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''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; 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.  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.  (For our purposes, an EHR is any application which is the primary site for documenting patient care, and retrieving patient care information.  Thus we include in our span of interest many systems installed today that are not quite EHRs in the strictest sense, but which would still benefit from this approach.) "
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<p>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; 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.  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.  (For our purposes, an EHR is any application which is the primary site for documenting patient care, and retrieving patient care information.  Thus we include in our span of interest many systems installed today that are not quite EHRs in the strictest sense, but which would still benefit from this approach.)</p>
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"Holbin’s involvement in a clinical study begins when the Research Department receives a request for proposal from a study sponsor.  A Study Coordinator, Patricia Zone, RN, evaluates the RFP for business viability and clinical appropriateness, and provides the requested documentation back to the sponsor.  After being selected as a site for the trial, identified as #1234, and providing the required regulatory documentation to the sponsor, the physician identified as the Principal Investigator and other study personnel receive protocol-specific training from the sponsor.  During the trial set-up period,  Patricia ensures that the appropriate system security is in place for this protocol, recruits patients to participate as subjects according to inclusion and exclusion criteria described in the study protocol, schedules patient visits, manages data capture and data entry, and performs all the attendant financial tasks. "
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<p>Holbin’s involvement in a clinical study begins when the Research Department receives a request for proposal from a study sponsor.  A Study Coordinator, Patricia Zone, RN, evaluates the RFP for business viability and clinical appropriateness, and provides the requested documentation back to the sponsor.  After being selected as a site for the trial, identified as #1234, and providing the required regulatory documentation to the sponsor, the physician identified as the Principal Investigator and other study personnel receive protocol-specific training from the sponsor.  During the trial set-up period,  Patricia ensures that the appropriate system security is in place for this protocol, recruits patients to participate as subjects according to inclusion and exclusion criteria described in the study protocol, schedules patient visits, manages data capture and data entry, and performs all the attendant financial tasks. </p>
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"Patricia contacts Corey Jones, a patient at Holbin, about participating in the trial, and Corey agrees to participate as a subject.  Patricia registers Corey in the EHR as a subject in trial #1234, using the EHR’s patient index.  She schedules Corey’s study visits using the EHR scheduling module, and flags the visits as pertaining to the trial #1234.  After the set-up stage, the site initiates clinical trial care and trial-specific documentation.   
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<p>Patricia contacts Corey Jones, a patient at Holbin, about participating in the trial, and Corey agrees to participate as a subject.  Patricia registers Corey in the EHR as a subject in trial #1234, using the EHR’s patient index.  She schedules Corey’s study visits using the EHR scheduling module, and flags the visits as pertaining to the trial #1234.  After the set-up stage, the site initiates clinical trial care and trial-specific documentation.   
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The use case continues with current state and desired state scenarios, which describe data capture utilizing EDC technology during a patient clinical trial visit before and after the RFD implementation.''
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The use case continues with current state and desired state scenarios, which describe data capture utilizing EDC technology during a patient clinical trial visit before and after the RFD implementation.</p>
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''<Feel free to add a second use case scenario demonstrating how it “should” work.  Try to indicate the people/systems, the tasks they are doing, the information they need, and hopefully where the information should come from.>''
 
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<To focus on the end user requirements, and not just the solution mechanism, and to give people trying to understand the applications concrete examples of the problems existing and the nature of the solution required.  State the problem domain and outline the workflows in terms of the people, tasks, systems and information involved.  Feel free to describe both the current “problematic” workflow as well as a desirable future workflow where appropriate. Remember that other committee members reviewing the proposal may or may not have a detailed familiarity with this problem.  Where appropriate, define terms.>
 

Revision as of 09:23, 18 November 2008

1. Proposed Profile: Retrieve Protocol for Execution

  • Proposal Editor: Landen Bain, CDISC
  • Profile Editor: Diane Wold, Glaxo Smith Klein; Peter Villiers, SAS
  • Date: N/A (Wiki keeps history)
  • Version: N/A (Wiki keeps history)
  • Domain: Quality, Research, and Public Health

Summary

<Many people find it easier to write this section last. Use simple declarative sentences. Avoid going into background. If it's more than a dozen lines, it's not a summary.>


<Summarize in one or two lines the existing problem . E.g. "It is difficult to monitor radiation dose for individual patients and almost impossible to assemble and compare such statistics for a site or a population.">

<Demonstrate in a line or two that the key integration features are available in existing standards. E.g. "DICOM has an SR format for radiation dose events and a protocol for exchanging them.">

<Summarize in a few lines how the problem could be solved. E.g. "A Radiation Dose profile could require compliant radiating devices to produce such reports and could define transactions to actors that collect, analyze and present such information.">

<Summarize in a line or two market interest & available resources. E.g. "Euratom and ACR have published guidelines requiring/encouraging dose tracking. Individuals from SFR are willing to participate in Profile development.">

<Summarize in a line or two why IHE would be a good venue to solve the problem. E.g. "The main challenges are dealing with the chicken-and-egg problem and avoiding inconsistent implementations.">

2. 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.

3. Key Use Case: Investigational New Drug Clinical Trial

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; 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. 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. (For our purposes, an EHR is any application which is the primary site for documenting patient care, and retrieving patient care information. Thus we include in our span of interest many systems installed today that are not quite EHRs in the strictest sense, but which would still benefit from this approach.)

Holbin’s involvement in a clinical study begins when the Research Department receives a request for proposal from a study sponsor. A Study Coordinator, Patricia Zone, RN, evaluates the RFP for business viability and clinical appropriateness, and provides the requested documentation back to the sponsor. After being selected as a site for the trial, identified as #1234, and providing the required regulatory documentation to the sponsor, the physician identified as the Principal Investigator and other study personnel receive protocol-specific training from the sponsor. During the trial set-up period, Patricia ensures that the appropriate system security is in place for this protocol, recruits patients to participate as subjects according to inclusion and exclusion criteria described in the study protocol, schedules patient visits, manages data capture and data entry, and performs all the attendant financial tasks.

Patricia contacts Corey Jones, a patient at Holbin, about participating in the trial, and Corey agrees to participate as a subject. Patricia registers Corey in the EHR as a subject in trial #1234, using the EHR’s patient index. She schedules Corey’s study visits using the EHR scheduling module, and flags the visits as pertaining to the trial #1234. After the set-up stage, the site initiates clinical trial care and trial-specific documentation. The use case continues with current state and desired state scenarios, which describe data capture utilizing EDC technology during a patient clinical trial visit before and after the RFD implementation.

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