Product RR CRFQ

Product Brief - HL7 Version 3 Standard: Regulated Studies; CRFQ SFM

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Product Name

HL7 Version 3 Standard: Regulated Studies; Clinical Research Filtered Query (CRFQ) Service Functional Model (SFM), Release 1

Topics

• Clinical Research Filtered Query (CRFQ) Service Functional Model (SFM)

Standard Category

• Application Functional Specifications

Integration Paradigm

• Services

Type

DSTU

Releases

HL7 V3 CRFQSFM R1-2008: HL7 V3: Regulated Studies; Clinical Research Filtered Query (CRFQ) Service Functional Model, Release 1 May 2008

Summary

This Service Functional Model (SFM) defines the functional requirements of a Clinical Research Filtered Query (CRFQ) service. In particular, the CRFQ service focuses on the relationship between individual person/animal/etc. genotypic/phenotypic data and the so-called ‘Inclusion and Exclusion (I/E) (or Eligibility) criteria’ associated with a protocol, i.e. the characteristics that are considered essential as being present (or absent) in a person/animal/etc. in order for that person/animal/etc. to be viewed -- in the context of a particular protocol -- as a potential subject

Description

The CRFQ service is provided by a repository, either an EHR Repository or a Protocol Repository. The goal of an interaction between a Provider of the CRFQ service and a given Client to whom the functionality is provided can be summarized in a sequence of three high-level tasks:

Client: Submit structured Inclusion/Exclusion (I/E) criteria to CRFQ

CRFQ: Query an EHR or Protocol repository to identify records that meet the submitted I/E criteria

CRFQ: Return candidate list to Client

Examples of I/E criteria include demographic, phenotypic, and/or genotypic parameters.

Successful deployment of the CRFQ service assumes the following:

• the presence of protocols encoded with protocol-specific metadata that sufficiently describe the protocol’s I/E criteria; and
• the existence of patient repositories with sufficient amounts of appropriately encoded demographic, phenotypic, and/or genotypic data to enable automated comparisons of patient data with protocol I/E criteria.

Thus, the CRFQ’s composite functionality enables the automation and operationalization of critical business process in the domains of Clinical Trials and Protocol Development domains which are currently done largely by hand. In addition, it enables both clinicians and patients/patient advocates to identify potential protocols-of-interest-or-relevance based on individual patient data.

Business Case (Intended Use, Customers)

A number of stakeholders including Pharmaceutical Companies/Clinical Research, Clinical Research Organizations, Patients, and Healthcare Providers provide the business case for the CRFQ service which is defined in two contexts, one “Protocol-Selection-Focused” and one “Cohort-Selection-Focused.”

Protocol-Selection-Focused: as a service provided by a protocol repository which filters individual protocols – based on protocol meta-data describing the protocol’s Inclusion and Exclusion criteria – against incoming individual person/animal/etc. to find one or more protocols in which the person/animal/etc. may qualify as a research subject;

Cohort-Selection-Focused: Trial-recruitment focused: as a service provided by an EHR repository which filters individual protocol meta-data (Inclusion and Exclusion criteria) against patient data to find a suitable potential ‘cohort’ for the protocol. In addition, if one generalizes the latter notion of ‘finding cohorts based on defined signal descriptions as inputs,’ the CRFQ service may also be used in the context of ‘real-time safety monitoring,’ i.e. the desire to search an EHR repository for a set of patients satisfying a particular ‘signal definition.’

The CRFQ SFM is specifically restricted to application in the Clinical Trials context and thus should not be seen as a generalized query service. The scoping was made because of the clearly-defined business case that was made for CRFQ in the Clinical Trials and Protocol Development domains

Benefits

By virtue of its ability to efficiently and effectively pair subject- or protocol-based I/E with Protocol- or EHR-based demographic, phenotypic, and/or genotypic data, the CRFQ will enable three benefits to be realized:

• Increased efficiency of potential cohort identification
• Increased empowerment of patients and providers to identify relevant protocols
• Increased efficacy of real-time, post-marketing clinical safety data monitoring

Implementations/ Case Studies (Actual Users)

Interest from several Pharmaceutical Companies and Clinical Research Organizations including the National Cancer Institute. All interested parties are requesting Platform-Independent Model (logical model) as a development of the SFM.

Resources

Work Groups

• RCRIM
• Pending Implementation WG

Education

• See more at http://www.hl7.org/implement/training.cfm

Certification Available

• none

Relationship to/ Dependencies on, other standards

Specifically excluded from – but, in many cases, essential to the successful and relevant application of – the CRFQ service are additional, closely-coupled functions (which could be provided as services – see Section 1) including:

• Security services including identification, authentication, and authorization (EIS services)
• Resource Location and Update service (RLUS service)
• Decision Support/Inference service (DSS service)
• Consent management service (Trusted Broker) Service (CM/TB service)
• Anonymization/pseudonymization service (A/P service)

Links to current projects in development

• Project Insight ID # 541, Clinical Research Filtered Query Service Funtion Model (CRFQ SFM)