Project Summary for Clinical Research Filltered Query Service Funtion Model (CRFQ SFM)
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Project Details
Number | 541 View Ballot Items List (with NIBs) |
---|---|
Name | Clinical Research Filltered Query Service Funtion Model (CRFQ SFM) |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | |
Steering Division | Clinical |
Description | The CRFQ defines a single service with two service profiles: i) EHR service provider: service client provides CRFQ instance with computable Inclusion or Exclusion criteria, service provides queries all EHR records to provide data on counts of patients who satisfy the I or E criteria and - if appropriate security, annonymization, etc. Companion services are in place - can provide specific patients associated with specific I/E criteria. ii) Protocol repository provider: service client provides CRFQ instance with patient data and receives a list of protocols for which the clinical data (and hence the patient whose data the submitted data represents) qualifies the patient. |
Project Facilitator | Charlie Mead |
Status | Archived |
SD Approval Date | Jun 28, 2010 |
TSC Approval Date | Jul 14, 2010 |
Type | Ballot - STU |
Objectives / Deliverables | Calendar 2011 - implementation of CRFQ within NCI and IMI projects Sept 2009: Project is in DSTU: no Project Scope Statement on file. IMI is the Innovative Medicines Initiative (IMI) programme, under this program they have the EHR for Clinical Research (EHR4CR) which aims to design and demonstrate a scalable and cost-effective approach to interoperability between Electronic Health Record systems (EHRs) and Clinical Research. 10 Pharmaceutical Companies and 22 Public Partners (Academia, Hospitals and SMEs) are joined on the project and CRQF - SFM is a cornerstone standard to the work. |
Next Milestone Date | 2014 January WGM |
Project End Date | 2014 January WGM |
Project Intent | |
Project Need | 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 Initially, The RCRIM WG requested that the Clinical Research Filtered Query (CRFQ) Service Functional Model be extended for the maximum 12 months past the original expiration date (May 18, 2010). The project, which was originally sponsored by NCI, had difficulty securing the implementers necessary to test the draft standard before taking it to normative ballot. |
Implementers | 1) NCI is developing strategies at the intersection of clinical care and clinical trial that are directly related to CRFQ and the representation of computable Inclusion and Exclusion criteria. In the context of the caEHR project, we expect to build at least the “caEHR as service provider” implementation of CRFQ. 2) Innovative Medicines Initiative (IMI), a 5-year, multi-billion Euro collaborative project involving 10 commercial pharma companies organizations within the European Union focused on interoperability issues at the intersection of healthcare and pharma has developed at least two business-level use cases that are directly related to CRFQ (they are, in fact, simply restatements of use cases presented in the original CRFQ document.) As a result of this interest, it seems certain that several implementations of CRFQ will be developed over the next 12-24 months. |
Security Risks | |
External Drivers | |
Common Names / Keywords/ Aliases | |
Lineage | |
Dependancies | 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 (S services) - Resource Location and Update service (RLU service) - Decision Support/Inference service (DS service) - Consent management service (Trusted Broker) Service (CM/TB service) - Anonymization/pseudonymization service (A/P service) |
Project Document Repository |
https://wiki.nci.nih.gov/display/caEHR/caEHR+Project+Wiki+Home+Page;jsessionid=A94D527B085720B09FC031E4EB678BED; http://www.hl7.org/dstucomments/ex_showdetail.cfm?dstuid=21 http://imi.europa.eu/index_en.html |
Backwards Compatibility | |
External Vocabularies | |
Products | V3 Services-Web Services (OMG) |
Joint Copyright? | |
External Pjt Collaborators | |
Realm | - Choose One - |
HL7 Affiliate | |
Stakeholders | Other (specify in Misc. Notes below) |
Vendors | Other (specify in Misc. Notes below) |
Providers | Other (specify in Misc. Notes below) |
Ballot Cycle Info | 2012 Jan Ballot Cycle Info: DSTU Ballot results: Met basic vote requirements. 7 Negatives to reconcile Document Name: HL7 Version 3 Standard: Regulated Studies; Clinical Research Filtered Query (CRFQ) Service Functional Model (SFM), Release 1 Ballot Code: V3_CRFQSFM_R1_U1_2012JAN NIB Submitted By: Edward Tripp January 2008 Ballot Cycle Info: DSTU Document Name: HL7 Version 3 Standard: Regulated Studies; Clinical Research Filtered Query (CRFQ) Service Functional Model (SFM), Release 1 Ballot Code: V3_CRFQSFM_R1_D1_2008JAN NIB Submitted By: Charlie Mead? (or Ed Tripp?) |
Misc Notes | April 2016: TSC approved withdrawal request. PMO archiving project. DSTU-Accepting Comments thru May 18, 2012 HL7 Version 3 Standard: Regulated Studies; Clinical Research Filtered Query (CRFQ) Service Functional Model (SFM), Release 1 May 2011: Ed Tripp: RCRIM would like to re-ballot the DSTU (no changes) because the IMI project that will be utilizing this will is just getting up and running, the DSTU period will run out before the project completes testing and we have already extended this one once. The PMO indicated that no changes would be needed to the project scope statement. July 2010: TSC Issue# 1565. TSC approved the following DSTUs for 24-month extension. The original DSTU period expired on May 18, 2010. Nov2010: (LL) updated project status based on RCRIM three-year plan. INtent is to ballot normative in 2012Sep cycle. June 2010: Lynn Laakso completed the project scope statement and Charlie Mead added Stakeholders / Vendors / Provider info: 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 're... |
U.S. Govt Interest? | |
USRSC Approval | |
FMG Approval | |
ARB Approval | |
Start Date | Sep 11, 2009 |
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