Regulated Clinical Research Information Management

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Below is a list of the current projects this work group is sponsoring. Visit Project Insight to see the full project details. Visit the searchable project database to find projects sponsored by other work groups.

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Num Name
Sponsor(s)/
Co-Sponsor(s)
 Description Project Facilitator
SD
Approval
Date
TSC
Approval
Date
Status
851
 Study Design: Structured Document Sponsor(s):
Regulated Clinical Research Information Management Work Group

Co-Sponsor(s):
Structured Documents Work Group 		The project will take relevant existing material from Study Design V3 message - currently a DSTU, CTRR, Study Participation - and BRIDG as a starting point to inform the creation of a structured document capable of exchanging the human- readable text (i. e. . . . Jonathan Levine Awaiting Approval Awaiting Approval Active Project (Resources assigned to pjt)
840
 Schizophrenia Domain Analysis Model Sponsor(s):
Clinical Interoperability Council Work Group

Co-Sponsor(s):
Regulated Clinical Research Information Management Work Group 		The scope of this project is to identify and harmonize data elements necessary for regulatory decision making (marketing authorization) in Schizophrenia drugs. These data elements will include population characteristics specific to schizophrenia, and endp. . . Meredith Nahm Dec 20, 2011 Jan 9, 2011 Informative - Preparing for Ballot
833
 Regulated Product Submission Release 2 Draft 2 (RPS R2D2) Sponsor(s):
Regulated Clinical Research Information Management Work Group 		The RPS R2D2 project scopes builds on the scope defined in RPS R1 and RPS R2's first draft. RPS R2 incorporated medical device and international requirements, but the focus was on the United States Food and Drug Administration (US FDA) requirements to mee. . . Patty Garvey Nov 28, 2011 Dec 5, 2011 Active Project (Resources assigned to pjt)
822
 CDA Implementation Guide for the Exchange of Clinical Trial Subject Data: Patient Narratives Sponsor(s):
Regulated Clinical Research Information Management Work Group

Co-Sponsor(s):
Structured Documents Work Group 		The project will reference the withdrawn Subject Data DSTU V3 message (project 205) as a starting point to limit the scope of the CDA document to create a CDA R2 Implementation Guide. The scope of the CDA implementation guide is limited to the exchange of. . . Armando Oliva/Patty Garvey Oct 24, 2011 Oct 31, 2011 DSTU - Balloting
721
 a ECG r2 (Annotated ECG, Release 2) Sponsor(s):
Regulated Clinical Research Information Management Work Group 		RCRIM WG Awaiting Approval Awaiting Approval 3-Year Plan Item
720
 Regulatory Activity Submission Hierarchy (RASH) Sponsor(s):
Regulated Clinical Research Information Management Work Group 		RCRIM WG Awaiting Approval Awaiting Approval 3-Year Plan Item
719
 Subject Data Validation Service Functional Model Sponsor(s):
Regulated Clinical Research Information Management Work Group 		RCRIM WG Awaiting Approval Awaiting Approval 3-Year Plan Item
718
 Clinical Study Functional Profiles Sponsor(s):
Regulated Clinical Research Information Management Work Group 		Clinical Study Functional Profiles RCRIM WG Awaiting Approval Awaiting Approval 3-Year Plan Item
717
 Notification to Physicians for marketed product information Sponsor(s):
Regulated Clinical Research Information Management Work Group 		Notification to Physicians for marketed product information RCRIM WG Awaiting Approval Awaiting Approval 3-Year Plan Item
716
 Clinical Trial Registration and Reporting R2 (CTR&R- R2) Sponsor(s):
Regulated Clinical Research Information Management Work Group 		Further development of the Clinical Trial Registration and Reporting for enhancements after initial normative ballot. RCRIM WG Awaiting Approval Awaiting Approval 3-Year Plan Item
625
 CPM DSTU R2 (Common Product Model) Sponsor(s):
Orders and Observations Work Group

Co-Sponsor(s):
Health Care Devices Work Group, Patient Safety Work Group, Pharmacy Work Group, Regulated Clinical Research Information Management Work Group 		The objective of the CPM DSTU R2 project is to establish a new DSTU release addressing the following topics: - Incorporate support for medical devices' regulatory data requirements - This project will extend the Common Product Model structures required to. . . Ed Tripp, Myron Finseth Feb 9, 2010 Feb 22, 2010 DSTU - Request Publication
541
 Clinical Research Filltered Query Service Funtion Model (CRFQ SFM) Sponsor(s):
Regulated Clinical Research Information Management Work Group 		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. . . Charlie Mead Jun 28, 2010 Jul 14, 2010 DSTU - Test Period/Accepting Comments
539
 Regulated Product Submission Release 3 (RPS R3) Sponsor(s):
Regulated Clinical Research Information Management Work Group 		The RPS R3 project scopes builds on the scope defined in RPS R1 and RPS R2. RPS R2 incorporated medical device and international requirements, but the focus was on the United States Food and Drug Administration (US FDA) requirements to meet Prescription D. . . Geoff Williams (EFPIA) Apr 22, 2011 May 2, 2011 DSTU - Balloting
538
 BRIDG (Biomedical Research Integrated Domain) Domain Analysis Model (DAM) (ISO/JIC Project) Sponsor(s):
Regulated Clinical Research Information Management Work Group 		The scope of this project is to ballot the static components of the BRIDG DAM. The scope of the BRIDG model is Protocol- driven research and its associated regulatory artifacts, i. e. the data, organization, resources, rules, and processes involved in the f. . . Julie Evans; Edward Tripp Sep 11, 2009 Sep 22, 2009 Informative - Reconcile
509
 Diabetes Data Strategy Sponsor(s):
Electronic Health Records Work Group

Co-Sponsor(s):
Clinical Interoperability Council Work Group, Patient Care Work Group, Regulated Clinical Research Information Management Work Group 		The scope for this project is to focus on the minimum data set and data standards in EHR systems for diabetes assessment in children in outpatient clinic settings, based on clinical and business requirements. The intention is to determine the data require. . . Don Mon Jun 12, 2009 Jun 22, 2009 Active Project (Resources assigned to pjt)
372
 Clinical Trial Registration and Results (CTR&R) (JIC Project) Sponsor(s):
Regulated Clinical Research Information Management Work Group 		This project will be focused on the development and maintenance of an HL7 V3 message in support of the global data exchange requirements brought about by the increasing number of national, regional, global and organizational clinical trial registries and . . . Ed Helton; Tracy Beck; Scott Getzin Dec 8, 2008 Dec 15, 2008 DSTU - Request Publication
325
 Medical Product Information (includes Drugs, Devices, Biologics, Veterinary Products) (SPLr5) Sponsor(s):
Regulated Clinical Research Information Management Work Group 		The original SPL project developed a standardized specification of the data elements and exchange format for the transmission of information that uniquely and certainly identifies a medical pharmaceutical product at the packaging configuration level. This. . . Myron Finseth Feb 22, 2010 Mar 1, 2010 Informative - Request Publication
217
 Regulated Product Submission Release 2 Sponsor(s):
Regulated Clinical Research Information Management Work Group 		The project scope is to extend the existing HL7 V3 Regulated Product Submission message with new requirements. The project will take the existing RPS Release 1 standard and enhance this message in a two phase effort ultimately intended to yield a global s. . . Ed Tripp Mar 28, 2008 Apr 21, 2008 DSTU - Test Period/Accepting Comments
205
 CDISC Content to Message Sponsor(s):
Regulated Clinical Research Information Management Work Group 		The project scope is to create HL7 V3 messages from existing content within the CDISC standard. This project will specifically include a) study summary, b) eligibility criteria, c) trial design (including parts I and II: arms, elements visits, planned ass. . . Jason Rock Nov 30, 2007 Nov 30, 2007 DSTU - Test Period/Accepting Comments
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