Biomedical Research and Regulation
Biomedical Research Integrated Domain Group (Archived)Below is a list of the current products this work group is stewarding.
If you are looking for a specific product, you may wish to visit the Master grid of all standards to see the full list of HL7 products.
| Name | Description | Type |
|---|---|---|
| HL7 FHIR® Implementation Guide: Clinical Research Sponsor Laboratory Semantics in FHIR, Release 1 | FHIR provides an effective standard for sites and sponsors to utilize in exchanging clinical research laboratory data. The end-to-end process includes site data storage, site data preparation/transformation, production of FHIR format files, transformation from FHIR to CDISC labora... |
STU |
| HL7 FHIR® Implementation Guide: Common Data Model Harmonization for Research (CDMH), Release 1 - US Realm | The Common Data Models Harmonization (CDMH) FHIR Implementation Guide (IG) will focus on mapping and translating observational data extracted for Patient Centered Outcome Research (PCOR) and other purposes into FHIR format. The project focuses on the mappings for the following four C... |
STU |
| HL7 FHIR® Implementation Guide: Electronic Medicinal Product Information, Release 1 | A FHIR Implementation Guide that allows for the exchanging of medicinal product information between computer systems based on FHIR. |
STU |
| HL7 FHIR® Implementation Guide: FHIR to CDISC Joint Mappings, Release 1 | This implementation guide, a joint effort of CDISC and HL7, defines mappings between FHIR release 4.0 and three specific CDISC standards: SDTM, CDASH and LAB. |
STU |
| HL7 FHIR® Implementation Guide: FHIR to OMOP, Edition 1 | An Implementation Guide that provides guidance and sample mappings from FHIR Resources to OMOP CDM Tables. |
Informative |
| HL7 FHIR® Implementation Guide: ICHOM Patient Centered Outcomes Measure Set for Breast Cancer, Edition 1 | This Implementation Guide simplifies the efforts of healthcare provider organizations to collect data needed for the ICHOM patient centered outcome measures for breast cancer, by defining a standard representation for that data. The Guide shows how to represent the patient reported outcom... |
STU |
| HL7 FHIR® Implementation Guide: Pharmaceutical Quality (Industry), Edition 1 | A universal realm FHIR Implementation Guide for standardized exchange of structured pharmaceutical quality data internationally within or between biopharmaceutical companies and their stakeholders. |
STU |
| HL7 FHIR® Implementation Guide: Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) Submissions to FDA, Edition 2- US Realm | A US realm FHIR Implementation Guide for standardized exchange of structured pharmaceutical quality data between biopharmaceutical companies and the US Food & Drug Administration (FDA).
See the specification at http://hl7.org/fhir/us/pq-cmc-fda/STU2 ... |
STU |
| HL7 FHIR® Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting, Release 1 - US Realm | The FHIR Implementation Guide provides a set of profiles for detection, validation, reporting, and ultimately recording/persisting Adverse Events associated with blood transfusions and vaccinations.
See the specification at www.hl... |
STU |
| HL7 FHIR® Implementation Guide: Retrieval of Real World Data for Clinical Research, Release 1 | A FHIR Implementation Guide that defines FHIR profiles that can be used to retrieve relevant research data from Real World Data sources – specifically Electronic Health Record (EHR) systems - and ultimately transform that data into a format suitable for submission to pharma... |
STU |
| HL7 FHIR® R4 Implementation Guide: Adverse Event Clinical Research R4 Backport, Edition 1 | This guide provides a baseline profile on the FHIR AdverseEvent Resource suitable for Clinical Research. The profile serves as foundational specification to meet general needs in communicating serious and non-serious adverse events in clinical research. For example, to meet the ne... |
STU |
| HL7 FHIR® R4 Implementation Guide: Clinical Study Schedule of Activities, Edition 1 | The core of this project is to define a usable pattern for a Clinical Trial Schedule of Activities structure using FHIR Resources and Processes, such that:
|
STU |
| HL7 FHIR® R4 Implementation Guide: Single Institutional Review Board Project (sIRB), Edition 1- US Realm | Data standards to move data and documents from clinical research sites to a single ethics review board in support of the “NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.
See the specification at&nb... |
STU |
| HL7 FHIR® R5 Implementation Guide: Adverse Event Clinical Research, Edition 1 | This guide provides a baseline profile on the FHIR AdverseEvent Resource suitable for Clinical Research. The profile serves as foundational specification to meet general needs in communicating serious and non-serious adverse events in clinical research. For example, to meet the ne... |
STU |
| HL7 Version 3 Domain Analysis Model: Biomedical Research Integrated Domain Group (BRIDG), Edition 5.3.1 | The BRIDG Model is the result of a collaborative effort between CDISC, HL7, ISO, the US FDA, and the US NCI to build a Domain Information Model for Biomedical Research. These groups have participated in the BRIDG development and are working towards the model being approved as an ... |
Informative |
| HL7 Version 3 Implementation Guide: Annotated ECG (aECG) R1, Release 2 - US Realm | This HL7 Version 3 implementation guide offers supplemental material for the January, 2004 annotated ECG (aECG), standard. This implementation guide is not complete in itself and should be used in conjunction with the HL7 aECG standard, R1 as well as the standard’s XML schema... |
Informative |
| HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2 | HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report has two parts: Part 1: The Framework for Adverse Event Reporting, R2 has been published by ANSI as ANSI/HL7 V3 ICSRP1, R2-2012; Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2; has been approved by ANSI a... |
Normative |
| HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2 | HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report has two parts: Part 1: The Framework for Adverse Event Reporting, R2 has been published by ANSI as ANSI/HL7 V3 ICSRP1, R2-2012; Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2; has been approved by ANSI a... |
Normative |
| HL7 Version 3 Standard: Regulated Studies; Annotated ECG (aECG), Release 1 | The purpose of the HL7 Version 3 Annotated Electrocardiogram (aECG) standard is to provide a means to systematically evaluate the ECG waveforms and measurement locations. The US Food and Drug Association (FDA) continues to be concerned about evaluating noncardiac drugs for negative cardia... |
Normative |
| HL7 Version 3 Standard: Structured Product Labeling Release 8 | SPL release 8 (normative) is a fairly minor extension of the previous releases of SPL, that all received extensive use in production, especially the releases 1, 3, 4, 5 (DSTU and Normative), 6, and 7. In addition to labeling submissions, SPL has been used since 2009 for regist... |
Normative |