Biomedical Research and Regulation
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: 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: 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: 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: 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: 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 Implementation Guide for CDA® Release 2: Exchange of Clinical Trial Subject Data; Patient Narratives, Release 1 - US Realm | The scope of this CDA implementation guide is limited to the exchange of patient narratives, which are created as a summary document during the conduct of a clinical trial. The CDA Implementation Guide will focus on a constrained dataset that supports the exchange of both human and ma... |
DSTU |
| HL7 Version 3 Domain Analysis Model: Biomedical Research Integrated Domain Group (BRIDG), Release 5 | 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 Domain Analysis Model: Clinical Trials Registration and Results (CTR&R), Release 1 | HL7 Version 3 Standard: Clinical Trial Registration and Results (CTR&R), Release 1 represents the behavioral and information requirements for the CTR&R domain. It serves as a tool for subject matter experts to examine, express, and evaluate their requirements for us... |
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 Implementation Guide: Drug Stability Reporting (eStability) R1, Release 2 | Describes the basic requirements needed for using the Stability standard and the requirements needed for submitting information to the Food and Drug Administration (FDA) using the standard. This implementation guide is superseded with updates included in HL7 Version 3 Implementation Guide: Drug S... |
|
| HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 2 | Describes the basic requirements needed for using the Stability standard and the requirements needed for submitting information to the Food and Drug Administration (FDA) using the standard. This implementation guide is superseded with updates included in HL7 Version 3 Implementation Guide: Drug S... |
Informative |
| HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 3 | This implementation guide for Drug Stability Reporting (eStability) describes the basic requirements needed for using the standard, and the requirements needed for submitting information to the Food and Drug Administration (FDA) agencies using the standard. It is meant to be used for all regula... |
Informative |
| HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 1 | This document provides technical conformance criteria for Structured Product Labeling (SPL) files based on the drug establishment registration and drug listing process at the United States Food and Drug Administration (FDA). Information on electronic submission may be found in guidance entitl... |
Informative |
| HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 3: FDA Content of Labeling | This document provides technical conformance criteria for Structured Product Labeling (SPL) files based on the drug establishment registration and drug listing process at the United States Food and Drug Administration (FDA). Information on electronic submission may be found in guidance entitl... |
Informative |
| HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 4 | This document provides technical conformance criteria for Structured Product Labeling (SPL) files based on the drug establishment registration and drug listing process at the United States Food and Drug Administration (FDA). Information on electronic submission may be found in guidance entitl... |
Informative |
| HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 5 | This document provides technical conformance criteria for Structured Product Labeling (SPL) files based on the drug establishment registration and drug listing process at the United States Food and Drug Administration (FDA). Information on electronic submission may be found in guidance entitl... |
Informative |
| HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability) | The HL7 Version 3 Drug Stability Reporting (eStability) standard standardizes the format and the type of information in Drug Stability Reports for drug: substances; products; and devices. The purpose of eStability is to provide a method to communicate stability data in a standard electr... |
Normative |
| HL7 Version 3 Standard: Clinical Trial Registration and Results (CTR&R) | HL7 Version 3 Standard: Clinical Trial Registration and Results (CTR&R), Release 1 focuses 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 or... |
DSTU |
| 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: Regulated Studies; Regulated Product Submissions (RPS), Release 2 | The scope of the standard is to define the message for exchanging information electronically between Regulators and Industry, and between sets of regulators. The message provides the ability to describe the contents of the regulatory exchange and all information needed to process the exchange betwee... |
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 |
| HL7 Version 3 Standard: Structured Product Labeling, Release 1 | Normative | |
| HL7 Version 3 Standard: Structured Product Labeling, Release 2 | Normative | |
| HL7 Version 3 Standard: Structured Product Labeling, Release 3 | Normative | |
| HL7 Version 3 Standard: Structured Product Labeling, Release 4 | The HL7 Version 3 Structured Product Labeling (SPL) specification is a document markup standard that specifies the structure and semantics of the content of authorized published information that accompanies any medicine licensed by a medicines licensing authority. An SPL docume... |
Normative |
| HL7 Version 3 Standard: Structured Product Labeling, Release 5 | SPL release 5 (normative) is an extension of the previous releases of SPL, that all received extensive use in production, especially the releases 1, 3, 4, and 5 (DSTU). In addition to labeling submissions, SPL has been used since 2009 for registering and listing of all drug products legall... |
Normative |
| HL7 Version 3 Standard: Structured Product Labeling, Release 6 | The Structured Product Labeling (SPL) specification is a document markup standard that specifies the structure and semantics of the content of authorized published information that accompanies any medicine licensed by a medicines licensing authority. These documents are known as "... |
Normative |
| HL7 Version 3 Standard: Structured Product Labeling, Release 7 (SPL R7) | The Structured Product Labeling (SPL) specification is a document markup standard that specifies the structure and semantics of the content of authorized published information that accompanies any medicine or device licensed by a regulatory authority. These documents are known as "... |
Normative |
| HL7 Version 3 Standard: Study Design: Structured Document, Release 1 - US Realm | A structured document capable of exchanging the human-readable text (i.e. the traditional text-based protocol document currently provided as either a paper document, or a pdf file) in addition to structured protocol data. Some of the requirements for this structured document cannot be met... |
DSTU |
| Version 3 Implementation Guide: Regulated Product Submission, Release 1 | The Version 3 Regulated Product Submission (RPS) Implementation Guide provides technical details (conformance criteria) on using the Regulated Product Submission (RPS) standard. The RPS standard provides a common means of exchange of documentation and status between product sponso... |
Informative |