Structured Regulatory Correspondence (SRC)
0.1.0 - ci-build
Structured Regulatory Correspondence (SRC), published by Gravitate Health and HL7 Biomedical Research & Regulation (BR&R). This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/src-ig/ and changes regularly. See the Directory of published versions
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
These define constraints on FHIR resources for systems conforming to this implementation guide.
| Regulatory Questionnaire |
A Questionnaire used by a health authority to issue a List of Questions (LOQ), List of Issues (LOI), or Request for Information (RFI) to a Market Authorization Holder. Supports rich-text questions, hierarchical CTD coding, and full contact signature. |
These define new code systems used by systems conforming to this implementation guide.
| CTD Question Categories Full |
Hierarchical terminology derived from ICH CTD Modules 2-5 for classifying regulator-to-sponsor questions in Structured Regulatory Correspondence (SRC). Supports multi-level granularity for EMA, FDA, and Health Canada harmonization. |
These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.
| Responses to Question Set ID001 |