Response to Regulatory Questions (RTQ)
0.1.0 - ci-build
Response to Regulatory Questions (RTQ), published by HL7 International. 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/HL7/rtq-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.
| RTQ QuestionnaireResponse Profile |
Profile of QuestionnaireResponse for structured responses to regulatory questions and answers in the context of medicinal product variations and other regulatory procedures. |
| Regulatory Questionnaire |
Profile of Questionnaire for regulatory exchange of questions, issues and information requests between regulators and industry in the medicinal product lifecycle. |
These define new code systems used by systems conforming to this implementation guide.
| CTD-Based Regulatory Question Categories (Full Granularity) |
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. |
| Contact Purpose Code System |
Defines the role of a contact in regulatory correspondence. Used to distinguish the sender (health authority) and recipient (marketing authorization holder) in structured Q&A. |
| RTQ Identifier Type Code System | |
| RTQ Questionnaire Type Code System |
Code system defining the high-level types of regulatory questionnaires exchanged between industry and health authorities. |
These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.
| Question Set ID001 |
| QuestionnaireResponse |