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
Contents:
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.
| Questionnaire |
Profile for a set of Questions issued from a regulator to a market authorization holder/applicant during the regulated product application lifecycle. |
| Questionnaire Response |
Profile for a Response to Questions submitted to a regulator from a market authorization holder/applicant during the regulated product application lifecycle. |
| RTQ Document Reference |
A profile on the DocumentReference resource for use within the Response to Regulatory Questions (RTQ) process to attach supporting documents. |
These define constraints on FHIR data types for systems conforming to this implementation guide.
| RTQ Item Reference Extension |
An extension to allow referencing an RTQDocumentReference from a Questionnaire item (the question). |
These define new code systems used by systems conforming to this implementation guide.
| CTD-Based Regulatory Question Categories |
Hierarchical terminology derived from ICH CTD Modules 2-5 for classifying regulator-to-sponsor questions. Supports multi-level granularity for international 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 | |
| example-docref |
Comprehensive validation of analytical procedures for the WonderDrug 10mg product lifecycle. |
| questionnaireresponse-ID001 |