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 technical outline of the Regulatory Questionnaire profile structure. Built on HL7 FHIR R5, this resource enables the structured, machine-readable exchange of regulatory questions while preserving rich formatting and traceability to the Common Technical Document (CTD) structure.
View the example below:
The following table maps the technical components of a regulatory question to their implementation in the RTQ Questionnaire profile. This breakdown details the required data structures for CTD section mapping, rich-text rendering, and participant identification.
| Element | Cardinality | Purpose / Notes |
|---|---|---|
meta.profile |
1..1 | Fixed to http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaire to ensure conformance and API routing. |
identifier |
1..2 | Unique IDs. Slices: regulator-id (Mandatory) and company-id (Optional). |
version |
1..1 | The business version of the questionnaire set (e.g., "1.0"). |
text |
1..1 | Human-readable narrative (XHTML) containing the summary of the question set. |
subjectType |
1..* | Coded context of the regulatory procedure (e.g., variation-type-ii). |
contact (SENDER) |
1..1 | Issuing health authority (Regulator) with full organizational IDs, address, and primary contact info. |
contact (RECEIVER) |
1..1 | The pharmaceutical MAH or applicant expected to respond. |
item.code |
1..* | Mandatory CTD section mapping (e.g., 3.2.P.8.1) using the RTQ CTD Categories CodeSystem. |
item.text |
1..1 | The question text. Requires the rendering-xhtml extension for formatted content like tables or lists. |