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 (including the accompanying cover letter, questions, supporting attachments, and metadata) while preserving rich formatting and traceability to the Common Technical Document (CTD) structure.
View the example below:
The following table is a simplified view of the key elements of a regulatory question. It 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.extension (itemReference) |
0..* | Inline extension to explicitly attach an RTQ DocumentReference to this specific question. |
item.text |
1..1 | The question text. Requires the rendering-xhtml extension for formatted content like tables or lists. |