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 Response profile structure. Built on HL7 FHIR R5, this resource enables the structured, machine-readable exchange of answers from a Marketing Authorization Holder (MAH) back to a regulator.
View the example below:
The following table maps the business requirements of a regulatory response to their technical implementation in the RTQ QuestionnaireResponse profile. It highlights mandatory fields, cardinality, and the specific FHIR elements used to convey the response data.
| Element | Cardinality | Purpose / Notes |
|---|---|---|
meta.profile |
1..1 | Fixed to http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaireresponse to ensure conformance and API routing. |
identifier |
1..2 | Unique IDs. Slices: regulator-id (Mandatory) and company-id (Optional). |
questionnaire |
1..1 | Canonical reference to the original rtq-questionnaire being answered. |
status |
1..1 | Lifecycle state (e.g., completed for final submissions). |
text |
1..1 | Human-readable narrative (XHTML) containing the overview of the whole response. |
author (SENDER/MAH) |
1..1 | The Marketing Authorization Holder or applicant providing the response. |
item.linkId |
1..1 | Matches the linkId of the corresponding question in the source Questionnaire. |
item.answer.extension |
1..1 | The answer text. Requires the rendering-xhtml extension for formatted content like tables or lists. |
item.answer.valueReference |
0..* | Reference to supporting documents (e.g., PDFs) using the APIX DocumentReference profile. |