Regulatory Reporting Requirements
https://w3id.org/m11-rdf/C217350.C218796
- Definition
- A description of the requirements for the sponsor/designee to report adverse events, serious adverse events, pregnancy and postpartum events, and medical device product complaints, including the criteria for reporting, to the relevant regulatory authority.
- Namespace
- ICH M11 Section 9 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.9+C218796(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218796 (EVS identifier)
NCIT_C218796 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217350.C218796 (EVS term IRI; does not resolve)
- Label from
- ICH M11 Terminology, NCI EVS, release 2025-12-19
Specifications in the Technical Specification
One row per component block of Appendix 1 that names this element. Text as printed.
| Block | Term | Section | Conformance | Cardinality | Data type | Value code list | Repeating / reuse |
|---|---|---|---|---|---|---|---|
| 447 | <Regulatory Reporting Requirements> | 9.2.3.1 Regulatory Reporting Requirements | Required | One to one | Text (D) | No |
In the ICH M11 Template
The Template heading of 9.2.3.1 Regulatory Reporting Requirements is this element.
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 9.2.3.1 Regulatory Reporting Requirements 9.2.3.1 | <Enter Regulatory Reporting Requirements> | p. 52 | ts-term / verb-dropped / section |
Mapping statements to USDM v4
One row per published mapping row that names this element (SSSOM record). The link to the USDM attribute is the mapping publisher's; how the row was tied to this element is in the third column. Paths as given.
| Source | USDM attribute (usdm-rdf) | Identified | Target path | Condition |
|---|---|---|---|---|
| HL7 CSP IG ballot row 258 | NarrativeContentItem-text stated: NarrativeContentItem.text (attribute name) | by-unique-name | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text | Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section> |
| CDISC DDF-RA v4.0.0 row 259 | NarrativeContentItem-text stated: NarrativeContentItem.text (attribute name) | by-unique-name | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@contentItem/NarrativeContentItem/@text | Study/@documentedBy/StudyDefinitionDocument/@type/Code/@code='C70817' | StudyVersion/@documentVersion/StudyProtocolDocumentVersion/@contents/NarrativeContent/@sectionNumber=<desired section> |
Draft, not normative. A derived rendering of the ICH M11 Technical Specification, Template, code lists and OID Listing (© ICH, used under the ICH Legal Mentions) and of the ICH M11 Terminology published by NCI EVS (CC BY 4.0). Not an ICH, CDISC or HL7 artifact, and not endorsed or sponsored by ICH.