9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
https://w3id.org/m11-rdf/C217272.C218608
- Definition
- Section 9 of the ICH M11 Protocol standard, ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS.
- Section number
- 9
- Broader
- top level
- Namespace
- ICH M11 Section 9 Terminology
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218608 (EVS identifier)
NCIT_C218608 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218608 (EVS term IRI; does not resolve)
Subsections
- 9.1 Definitions
- 9.2 Timing and Procedures for Collection and Reporting
- 9.3 Pregnancy and Postpartum Information
- 9.4 Special Safety Situations
Elements specified in this section
None.
In the ICH M11 Template
- Heading
- ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
- Page
- p. 50
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.