9.2 Timing and Procedures for Collection and Reporting
https://w3id.org/m11-rdf/C217272.C218614
- Definition
- Section 9.2 of the ICH M11 Protocol standard, Timing and Procedures for Collection and Reporting.
- Section number
- 9.2
- Broader
- 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218614 (EVS identifier)
NCIT_C218614 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217272.C218614 (EVS term IRI; does not resolve)
Subsections
- 9.2.1 Timing
- 9.2.2 Collection Procedures
- 9.2.3 Reporting
- 9.2.4 Adverse Events of Special Interest
- 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
Elements specified in this section
| Element | IRI | Conformance | TS block |
|---|---|---|---|
| Event Type | C217350.C218784 | Optional if the table is used | 417 |
| Other Event Type | C217350.C222263 | Optional if table used | 418 |
| Situational Scope | C217350.C218785 | Optional if table used | 420 |
| Reportable Period Start | C217350.C218786 | Optional if table used | 422 |
| Reportable Period End | C217350.C218787 | Optional if table used | 424 |
| Timing for Reporting to Sponsor or Designee | C217350.C218788 | Optional if table used | 426 |
| Method for Reporting | C217350.C218789 | Optional if used | 428 |
| Back-up Method for Reporting | C217350.C218790 | Optional if table is used | 430 |
In the ICH M11 Template
- Heading
- Timing and Procedures for Collection and Reporting
- Page
- p. 50
| Field | Template | Page | Realises | Linked by |
|---|---|---|---|---|
<Event Type> | optional | p. 51 | Event Type | ts-term / exact / section |
<Situational Scope> | optional | p. 51 | Situational Scope | ts-term / exact / section |
<Reportable Period Start> | optional | p. 51 | Reportable Period Start | ts-term / exact / section |
<Reportable Period End> | optional | p. 51 | Reportable Period End | ts-term / exact / section |
<Timing for Reporting to Sponsor or Designee> | optional | p. 51 | Timing for Reporting to Sponsor or Designee | ts-term / exact / section |
<Method for Reporting> | optional | p. 51 | Method for Reporting | ts-term / exact / section |
<Backup Method for Reporting> | optional | p. 51 | none |
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.