Amendment Details

https://w3id.org/m11-rdf/C217272.C222770

Definition: Amendment Details Section of the ICH M11 Protocol standard, Amendment Details.
Section number: none
Broader: top level
Namespace: ICH M11 Section Amendment Details Terminology
NCIt concept: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C222770 (EVS identifier)
NCIT_C222770 (OBO PURL)
EVS term: http://rdf.ich.org/ich-terminology#C217272.C222770 (EVS term IRI; does not resolve)

Elements specified in this section

Element	IRI	Conformance	TS block
Amendment Details	`C217357.C218694`	Required	57
Approximately <#/%> enrolled	`C217357.C218478`	Conditional if Original Protocol =No	61
Amendment Scope Enrollment Definition	`C217357.C218695`	Conditional if Original Protocol =No	62
Primary Reason for Amendment	`C217357.C218696`	Conditional: if the protocol is = No	65
Other description	`C217357.C17649`	Conditional if Other is selected as a Valid Value	67
Secondary Reason for Amendment	`C217357.C218697`	Conditional If Protocol Original = No	69
Other description	`C217357.C17649`	Conditional if Other is selected as a Valid Value	71
Amendment Summary	`C217357.C42581`	Conditional: if there is an amendment	73
Is this amendment likely to have a substantial impact on the safety or rights of the participants?	`C217357.C218698`	Conditional If there is an amendment	75
Briefly Explain Substantial Impact On Safety	`C217357.C218699`	Conditional: if there is an amendment and if "Is this amendment likely to have a substantial impact on the safety or rights of the participants? " is Yes	76
Is this amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial?	`C217357.C218700`	Conditional: if there is an amendment	78
Briefly Explain Substantial Impact on Data	`C217357.C218701`	Conditional: if there is an amendment and if the answer to "Is this amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial?" is Yes	79
Description of Change	`C217357.C218483`	Conditional: if there is an amendment	82
Brief Rationale for Change	`C217357.C181233`	Conditional: if there is an amendment	84
Section # and Name	`C217357.C218479`	Conditional: if there is an amendment	86
Other Intervention Assignment Method	`C217342.C223138`	Conditional if Other is selected as a Valid Value	121
Approximately <#/%> enrolled	`C217353.C218478`	Optional: if Original Protocol =No	557
Amendment Scope Enrollment Description	`C217353.C218695`	Conditional if Original Protocol =No	558

In the ICH M11 Template

Heading: Amendment Details
Page: p. 13
Heading is: Amendment Details (TS term, section)

Field	Template	Page	Realises	Linked by
`<#/%>`	optional	p. 13	none
`<#/%>`	optional	p. 13	none
`<enter Amendment Scope Enrollment Definition>`	optional	p. 13	Amendment Scope Enrollment Definition	ts-term / verb-dropped / section
`[Primary Reason for Amendment]`	conditional	p. 13	Primary Reason for Amendment	ts-term / exact / section
`[Secondary Reason for Amendment]`	conditional	p. 13	Secondary Reason for Amendment	ts-term / exact / section
`<Amendment Summary>`	conditional	p. 14	Amendment Summary	ts-term / exact / section
`[Yes/No]`	conditional	p. 14	Is this amendment likely to have a substantial impact on the safety or rights of the participants?	ts-heading-context / exact / section
`<If yes, briefly explain>`	conditional	p. 14	Briefly Explain Substantial Impact On Safety	ts-heading-context / exact / section
`[Yes/No]`	conditional	p. 14	Is this amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial?	ts-heading-context / exact / section
`<If yes, briefly explain>`	conditional	p. 14	Briefly Explain Substantial Impact on Data	ts-heading-context / exact / section
`<Enter Description of Change>`	optional	p. 15	Description of Change	ts-term / verb-dropped / section
`<Enter Brief Rationale for Change>`	optional	p. 15	Brief Rationale for Change	ts-term / verb-dropped / section
`<Enter Section # and Name>`	optional	p. 15	Section # and Name	ts-term / verb-dropped / 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.