ShortName = Reason for Amendment Response Terminology LongName = Reason for Amendment Response Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.1.14 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.1.14.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217276
| code Id="code" (required) Type="string" |
english-label Id="en" (optional) Type="string" Lang="en" |
M11 Definition Id="en_def" (optional) Type="string" Lang="en" |
current flag Id="cf" (optional) Type="string" Lang="en" |
|---|---|---|---|
| C218497 | Change In Standard Of Care | A change in the standard of care necessitates a change(s) to, or formal clarification of, the protocol. | y |
| C218496 | Change In Strategy | A change in the study purpose or intent of the scientific plan necessitates a change(s) to, or formal clarification of, the protocol. | y |
| C218495 | IMP Addition | The addition of an investigational medicinal product to a clinical trial design necessitates a change(s) to, or formal clarification of, the protocol. | y |
| C218501 | Inconsistency And/Or Error In The Protocol | An error or inconsistency in the protocol necessitates a change(s) to, or formal clarification of, the protocol. | y |
| C218499 | Investigator/Site Feedback | Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol. | y |
| C218492 | IRB/IEC Feedback | Feedback from the institutional review board or independent ethics committee necessitates a change(s) to, or formal clarification of, the protocol. | y |
| C218494 | Manufacturing Change | A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol. | y |
| C218498 | New Data Available (Other Than Safety Data) | Previously unavailable data (other than safety data) becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. | y |
| C218491 | New Regulatory Guidance | A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol. | y |
| C218493 | New Safety Information Available | Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. | y |
| C48660 | Not Applicable | Determination of a value is not relevant in the current context. | y |
| C17649 | Other | Different than the one(s) previously specified or mentioned. | y |
| C218502 | Protocol Design Error | A protocol design error necessitates a change(s) to, or formal clarification of, a document. | y |
| C218500 | Recruitment Difficulty | Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol. | y |
| C218490 | Regulatory Agency Request To Amend | A regulatory agency has expressed a need for a change(s) to, or formal clarification of, the protocol. | y |
This file contains a code list co-maintained by ICH M2 ESTRI and CDISC in collaboration with the NCI Enterprise Vocabulary Services (EVS). It is encoded using OASIS genericode. More information on ICH technical standards is available via the M2 ESTRI webpages at www.ich.org.
Change History: v1.0 (November 11 2025)
Report created by ICH_M2_CDISC_Codelist.xsl : [Revision: 1.1 ] : ICH : Harmonisation for Better Health