ShortName = ICH M11 Section Amendment Details Terminology LongName = ICH M11 Section Amendment Details Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.15 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.15.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217357
| 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" |
|---|---|---|---|
| C218694 | Amendment Details | A written message within the study protocol that describes the amendment details, especially as to whether the protocol has been amended previously. | y |
| C218695 | Amendment Scope Enrollment Description | The enrollment description as to whether the amendment scope applies globally, locally, or per cohort across the trial. | y |
| C42581 | Amendment Summary | A short description describing the changes introduced in the current version of the protocol. | y |
| C218478 | Approximately <#/%> enrolled | The value (expressed either numerically or as a percentage) for the estimated number of participants enrolled at the time of the protocol amendment. | y |
| C181233 | Brief Rationale for Change | The brief reason for the change introduced in the current or prior version of the protocol. | y |
| C218701 | Briefly Explain Substantial Impact on Data | A short descriptive account of any substantial impacts on the reliability and robustness of the data generated in the clinical trial due to the protocol amendment. | y |
| C218699 | Briefly Explain Substantial Impact On Safety | A short descriptive account of any substantial impacts on the safety or rights of the participants due to the protocol amendment. | y |
| C218483 | Description of Change | A description of the change introduced in the current or prior version of the protocol. | y |
| C218700 | Is this amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial? | An indication as to whether the amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial. | y |
| C218698 | Is this amendment likely to have a substantial impact on the safety or rights of the participants? | An indication as to whether the amendment is likely to have a substantial impact on the safety or rights of the participants. | y |
| C218696 | Primary Reason for Amendment | The rationale of greatest importance for the protocol amendment. | y |
| C218697 | Secondary Reason for Amendment | Additional rationale for the protocol amendment that is not considered the primary rationale. | y |
| C218479 | Section # and Name | The protocol section number and name containing the change introduced in the current or prior version 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