ShortName = ICH M11 Section 12 Terminology LongName = ICH M11 Section 12 Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.12 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.12.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217353
| 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" |
|---|---|---|---|
| C220640 | Additional Appendices | Extra or supplementary appendices added to the end of a document. | y |
| C218477 | Amendment Identifier | A sequence of characters used to uniquely identify a protocol amendment. | 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 |
| 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 |
| C25294 | Clinical Laboratory Tests | Any procedure that involves testing or manipulating a sample of blood, urine, or other body substance in a laboratory setting. | y |
| C218832 | Country/Region Identifier | A sequence of characters used to identify and/or name a country or region. | y |
| C218834 | Country/Region Specific Protocol Clarifications | A description of any country or region-specific clarifications related to a protocol item. | y |
| C218833 | Country/Region-Specific Requirements | A description of any country or region-specific requirements related to the trial but not related to individual items in the protocol. | y |
| C218483 | Description of Change | A description of the change introduced in the current or prior version of the protocol. | y |
| C218835 | Prior Protocol Amendment(s) | An indication as to whether the protocol has not been amended, is the first protocol amendment, or a statement that the protocol has been amended previously. | 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 |
| C218836 | specify alternative location | The physical or virtual location of the overview of changes from each prior amendment. | y |
| C132352 | Sponsor Approval Date | The date that the sponsor approved a 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