ShortName = ICH M11 Section 8 Terminology LongName = ICH M11 Section 8 Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.8 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.8.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217349
| 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" |
|---|---|---|---|
| C218771 | Baseline Assessments and Procedures | Trial assessments and procedures related to the baseline epoch of the trial. | y |
| C218774 | Clinical Laboratory Assessments | Trial-related laboratory assessments and procedures. | y |
| C218772 | Efficacy Assessments and Procedures | Trial assessments and procedures related to trial intervention efficacy. | y |
| C168186 | Electrocardiograms | The procedures for the recordings produced by the variations in electrical potential caused by electrical activity of the heart muscle and detected at the body surface, as a method for studying the action of the heart muscle. | y |
| C218777 | Genetics, Genomics, Pharmacogenetics and Pharmacogenomics | A narrative description containing information about the collection, use, and retention of biospecimens, and their use in genetic, genomic, pharmacogenetic and pharmacogenomic biomarker assessments within the trial. | y |
| C218780 | Immunogenicity Assessments | A narrative description containing information about the collection, use, and retention of biospecimens, and their use in immunogenicity assessments within the trial. | y |
| C176849 | Medical Resource Utilisation and Health Economics | A narrative description containing information about medical resource utilisation and the health outcome measures, collection method and participant burden. | y |
| C218779 | Other Biomarkers | A narrative description containing information about the collection, use, and retention of biospecimens, and their use in other biomarker assessments within the trial. | y |
| C218778 | Pharmacodynamic Biomarkers | A narrative description containing information about the collection, use, and retention of biospecimens, and their use in pharmacodynamic biomarker assessments within the trial. | y |
| C218776 | Pharmacokinetics | A narrative description containing information about the collection, use, and retention of biospecimens, and their use in pharmacokinetic assessments within the trial. | y |
| C20989 | Physical Examination | The procedures for a physical examination of the body and its functions to be conducted for the trial. | y |
| C92949 | Pregnancy Testing | Any examination performed to assess if a female is gravid. | y |
| C218773 | Safety Assessments and Procedures | A description of the assessments and procedures related to participant safety within the trial. | y |
| C218770 | Screening Assessments and Procedures | Trial assessments and procedures related to the screening epoch of the trial. | y |
| C218775 | Suicidal Ideation and Behaviour Risk Monitoring | A description of data collection procedures and analysis related to suicidal ideation and behaviour risk monitoring. | y |
| C218769 | Trial Assessments and Procedures Considerations | A description of general considerations applicable across trial assessments and procedures. | y |
| C154628 | Vital Signs | The procedures for measurements of the body's basic functions that provide insight into the health status of the person. | 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