ShortName = ICH M11 Section 2 Terminology LongName = ICH M11 Section 2 Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.2 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.2.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217343
| 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" |
|---|---|---|---|
| C218724 | Benefit Summary | A short textual description containing the potential physical, psychological, social, legal, and other benefits to the trial participant. | y |
| C218725 | Overall Risk-Benefit Assessment | A short textual description containing the risks and benefits associated with participation in the trial. | y |
| C146997 | Purpose of Trial | The overall rationale, reason, or intention of the clinical trial. | y |
| C218721 | Trial-specific Intervention Risks and Mitigations | A description of the potential risks associated with the trial interventions and mitigation strategies to be employed within the trial. | y |
| C218723 | Trial-specific Other Risks and Mitigations | A description of the potential risks associated with the trial procedures and mitigation strategies to be employed within the trial that are different than the one(s) previously specified or mentioned. | y |
| C218722 | Trial-specific Procedure Risks and Mitigations | A description of the potential risks associated with the trial procedures and mitigation strategies to be employed within the trial. | 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