ShortName = ICH M11 Section 9 Terminology LongName = ICH M11 Section 9 Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.9 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.9.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217350
| 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" |
|---|---|---|---|
| C217358 | Adverse Events of Special Interest | A description of the processes and procedures used to define, measure, confirm, and report the occurrence of adverse events that are of special interest to the specific trial, or state not applicable. | y |
| C218790 | Back-up Method for Reporting | A description of alternative techniques by which trial related events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events, are reported to the sponsor and/or regulatory authority. | y |
| C82552 | Causality | The description of the degree of causality (attributability) between a trial intervention and an event. | y |
| C218476 | Definitions of Adverse Events | A concise explanation of the meaning of adverse events within the context of the trial. | y |
| C218783 | Definitions of Medical Device Product Complaints | A concise explanation of the meaning of medical device product complaints within the context of the trial. | y |
| C218782 | Definitions of Product Complaints | A concise explanation of the meaning of product complaints within the context of the trial. | y |
| C218781 | Definitions of Serious Adverse Events | A concise explanation of the meaning of serious adverse events within the context of the trial. | y |
| C218797 | Disease-related Events or Outcomes Not Qualifying as AEs or SAEs | A description of events or outcomes related to the trial disease indication but not qualifying as adverse events or serious adverse events within the trial, or state not applicable. | y |
| C218791 | Event Collection and Reporting Timing | A description of the timing as it relates to the collection and reporting of trial related events, and the frequency of collection of those events to the sponsor or designee. | y |
| C218784 | Event Type | A characterisation or classification of trial-related safety events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events. | y |
| C218794 | Follow-up | A description of the procedures for follow-up, including the assessment tools that will be used to monitor an event and the duration of follow-up. | y |
| C218792 | Identification | A description of how trial-related events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events, will be identified. | y |
| C218789 | Method for Reporting | A description of the technique by which trial related events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events, are reported to the sponsor and/or regulatory authority. | y |
| C222263 | Other Event Type | An event type that is different than the one(s) previously specified or mentioned. | y |
| C218798 | Participants Who Become Pregnant During the Trial | A description of the processes and procedures used to collect pregnancy data for a trial participant who becomes pregnant while the participant is in the trial, as well as data collection about the foetus, neonate, infant, or child. | y |
| C218799 | Participants Whose Partners Become Pregnant During the Trial | A description of the processes and procedures used to collect pregnancy data for a trial participant's partner, who becomes pregnant while the participant is in the trial. | y |
| C218793 | Recording | A description for the procedures used to document an event. | y |
| C218796 | Regulatory Reporting Requirements | A description of the requirements for the sponsor/designee to report adverse events, serious adverse events, pregnancy and postpartum events, and medical device product complaints, including the criteria for reporting, to the relevant regulatory authority. | y |
| C218787 | Reportable Period End | The date on which reporting will cease for trial related events such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events. | y |
| C218786 | Reportable Period Start | The date on which reporting will begin for trial related events such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events. | y |
| C218795 | Reporting | A description of the method and timelines for reporting adverse events, serious adverse events, pregnancy and postpartum events, and medical device product complaints to the sponsor. | y |
| C25676 | Severity | The description of the intensity (severity) of an event. | y |
| C218785 | Situational Scope | A description of the specific circumstances and context in which safety events are collected and monitored. | y |
| C218800 | Special Safety Situations | A characterisation or classification of those trial specific situations that are associated with the trial intervention(s) and require regulatory reporting, but that do not qualify as an adverse event or serious adverse event for the given trial. | y |
| C218788 | Timing for Reporting to Sponsor or Designee | A description of the timing window between trial related events and their reporting to the sponsor or designee. | 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