ShortName = ICH M11 Section 11 Terminology LongName = ICH M11 Section 11 Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.11 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.11.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217352
| 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" |
|---|---|---|---|
| C218819 | Committees | A description of the type and administrative structure of any committee associated with the trial. | y |
| C218829 | Criteria for Early Closure | The requirements that must be met in order to close a trial site prematurely. | y |
| C218831 | Data Dissemination | A description of whether and which public databases the clinical trial, and results if applicable, will be registered. | y |
| C218822 | Data Governance | A description of the key processes to ensure data integrity, traceability and security, in order to enable accurate collection, reporting, monitoring, transfer, retention, access and publication. | y |
| C218823 | Data Protection | A description of the measures taken to protect the privacy and confidentiality of person information of trial participants in accordance with applicable regulatory requirements on personal data protection and any measures that should be taken in case of a data security breach. | y |
| C218828 | Decision Rights for Site Closure | A description of the legal principles of entitlement for the sponsor to close a trial site, or for the investigator to initiate the closure of a trial site. | y |
| C218815 | Description of Assent Process | A description of the assent process for those individuals unable to give informed consent on their own behalf, to participate in the trial. | y |
| C218816 | Description of Emergency Consent Process | A type of informed consent process that may occur during an emergency situation in which the participant or their legally authorised representative is not available to give consent. | y |
| C184390 | Description of Informed Consent Process | The procedure by which informed consent is obtained and documented by means of a written, signed, and dated informed consent form. This process may include obtaining assent from participants with legally authorised representatives. | y |
| C222675 | Identification of Source Records | A description of how trial-related source records will be identified. | y |
| C218817 | Informed Consent for Rescreening | A description of the consent requirements for participants in the event of screen failure and rescreening. | y |
| C218818 | Informed Consent for Use of Remaining Samples in Exploratory Research | A description of the consent requirements for exploratory research using the remainder of mandatory samples. If applicable, this may include text in the original consent that address the use of remaining samples or additional text. | y |
| C218820 | Insurance and Indemnity | A concise summary of the arrangements for participants insurance and indemnity as required by the applicable regulatory body. | y |
| C218825 | Investigator Expectations for Source Records | A description of the obligations of the investigator with respect to maintaining and ensuring availability of the source records. | y |
| C218813 | Investigator Responsibilities | A description of the obligations of the investigator with respect to the trial. | y |
| C218827 | Protocol Deviations | A description of plans for detecting, reviewing, and reporting any deviations from the protocol. | y |
| C218811 | Regulatory and Ethical Considerations | Careful thought or deliberation related to the regulatory and ethical aspects of the trial. | y |
| C218830 | Responsibilities Following Early Site Closure | The responsibilities of the sponsor and/or investigator following an unplanned early termination or suspension of the trial at an individual site. | y |
| C218821 | Risk-Based Quality Management | A description of how potential risks and critical to quality factors associated with the trial will be identified and handled. | y |
| C218824 | Source Records Introduction | A description of trial-related source records including the importance of source record maintenance and expectations for data traceability. | y |
| C218814 | Sponsor Responsibilities | A description of the obligations of the sponsor with respect to the trial. | y |
| C218826 | Trial Monitor Expectations for Source Records | A description of the obligations of the trial monitor with respect to maintaining and ensuring availability of the source records. | y |
| C218812 | Trial Oversight | A description of the planned processes and procedures to govern and conduct a clinical trial in order to protect the rights, safety and welfare of the trial participants. | 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