ShortName = ICH M11 Section Title Page Terminology LongName = ICH M11 Section Title Page Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.3.16 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.3.16.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217356
| 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" |
|---|---|---|---|
| C218477 | Amendment Identifier | A sequence of characters used to uniquely identify a protocol amendment. | y |
| C218673 | Amendment Scope | A description as to whether the amendment scope applies globally across the trial. | y |
| C132352 | Approval Date | The date that the sponsor approved a version of the protocol. | y |
| C218679 | Co-Sponsor Legal Address | The legally registered address of the trial co-sponsor. | y |
| C218678 | Co-Sponsor Name | The literal identifier (i.e., distinctive designation) of the trial co-sponsor. | y |
| C218693 | Medical Expert contact information (as designated by sponsor) | The contact information for the sponsor's representative who can advise on specific trial-related medical questions or problems. | y |
| C20108 | Country Identifier | A sequence of characters used to identify and/or name the country. | y |
| C218683 | Device Manufacturer Legal Address | The legally registered address of the device manufacturer. | y |
| C218682 | Device Manufacturer Name | The literal identifier (i.e., distinctive designation) of the organisation defined as being responsible for creating the device as stated on the package in which the product is supplied. | y |
| C218684 | EU CT Number | A sequence of characters used to identify a clinical trial, as assigned by the Clinical Trials Information System (CTIS) of the European Medicines Agency. | y |
| C218685 | FDA IND Number | A sequence of characters used to identify a clinical trial under an Investigational New Drug (IND) application, as assigned by the US Food and Drug Administration. | y |
| C132346 | Full Title | The formal descriptive name for the protocol that contains key elements of the study. (CDISC) | y |
| C218686 | IDE Number | A sequence of characters used to identify a clinical trial under an Investigational Device Exemption (IDE) application, as assigned by the US Food and Drug Administration. | y |
| C218687 | jRCT Number | A sequence of characters used to identify a clinical trial, as assigned by the Japan Registry for Clinical Trials (JRCT) of the Ministry of Health, Labour and Welfare (MHLW) in Japan. | y |
| C218681 | Local Sponsor Legal Address | The legally registered address of the sponsor's legal representative at a geographical region within which the sponsor has no legal presence. | y |
| C218680 | Local Sponsor Name | The literal identifier (i.e., distinctive designation) of the sponsor's legal representative at a geographical region within which the sponsor has no legal presence. | y |
| C172240 | NCT Number | A sequence of characters used to identify a clinical trial, as assigned by the protocol registration and results (PRS) system of the US National Library of Medicine. | y |
| C218688 | NMPA IND Number | A sequence of characters used to identify a clinical trial under an Investigational New Drug (IND) application, as assigned by the Chinese National Medicinal Products Administration (NMPA). | y |
| C97054 | Nonproprietary Name(s) | Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name. | y |
| C218672 | Original Protocol Indicator | An indication as to whether the protocol document reflects the original version of the protocol. | y |
| C218690 | Other Regulatory or Clinical Trial Identifier | A sequence of characters assigned by a regulatory agency or other health authority that is used to identify a clinical trial, and that is different than the one(s) previously specified or mentioned. | y |
| C71898 | Proprietary Name(s) | A commercial name granted by an authority for use in marketing/registering a product. | y |
| C218674 | Region Identifier | A sequence of characters used to identify and/or name the region. | y |
| C83081 | Site Identifier | A sequence of characters used to identify and/or name the study site. | y |
| C181236 | Sponsor Confidentiality Statement | A written message within the study protocol that asserts a statement of non-disclosure, such that information contained within the protocol document may only be shared with authorised parties. | y |
| C218677 | Sponsor Legal Address | The legally registered address of the trial sponsor. | y |
| C222495 | Sponsor Name | The literal identifier (i.e., distinctive designation) of the trial sponsor. | y |
| C132351 | Sponsor Protocol Identifier | A sequence of characters assigned by the sponsor that uniquely identifies a specific protocol. | y |
| C222014 | sponsor signatory (e.g., name, title, signature and date) | A block of text containing the name and signature of the sponsor's signatory, along with the signature date. | y |
| C218675 | Sponsor's Investigational Product Code(s) | A symbol or combination of symbols that are assigned by the sponsor to uniquely identify an experimental intervention. | y |
| C222063 | state location where Medical Expert contact information can be found | The physical or virtual location of the medical expert (as designated by the sponsor) contact information. | y |
| C218484 | State location where sponsor approval information can be found | The physical or virtual location of the date on which the sponsor approved the current version of the protocol. | y |
| C222064 | state location where sponsor signatory information can be found (e.g., electronic signature) | The physical or virtual location of the sponsor signatory information. | y |
| C94108 | Trial Acronym | Acronym or abbreviation used publicly to identify the clinical trial. | y |
| C48281 | Trial Phase | A stage in the clinical research and development of a therapy from first-in-human to post-approval clinical trials. | y |
| C94105 | Trial Short Title | The short descriptive name for the trial. | y |
| C93813 | Version Date | The date on which the document is versioned. | y |
| C181232 | Version Number | A string of alphanumeric characters that uniquely identifies a specific version of a study protocol. | y |
| C218689 | WHO/UTN Number | A sequence of characters used to identify a clinical trial, as assigned by the World Health Organisation's International Clinical Trial's Registry Platform (ICTRP). | 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