October 1, 2020
This document describes the definitions for protocol registration data elements submitted to ClinicalTrials.gov for interventional studies (clinical trials) and observational studies. These definitions are mostly adapted from 42 CFR Part 11.
Data element entries are annotated with symbols to indicate generally what information is required to be submitted (and under which circumstances). The responsible party must ensure that the information provided complies with any applicable laws, regulations, or policies. For more information about various requirements and definitions of regulatory terms under 42 CFR Part 11, see Support Materials.
Note: The term "clinical study" is used to refer to both interventional and observational studies. The term "participant" is used to refer to human subjects.
* | Required |
*§ | Required if Study Start Date is on or after January 18, 2017 |
[*] | Conditionally required |
Brief Title
*
Definition: A short title of the clinical study written in language intended for the lay public.
The title should include, where possible, information on the participants, condition being evaluated, and intervention(s) studied.
Limit: 300 characters.
Acronym
[*]
Definition: An acronym or abbreviation used publicly to identify the clinical study, if any.
Limit: 14 characters.
Official Title
*§
Definition: The title of the clinical study, corresponding to the title of the protocol.
Limit: 600 characters.
Secondary IDs
[*]
Definition: An identifier(s) (ID), if any, other than the organization's Unique Protocol Identification Number or the NCT number that is assigned to the clinical study. This includes any unique clinical study identifiers assigned by other publicly available clinical trial registries. If the clinical study is funded in whole or in part by a U.S. Federal Government agency, the complete grant or contract number must be submitted as a Secondary ID.
Limit: 30 characters.
If there is a Secondary ID, then the following information must be provided:
Description
[*]
Definition: If a Secondary ID Type of "Other Grant/Funding Number," "Registry Identifier," or "Other Identifier" is selected, provide the name of the funding organization, clinical trial registry, or organization that issued the identifier.
Limit: 119 characters.
Study Type
*
Definition: The nature of the investigation or investigational use for which clinical study information is being submitted. Select one.
Record Verification Date
*
Definition: The date on which the responsible party last verified the clinical study information in the entire ClinicalTrials.gov record for the clinical study, even if no additional or updated information is being submitted.
Overall Recruitment Status
*
Definition: The recruitment status for the clinical study as a whole, based upon the status of the individual sites. If at least one facility in a multi-site clinical study has an Individual Site Status of "Recruiting," then the Overall Recruitment Status for the study must be "Recruiting." Select one.
Why Study Stopped
*§
Limit: 250 characters.
Definition: A brief explanation of the reason(s) why such clinical study was stopped (for a clinical study that is "Suspended," "Terminated," or "Withdrawn" prior to its planned completion as anticipated by the protocol).
Study Start Date
*§
Definition: The estimated date on which the clinical study will be open for recruitment of participants, or the actual date on which the first participant was enrolled.
Note: "Enrolled" means a participant's, or their legally authorized representative’s, agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for the study, but do not participate in the study, are not considered enrolled, unless otherwise specified by the protocol.
Primary Completion Date
*
Definition: The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the pre-specified protocol or was terminated. In the case of clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes.
Once the clinical study has reached the primary completion date, the responsible party must update the Primary Completion Date to reflect the actual primary completion date.
Study Completion Date
*§
Definition: The date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated.
Once the clinical study has reached the study completion date, the responsible party must update the Study Completion Date to reflect the actual study completion date.
Responsible Party, by Official Title
*
Definition: An indication of whether the responsible party is the sponsor, the sponsor-investigator, or a principal investigator designated by the sponsor to be the responsible party. Select one.
Investigator Information
[*]
If the Responsible Party, by Official Title is either "Principal Investigator" or "Sponsor-Investigator," the following is required:
Name of the Sponsor
*
Definition: The name of the entity or the individual who is the sponsor of the clinical study.
Limit: 160 characters.
Note: When a clinical study is conducted under an investigational new drug application (IND) or investigational device exemption (IDE), the IND or IDE holder is considered the sponsor. When a clinical study is not conducted under an IND or IDE, the single person or entity who initiates the study, by preparing and/or planning the study, and who has authority and control over the study, is considered the sponsor.
Collaborators
Definition: Other organizations (if any) providing support. Support may include funding, design,
implementation, data analysis or reporting.
The responsible party is responsible for confirming all collaborators before listing them.
Limit: 160 characters.
Studies a U.S. FDA-regulated Drug Product
*§
(Optional for Observational Studies)
Definition: Indication that a clinical study is studying a drug product (including a biological product) subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section 351 of the Public Health Service Act. Select Yes/No.
Studies a U.S. FDA-regulated Device Product
*§
(Optional for Observational Studies)
Definition: Indication that a clinical study is studying a device product subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act. Select Yes/No.
Post Prior to U.S. FDA Approval or Clearance
Definition: Authorize NIH to post publicly clinical trial registration information for a clinical study of a device product that has not been previously approved or cleared (that would otherwise be subject to delayed posting). Select Yes/No.
Investigational New Drug Application (IND)/Investigational Device Exemption (IDE) Information
(Optional for Observational Studies)
Definition: Complete the following information regarding an IND or IDE for the clinical study as defined under U.S. Food and Drug Administration (FDA) regulations in 21 CFR 312.3 or 21 CFR 812, respectively.
FDA Center
[*]
Definition: The name or abbreviation of the FDA Center with which the IND or IDE is filed. Select one. (Will not be made public - for administrative purposes only.)
IND/IDE Number
[*]
Definition: IND or IDE number assigned by the FDA Center. (Will not be made public - for administrative purposes only.)
IND Serial Number
[*]
Definition: For an IND, the IND serial number, as defined in 21 CFR 312.23(e), if any, assigned to the clinical study.
(Will not be made public - for administrative purposes only.)
Availability of Expanded Access
[*]
Definition: Whether there is expanded access to the investigational product for patients who do not qualify for enrollment in a clinical trial. Expanded Access for investigational drug products (including biological products) includes all expanded access types under section 561 of the Federal Food, Drug, and Cosmetic Act: (1) for individual participants, including emergency use; (2) for intermediate-size participant populations; and (3) under a treatment IND or treatment protocol. Select one.
Expanded Access Record NCT Number
[*]
Definition: If expanded access is available, the NCT number of the expanded access record. If there is no existing expanded access record, the responsible party who is both the manufacturer of the investigational drug product (including a biological product) and the sponsor of the ACT is required to create an expanded access record. (For more information on data requirements for this Study Type, see Expanded Access Data Element Definitions).
Product Manufactured in and Exported from the U.S.
[*]
Definition: Whether any drug product (including a biological product) or device product studied in the clinical study is manufactured in the United States or one of its territories and exported for study in a clinical study in another country. Required if U.S. FDA-regulated Drug and/or U.S. FDA-regulated Device is "Yes," U.S. FDA IND or IDE is "No", and Facility Information does not include at least one U.S. location. Select Yes/No.
Human Subjects Review
*
Definition: Studies must have approval (or be exempt, as appropriate) from a Human Subjects Protection Review Board prior to the enrollment of the first participant to be eligible for registration. A study may be submitted for registration prior to approval by the review board so long as the study is not yet recruiting participants.
If the study is not an applicable clinical trial that is required to be registered under 42 CFR Part 11, is not funded in whole or in part by the U.S. Government, and is not conducted under an IND or IDE, then the following information is required:
Keywords
Definition: Words or phrases that best describe the protocol. Keywords help users find studies in the database. Use NLM's Medical Subject Heading (MeSH)-controlled vocabulary terms where appropriate. Be as specific and precise as possible. Avoid acronyms and abbreviations.
Note: "Arm" means a pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol.
Note: "Enrolled" means a participant’s, or their legally authorized representative’s, agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for a study, but do not participate in the study, are not considered enrolled, unless otherwise specified by the protocol.
Note: "Enrolled" means a participant’s, or their legally authorized representative’s, agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for a study, but do not participate in the study, are not considered enrolled, unless otherwise specified by the protocol.
Arm Information
*
(For interventional studies only)
Definition: A description of each arm of the clinical trial that indicates its role in the clinical trial; provides an informative title; and, if necessary, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.
Note: "Arm" means a pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol.
Arm Title
*
Definition: The short name used to identify the arm.
Limit: 100 characters.
Group/Cohort Information (For observational studies only)
Definition: Specify the predefined participant groups (cohorts) to be studied, corresponding to Number of Groups specified under Study Design (for single-group studies, the following data elements are optional). Do not use this section to specify strata (Detailed Description can be used for that purpose, if desired).
Note: The overall study population should be described under Eligibility.
Interventions
*
Definition: Specify the intervention(s) associated with each arm or group; at least one intervention must be specified for interventional studies. For observational studies, specify the intervention(s)/exposure(s) of interest, if any. If the same intervention is associated with more than one arm or group, provide the information once and use the Arm or Group/Intervention Cross-Reference to associate it with more than one arm or group.
Primary Outcome Measure Information
*
Definition: A description of each primary outcome measure (or for observational studies, specific key measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment).
Note: "Primary outcome measure" means the outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation. Most clinical studies have one primary outcome measure, but a clinical study may have more than one.
For each primary outcome measure, include the following information:
Note: "Secondary outcome measure" means an outcome measure that is of lesser importance than a primary outcome measure, but is part of a pre-specified analysis plan for evaluating the effects of the intervention or interventions under investigation in a clinical study and is not specified as an exploratory or other measure. A clinical study may have more than one secondary outcome measure.
For each secondary outcome measure, include the following information:
Note: "Sex" means a person's classification as male or female based on biological distinctions.
Note: "Gender" means a person's self-representation of gender identity.
Maximum Age
*
Definition: The numerical value, if any, for the maximum age a potential participant can be to be eligible for the clinical study.
Individual Site Status
*
Definition: The recruitment status of each participating facility in a clinical study.
Facility Contact
*
(or Central Contact required)
Definition: For each facility participating in a clinical study, including the name or title, telephone number, and email address of a person to whom questions concerning the study and enrollment at that site can be addressed. Include the following information:
Description
Definition: Title or brief description of the linked page.
Limit: 254 characters.
Note: "Responsible party" means with respect to a clinical study, the sponsor of the clinical study, as defined in 21 CFR 50.3; or the principal investigator of such clinical study if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the study, has access to and control over the data from the clinical study, has the right to publish the results of the study, and has the ability to meet all of the requirements for the submission of clinical study information. For a pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible party is the entity who FDA orders to conduct the pediatric postmarket surveillance of the device product.