Title 42

SECTION 11.28

11.28 What constitutes clinical trial registration information

§ 11.28 What constitutes clinical trial registration information?

(a) For each applicable clinical trial that must be registered with ClinicalTrials.gov, other than a pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible party must submit the following information:

(1) For such applicable clinical trials that were initiated before January 18, 2017, the responsible party must submit the information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)).

(2) For such applicable clinical trials that are initiated on or after January 18, 2017, the responsible party must submit the data elements listed below:

(i) Descriptive information:

(A) Brief Title;

(B) Official Title;

(D) Primary Purpose;

(E) Study Design;

(F) Study Phase, for an applicable drug clinical trial;

(G) Study Type;

(H) Pediatric Postmarket Surveillance of a Device Product, for an applicable device clinical trial that is a Pediatric Postmarket Surveillance of a Device Product;

(I) Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study;

(J) Intervention Name(s), for each intervention studied;

(K) Other Intervention Name(s), for each intervention studied;

(L) Intervention Description, for each intervention studied;

(M) Intervention Type, for each intervention studied;

(N) Studies a U.S. FDA-regulated Device Product;

(O) Studies a U.S. FDA-regulated Drug Product;

(P) Device Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product;

(Q) Post Prior to U.S. FDA Approval or Clearance, for an applicable device clinical trial that studies at least one device product not previously approved or cleared by the U.S. FDA;

(R) Product Manufactured in and Exported from the U.S., if the entry for U.S. Food and Drug Administration IND or IDE Number in § 11.28(a)(2)(iv)(C) indicates that there is no IND or IDE for the clinical trial, and the entry(ies) for Facility Information in § 11.28(a)(2)(iii)(C) include no facility locations in the United States or its territories;

(S) Study Start Date;

(T) Primary Completion Date;

(U) Study Completion Date;

(V) Enrollment;

(W) Primary Outcome Measure Information, for each primary outcome measure; and

(X) Secondary Outcome Measure Information, for each secondary outcome measure.

(ii) Recruitment information:

(A) Eligibility Criteria;

(B) Sex/Gender;

(D) Accepts Healthy Volunteers;

(E) Overall Recruitment Status;

(F) Why Study Stopped;

(G) Individual Site Status; and

(H) Availability of Expanded Access. If expanded access is available for an investigational drug product (including a biological product), an expanded access record must be submitted in accordance with § 11.28(c), unless an expanded access record was submitted previously in accordance with that provision.

(iii) Location and contact information:

(A) Name of the Sponsor;

(B) Responsible Party, by Official Title; and

(iv) Administrative data:

(A) Unique Protocol Identification Number;

(B) Secondary ID;

(D) Human Subjects Protection Review Board Status;

(E) Record Verification Date; and

(F) Responsible Party Contact Information.

(b) Pediatric postmarket surveillance of a device product that is not a clinical trial. For each pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible party must submit the following information:

(1) For such applicable device clinical trials that were initiated before January 18, 2017, the responsible party must submit the information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)).

(2) For such applicable device clinical trials that are initiated on or after January 18, 2017, the responsible party must submit the data elements listed below:

(i) Descriptive information:

(A) Brief Title. A short title of the pediatric postmarket surveillance of a device product in language intended for the lay public. If an acronym or abbreviation is used to publicly identify the surveillance, it must be provided.

(B) Official Title. The title of the pediatric postmarket surveillance of a device product, corresponding to the title of the protocol or the FDA-approved plan for conducting the surveillance

(C) Brief Summary. A short description of the pediatric postmarket surveillance of a device product, including a brief statement of the hypothesis or objective, written in language intended for the lay public, and a general description of the surveillance design, including relevant population information

(D) Study Type. The type of study being registered. In the case of a pediatric postmarket surveillance of a device product that is not a clinical trial, a study type of “observational” is required.

(E) Pediatric Postmarket Surveillance of a Device Product. For a study that includes an FDA-regulated device product as an intervention and is a pediatric postmarket surveillance of a device product

(F) Primary Disease or Condition Being Studied, or the Focus of the Study. The name(s) of the disease(s) or condition(s) being studied in the pediatric postmarket surveillance of a device product, or the focus of the surveillance study. Use, if available, appropriate descriptors fromNLM's MeSH-controlled vocabulary thesaurus or terms from another vocabulary, such as the SNOMED CT, that has been mapped to MeSH within the UMLS Metathesaurus.

(G) Intervention Name(s). A brief descriptive name used to refer to each intervention studied in the pediatric postmarket surveillance of a device product. A non-proprietary name of the intervention must be used, if available. If a non-proprietary name is not available, a brief descriptive name or identifier must be used.

(H) Other Intervention Name(s). Any other current and former name(s) or alias(es), different from the Intervention Name(s), that the sponsor has used publicly to identify the intervention(s), including, but not limited to, past or present names such as brand name(s), or serial numbers

(I) Intervention Description. Details that can be made public about each intervention, other than the Intervention Name(s) and Other Intervention Name(s), sufficient to distinguish the intervention from other, similar interventions studied in the same or another clinical trial or pediatric postmarket surveillance of a device product that is not a clinical trial

(J) Intervention Type. For each intervention studied in the pediatric postmarket surveillance of a device product, the general type of intervention

(K) Study Start Date. The date on which FDA approves the pediatric postmarket surveillance plan, as specified in 21 CFR 822.19(a).

(L) Primary Completion Date. The estimated or actual date on which the final report of the pediatric postmarket surveillance of a device product is expected to be submitted to FDA. Once the final report has been submitted, this is the actual date on which the final report is submitted to FDA.

(ii) Location and contact information:

(A) Name of the Sponsor.

(B) Responsible Party, by Official Title:

(1) If the responsible party is an entity, the official name of the entity; or

(2) If the responsible party is an individual, the official title and primary organizational affiliation of the individual.

(C) Contact Information. The name or official title, toll-free telephone number, and email address of a person to whom questions concerning the pediatric postmarket surveillance of a device product can be addressed.

(iii) Administrative data:

(A) Unique Protocol Identification Number. The unique identifier assigned to the pediatric postmarket surveillance of a device product by the sponsor, if any.

(B) Secondary ID: (1) Identifier(s) other than the organization's unique protocol identifier or NCT number that is assigned to the pediatric postmarket surveillance of a device product, if any, including any unique identifiers assigned by other publicly available clinical study registries. If the pediatric postmarket surveillance of a device product 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.

(2) For each secondary ID listed, a description of the type of secondary ID.

(C) Human Subjects Protection Review Board Status. Information to indicate whether a pediatric postmarket surveillance of a device product has been reviewed and approved by a human subjects protection review board or whether such review is not required per applicable law (e.g., 21 CFR part 56, 45 CFR part 46, or other applicable regulation). Human Subjects Protection Review Board Status must be listed as “approved” if at least one human subjects protection review board has approved the pediatric postmarket surveillance.

(D) Record Verification Date. The date on which the responsible party last verified the clinical trial information in the entire ClinicalTrials.gov record for the pediatric postmarket surveillance of a device product, even if no additional or updated information was submitted at that time

(E) Responsible Party Contact Information. Administrative information sufficient to identify and allow communication with the responsible party by telephone, email, and regular mail or delivery service. Responsible Party Contact Information includes the name, official title, organizational affiliation, physical address, mailing address, phone number, and email address of the individual who is the responsible party or of a designated employee of the organization that is the responsible party.

(c) Expanded access record. If expanded access is available, as specified in 21 CFR 312.315 (for an intermediate-size patient population) or 21 CFR 312.320 (under a treatment IND or treatment protocol), for an investigational drug product (including a biological product) studied in an applicable drug clinical trial, and the data elements set forth in paragraphs (c)(1) through (4) of this section have not been submitted in an expanded access record for that investigational product, the responsible party, if both the manufacturer of the investigational product and the sponsor of the applicable clinical trial, must submit the clinical trial information specified in paragraphs (c)(1) through (4) of this section to ClinicalTrials.gov in the form of an expanded access record. If expanded access is available only as specified in 21 CFR 312.310 (for individual patients, including for emergency use) for an investigational drug product (including a biological product) studied in an applicable drug clinical trial, and the data elements set forth in paragraphs (c)(1)(i), (iii), (iv), (vi), (ix), (x), (c)(2)(iv), (c)(3), (c)(4)(i), (iii),(iv), and (v) of this section have not been submitted in an expanded access record for that investigational product, the responsible party, if both the manufacturer of the investigational product and the sponsor of the applicable clinical trial, must submit the clinical trial information specified in those paragraphs to ClinicalTrials.gov in the form of an expanded access record.

(1) Descriptive information:

(i) Brief Title. A short title identifying the expanded access, written in language intended for the lay public. If an acronym or abbreviation is used publicly to identify the expanded access, it must be provided.

(ii) Official Title. The title, if any, of the expanded access program corresponding to the title that has been submitted to FDA for that program

(iii) Brief Summary. A short description of the availability of expanded access, including the procedure for requesting the investigational drug product (including a biological product).

(iv) Study Type. The nature of the investigation or investigational use for which clinical trial information is being submitted, i.e., “expanded access”.

(v) Primary Disease or Condition. The name(s) of the disease(s) or condition(s) for which expanded access to the investigational drug product (including a biological product) is available. Use, if available, appropriate descriptors from NLM's MeSH-controlled vocabulary thesaurus, or terms from another vocabulary, such as the SNOMED CT, that has been mapped to MeSH within the UMLS Metathesaurus.

(vi) Intervention Name(s). A brief descriptive name used to refer to the investigational drug product (including a biological product) that is available through expanded access. A non-proprietary name of the intervention must be used, if available. If a non-proprietary name is not available, a brief descriptive name or identifier must be used.

(vii) Other Intervention Name(s). Any other current and former name(s) or alias(es), different from the Intervention Name(s), that the sponsor has used publicly to identify the intervention, including, but not limited to, past or present names such as brand name(s), or serial numbers.

(viii) Intervention Description. Details that can be made public about each intervention, other than the Intervention Name(s) or Other Intervention Name(s), sufficient to distinguish the intervention from other, similar interventions that are available through expanded access or in clinical trials.

(ix) Intervention Type. For each investigational drug product (including a biological product) for which expanded access is available, the general type of intervention, e.g., drug.

(x) Expanded Access Type. The type(s) of expanded access for which the investigational drug product (including a biological product) is available, as specified in § 11.10(b)(28).

(2) Recruitment information:

(i) Eligibility Criteria. A limited list of criteria for determining who is eligible to receive the investigational drug product (including a biological product) through expanded access, provided in terms of inclusion and exclusion criteria and suitable for assisting potential patients in identifying investigational drug products (including biological products) of interest for which expanded access is available.

(ii) Sex/Gender. The sex and gender (if applicable) of the patients for whom expanded access is available.

(iii) Age Limits. The minimum and maximum age of patients for whom expanded access is available, provided in relevant units of time.

(iv) Expanded Access Status. The status of availability of the investigational drug product (including a biological product) through expanded access.

(3) Contact information:

(i) Name of the Sponsor.

(ii) Responsible Party, by Official Title. The official name of the entity.

(iii) Contact Information. The name or official title, toll-free telephone number, and email address of a person to whom questions concerning expanded access can be addressed.

(4) Administrative data:

(i) Unique Protocol Identification Number. Any unique identifier assigned by the sponsor to refer to the availability of its investigational drug product (including a biological product) for expanded access use or to identify the expanded access record.

(ii) Secondary ID: (A) Any identifier(s) other than the Unique Protocol Identification Number or the NCT number that is assigned to the expanded access record, including any unique identifiers assigned by other publicly available clinical trial or expanded access registries.

(B) For each Secondary ID listed, a description of the type of Secondary ID.

(iii) U.S. Food and Drug Administration IND Number. An indication of whether there is an IND and, if so, each of the following elements:

(A) Name or abbreviation of the FDA center with whom the IND is filed (i.e., CDER or CBER), if applicable;

(B) IND number (assigned by the FDA center) under which the investigational drug product (including a biological product) is being made available for expanded access, if applicable; and

(iv) Record Verification Date. The date on which the responsible party last verified the information in the expanded access record, even if no additional or updated information was submitted at that time.

(v) Responsible Party Contact Information. Administrative information sufficient to identify and allow communication with the responsible party entering the clinical trial information into the expanded access record by telephone, email, and regular mail or delivery service. Responsible Party Contact Information includes the name, official title, organizational affiliation, physical address, mailing address, phone number, and email address of the individual who is the responsible party or of a designated employee of the organization that is the responsible party.