PART 11—CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION Authority: 42 U.S.C. 282(i); 42 U.S.C. 282(j); 5 U.S.C. 301; 42 U.S.C. 286(a); 42 U.S.C. 241(a); 42 U.S.C. 216(b). Source: 81 FR 65138, Sept. 21, 2016, unless otherwise noted. Subpart A—General Provisions § 11.2 What is the purpose of this part? This part implements section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) by providing requirements and procedures for the submission of clinical trial information for certain applicable clinical trials and other clinical trials to the Director of the National Institutes of Health (NIH) to be made publicly available via ClinicalTrials.gov, the Internet-accessible clinical trial registry and results data bank established by the National Library of Medicine (NLM) at https://clinicaltrials.gov. § 11.4 To whom does this part apply? (a) This part applies to the responsible party for an applicable clinical trial that is required to be registered under § 11.22, a clinical trial for which clinical trial registration information or clinical trial results information is submitted voluntarily in accordance with § 11.60, or an applicable clinical trial that is required by the Director to have clinical trial information submitted to protect the public health under § 11.62. (b) The responsible party must communicate the identity and contact information of the responsible party to the Director by submitting the Responsible Party, by Official Title and Responsible Party Contact Information data elements under § 11.28(a)(2)(iii)(B) and (a)(2)(iv)(F) as part of the clinical trial information submitted at the time of registration. Changes must be communicated to the Director by updating information in accordance with § 11.64(a). (c) Determination of responsible party. (1) Determination of sponsor. (i) When an applicable clinical trial or other clinical trial is conducted under an investigational new drug application (IND) or investigational device exemption (IDE), the IND or IDE holder will be considered the sponsor. (ii) When an applicable clinical trial or other clinical trial is not conducted under an IND or IDE, the single person or entity who initiates the trial, by preparing and/or planning the trial, and who has authority and control over the trial, will be considered the sponsor. (2) Designation of a principal investigator as the responsible party. (i) The sponsor may designate a principal investigator as the responsible party if such principal investigator meets all of the following requirements: (A) Is responsible for conducting the trial; (B) Has access to and control over the data from the trial; (C) Has the right to publish the results of the trial; and (D) Has the ability to meet all of the requirements for submitting and updating clinical trial information as specified in this part. (ii) With regard to an applicable clinical trial or other clinical trial, a designation by the sponsor under paragraph (c)(2)(i) of this section shall consist of the sponsor obtaining from the principal investigator an acknowledgment of the principal investigator's responsibilities under this part as responsible party, and the principal investigator acknowledging the designation as responsible party to the Director in the format specified at https://clinicaltrials.gov (3) Withdrawal of the designation of a principal investigator as the responsible party. In the event that a principal investigator who has been designated the responsible party no longer meets or is no longer able to meet all the requirements for being so designated under paragraph (c)(2)(i) of this section, the sponsor must withdraw the designation in the format specified at https://clinicaltrials.gov [81 FR 65138, Sept. 21, 2016, as amended at 89 FR 97559, Dec. 9, 2024] § 11.6 What are the requirements for the submission of truthful information? The clinical trial information submitted by a responsible party under this part shall not be false or misleading in any particular. A responsible party who submits false and/or misleading information is subject to civil monetary penalties and/or other civil or criminal remedies available under U.S. law. § 11.8 In what format must clinical trial information be submitted? Information submitted under this part must be submitted electronically to ClinicalTrials.gov, in the format specified at https://clinicaltrials.gov [81 FR 65138, Sept. 21, 2016, as amended at 89 FR 97559, Dec. 9, 2024] § 11.10 What definitions apply to this part? (a) The following definitions apply to terms used in this part: Adverse event Applicable clinical trial Applicable device clinical trial (1) A prospective clinical study of health outcomes comparing an intervention with a device product subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 21 U.S.C. 360e, 21 U.S.C. 360j(m)) against a control in human subjects (other than a small clinical trial to determine the feasibility of a device product, or a clinical trial to test prototype device products where the primary outcome measure relates to feasibility and not to health outcomes); (2) A pediatric postmarket surveillance of a device product as required under section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3601); or (3) A clinical trial of a combination product with a device primary mode of action under 21 CFR part 3, provided that it meets all other criteria of the definition under this part. Applicable drug clinical trial Approved drug Approved or cleared device Arm Clinical study Clinical trial Clinical trial information ClinicalTrials.gov Clinical trial registration information ClinicalTrials.gov Clinical trial results information ClinicalTrials.gov, Comparison group Completion date Control or controlled e.g., Device Director Drug Enroll or enrolled Human subjects protection review board Interventional Investigational Device Exemption (IDE) Investigational New Drug Application (IND) NCT number ClinicalTrials.gov, Ongoing Outcome measure Pediatric postmarket surveillance of a device product Primary completion date Primary outcome measure Principal investigator Protocol Responsible party Secondary outcome measure Secretary Serious adverse event Sponsor Study completion date e.g., U.S. FDA-regulated device product U.S. FDA-regulated drug product (b) The following definitions apply to data elements of clinical trial information referenced in this part, unless otherwise specified: (1) Brief Title (2) Official Title (3) Brief Summary (4) Primary Purpose (5) Study Design (i) Interventional Study Model. (ii) Number of Arms. (iii) Arm Information. (iv) Allocation. (v) Masking. (6) Study Phase (7) Study Type e.g., (8) Pediatric Postmarket Surveillance of a Device Product (9) Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study (10) Intervention Name(s) (11) Other Intervention Name(s) (12) Intervention Description (13) Intervention Type e.g., (14) Device Product Not Approved or Cleared by U.S. FDA (15) Product Manufactured in and Exported from the U.S. (16) Study Start Date (17) Primary Completion Date (18) Enrollment (19) Primary Outcome Measure Information (i) Name of the specific primary outcome measure; (ii) Description of the metric used to characterize the specific primary outcome measure; and (iii) Time point(s) at which the measurement is assessed for the specific metric used. (20) Secondary Outcome Measure Information (i) Name of the specific secondary outcome measure; (ii) Description of the metric used to characterize the specific secondary outcome measure; and (iii) Time point(s) at which the measurement is assessed for the specific metric used. (21) Eligibility Criteria (22) Sex/Gender (23) Age Limits (24) Accepts Healthy Volunteers (25) Overall Recruitment Status (26) Why Study Stopped (27) Individual Site Status (28) Availability of Expanded Access (i) An indication of whether there is expanded access to the investigational drug product (including a biological product) under section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) for those individuals who do not qualify for enrollment in the applicable clinical trial, under one or more of the following types of expanded access programs: for individual patients, including for emergency use, as specified in 21 CFR 312.310; for intermediate-size patient populations, as specified in 21 CFR 312.315; or under a treatment IND or treatment protocol, as specified in 21 CFR 312.320; and (ii) If expanded access is available under section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb), the NCT number of the expanded access record. (29) Name of the Sponsor (30) Responsible Party, by Official Title (i) Indication of whether the responsible party is the sponsor of the clinical trial, as that term is defined in 21 CFR 50.3; the sponsor-investigator, as that term is defined in 21 CFR 50.3; or a principal investigator designated pursuant to this part; and (ii) Either: (A) The official name of the entity, if the responsible party is an entity; or (B) The official title and primary organizational affiliation of the individual, if the responsible party is an individual. (31) Facility Information (i) Facility Name, meaning the full name of the organization where the clinical trial is being conducted; (ii) Facility Location, including city, state, country and zip code for U.S. locations (including territories of the United States) and city and country for locations in other countries; and (iii) Either: (A) For each facility participating in a clinical trial, Facility Contact, including the name or title, telephone number, and email address of a person to whom questions concerning the trial and enrollment at that site can be addressed; or (B) Central Contact Person, including the name or title, toll-free telephone number, and email address of a person to whom questions concerning enrollment at any location of the trial can be addressed. (32) Unique Protocol Identification Number (33) Secondary ID (i) Any identifier(s) other than the organization's unique protocol identifier or NCT number that is assigned to the clinical trial, including any unique clinical trial identifiers assigned by other publicly available clinical trial registries. If the clinical trial 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. (ii) A description of the type of Secondary ID. (34) U.S. Food and Drug Administration IND or IDE Number (i) Name or abbreviation of the FDA center with whom the IND or IDE is filed; (ii) IND or IDE number assigned by the FDA center; and (iii) For an IND, the IND serial number, as defined in 21 CFR 312.23(e), if any, assigned to the clinical trial. (35) Human Subjects Protection Review Board Status e.g., (36) Record Verification Date (37) Responsible Party Contact Information (38) Studies a U.S. FDA-regulated Device Product (39) Studies a U.S. FDA-regulated Drug Product (40) Post Prior to U.S. FDA Approval or Clearance (41) Study Completion Date Subpart B—Registration § 11.20 Who must submit clinical trial registration information? The responsible party for an applicable clinical trial specified in § 11.22 must submit clinical trial registration information for that clinical trial. § 11.22 Which applicable clinical trials must be registered? (a) General specification. (2) Any applicable clinical trial that is initiated on or before September 27, 2007, and is ongoing on December 26, 2007, must be registered. (3) Determining the date of initiation for an applicable clinical trial. (b) Determination of applicable clinical trial for a clinical trial or study initiated on or after January 18, 2017. (1) Applicable device clinical trial. (i) The study is a pediatric postmarket surveillance of a device product as required by FDA under section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3601). (ii) The study is a clinical trial with one or more arms that meets all of the following criteria: (A) Study Type is interventional; (B) Primary Purpose of the clinical trial is other than a feasibility study; (C) The clinical trial Studies a U.S. FDA-regulated Device Product; and (D) One or more of the following applies: ( 1 ( 2 ( 3 (2) Applicable drug clinical trial. (i) Study Type is interventional; (ii) Study Phase is other than phase 1; (iii) The clinical trial Studies a U.S. FDA-regulated Drug Product; and (iv) One or more of the following applies: (A) At least one Facility Location for the clinical trial is within the United States or one of its territories, (B) A drug product (including a biological product) under investigation is a Product Manufactured in and Exported from the U.S. or one of its territories for study in another country, or (C) The clinical trial has a U.S. Food and Drug Administration IND Number. § 11.24 When must clinical trial registration information be submitted? (a) General. (b) Exceptions:. (2) The responsible party for an applicable device clinical trial that is a pediatric postmarket surveillance of a device product and is not a clinical trial must submit clinical trial registration information, as specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or § 11.28(b), not later than December 26, 2007, or 21 calendar days after FDA approves the postmarket surveillance plan, whichever date is later. § 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; (C) Brief Summary; (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; (C) Age Limits; (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 (C) Facility Information. (iv) Administrative data: (A) Unique Protocol Identification Number; (B) Secondary ID; (C) U.S. Food and Drug Administration IND or IDE Number; (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. (B) Official Title. (C) Brief Summary. (D) Study Type. (E) Pediatric Postmarket Surveillance of a Device Product. (F) Primary Disease or Condition Being Studied, or the Focus of the Study. (G) Intervention Name(s). (H) Other Intervention Name(s). (I) Intervention Description. (J) Intervention Type. (K) Study Start Date. (L) Primary Completion Date. (ii) Location and contact information: (A) Name of the Sponsor. (B) Responsible Party, by Official Title: ( 1 ( 2 (C) Contact Information. (iii) Administrative data: (A) Unique Protocol Identification Number. (B) Secondary ID: 1 ( 2 (C) Human Subjects Protection Review Board Status. e.g., (D) Record Verification Date. (E) Responsible Party Contact Information. (c) Expanded access record. (1) Descriptive information: (i) Brief Title. (ii) Official Title. (iii) Brief Summary. (iv) Study Type. i.e., (v) Primary Disease or Condition. (vi) Intervention Name(s). (vii) Other Intervention Name(s). (viii) Intervention Description. (ix) Intervention Type. e.g., (x) Expanded Access Type. (2) Recruitment information: (i) Eligibility Criteria. (ii) Sex/Gender. (iii) Age Limits. (iv) Expanded Access Status. (3) Contact information: (i) Name of the Sponsor. (ii) Responsible Party, by Official Title. (iii) Contact Information. (4) Administrative data: (i) Unique Protocol Identification Number. (ii) Secondary ID: (B) For each Secondary ID listed, a description of the type of Secondary ID. (iii) U.S. Food and Drug Administration IND Number. (A) Name or abbreviation of the FDA center with whom the IND is filed ( i.e., (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 (C) IND serial number. as defined in 21 CFR 312.23(e), if any, assigned to the expanded access. (iv) Record Verification Date. (v) Responsible Party Contact Information. § 11.35 By when will the NIH Director post clinical trial registration information submitted under § 11.28? (a) Applicable drug clinical trial. ClinicalTrials.gov (b) Applicable device clinical trial. ClinicalTrials.gov (2) For an applicable device clinical trial of a device product that has not been previously approved or cleared: (i) The Director will post publicly on ClinicalTrials.gov (ii) If, prior to the date of approval or clearance of the device product, the responsible party for an applicable clinical trial that is initiated on or after January 18, 2017, indicates to the Director, by submitting the Post Prior to U.S. FDA Approval or Clearance data element under § 11.28(a)(2)(i)(Q), that it is authorizing the Director to publicly post its clinical trial registration information, which would otherwise be subject to delayed posting as specified in paragraph (b)(2)(i) of this section, prior to the date of FDA approval or clearance of its device product, the Director will publicly post the registration information, except for certain administrative data, as soon as practicable. Subpart C—Results Information Submission § 11.40 Who must submit clinical trial results information? The responsible party for an applicable clinical trial specified in § 11.42 must submit clinical trial results information for that clinical trial. § 11.42 For which applicable clinical trials must clinical trial results information be submitted? (a) Applicable clinical trials for which the studied product is approved, licensed, or cleared by FDA. (1) If the primary completion date is before January 18, 2017, the responsible party must submit the clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)); or (2) If the primary completion date is on or after January 18, 2017, the responsible party must submit the clinical trial results information specified in § 11.48. (b) Applicable clinical trials for which the studied product is not approved, licensed, or cleared by FDA. § 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42? (a) Standard submission deadline. (b) Delayed submission of results information with certification if seeking approval, licensure, or clearance of a new use General requirements. (i) FDA approves, licenses, or clears the drug product (including a biological product) or device product for the use studied in the applicable clinical trial; (ii) FDA issues a letter that ends the regulatory review cycle for the application or submission but does not approve, license, or clear the drug product (including a biological product) or device product for the use studied in the applicable clinical trial; or (iii) The application or premarket notification seeking approval, licensure, or clearance of the new use is withdrawn without resubmission for not less than 210 calendar days. (2) Two-year limitation. (3) Additional requirements. (i) The applicable clinical trial is required to be submitted in an application or premarket notification seeking approval, licensure, or clearance of a new use; and (ii) The applicable clinical trial studies the same drug product (including a biological product) or device product for the same use as studied in the applicable clinical trial for which the initial certification was submitted. (c) Delayed submission of results with certification if seeking initial approval, licensure, or clearance. General requirements. (i) FDA approves, licenses, or clears the drug product (including a biological product) or device product for any use that is studied in the applicable clinical trial; or (ii) The marketing application or premarket notification is withdrawn without resubmission for not less than 210 calendar days. (2) Two-year limitation. (d) Submitting partial results information. (i) For secondary outcome measure(s), by the later of: (A) One year after the date on which the final subject is examined or receives an intervention for the purposes of final collection of data for that secondary outcome measure, whether the clinical trial was concluded according to the pre-specified protocol or was terminated; or (B) If a certification to delay results information submission has been submitted under paragraph (b) or (c) of this section, the date on which results information for the primary outcome measures is due pursuant to paragraph (b) or (c) of this section. (ii) For additional adverse event information, by the later of: (A) One year after the date of data collection for additional adverse event information, whether the clinical trial was concluded according to the pre-specified protocol or was terminated; or (B) If a certification to delay results information submission has been submitted under paragraph (b) or (c) of this section, the date on which results information for the primary outcome measures is due pursuant to paragraph (b) or (c) of this section. (2) Except, if clinical trial results information was submitted for the primary outcome measure(s) prior to the effective date of these regulations but data collection for all of the secondary outcome measure(s) or additional adverse event information is not completed until on or after January 18, 2017, clinical trial results information for all primary and secondary outcome measures and adverse event information for the clinical trial must be submitted as specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)). (3) For each submission of partial results information for a clinical trial, as specified in paragraph (d)(1) of this section: (i) If any amendments were made to the protocol and/or statistical analysis plan as described in § 11.48(a)(5) since the previous submission of partial results information, the responsible party must submit a copy of the revised protocol and/or statistical analysis plan; and (ii) If information about certain agreements as described in § 11.48(a)(6)(ii) has changed since the previous submission of partial results information, the responsible party must submit information to reflect the new status of certain agreements between the principal investigator and the sponsor. (e) Extensions for good cause. (i) The responsible party must submit a request for an extension to ClinicalTrials.gov (ii) A request for an extension must contain the following: (A) Description of the reason(s) why clinical trial results information cannot be provided according to the deadline, with sufficient detail to allow for the evaluation of the request; and (B) Estimate of the date on which the clinical trial results information will be submitted. (2) Decision and submission deadline. (i) If the extension request is granted, the responsible party must submit clinical trial results information not later than the date of the deadline specified in the electronic response. (ii) If the extension request is denied, the responsible party must either appeal in accordance with paragraph (e)(3) of this section or submit clinical trial results information specified in § 11.48 by the later of the submission deadline specified in paragraph (a), (b), (c), (d), (e), or (f) of this section, as applicable, or 30 calendar days after the date on which the electronic notice of the denial is sent to the responsible party. (3) Appealing a denied extension request. https://clinicaltrials.gov (ii) An appeal must contain an explanation of the reason(s) why the initial decision to deny the extension request or to grant the extension request with a shorter deadline than requested should be overturned or revised, with sufficient detail to allow for the evaluation of the appeal. (iii) The Director will provide an electronic notification to the responsible party indicating whether the requested extension has been granted upon appeal. (iv) If the Director grants the extension request upon appeal, the responsible party must submit clinical trial results information not later than the deadline specified in the electronic notification specified in paragraph (e)(3)(iii) of this section. (v) If the Director denies the appeal of a denied extension request, the responsible party must submit clinical trial results information by the later of the deadline specified in paragraph (a), (b), (c), (d), (e), or (f) of this section, or 30 calendar days after the electronic notification of the denial of the appeal, specified in paragraph (e)(3)(iii) of this section, is sent to the responsible party. (vi) If the Director denies an appeal of a denied deadline specified in a granted extension request, the responsible party must submit clinical trial results information by the later of the deadline specified in the notification granting the extension request, specified in paragraph (e)(2)(i) of this section, or 30 calendar days after the electronic notification denying the appeal, specified in paragraph (e)(3)(iii) of this section, is sent to the responsible party. (f) Pediatric postmarket surveillance of a device product that is not a clinical trial. [81 FR 65138, Sept. 21, 2016, as amended at 89 FR 97559, Dec. 9, 2024] § 11.48 What constitutes clinical trial results information? (a) For each applicable clinical trial, other than a pediatric postmarket surveillance of a device product that is not a clinical trial, for which clinical trial results information must be submitted under § 11.42, the responsible party must provide the following: (1) Participant flow. (i) Participant Flow Arm Information. (ii) Pre-assignment Information. (iii) Participant Data. (2) Demographic and baseline characteristics. (i) Baseline Characteristics Arm/Group Information. (ii) Baseline Analysis Population Information Overall Number of Baseline Participants. (B) Overall Number of Units Analyzed. (C) Analysis Population Description. (iii) Baseline Measure Information. (A) Name and description of the measure, including any categories that are used to submit Baseline Measure Data. (B) Measure Type and Measure of Dispersion: (C) Unit of Measure. (iv) Baseline Measure Data. (v) Number of baseline participants (and units), by arm or comparison group and overall, if different from the Overall Number of Baseline Participants or Overall Number of Units Analyzed in § 11.48(a)(2)(ii)(A) and (B), respectively. (3) Outcomes and statistical analyses. (i) Outcome Measure Arm/Group Information. (ii) Analysis Population Information Number of Participants Analyzed. (B) Number of Units Analyzed. (C) Analysis Population Description. (iii) Outcome Measure Information. (A) Name of the specific outcome measure, including the titles of any categories in which Outcome Measure Data in § 11.48(a)(3)(iv) are aggregated. (B) Description of the metric used to characterize the specific outcome measure. (C) Time point(s) at which the measurement was assessed for the specific metric. (D) Outcome Measure Type. (E) Measure Type and Measure of Dispersion or Precision. (F) Unit of Measure. (iv) Outcome Measure Data. (v) Statistical Analyses. (A) A statistical analysis is required to be submitted if it is: ( 1 ( 2 ( 3 (B) Information for each statistical analysis specified in paragraph (a)(3)(v)(A) of this section must include the following elements: ( 1 Statistical Analysis Overview: ( 2 ( i Statistical Test of Hypothesis: ( ii) Method of Estimation: (4) Adverse event information. (A) Time Frame. (B) Adverse Event Reporting Description. (C) Collection Approach. (ii) Information for completing three tables summarizing anticipated and unanticipated adverse events collected during an applicable clinical trial: (A) Table of all serious adverse events grouped by organ system, with the number and frequency of each event by arm or comparison group; (B) Table of all adverse events, other than serious adverse events, that exceed a frequency of 5 percent within any arm of the clinical trial, grouped by organ system, with the number and frequency of each event by arm or comparison group; and (C) Table of all-cause mortality, with the number and frequency of deaths due to any cause by arm or comparison group. (iii) Information for each table specified in paragraph (a)(4)(ii) of this section must include the following elements, unless otherwise specified: (A) Adverse Event Arm/Group Information. (B) Total Number Affected. ( 1 ( 2 ( 3 (C) Total Number at Risk. ( 1 ( 2 ( 3 (D) Adverse Event Information. ( 1 ( 2 (E) Adverse Event Data. ( 1 ( 2) (5) Protocol and statistical analysis plan. https://clinicaltrials.gov (6) Administrative information Results Point of Contact. (A) Name or official title of the point of contact (B) Name of the affiliated organization, and (C) Telephone number and email address of the point of contact. (ii) Certain Agreements. (7) Additional clinical trial results information for applicable device clinical trials of unapproved or uncleared device products. (ii) The responsible party shall submit all the results information specified in paragraph (a)(7)(i) and must submit an affirmation that any information previously submitted to ClinicalTrials.gov (b) Pediatric postmarket surveillance of a device product that is not a clinical trial. https://clinicaltrials.gov [81 FR 65138, Sept. 21, 2016, as amended at 89 FR 97559, Dec. 9, 2024] § 11.52 By when will the NIH Director post submitted clinical trial results information? Except for clinical trial results information submitted under section 402(j)(4)(A) of the PHS Act and § 11.60, the Director will post publicly clinical trial results information on ClinicalTrials.gov § 11.54 What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission? (a) Waiver request. https://clinicaltrials.gov (2) The waiver request must contain: (i) The NCT number, Brief Title, and Name of the Sponsor of the applicable clinical trial for which the waiver is requested; (ii) The specific requirement(s) of this subpart C for which the waiver is requested; and (iii) A description of the extraordinary circumstances that the responsible party believes justify the waiver and an explanation of why granting the request would be consistent with the protection of public health or in the interest of national security. (3) The responsible party will not be required to comply with the specified requirements of this subpart for which a waiver is granted. (4) The responsible party must comply with any requirements of this subpart for which a waiver is not granted or must submit an appeal as set forth in paragraph (b) of this section. The deadline for submitting any required clinical trial results information will be the later of the original submission deadline or 30 calendar days after the notification of the denial is sent to the responsible party. (b) Appealing a denied waiver request. https://clinicaltrials.gov (2) The responsible party is not required to comply with any requirements of this subpart for which a waiver is granted upon appeal. (3) The responsible party must submit clinical trial results information to comply with any requirements of this subpart that are not waived upon appeal by the later of the original submission deadline or 30 calendar days after the notice of the denial upon appeal is sent to the responsible party. (c) If a waiver is granted under paragraph (a) or (b) of this section: (1) The Director will include a notation in the clinical trial record that specified elements of the requirements of this part have been waived. (2) The Secretary will notify, in writing, the appropriate committees of Congress and provide an explanation for why the waiver was granted, not later than 30 calendar days after any waiver is granted. (d) A responsible party for an applicable clinical trial with a primary completion date before January 18, 2017 may request a waiver from any applicable requirement(s) for clinical trial results information submission by submitting a waiver request, as specified in section 402(j)(3)(H) of the Public Health Service Act (42 U.S.C. 282(j)(3)(H)). [81 FR 65138, Sept. 21, 2016, as amended at 89 FR 99759, Dec. 9, 2024] Subpart D—Additional Submission of Clinical Trial Information § 11.60 What requirements apply to the voluntary submission of clinical trial information for clinical trials of FDA-regulated drug products (including biological products) and device products? (a) If a responsible party voluntarily submits clinical trial information for a clinical trial described in paragraph (a)(1) of this section, the responsible party must meet the conditions specified in paragraph (a)(2) of this section. (1) The requirements of paragraph (a) of this section apply to a clinical trial that was initiated before January 18, 2017 and has a primary completion date before January 18, 2017, and that is either: (i) A clinical trial of an FDA-regulated drug product (including a biological product) or device product that is not an applicable clinical trial, or (ii) An applicable clinical trial that is not otherwise required to submit clinical trial registration information. (2) If the responsible party for a clinical trial described in paragraph (a)(1) of this section voluntarily submits clinical trial registration information and/or clinical trial results information, the responsible party must comply with the following requirements: (i) The responsible party must submit the information in paragraphs (b)(2)(i)(A), (B), or (C) of this section for the clinical trial being submitted voluntarily. (A) If the responsible party voluntarily registers a clinical trial, the responsible party must submit clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)). (B) If the responsible party voluntarily submits clinical trial results information for a clinical trial for which the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) has not been submitted, the responsible party must submit the clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)). (C) If the responsible party both voluntarily submits clinical trial registration information and voluntarily submits clinical trial results information, the responsible party must submit both clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)). (ii) If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to FDA for approval, licensure, or clearance of a drug product (including a biological product) or device product under sections 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 355, 360(k), 360e, 360j(m)) or section 351 of the Public Health Service Act (42 U.S.C. 262) for the use studied in the clinical trial submitted under paragraph (a)(1) of this section, the responsible party specified in paragraph (a)(1) of this section must also submit the information specified in paragraph (a)(2)(iii) of this section by the deadline specified in paragraph (a)(2)(iv)(B) of this section for any applicable clinical trial that has not been submitted to ClinicalTrials.gov (A) The applicable clinical trial is required to be submitted to FDA under sections 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of the Public Health Service Act (42 U.S.C. 262) in an application or premarket notification for approval, licensure, or clearance to market the drug product (including a biological product) or device product for the use studied in the clinical trial specified in paragraph (a)(1) of this section; and (B) The manufacturer of the drug product (including a biological product) or device product studied in the applicable clinical trial is also the responsible party for the clinical trial specified in paragraph (a)(1) of this section. (iii) Information to be submitted for clinical trials described in paragraph (a)(2)(ii) of this section: (A) If the clinical trial information voluntarily submitted for a clinical trial described in paragraph (a)(1) of this section consists only of the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)), the information to be submitted in accordance with paragraph (a)(2)(ii) of this section must consist, at minimum, of the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)). (B) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph (a)(1) of this section consists of the clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)), the information to be submitted in accordance with paragraph (a)(2)(ii) of this section must consist of the clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)). (C) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph (a)(1) of this section consists of both the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and the clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)), the information to be submitted in accordance with paragraph (a)(2)(ii) of this section must consist of both the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and the clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)). (iv) Submission deadlines: (A) Secondary outcome measure(s) and adverse event information for voluntarily submitted clinical trials, under paragraph (a) of this section: ( 1) ( 2) (B) The clinical trial information specified in paragraph (a)(2)(iii) of this section must be submitted not later than the later of the date on which the application or premarket notification to FDA for approval, licensure, or clearance to market a drug product (including a biological product) or device product under section 351 of the Public Health Service Act (42 U.S.C. 262) or section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) for the use studied in the clinical trial specified under paragraph (a)(1) of this section is submitted to FDA or the date on which the clinical trial information specified in paragraph (a)(2)(i) of this section for the clinical trial specified under paragraph (a)(1) of this section is submitted to ClinicalTrials.gov (b) If a responsible party voluntarily submits clinical trial information for a clinical trial described in paragraph (b)(1) of this section, the responsible party must meet the conditions specified in paragraph (b)(2) of this section. (1) The requirements of paragraph (b) of this section apply to a clinical trial that was initiated before January 18, 2017 and has a primary completion date on or after January 18, 2017, and that is either: (i) A clinical trial of an FDA-regulated drug product (including a biological product) or device product that is not an applicable clinical trial; or (ii) An applicable clinical trial that is not otherwise required to submit clinical trial registration information. (2) If the responsible party for a clinical trial described in paragraph (b)(1) of this section voluntarily submits clinical trial registration information and/or clinical trial results information, the responsible party must comply with the following requirements: (i) The responsible party must submit the information in paragraph (b)(2)(i)(A), (B), or (C) of this section for the clinical trial being submitted voluntarily. (A) If the responsible party voluntarily registers a clinical trial, the responsible party must submit clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)). (B) If the responsible party voluntarily submits clinical trial results information for a clinical trial for which the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) has not been submitted, the responsible party must submit the data elements specified in § 11.48, as well as the data elements listed below, as those data elements are defined in § 11.10(b) and apply to the clinical trial and the intervention(s) studied: Brief Title; Official Title; Brief Summary; Primary Purpose; Study Design; Study Phase, for a clinical trial of a drug product (including a biological product); Study Type; Pediatric Postmarket Surveillance of a Device Product; Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study; Intervention Name(s), for each intervention studied; Other Intervention Name(s), for each intervention studied; Intervention Description, for each intervention studied; Intervention Type, for each intervention studied; Device Product Not Approved or Cleared by U.S. FDA, if any studied intervention is a device product; Product Manufactured in and Exported from the U.S.; Studies a U.S. FDA-regulated Device Product; Studies a U.S. FDA-regulated Drug Product; Study Start Date; Primary Completion Date; Study Completion Date; Enrollment; Eligibility Criteria; Sex/Gender; Age Limits; Accepts Healthy Volunteers; Overall Recruitment Status; Why Study Stopped; Availability of Expanded Access, if any studied intervention is an investigational drug product (including a biological product); Name of the Sponsor; Responsible Party, by Official Title; Facility Information, for each participating facility; Unique Protocol Identification Number; Secondary ID; U.S. Food and Drug Administration IND or IDE Number; Human Subjects Protection Review Board Status; Record Verification Date; and Responsible Party Contact Information. (C) If the responsible party both voluntarily submits clinical trial registration information and voluntarily submits clinical trial results information, the responsible party must submit both the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and the clinical trial results information specified in § 11.48. (ii) If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to FDA for approval, licensure, or clearance of a drug product (including a biological product) or device product under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of the Public Health Service Act (42 U.S.C. 262) for the use studied in the clinical trial submitted under paragraph (b)(1) of this section, the responsible party specified in paragraph (b)(1) of this section must also submit the information specified in paragraph (b)(2)(iii) of this section by the deadline specified in paragraph (b)(2)(iv)(B) of this section for any applicable clinical trial that has not been submitted to ClinicalTrials.gov (A) The applicable clinical trial is required to be submitted to FDA under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of the Public Health Service Act (42 U.S.C. 262) in an application or premarket notification for approval, licensure, or clearance to market the drug product (including a biological product) or device product for the use studied in the clinical trial specified in paragraph (b)(1) of this section; and (B) The manufacturer of the drug product (including a biological product) or device product studied in the applicable clinical trial is also the responsible party for the clinical trial specified in paragraph (b)(1) of this section. (iii) Information to be submitted for clinical trials described in paragraph (b)(2)(ii) of this section: (A) If the clinical trial information voluntarily submitted for a clinical trial described in paragraph (b)(1) of this section consists only of the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)), the information to be submitted in accordance with paragraph (b)(2)(ii) of this section must consist, at minimum, of the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)). (B) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph (b)(1) of this section consists of the clinical trial results information specified in § 11.60(b)(2)(i)(B), the information to be submitted in accordance with paragraph (b)(2)(ii) of this section must consist of the clinical trial results information specified in § 11.60(b)(2)(i)(B). (C) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph (b)(1) of this section consists of both the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and the clinical trial results information specified in § 11.48, the information to be submitted in accordance with paragraph (b)(2)(ii) of this section must consist of both the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) and the clinical trial results information specified in § 11.48. (iv) Submission deadlines: (A) Secondary outcome measure(s) and adverse event information for voluntarily submitted clinical trials, under paragraph (b) of this section: ( 1 ( 2 (B) The clinical trial information specified in paragraph (b)(2)(iii) of this section must be submitted not later than the later of the date on which the application or premarket notification to FDA for approval, licensure, or clearance to market a drug product (including a biological product) or device product under section 351 of the Public Health Service Act (42 U.S.C. 262) or section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) for the use studied in the clinical trial specified under paragraph (b)(1) of this section is submitted to FDA or the date on which the clinical trial information specified in paragraph (b)(2)(i) of this section for the clinical trial specified under paragraph (b)(1) of this section is submitted to ClinicalTrials.gov (c) If a responsible party voluntarily submits clinical trial information for a clinical trial described in paragraph (c)(1) of this section, the responsible party must meet the conditions specified in paragraph (c)(2) of this section. (1) The requirements of paragraph (c) of this section apply to a clinical trial that was initiated on or after January 18, 2017 and has a primary completion date on or after January 18, 2017, and that is either: (i) A clinical trial of an FDA-regulated drug product (including a biological product) or device product that is not an applicable clinical trial; or (ii) An applicable clinical trial that is not otherwise required to submit clinical trial registration information. (2) If the responsible party for a clinical trial described in paragraph (c)(1) of this section voluntarily submits clinical trial registration information and/or clinical trial results information, the responsible party must comply with the following requirements: (i) The responsible party must submit the information in paragraph (c)(2)(i)(A), (B), or (C) of this section for the clinical trial being submitted voluntarily. (A) If the responsible party voluntarily registers a clinical trial, the responsible party must submit the clinical trial registration information specified in § 11.28(a). (B) If the responsible party voluntarily submits clinical trial results information for a clinical trial for which the clinical trial registration information specified in § 11.28(a) has not been submitted, the responsible party must submit the data elements specified in paragraph (b)(2)(i)(B) of this section. (C) If the responsible party both voluntarily submits clinical trial registration information and voluntarily submits clinical trial results information, the responsible party must submit both the clinical trial registration information specified in § 11.28(a) and the clinical trial results information specified in § 11.48. (ii) If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to FDA for approval, licensure, or clearance of a drug product (including a biological product) or device product under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of the Public Health Service Act (42 U.S.C. 262) for the use studied in the clinical trial submitted under paragraph (c)(1) of this section, the responsible party specified in paragraph (c)(1) of this section must also submit the information specified in paragraph (c)(2)(iii) of this section by the deadline specified in paragraph (c)(2)(iv)(B) of this section for any applicable clinical trial that has not been submitted to ClinicalTrials.gov (A) The applicable clinical trial is required to be submitted to FDA under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) or section 351 of the Public Health Service Act (42 U.S.C. 262) in an application or premarket notification for approval, licensure, or clearance to market the drug product (including a biological product) or device product for the use studied in the clinical trial specified in paragraph (c)(1) of this section; and (B) The manufacturer of the drug product (including a biological product) or device product studied in the applicable clinical trial is also the responsible party for the clinical trial specified in paragraph (c)(1) of this section. (iii) Information to be submitted for clinical trials described in paragraph (c)(2)(ii) of this section: (A) If the clinical trial information voluntarily submitted for a clinical trial described in paragraph (c)(1) of this section consists only of the clinical trial registration information specified in § 11.28(a), the information to be submitted in accordance with paragraph (c)(2)(ii) of this section must consist, at minimum, of the clinical trial registration information specified in § 11.28(a). (B) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph (c)(1) of this section consists of the clinical trial results information specified in § 11.60(c)(2)(i)(B), the information to be submitted in accordance with paragraph (c)(2)(ii) of this section must consist of the clinical trial results information specified in § 11.60(c)(2)(i)(B). (C) If the clinical trial information voluntarily submitted for a clinical trial described by paragraph (c)(1) of this section consists of both the clinical trial registration information specified in § 11.28(a) and the clinical trial results information specified in § 11.48, the information to be submitted in accordance with paragraph (c)(2)(ii) of this section must consist of both the clinical trial registration information specified in § 11.28(a) and the clinical trial results information specified in § 11.48. (iv) Submission deadlines: (A) Secondary outcome measure(s) and adverse event information for voluntarily-submitted clinical trials, under paragraph (c) of this section: ( 1 ( 2) (B) The clinical trial information specified in paragraph (c)(2)(iii) of this section must be submitted not later than the later of the date on which the application or premarket notification to FDA for approval, licensure, or clearance to market a drug product (including a biological product) or device product under section 351 of the Public Health Service Act (42 U.S.C. 262) or section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360e, 360j(m)) for the use studied in the clinical trial specified under paragraph (c)(1) of this section is submitted to FDA or the date on which the clinical trial information specified in paragraph (c)(2)(i) of this section for the clinical trial specified under paragraph (c)(1) of this section is submitted to ClinicalTrials.gov (v) All submissions of clinical trial information under paragraph (c) of this section are subject to the applicable update and corrections requirements specified in § 11.64. (d) Statement to accompany applicable clinical trials submitted under paragraphs (a), (b), and (c) of this section. Each applicable clinical trial for which clinical trial information is submitted under paragraphs (a), (b), and (c) of this section and posted on ClinicalTrials.gov § 11.62 What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health? (a) A responsible party who receives notification that the Director has determined that posting of clinical trial information for an applicable clinical trial described in paragraph (b) of this section is necessary to protect the public health must submit clinical trial information as specified in paragraph (c) of this section. (b) An applicable clinical trial subject to this section must be either: (1) An applicable clinical trial of an approved, licensed, or cleared drug product (including a biological product) or device product that has a primary completion date on or after September 27, 1997; or (2) An applicable clinical trial that is subject to registration under § 11.22(a) and studies a drug product (including a biological product) or device product that is unapproved, unlicensed, or uncleared, regardless of whether approval, licensure, or clearance was, is, or will be sought, and that is not otherwise subject to results information submission in accordance with the regulation. (c) Deadline for submission of clinical trial information: (1) General. (2) Exception. (3) If a responsible party submitted clinical trial registration information describing the applicable clinical trial specified in the notification described in paragraph (a) of this section prior to the date on which the notification is sent to the responsible party, the responsible party must update such clinical trial information to reflect changes, if any, in the applicable clinical trial not later than 30 calendar days after the submission date specified in the notification described in paragraph (a) of this section, irrespective of the deadline for updates specified in § 11.64. § 11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected? (a) Updates. (i) The responsible party for an applicable clinical trial for which clinical trial registration information was required to be submitted if the clinical trial was initiated before January 18, 2017, must submit updates in accordance with the following: (A) In general, changes to the clinical trial registration information specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) that was required at the time of submission must be updated not less than once every 12 months. (B) Overall Recruitment Status must be updated not later than 30 calendar days after any change in overall recruitment status. (C) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its actual primary completion date. (ii) The responsible party for an applicable clinical trial, or for another clinical trial for which registration information was voluntarily submitted pursuant to § 11.60(c), if the clinical trial was initiated on or after January 18, 2017, must submit updates in accordance with the following: (A) In general, changes to clinical trial registration information specified in § 11.28 must be updated not less than once every 12 months. (B) If the first human subject was not enrolled in the clinical trial at the time of registration, the Study Start Date data element must be updated not later than 30 calendar days after the first human subject is enrolled. (C) Intervention Name(s) must be updated to a non-proprietary name not later than 30 calendar days after a non-proprietary name is established for any intervention included in the Intervention Name(s) data element. (D) Availability of expanded access: ( 1 ( 2 (E) Expanded access record: ( 1 ( 2 (F) Overall Recruitment Status must be updated not later than 30 calendar days after any change in overall recruitment status. If, at any time, Overall Recruitment Status is changed to “suspended,” “terminated,” or “withdrawn,” the responsible party must also submit the Why Study Stopped data element. (G) Individual Site Status must be updated not later than 30 calendar days after a change in status for any individual site. (H) Human Subjects Protection Review Board Status must be updated not later than 30 calendar days after a change in status. (I) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its actual primary completion date. At the time, the date is changed to “actual,” and the Enrollment data element specifying the actual number of participants enrolled must be submitted. (J) Study Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its actual study completion date. (K) Responsible Party, by Official Title must be updated not later than 30 calendar days after a change in the responsible party or the official title of the responsible party. (L) Responsible Party Contact Information must be updated not later than 30 calendar days after a change in the responsible party or the contact information for the responsible party. (M) Device Product Not Approved or Cleared by U.S. FDA must be updated not later than 15 calendar days after a change in approval or clearance status has occurred. (N) Record Verification Date must be updated any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time. (O) If a protocol is amended in such a manner that changes are communicated to human subjects in the clinical trial, updates to any relevant clinical trial registration information data elements must be submitted not later than 30 calendar days after the protocol amendment is approved by a human subjects protection review board. (iii) In addition to the update requirements established in paragraphs (a)(1)(i) and (a)(1)(ii) of this section, clinical trial registration information must be updated at the time that clinical trial results information for that clinical trial is initially submitted. (A) If the clinical trial was initiated before January 18, 2017, a responsible party must submit updates to the clinical trial registration information described in § 11.64(a)(1)(i). (B) If the clinical trial was initiated on or after January 18, 2017, the responsible party must submit updates to the clinical trial registration information in accordance with § 11.64(a)(1)(ii). (2) Clinical trial results information. (i) In general, changes to required clinical trial results information, other than the protocol and statistical analysis plan specified in § 11.48(a)(5) and certain agreements specified in § 11.48(a)(6)(ii),must be updated not less than once every 12 months. (ii) For applicable device clinical trials of unapproved or uncleared device products, the responsible party must update the following data elements, as defined in § 11.10(b), in accordance with the following: (A) Intervention Name(s) must be updated to a non-proprietary name not later than 30 calendar days after a non-proprietary name is established for any intervention included in the Intervention Name(s) data element. (B) Primary Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its actual primary completion date. At the time the date is changed to “actual,” the Enrollment data element specifying the actual number of participants enrolled must be submitted. (C) Study Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its actual study completion date. (D) Overall Recruitment Status must be updated not later than 30 calendar days after any change in overall recruitment status. If, at any time, Overall Recruitment Status is changed to “suspended,” “terminated,” or “withdrawn,” the responsible party must also submit the Why Study Stopped data element. (E) Record Verification Date must be updated any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time. (3) A responsible party's obligation to submit updates as specified in this section ends on the date on which all required clinical trial results information has been submitted as specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C)) and 42 U.S.C. 282(j)(3)(I)) or as specified in § 11.48, as applicable, and corrections have been made or addressed in response to any electronic notice received under § 11.64(b)(1). If no clinical trial results information is required to be submitted, a responsible party's obligation to submit updates to clinical trial registration information ends on the date on which all required clinical trial registration information has been submitted as specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii) or § 11.28, as applicable, and corrections have been made or addressed in response to any electronic notice received under § 11.64(b)(1). (4) Public availability of updates. (ii) The Director will retain prior clinical trial registration information and clinical trial results information and make it publicly available in accordance with § 11.35 and § 11.52, respectively, through ClinicalTrials.gov (b) Corrections—(1) Quality control. https://clinicaltrials.gov (2) Other corrections. (ii) A responsible party's obligation to correct or address errors as specified in paragraph (b)(2) of this section ends on the date on which all required clinical trial results information has been submitted as specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or § 11.48, as applicable, and corrections have been made or addressed in response to any electronic notice received under § 11.64(b)(1). If no clinical trial results information is required to be submitted, a responsible party's obligation to correct or address errors ends on the date on which all required clinical trial registration information has been submitted as specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or § 11.28, as applicable, and corrections have been made or addressed in response to any electronic notice received under § 11.64(b)(1). (3) Compliance with the quality control review process, including the requirements of this section, does not constitute a legal defense to enforcement pursuant to section 301(jj) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 331(jj)), section 303(f)(3) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 333(f)(3)), or any other Federal law. [81 FR 65138, Sept. 21, 2016, as amended at 89 FR 97559, Dec. 9, 2024] Subpart E—Potential Legal Consequences of Non-Compliance § 11.66 What are potential legal consequences of not complying with the requirements of this part? (a) Civil or criminal judicial actions. (1) Failure to submit the certification required by section 402(j)(5)(B) of the Public Health Service (42 U.S.C. 282(j)(5)(B)) that all applicable requirements of section 402(j) have been met, or knowingly submitting a false certification under section 402(j)(5)(B), is a prohibited act under section 301(jj)(1) of the Federal Food, Drug, and Cosmetic Act. (2) Failure to submit clinical trial information required under section 402(j) of the Public Health Service Act is a prohibited act under section 301(jj)(2) of the Federal Food, Drug, and Cosmetic Act. (3) Submission of clinical trial information under section 402(j) that is false or misleading in any particular is a prohibited act under section 301(jj)(3) of the Federal Food, Drug, and Cosmetic Act. (b) Civil monetary penalty actions. (c) Grant funding actions.