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MSU HRPP Manual Section 7-9-D

ClinicalTrials.gov Requirements: Voluntary Registration and/or Results Reporting under 42 CFR 11

This section provides the requirements when a Responsible Party voluntarily submits clinical trial information to ClinicalTrials.gov for a clinical trial that meets the specific clinical trial type requirements in 42 CFR 11.60.

These requirements apply to Michigan State University (MSU) individuals who are designated as the Responsible Party for a clinical trial that meets specific requirements for voluntary submission in 42 CFR 11.60. The Responsible Party must comply with voluntary registration and/or results reporting as provided in 21 CFR 11.60.

For definitions, see HRPP Manual Section 7-9-A, General Requirements under 42 CFR 11.

Voluntary Submission

Voluntary submission means that the trial:

  • Is not required to be registered under 42 CFR 11.22 (registration requirements), and / or
  • Is not required to have results reported under 42 CFR 11.42 (results requirements), and
  • Meets the specified clinical trial type requirements in 42 CFR 11.60.

This means that a study may be considered to have a “voluntary” submission under 42 CFR 11 even if the clinical trial must be registered with ClinicalTrials.gov under another requirement such as a federal grant requirement or journal requirement.

The requirements for voluntary submission of clinical trial information are based upon:

  • Meeting the criteria for a specific clinical trial type that is defined in 42 CFR 11
  • When that clinical trial was initiated, and
  • The primary completion date of the clinical trial.

Voluntary Submission Requirements for Specific Clinical Trials:

  • Initiated On or After July 18, 2017 and
  • Has a Primary Completion Date On or After July 18, 2017

If a Responsible Party voluntarily submits clinical trial information for a study described below, the Responsible Party must meet specific requirements provided in 42 CFR 11.60(c)(2). This applies to a clinical trial that was:

  • Initiated on or after January 18, 2017
  • Has a primary completion date on or after January 18, 2017
  • Is either:
    • A clinical trial:
      • Of an FDA-regulated drug product (including a biological product) or device product
      • That is not an applicable clinical trial, or
    • An applicable clinical trial that is not otherwise required to submit clinical trial registration information. 42 CFR 11.60(c)(1)

If the clinical trial meets the conditions above, the voluntary registration and/or reporting requirements in 42 CFR 11.60(c)(2) apply and are described below.

1. Voluntary Registration and/or Reporting Requirements (42 CFR 11.60(c)(2)(i))

If the Responsible Party voluntarily submits registration and/or results information, they must comply with the following requirements:

  • Voluntarily registers a trial
    • The Responsible Party must submit the registration information specified in 42 CFR 11.28(a). 42 CFR 11.60(c)(2)(i)(A)
  • Voluntarily submits results
    • The Responsible Party must submit the data elements specified in 42 CFR 11.60(b)(2)(i)(B).
    • Note that this applies when registration information specified in 42 CFR 11.28(a) has not been submitted. 42 CFR 11.60(c)(2)(i)(B)
  • Voluntarily submits both registration and results information
    • The Responsible Party must submit the clinical trial registration information specified in 42 CFR 11.28(a), and
    • The Responsible Party must submit the results information specified in 42 CFR 11.48. 42 CFR 11.60(c)(2)(i)(C)
2. Additional Requirements upon Certain Manufacturer Actions (42 CFR 11.60(c)(2)(ii))

If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to FDA for the use studied in the clinical trial submitted voluntarily, additional information must be submitted as provided in 42 CFR 11.60(c)(2)(ii), 42 CFR 11.60(c)(2)(iii), and 42 CFR 11.60(c)(2)(iv)(B).

3. Submission Deadlines for Secondary Outcome Measure(s) and Adverse Events (42 CFR 11.60(c)(2)(iv)

Submission deadlines for secondary outcome measure(s) and adverse event information for voluntarily submitted clinical trials:

  • If data collection for secondary outcome measure(s) is not completed by the primary completion date:
    • Results information for the secondary outcome measure(s) required in 42 CFR 11.48(a)(3) must be submitted by:
      • The later of the date that the clinical trial results information is voluntarily submitted for the primary outcome measure(s) or
      • 1 year after the date on which the final subject was examined or received an intervention for the purposes of final collection of data for the secondary outcome(s), whether the clinical trial was concluded according to the pre-specified protocol or was terminated. 42 CFR 11.60(c)(2)(iv)(A)(1)
  • If data collection for adverse event information continues after the primary completion date:
    • Any adverse event information collected after the primary completion date and subject to the submission requirements in 42 CFR 11.48(a)(4) must be submitted by:
      • The later of the date that the clinical trial results information is voluntarily submitted for the primary outcome measure(s) or
      • 1 year after the date of final collection of data for adverse events information, whether the clinical trial was concluded according to the pre-specified protocol or was terminated. 42 CFR 11.60(c)(2)(iv)(A)(2)

Voluntary Submission Requirements for Specific Clinical Trials:

  • Initiated Before July 18, 2017 and
  • Has a Primary Completion Date On or After July 18, 2017

If a Responsible Party voluntarily submits clinical trial information for a study described below, the Responsible Party must meet specific requirements provided in 42 CFR 11.60(b)(2). This applies to a clinical trial that was:

  • Initiated before January 18, 2017
  • Has a primary completion date on or after January 18, 2017
  • Is either:
    • A clinical trial:
      • Of an FDA-regulated drug product (including a biological product) or device product
      • That is not an applicable clinical trial, or
    • An applicable clinical trial that is not otherwise required to submit clinical trial registration information. 42 CFR 11.60(b)(1)

If the clinical trial meets the conditions above, the requirements in 42 CFR 11.60(b)(2) apply and are described below.

1. Voluntary Registration and/or Reporting Requirements (42 CFR 11.60(b)(2)(i))

If the Responsible Party voluntarily submits registration and/or results information, they must comply with the following requirements:

  • Voluntarily registers a trial
    • 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)). 42 CFR 11.60(b)(2)(i)(A)
  • Voluntarily submits results
    • Responsible Party must submit the data elements specified in 42 CFR 11.48, as well as the data elements listed in 42 CFR 11.60(b)(2)(i)(B)
    • Note that this applies when the 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. 42 CFR 11.60(b)(2)(i)(B)
  • Voluntarily submits both registration and results information
    • Responsible Party must submit the 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
    • Responsible Party must submit results information specified in 42 CFR 11.48. 42 CFR 11.60(b)(2)(i)(C)
2. Additional Requirements upon Certain Manufacturer Actions (42 CFR 11.60(b)(2)(ii))

If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to FDA for the use studied in the clinical trial submitted voluntarily, additional information must be submitted as provided 42 CFR 11.60(b)(2)(ii), 42 CFR 11.60(b)(2)(iii), and 42 CFR 11.60(b)(2)(iv)(B). See 42 CFR 11.60(b)(2)(ii) for full requirements.

3. Submission Deadlines for Secondary Outcome Measure(s) and Adverse Events (42 CFR 11.60(b)(2)(iv)

Submission deadlines for secondary outcome measure(s) and adverse event information for voluntarily submitted clinical trials:

  • If data collection for secondary outcome measure(s) is not completed by the primary completion date:
    • Clinical trial results information for the secondary outcome measure(s) required in 42 CFR 11.48(a)(3) must be submitted by:
      • The later of the date that the clinical trial results information is voluntarily submitted for the primary outcome measure(s) or
      • 1 year after the date on which the final subject was examined or received an intervention for the purposes of final collection of data for the secondary outcome(s), whether the clinical trial was concluded according to the pre-specified protocol or was terminated. 42 CFR 11.60(b)(2)(iv)(A)(1)
  • If data collection for adverse event information continues after the primary completion date
    • Any adverse event information collected after the primary completion date and subject to the submission requirements in 42 CFR 11.48(a)(4) must be submitted by:
    • The later of the date that the clinical trial results information is voluntarily submitted for the primary outcome measure(s) or
    • 1 year after the date of final collection of data for adverse event information, whether the clinical trial was concluded according to the pre-specified protocol or was terminated. 42 CFR 11.60(b)(2)(iv)(A)(2)

Voluntary Submission Requirements for Specific Clinical Trials Initiated:

  • Before July 18, 2017 and
  • Has a Primary Completion Date Before July 18, 2017

If a Responsible Party voluntarily submits clinical trial information for a study described below, the Responsible Party must meet specific requirements provided in 42 CFR 11.60(a)(2). This applies to a clinical trial that was:

  • Initiated before January 18, 2017
  • Has a primary completion date before January 18, 2017
  • Is either:
    • A clinical trial:
      • Of an FDA-regulated drug product (including a biological product) or device product
      • That is not an applicable clinical trial, or
    • An applicable clinical trial that is not otherwise required to submit clinical trial registration information. 42 CFR 11.60(a)(1)

If the clinical trial meets the conditions above, the requirements in 42 CFR 11.60(a)(2) apply and are described below.

1. Voluntary Registration and/or Reporting Requirements (42 CFR 11.60(a)(2)(i))

If the Responsible Party voluntarily submits registration and/or results information, they must comply with the following requirements:

  • Voluntarily registers a trial
    • Responsible Party must submit 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)). 42 CFR 11.60(a)(2)(i)(A)
  • Voluntarily submits results
    • Responsible Party must submit results 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)).
    • Note that this applies when registration information specified in 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) has not been submitted 42 CFR 11.60(a)(2)(i)(B)
  • Voluntarily submits both registration and results information
    • Responsible Party must submit 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
    • Must submit 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)). 42 CFR 11.60(a)(2)(i)(C)
2. Additional Requirements upon Certain Manufacturer Actions (42 CFR 11.60(a)(2)(ii))

If, on or after September 27, 2007, a manufacturer submits an application or premarket notification to FDA for the use studied in the clinical trial submitted voluntarily, additional information must be submitted as provided in 42 CFR 11(a)(2)(ii), 42 CFR 11(a)(2)(iii), 42 CFR 11(a)(2)(iii)(B) and 42 CFR 11(a)(2)(iv)(B). See 42 CFR 11(a)(2)(ii) for full requirements.

3. Submission Deadlines for Secondary Outcome Measure(s) and Adverse Events (42 CFR 11.60(a)(2)(iv)

Submission deadlines for secondary outcome measure(s) and adverse event information for voluntarily submitted clinical trials

  • If data collection for secondary outcome measure(s) is not completed by the primary completion date
    • Results information for the secondary outcome measure(s) required in section 402(j)(3)(C) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C)) must be submitted by:
      • The later of the date that the clinical trial results information is voluntarily submitted for the primary outcome measure(s) or
      • 1 year after the date on which the final subject was examined or received an intervention for the purposes of final collection of data for the secondary outcome(s), whether the clinical trial was concluded according to the pre-specified protocol or was terminated. 42 CFR 11.60(a)(2)(iv)(A)(1)
  • If data collection for adverse event information continues after the primary completion date:
    • Any adverse event information collected after the primary completion date and subject to the submission requirements in section 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(I)) must be submitted by:
      • The later of the date that the clinical trial results information is voluntarily submitted for the primary outcome measure(s) or
      • 1 year after the date of final collection of data for adverse event information, whether the clinical trial was concluded according to the pre-specified protocol or was terminated. 42 CFR 11.60(a)(2)(iv)(A)(2)

Additional Requirement for Applicable Clinical Trials when Voluntarily Submitting Clinical Trial Information

Each applicable clinical trial for which clinical trial information is voluntarily submitted under 42 CFR 11.60(a), 42 CFR 11.60(b), or 42 CFR 11.60(c) and posted on ClinicalTrials.gov must include the following statement:

“This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 42 CFR 11.44.)” 42 CFR 11.60(d)

This applies to applicable clinical trials that are not otherwise required to submit clinical trial registration under 42 CFR 11.22.

Approved By

Vice President for Research and Innovation on 4-30-2025.

This policy and procedure supersedes those previously drafted.

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