MSU HRPP Manual Section 7-9-B

ClinicalTrials.gov Requirements: Applicable Clinical Trials under 42 CFR 11

This section provides the requirements for applicable clinical trials (ACT) that require registration and/or results reporting under 42 CFR 11, Clinical Trials Registration and Results Information Submission, which implements section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).

These requirements apply to Michigan State University (MSU) individuals:

Who are designated as the Responsible Party of an ACT and
Are required to submit registration and results information to ClinicalTrials.gov.

For an ACT, a Responsible Party must submit information for:

Registration as specified in 42 CFR 11.22 and/or
Results as specified in 42 CFR 11.42.

If the clinical trial is an ACT but the Responsible Party is not an MSU individual, see MSU Human Research Protection Program (HRPP) Manual Section 7-9-A, General Requirements under 42 CFR 11 for requirements.

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

Registration

Registration Requirements

Registration is required for any ACT that is:

Initiated after September 27, 2007, or
Initiated on or before September 27, 2007 and is ongoing on December 26, 2007 42 CFR 11.22

An ACT is considered to be initiated on the date on which the first human subject is enrolled, except for pediatric postmarket surveillance of a device product that is not a clinical trial (see 42 CFR 11.22(a) for requirements).

The following definitions apply to a clinical trial or study that is initiated on or after January 18, 2017. A clinical trial or study that, at any point in time, meets the following conditions will be considered to meet the definition of an ACT.

Applicable device clinical trial. A clinical trial or study that meets the conditions listed in either paragraph (b)(1)(i) or (ii) of this section is an 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;

(D) One or more of the following applies:

(1) At least one Facility Location is within the United States or one of its territories,

(2) A device 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

(3) The clinical trial has a U.S. Food and Drug Administration IDE Number. 42 CFR 11.22(b)(1)

Applicable drug clinical trial. A clinical trial with one or more arms that meets the following conditions is an 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

Registration Deadline

The Responsible Party for an ACT where registration is required must submit no later than 21 calendar days after the first human subject is enrolled, unless an exception applies. Exceptions can include ACTs that are pediatric postmarket surveillance of a device product that is not a clinical trial. See 42 CFR 11.24(b) for exception requirements.

Registration Information Requirements

The Responsible Party must submit the following information for each ACT that requires registration (except for pediatric postmarket surveillance of a device product that is not a clinical trial):

If initiated before January 18, 2017:
- 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 11.28(a)(1)
If initiated on or after January 18, 2017:
- Registration information listed in 42 CFR 11.28(a)(2)

For pediatric postmarket surveillance of a device product that is not a clinical trial see 42 CFR 11.28(b) for requirements.

For expanded access, see 42 CFR 11.28(c) for requirements.

Results

Results Requirements

The Responsible Party for an ACT must submit clinical trial results information for that clinical trial when required by 42 CFR 11.42. Requirements are based upon whether the studies product is approved, licensed, or cleared by the FDA or not.

1. Studied Product is Approved, Licensed, or Cleared by FDA

Clinical trial results information must be submitted for ACTs:

Where registration is required, and
For which the studied product is approved, licensed, or cleared by FDA,
Unless a waiver is granted.

The specific results information that must be submitted by the Responsible Party depends upon the primary completion date:

If before January 18, 2017:
- Results information 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))
If on or after January 18, 2017:
- Results information in 42 CFR 11.48. 42 CFR 11.42(a)

2. Studied Product is Not Approved, Licensed, or Cleared by FDA

Clinical trial results information must be submitted for ACTs:

Where registration is required, and
For which the studied product is not approved, licensed, or cleared by the FDA when the primary completion date is on or after January 18, 2017,
Unless a waiver is granted.

The clinical trial results information must be submitted by the Responsible Party as specified in 42 CFR 11.28.

For waiver of the requirement to submit clinical trial information, see 42 CFR 11.54 for requirements.

Results Deadlines

Results information must be submitted no later than one year after the primary completion date of the ACT when submission of results information is required. 42 CFR 11.44(a)

For delayed submission of results information with certification if seeking approval, licensure, or clearance of a new use, see 42 CFR 11.44(b) for requirements.

For pediatric postmarket surveillance of a device product that is not a clinical trial, see 42 CFR 11.44(f) for requirements.

Submission of Partial Results

If clinical trial results information has not been collected for a secondary outcome measure(s) or additional adverse event information by the primary completion date, the Responsible Party must submit the remaining required clinical trial results information for secondary outcome measure(s) or additional adverse event information for that clinical trial by the following deadlines:

For secondary outcome measure(s), by the later of:

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
If a certification to delay results information submission has been submitted under 42 CFR 11.44(b) or 42 CFR 11.44(c), the date on which results information for the primary outcome measures is due pursuant to 42 CFR 11.44(b) or 42 CFR 11.44(c).

For additional adverse event information, by the later of:

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
If a certification to delay results information submission has been submitted under 42 CFR 11.44(b) or 42 CFR 11.44(c), the date on which results information for the primary outcome measures is due pursuant to 42 CFR 11.44(b) or 42 CFR 11.44(c).

However, if clinical trial results information was submitted for the primary outcome measure(s) prior to the effective date of these regulations (January 18, 2017) 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)).

For each submission of partial results information for a clinical trial, as specified in 42 CFR 11.44(d)(1):

If any amendments were made to the protocol and/or statistical analysis plan as described in 42 CFR 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
If information about certain agreements as described in 42 CFR 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.

Request for Results Deadline Extension

A Responsible Party may request an extension of the deadline for submitting clinical trial results information and may request more than one extension for the same ACT.

The Responsible Party must submit a request for an extension to ClinicalTrials.gov prior to the date on which clinical trial results information would otherwise be due.
A request for an extension must contain 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 estimate of the date on which the clinical trial results information will be submitted.

ClinicalTrials.gov will provide a response electronically to the Responsible Party indicating whether the requested extension demonstrates good cause and has been granted. To see more information about denial and the appeal process, see 42 CFR 11.44(e)(2) and 42 CFR 11.44(e)(3).

The Responsible Party should notify the MSU HRPP Compliance office when making a request for a deadline extension.

Approved By

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

This policy and procedure supersedes those previously drafted.

Related HRPP Manual Sections

7-9-A, General Requirements under 42 CFR 11