MSU HRPP Manual Section 7-9-A
ClinicalTrials.gov Requirements: General Requirements under 42 CFR 11
Mandatory registration and reporting with ClinicalTrials.gov is required by Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) for certain types of clinical trials of drugs and devices. The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR 11) clarifies and expands the requirements and procedures for submitting registration and results information for certain trials to ClinicalTrials.gov, in accordance with FDAAA 801. This section provides the requirements for complying with 42 CFR 11 which implements section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
Definitions
This document provides several key definitions from 42 CFR 11.10. See 42 CFR 11.10 for all definitions.
Applicable clinical trial means an applicable device clinical trial or an applicable drug clinical trial. Expanded access use under section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) is not an applicable clinical trial.
Applicable device clinical trial means:
(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 means a controlled clinical investigation, other than a phase 1 clinical investigation, of a drug product subject to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or a biological product subject to section 351 of the Public Health Service Act (42 U.S.C. 262), where “clinical investigation” has the meaning given in 21 CFR 312.3 and “phase 1” has the meaning given in 21 CFR 312.21. A clinical trial of a combination product with a drug primary mode of action under 21 CFR part 3 is also an applicable drug clinical trial, provided that it meets all other criteria of the definition under this part.
Clinical trial means a clinical investigation or a clinical study in which human subject(s) are prospectively assigned, according to a protocol, to one or more interventions (or no intervention) to evaluate the effect(s) of the intervention(s) on biomedical or health-related outcomes.
Completion date means, for a clinical trial, including an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated.
- In the case of clinical trials with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes.
- For a pediatric postmarket surveillance of a device product that is not a clinical trial, completion date means the date on which the final report of the pediatric postmarket surveillance of the device product is submitted to FDA. For purposes of this part, completion date is referred to as “primary completion date.”
Enroll or enrolled means a human subject's, or their legally authorized representative's, agreement to participate in a clinical trial following completion of the informed consent process, as required in 21 CFR part 50 and/or 45 CFR part 46, as applicable. For the purposes of this part, potential subjects who are screened for the purpose of determining eligibility for a trial, but do not participate in the trial, are not considered enrolled, unless otherwise specified by the protocol.
Primary completion date means, for purposes of this part, “completion date.” See the definition of “completion date.”
Responsible party means, with respect to a clinical trial, the sponsor of the clinical trial, as defined in 21 CFR 50.3; or the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this part for the submission of clinical trial information. For a pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible party is the entity who FDA orders to conduct the pediatric postmarket surveillance of the device product.
Sponsor means either a “sponsor” or “sponsor-investigator,” as each is defined in 21 CFR 50.3.
U.S. FDA-regulated device product means, for purposes of this part, a device product subject to section 510(k), 515, 520(m), or 522 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), 21 U.S.C. 360l).
U.S. FDA-regulated drug product means, for purposes of this part, a drug product subject to section 505 of the Federal Food, Drug, and Cosmetic Act or a biological product subject to section 351 of the Public Health Service Act (21 U.S.C. 355, 42 U.S.C. 262) .
Applicability
The requirements in 42 CFR 11 apply to the Responsible Party for:
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an applicable clinical trial that is required to be registered under § 11.22
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a clinical trial for which clinical trial registration information or clinical trial results information is submitted voluntarily in accordance with § 11.60, or
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an applicable clinical trial that is required by the Director to have clinical trial information submitted to protect the public health under §11.62. 42 CFR 11.4 (a)
For requests to obtain a waiver of the requirements for clinical trial results information submission, see 42 CFR 11.54 for requirements.
Sponsor Determination
Each applicable clinical trial or other clinical trial must have one sponsor.
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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.
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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. 42 CFR 11.4 (c)(1)
The sponsor designation is made based upon the specifics of the clinical trial using the criteria provided in 42 CFR 11.4(c).
The sponsor designation for several common scenarios are described below:
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Industry sponsored clinical trials where Michigan State University (MSU) is a site: the industry sponsor is typically designated as the sponsor.
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Investigator-initiated studies where MSU has initiated the study: MSU is typically the sponsor. This includes studies where federal funding is received to conduct the study.
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Investigator-initiated studies where MSU has not initiated the study: the organization / entity that has initiated the study is typically the sponsor.
Investigators should contact the MSU Human Research Protection Program (HRPP) Compliance Office with any questions about designation of the sponsor.
Responsible Party
Each applicable clinical trial or other clinical trial must have one Responsible Party. With respect to a clinical trial, the sponsor of the clinical trial will be considered the Responsible Party unless and until a Principal Investigator has been designated the Responsible Party. 42 CFR 11.4(c)
The sponsor may designate a Principal Investigator as the Responsible Party if such Principal Investigator meets all of the following requirements:
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Is responsible for conducting the trial;
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Has access to and control over the data from the trial;
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Has the right to publish the results of the trial; and
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Has the ability to meet all of the requirements for submitting and updating clinical trial information as specified in this part.
A designation of a Principal Investigator by the sponsor as the Responsible Party 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 ClinicalTrials.gov. 42 CFR 11.4 (c)(2)(ii)
The Responsible Party designation is made based upon the specifics of the clinical trial using the criteria provided in 42 CFR 11.4(c). When an MSU individual is designated as the Responsible Party by the Sponsor, the individual must be an MSU faculty member.
The Responsible Party designation for several common scenarios is described below:
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Industry sponsored clinical trials where MSU is a site: the industry sponsor would typically determine the Responsible Party. In a multi-site clinical trial, the MSU Principal Investigator would not typically be designated as the Responsible Party.
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For clinical trials funded by NIH: the primary awardee would typically determine who is the Responsible Party.
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If MSU is the primary awardee, the MSU Principal Investigator would typically be designated as the Responsible Party.
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If MSU is not the primary awardee, the MSU Principal Investigator should work with the primary awardee or direct awardee (e.g. if there is a direct and prime award) to determine who the Responsible Party is and to assist with complying with the ClinicalTrials.gov requirements.
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Investigators should contact the MSU Human Research Protection Compliance Office with any questions about designation as the Responsible Party.
For pediatric postmarket surveillance of a device that is not a clinical trial, see 42 CFR 11.4(c).
Change in Responsible Party
If a Principal Investigator who has been designated the Responsible Party no longer meets or will no longer be able to meet all the requirements for being a Responsible Party, the sponsor must withdraw the designation in the format specified at ClinicalTrials.gov, at which time the sponsor will be considered the Responsible Party unless and until the sponsor makes a new designation. 42 CFR 11.4(c)(3)
If a request is submitted to the MSU Institutional Review Board office to change the Principal Investigator, the HRPP Compliance Office is assigned as an ancillary reviewer. If the study involves registration with ClinicalTrials.gov, the HRPP Compliance Office review will work with the Principal Investigator to determine the impact of the change in Principal Investigator to ClinicalTrials.gov registration.
Penalties
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. 42 CFR 11.6 For potential legal consequences of noncompliance, see 42 CFR 11.66.
Approved By
Vice President for Research and Innovation on 10-25-2024.
This policy and procedure supersedes those previously drafted.