MSU HRPP Manual Section 7-9
ClinicalTrials.gov Requirements
Investigators may be required and/or plan to register their human research clinical trial with the ClinicalTrials.gov website. When registering on ClinicalTrials.gov, information must be submitted electronically in the format specified by the applicable requirement or by the website. Individuals who register their studies on ClinicalTrials.gov are responsible for complying with all requirements regarding registration and/or results reporting. The clinical trial information submitted shall not be false or misleading in any particular.
Requirements under U.S. Law
Mandatory registration and reporting 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.
U.S. Federal Grant Requirements
The U.S National Institutes of Health (NIH) NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information sets the expectation that all NIH-funded awardees and investigators conducting clinical trials will register and report results of their trial in Clinicaltrials.gov. This policy applies to all NIH-funded clinical trials regardless of study phase, type of intervention, or whether they are subject to the regulation (42 CFR 11). If the clinical trial is NIH-funded in whole or in part, expectations for clinical trial registration and summary results submission will be included in the terms and conditions of the award.
Principal Investigators (PIs) of U.S. Veterans Health Administration (VHA) Office of Research and Development (ORD) funded clinical trials are responsible for registering their trials with and submitting summary results to the National Library of Medicine's (NLM) public registry, ClinicalTrials.gov, as a condition of funding.
Registration by Other Means
Investigators whose trials are not obligated under law or federal grant requirements to be registered may still be required or encouraged to register (e.g., by journals to be considered for publication, by funding sponsors in the grant or contract). Registration may be required in a public registry, of which ClinicalTrials.gov may be required or is an option to satisfy the requirement. Specific examples are included below:
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The International Committee of Medical Journal Editors (ICMJE) requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. The ICMJE accepts publicly accessible registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) that includes the minimum acceptable 24-item trial registration data set or in ClinicalTrials.gov, which is a data provider to the WHO ICTRP.
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The World Health Organization (WHO) specifies that "[t]here is an ethical imperative to report the results of all clinical trials, including those of unreported trials conducted in the past."
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The Patient-Centered Outcomes Research Institute (PCORI) requires registration of clinical trials with ClinicalTrials.gov, along with registration of other types of research at other sites.
Investigators should check with the journal or the sponsor for specific requirements or if there are questions regarding registration and/or results reporting.
Registration Not Required
Investigators may request registration with ClinicalTrials.gov when there is no requirement or expectation to register when they are conducting a clinical trial involving participants. All ClinicalTrials.gov site requirements must be followed. Investigators should contact the MSU Human Research Protection Program Compliance Office with any questions.
Submission Requirements
In addition to the specific requirements within the regulatory requirements or grant policy, each entity submitting data to ClinicalTrials.gov must comply with the website’s terms and conditions. This includes:
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Only data for studies that are in conformance with applicable human subjects or ethics review regulations (or equivalent) and applicable regulations of the national (or regional) health authority (or equivalent) may be submitted.
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Notice of changes in recruitment status (individual site status and overall recruitment status) and primary completion date must be provided as soon as possible, but no later than 30 days after such changes. All other submitted data must be reviewed, verified, and updated as necessary and no less than every 12 months.
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The submitting organization, or the individual designated as the Responsible Party, is responsible for completeness and accuracy of the data submitted to ClinicalTrials.gov.
These terms and conditions may change and it is the responsibility of each user to comply with ClinicalTrials.gov terms and conditions.
Because of the complexity of requirements related to updates, it is highly recommended that the Responsible Party review the record every thirty days to ensure compliance and up to date information.
ClinicalTrials.gov Protocol Registration and Results System (PRS) Account
ClinicalTrials.gov PRS accounts for MSU individuals are provided by the MSU Human Research Protection Program (HRPP) Compliance office. Accounts are only provided to MSU individuals who have a clinical trial with human subjects that has been submitted in the MSU IRB Online System.
While individuals other than MSU faculty may receive a ClinicalTrial.gov PRS account, only MSU faculty may be designated as the Responsible Party.
Compliance Office Review
When a human research study is submitted to the HRPP and there is an indication that the study may register and/or report results through ClinicalTrials.gov, the Compliance office will be assigned as an ancillary reviewer. Assignments will include exempt, expedited, or full board initial submissions where ClinicalTrials.gov may be applicable. Assignments will also include modifications that propose to add ClinicalTrials.gov submission.
Consent Requirements
When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act.
The statement is:
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.” 21 CFR 50.25(c)
If the clinical trial is not an applicable clinical trial as defined in 42 U.S.C. 282(j)(1)(A) but is a NIH clinical trial, the following informed consent language is recommended (removing “as required by U.S. Law”):
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
The recommended language may be modified when research involves external collaborators.
ClinicalTrials.gov Registration when Michigan State University (MSU) is Not the Sponsor or Responsible Party
When a study is registered on ClinicalTrials.gov but the MSU Principal Investigator is not designated as the Responsible Party as part of the ClinicalTrials.gov registration, they remain responsible for working with the Sponsor and/or Responsible Party to assure that MSU’s involvement in the study is included when appropriate in the ClinicalTrials.gov registration and results reporting (e.g., Contacts and Locations). ClinicalTrials.gov consent language should also be included in the consent form(s) when appropriate.
MSU Responsible Party Is Leaving or Has Left MSU
If the MSU Responsible Party is leaving MSU, they should notify the HRPP Compliance Office. If the MSU Responsible Party has left MSU without notifying the HRPP Compliance Office, the individual’s former department or unit will be contacted by the HRPP Compliance Office regarding ClinicalTrials.gov requirements.
Noncompliance
ClinicalTrials.gov provides notification to registered studies when there are problems with the record. The Responsible Party is responsible for correcting the issue(s) identified by ClinicalTrials.gov. If other noncompliance issues are identified (e.g., registration or results requirements are not complete), the Responsible Party is responsible for correcting the issue as soon as possible. The Responsible Party can contact the MSU HRPP Compliance Office with questions. They may also contact or be directed to the ClinicalTrials.gov help email.
The Responsible Party must correct the issue(s) as soon as possible. If the HRPP Compliance Office reaches out to the Responsible Party and the record is not corrected or the Responsible Party does not respond after a reasonable time period, the HRPP Compliance Office will notify the Responsible Party’s department chair or unit leader to obtain assistance with correcting the issue. A HRPP Compliance Office site visit may also be initiated.
Approved By
Vice President for Research and Innovation on 10-25-2024.
This policy and procedure supersedes those previously drafted.