Principal Investigators’ Responsibilities to Post Clinical Trial Information
The FDA recently issued a notice to a California-based principal investigator regarding non-compliance with the requirement to submit clinical trial results information to the ClinicalTrials.gov data bank. The requirement, part of the Food and Drug Administration Amendments Act of 2007 (FDAAA), was designed to improve clinical trial transparency.
Although the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) went into effect in 2017, the agency did not issue any Notices of Noncompliance until this year. This latest notice represents the first letter to an individual principal investigator, rather than a sponsor.
The responsible party of a clinical trial can be an academic institution, hospital, private company, a government research organization, or an individual principal investigator.
If a principal investigator is deemed the “responsible party,” then he or she is responsible for complying with this requirement. Typically the responsible party is the sponsor, but a principal investigator of a clinical trial can be the responsible party if he or she:
- 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 for the submission of clinical trial information
A responsible party for an FDA applicable clinical trial is required to submit to the ClinicalTrials.gov data bank certain results information for the clinical trial, within one year after the primary completion date of the applicable clinical trial. Certain exceptions include situations in which the responsible party has submitted:
- a certification of delay
- a request for an extension of good cause
- a request for a waiver of the requirements for submission of results information
A few things about this notice are worth noting in terms of what is considered sufficiently complying with the requirements.
Determine if a protocol meets the definition of an applicable clinical trial
The FDA has developed a to help responsible parties evaluate whether a clinical trial is an applicable clinical trial (ACT).
Notify Research Participants
Informed consent forms for applicable clinical trials must also advise research participants about the requirement to post clinical trials on ClinicalTrials.gov. A statement such as the one shown here can be included in the informed consent document:
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.”
Know the requirements for submission
The regulation in 42 CFR 11.48(a)(5) requires the responsible party to submit data in a tabular format summarizing:
- participant flow
- demographic and baseline characteristics
- primary and secondary outcomes,
- results of any scientifically appropriate statistical tests
- adverse event information
In addition, the rule requires the submission of the full protocol and statistical analysis plan (if a separate document), and all amendments that have been approved by an institutional review board (IRB).
Published results in a manuscript are not sufficient to meet the requirements for submission of clinical trial results information to the ClinicalTrials.gov data bank.
Understand the deadlines
The responsible party must register the applicable clinical trial on ClinicalTrials.gov within 21 days after the first human subject is enrolled and submit certain summary results information for those trials, generally no later than one year after the study’s completion date unless a deadline extension is obtained.
Analysts and observers say that the latest letters indicate a willingness of the FDA to “up the ante” on enforcement of the Final Rule. Non-compliance can mean a hefty monetary penalty. Violators are subject to a civil monetary penalty of up to $10,000. Investigators and research institutions should refresh their training regarding their responsibilities in order to avoid noncompliance.
CITI Program offers a webinar for Investigators and Institutions on “Building a ClinicalTrials.gov Compliance Program.” Learn more here.