Clinical Trials

In accordance with Section 801 of the Food and Drug Administration (FDA) Amendments Act (FDAAA 801), the federal government expanded the regulatory requirements and procedures for submitting registration and results information for studies that meet the definition of an applicable clinical trial (ACT).

The requirement applies to clinical trials that involve drug, biological, and device products. The rule went into effect January 18, 2017 with the FDA enforcing the requirements. A detailed summary of these requirements can be found on the FDAAA 801 and the Final Rule website.

Researchers are encouraged to use this flow chart to determine if their study qualifies as a clinical trial.

All NIH-funded clinical trials must be registered and  results must be submitted  to Clinicaltrials.gov, per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information" for competing applications and contract proposals submitted on or after January 18, 2017. 

NIH has created a resource to help researchers determine if they are required to comply with the clinicaltrials.gov reporting requirements. 

Researchers are encouraged to use this flow chart to determine if their study qualifies as a clinical trial.

The revised Common Rule at 45 CFR 46.116(h) requires that for each clinical trial conducted or supported by a federal department or agency, one IRB approved consent form used to enroll subjects must be posted on a publicly available federal website by the awardee or the federal department or agency component conducting the trial.  

The Human Research Protection Program strongly advises researchers to post IRB approved consent form on the clinicaltrials.gov website. Posting instructions and additional information is available on OHRP's website.

Researchers who plan to publish in an ICMJE journal must meet their guidelines for clinical trial registration. Researchers who initiate the registration process are subject to the same clinicaltrials.gov requirements and must keep their records up to date.  

Responsibility for registration and results reporting falls to the individual designated as the ‘responsible party’. In some cases, this may be the sponsor of the trial, however in most cases this responsibility falls to the principal investigator. 

Multi-site studies are not registered by individual sites. The study should be registered only once by the ‘responsible party’ or it’s designated principal investigator. 

Clinical trials are registered using the Protocol Registration System.  Researchers must have a Protocol Registration System account to register studies.

Researchers who do not have an account or an account registered through Virginia Tech should request an account by sending an email to the Virginia Tech PRS administrator at irb@vt.edu The following information should be included in all PRS account requests:

• Requestor’s Full Name
• Requestor’s Virginia Tech Email Address
• IRB Protocol Number
• Title of Protocol

Note: If the requestor is not the principal investigator, then an email from the principal investigator to the PRS administrator is required to create or change user access for each study record. 

All applicable clinical trials must be registered with clinicaltrials.gov prior to receipt of IRB approval. If registration is in process at the time of IRB submission and review, conditional approval may be issued with full approval granted once the clinical trial is registered. 

ClinicalTrials.gov outlines requirements surrounding study registration and record maintenance activities based upon the study’s status. A study’s PRS record should be updated at the following time points:

• Registration: Prior to enrollment of the first subject
• Actively Enrolling Studies: Update/Verification must occur every 6 months
• Studies Closed to Enrollment/Pending Results: Update/Verification must occur annually
• Change in Study Status: Must be updated within 30 days of status change
• Results Submission: Results are due within 1 year of the primary completion date. 

Under federal law, penalties for failure to register, or for providing incomplete, false or misleading registration information may include civil monetary penalties of more than $14,000 per incident per day, Non-compliance notices from the FDA, and for federally funded trials the withholding or recovery of grant funds.

Compliance with ClinicalTrials.gov registration requirements is a term and condition of NIH awards. NIH grantees are required to certify their compliance with registration and reporting requirements in grant applications and progress reports. Failure to comply may lead to suspension or termination of funding and publicly identifying the clinical trial record as noncompliant in clinicaltrials.gov. NIH may consider compliance with these requirements in decisions about future funding.

Unregistered or improperly registered trials risk not being accepted for publication consideration by ICMJE members or other journals.

Additionally, Virginia Tech principal investigators who are noncompliant with these registration and maintenance requirements will not be permitted to submit new protocols for IRB review.