ClinicalTrials.gov Guidance for Required Reporting

 

Support for ClinicalTrials.gov Study Registration

The Office of Regulatory Support (ORS) offers services to support research teams with registration and reporting of clinical research trials at ClinicalTrials.gov, a database of clinical research trials conducted in the United States and around the world. Please submit a request through our Research Request Dashboard to set up a clinicaltrials.gov account or register your study. View the University of Rochester Policy on Public Disclosure of Clinical Trial Information (Clinical Trials.gov).

• Determination of Registration Requirements
• Assistance with ClinicalTrials.gov Account Management
• Technical Assistance with Entry of Study Information

Determination of Registration Requirements

ORS provides guidance in determining whether a clinical research trial must be registered, who is responsible for the registration, whether study results must be reported and the deadlines for both registration and results reporting.

While the University of Rochester encourages registering all human subjects research in a public website, registration is required for three reasons:

1. Required by federal law for certain drug, device or biologic studies
2. Required by the NIH for NIH funded research that is interventional and prospective
3. Required by some journals for publication.

Use this decision tree to determine if your study should be registered on clinicaltrials.gov.

1. Study Registration and Reporting Required by Federal Law.

​Study registration and reporting of results and adverse events are required by federal law for most clinical trials. U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or FDAAA) requires registration of "Applicable Clinical Trials:" Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation;

Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation (other than small feasibility studies) and pediatric post-market surveillance studies.

Basic results and adverse events must be reported for applicable clinical trials.

A helpful flow chart to identify an "Applicable Clinical Trial"

Complete statutory definitions and more detailed information about their meaning

The consent form for registered clinical trials must include language about registering the study on clinicaltrials.gov. Please contact your IRB of record for this language.

  2. Study Registration and Reporting Required by the NIH:

The NIH now requires studies that meet their definition of a clinical trial to be registered on clinicaltrials.gov. The NIH has also provided this pdf checklist to determine if your study is an applicable clinical trial. This checklist should only be used for studies that will start on or after January 18, 2017.

 3. Registration Requirements by some journals

The International Committee of Medical Journal Editors (ICMJE) also requires trial registration as a condition for publication. Click here for more details about ICMJE requirements.

Guidance for Basic Experimental Studies with Humans (BESH) Funding Opportunities

Need help determining if your study falls within a Basic Experimental Studies with Humans (BESH) funding opportunity announcement? This link  has key considerations and associated examples to help you.

Responsible Party

The party responsible for registration and reporting is:

The sponsor of the clinical trial OR the principal investigator (PI), if the PI:

• Is designated by the sponsor; and
• Is responsible for conducting the trial; and
• Has access to and control over the data

A helpful flow chart to determine the Responsible Party

Investigators should confer with the study sponsor to determine who the responsible party is, and to ensure that the study is registered at ClinicalTrials.gov once, and only once. If a non-University of Rochester (UR) Sponsor delegates responsibility to UR faculty, registration must be managed within the non-UR Sponsor's ClinicalTrials.gov account.

Penalties for responsible parties who fail to register or who submit false or misleading information are significant, and may include civil monetary penalties and, for federally-funded trials, the withholding or recovery of grant funds.

When to Register

The law and the NIH require registration is to occur within 21 days of first subject enrollment. However, ORS recommends trial registration in the ClinicalTrials.gov database prior to first subject enrollment, to satisfy both the law and ICMJE requirements. ICMJE requires registration before any subjects are enrolled.

When to Report Results

FDAAA and the NIH requires reporting of study results for Applicable Clinical Trials no later than 12 months after the date of final data collection for the primary outcome measure, referred to as the “Primary Completion Date.”

Reporting of results can be delayed beyond the 12-month required timeline if:

• The trial is of a drug or device that has not been approved for marketing by the FDA for any indication; result reporting will be required within 30 days of initial approval;
• The trial is of a drug or device for which the manufacturer has filed or is preparing to file an application seeking approval of the new use studied in the trial; or
• A request for delay that “demonstrates good cause” has been granted by the Director of the NIH.

At this time, the ICMJE does not require the recording of study results in the ClinicalTrials.gov database. ORS recommends that PIs stay informed about these requirements, as they evolve.