Clinical Trials Registration and Reporting

 

Why this matters

Federal agencies require information about clinical trials to be placed in the public database called ClinicalTrials.gov (CT.gov). Specifically: the trials must be registered when they begin, the record must be updated throughout the study, and results must be provided when the study ends. Significant penalties can be applied by the agencies if these requirements are not met – including loss of an investigator’s ongoing or pending grant funding.

What changed on January 18, 2017

These requirements have existed for many years for most FDA-regulated trials but were significantly expanded as of January 18, 2017. The revised requirements now also apply to trials funded by NIH, whether or not they are FDA-regulated. The revised regulations also include expanded penalties for noncompliance, together with a statement that federal agencies will begin using the penalties to enforce compliance. In addition, many scientific journals have stated that they will not publish clinical trials that have not registered at ClinicalTrials.gov.

Which clinical trials

Clinical trials that are subject to these regulations are called applicable clinical trials. Three types of studies are considered to be applicable clinical trials (read the table below).

All of these are Applicable Clinical Trials
	Pediatric postmarket surveillance of a device (that is required by the FDA)		Clinical trials funded in whole or in part by the National Institutes of Health (NIH) in response to any type of application for funding (including competing renewals) submitted on or after January 18, 2017.
	A clinical trial initiated on or after September 27, 2007 that: Involves the study of a drug, biologic, or device that is regulated by the FDA AND Is controlled AND At least one of the following applies: At least one site is in the U.S. or its territories The drug, biologic, or device is a product manufactured in and exported from the U.S. or one of its territories for study in another country The study has a FDA IND or IDE number. AND It is none of the following: A Phase 1 drug trial (Phase 1/phase 2 trials are considered “applicable”) Primary purpose is to assess device feasibility An expanded access study

A UW investigator conducting an applicable clinical trial must comply with these requirements if:

• They are the Principal Investigator (PI), AND
• The clinical trial is not an industry trial whose protocol is developed, owned, and sponsored by a company. (Industry sponsors are responsible for registering their trials.)

Additional information

Multi-site clinical trials
The overall (lead PI) for the entire study is the party who must comply with the requirements. If the UW investigator is the PI solely for the UW site and is not the primary awardee or overall study PI, then the UW PI is not responsible.

IND, IDE, HDE
The holder of any IND, IDE, or HDE from the FDA must ensure compliance.

Relationship with NIH funding
The primary awardee must ensure compliance. It is not NIH’s responsibility.

UW studies reviewed by the Fred Hutchinson IRB
Although the UW PI is ultimately accountable for complying with this requirement, the Cancer Consortium Clinical Research Support office will (1) create the registration record for the UW PI, and provide some assistance (including statistical consultation) with results reporting.

When to register and report

Initial registration
No later than 21 days after enrollment of the first subject.

Interim updates
The record must be updated at least once a year (even if nothing has changed) until final results are reported. Certain types of changes must be reported within 30 days.

Results reporting
No later than one year after the trial’s primary completion date. For information about exceptions, read How to Report Clinical Trial Results.

Correction of errors
Within 15 days for registration information
Within 25 days for results information

PI responsibilities

The PI can delegate the responsibility for entering the information required for registration, updates, and results reporting – but the PI remains responsible for:

• The accuracy and completeness of the information
• The Approve and Release actions that are required each time information is entered into the trial record
• Obtaining an account with the PRS data entry system used by ClinicalTrials.gov, so that s/he can log into the system for the Approval and Release actions

Exception: UW applicable clinical trials that are reviewed by the Fred Hutchinson Cancer Center IRB will be registered for the PI by the Fred Hutch Clinical Research Support (CRS) office.

Delegating the data entry

An extensive amount of detailed information is required. The time and knowledge necessary to create a record (register) and to enter results should not be underestimated.

Initial registration and updates
This should be done by a person who knows the details of study design, eligibility criteria, outcome measures, and study status.

Results reporting
The information required for results reporting should be prepared by a person who knows the details of study design and analysis, such as an investigator or statistician, although others could then enter the information.

How to register, update, and report

View:

• How to Register a Clinical Trial
• How to Update a Clinical Trial
• How to Report Clinical Trial Results

Consent form requirements

Regulations require the trial consent form(s) to include the following statement, without revision. It is already included in the UW consent templates.

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.

Consequences and penalties

UW IRB approval for a clinical trial will not be renewed unless the trial has been registered.

Federal agency penalties for noncompliance were generally not enforced prior to January 18, 2017. However, the expanded requirements implemented on this date include additional possible penalties and a declaration of intent to enforce the penalties. The range of possible agency actions is summarized below.

FDA-regulated research

• Civil monetary penalties for the responsible party of $10,000 (initial) and $10,000/day for duration of the uncorrected noncompliance
• Public notice of noncompliance at ClinicalTrials.gov
• HHS agencies (e.g., NIH) may withhold continuing funds for existing grants, and/or awards of new funding to the PI
• HHS research funding to the entire institution could be withheld

NIH-sponsored research

• Public notice of noncompliance at ClinicalTrials.gov
• HHS agencies (e.g., NIH) may withhold continuing funds for existing grants and/or awards of new funding to the PI
• HHS research funding to the entire institution could be withheld

Medicare
Claims will not be paid

International Committee of Medical Journal Editors
Inability to publish in prominent medical journals

Human Subjects Division
UW IRB approval will not be renewed unless a trial has been registered

Question and Answers

Additional specific information is provided in a Question and Answer page.

HSD responsibilities

Identification of UW applicable clinical trials
HSD will identify whether a UW clinical trial is an applicable clinical trial, regardless of which IRB is reviewing the trial. This assessment may be overridden by a federal agency or sponsor but not by the UW PI. HSD will notify the PI and study contact person if a UW study is deemed to be an applicable clinical trial.

Guidance, templates, helpful information
HSD has developed and obtained guidance, tools, and templates to assist researchers in meeting these requirements. They are posted on the HSD webpages How to Register a Clinical Trial, How to Report Clinical Trial Results, and How to Update a Clinical Trial Record.

Administrator of PRS account
The University of Washington account at the CT.gov site is managed by HSD’s Regulatory Affairs team. This means that HSD:

• Manages creation of UW user accounts at the CT.gov site
• Releases records and their updates after information has been entered by the PI
• Assists PIs in identifying and resolving problems
• Answers questions
• Is the official channel of communication between the UW and the CT.gov administration group

Tracking registration
HSD will track whether applicable clinical trials have been registered. IRB approval will not be renewed until registration has occurred, for studies reviewed by the UW IRB.

Communication
HSD will communicate any changes or new information about these requirements, through its monthly eNews letter.

Definitions

Visit HSD’s Glossary