Clinical Trial Disclosure

Final Rule on Clinical Trials Registration and Results Information (42 CFR § 11)

On 16 September 2016, HHS took steps to provide more information about clinical trials to the public. The long awaited final rule specifying requirements for registering certain clinical trials and submitting summary results information to Clinicaltrials.gov was released. The new rule expands the legal requirements for submitting registration and result information for clinical trials involving U.S. FDA regulated drug, biological and device products. At the same time, the National Institutes of Health (NIH) issued a complementary policy.

The changes noted below are all effective January 18, 2017. RCQA is reviewing the final rule to determine if changes are needed to the University’s current policies and procedures on protocol registration and result reporting of clinical trials. The Office of RCQA has scheduled three Q & A Informational Sessions for further discussion of the Final Rule. To register to attend one of these sessions click on this link Final Rule Q & A Session and select the session you wish to attend. Space is limited so register early.

Summary of Changes from Current Practice Described in the Final Rule (42 CFR Part 11)

  • Additional data elements are required for registration and results information submission.
  • Results information is required for ALL applicable clinical trials that are required to register.
  • An expanded access record is required if an investigational drug product studied in an applicable drug clinical trial is available through an expanded access program.
  • Some data elements must be updated more frequently that the standard 12 months.
  • Responsible parties can evaluate whether a clinical trial is an applicable clinical trial (ACT) based on required registration data elements.
  • Corrections to submitted information will be required within 15 days (for registration information) and 25 days (for results information).

Summary of Changes for NIH Complementary Policy
The National Institutes of Health (NIH) is issuing this policy to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. The policy establishes the expectation that all investigators conducting clinical trials, funded in whole or in part by the NIH, will ensure that these trials are registered at ClinicalTrials.gov, and that results information of these trials is submitted to ClinicalTrials.gov.

What is Clinical Trial Disclosure (CTD)?

The act of making clinical trial information (protocol registration and protocol results) known and/or available publicly.

Why Should We Comply?

Clinical Trial Disclosure Regulations and RequirementsThe Food and Drug Administration (FDA), the National Institutes of Health (NIH), Centers of medicaid and Medicare Services (CMS), and the International Committee of Medical Journal Editors (ICMJE), all have regulations and/or requirements surrounding the registration and result reporting of clinical trials on the ClinicalTrials.gov website. As an Institution, the University of Miami requires that all clinical trials be registered on ClinicalTrials.gov before enrollment of the first participant.

Policies, Procedures, and Guidance Documents
Training

The Office of RCQA provides a series of formal trainings and interactive classes on Clinical Trial Disclosures. The objectives of these classes are:

  • That all researchers become familiar with the UM CTD Protocol Registration policy
  • To facilitate how to register, maintain, and report results for a clinical trial on www.ClinicalTrials.gov.

Faculty and staff are encouraged to attend the trainings and/or interactive classes scheduled. Those completing all four classes will receive a Certificate of Completion of the CTD unit. The fall training schedule for Clinical Trial Disclosure is below.

Course Name Date Time Location
Maintaining Your Record on ClinicalTrials.gov Oct 28 10:00am-11:00am Dominion Towers, 12th Floor Large Conference Room (1200)
Introduction and Overview of Clinical Trial Disclosure Oct 31 10:00am-11:30am Dominion Towers, 12th Floor Large Conference Room (1200)
Protocol Registration on ClinicalTrials.gov Nov 3 9:30am-12:30pm Dominion Towers 10th Floor Computer Lab (1003)
Introduction and Overview of Clinical Trial Disclosure Nov 17 10:00am-11:30am Dominion Towers, 12th Floor Large Conference Room (1200)
Result Reporting on ClinicalTrials.gov Nov 29 1:00pm-5:00pm Dominion Towers 10th Floor Computer Lab (1003)
Maintaining Your Record on ClinicalTrials.gov Dec 8 1:00pm-2:009m Dominion Towers, 12th Floor Large Conference Room (1200)
Resources and Tools
Compliance
  • Audit Clinical Trial Disclosure tasks
  • Produce and analyze metrics, and quality of submissions
  • Evaluate and report on trends and identify areas for improvements

Please contact Yolanda Davis for more information at y.p.davis@med.miami.edu or (305) 243-0494.