ClinicalTrials.gov Program

The ClinicalTrials.gov program will assist investigators to learn:

  • The ethical, scientific and legal reasons for clinical trials registration and reporting
  • Which trials are required to be registered and the timelines
  • Tips, tricks and helpful content to improve the process
  • The regulations and current performance gaps
  • Resources and assistance available

On March 16, 2017 the Program presented an updated ICTR Third Thursday information session incorporating the Final Rule, download the slides, or view the video.

You may also find this one-page handout helpful

Click the pages below to learn more:

Tips when Entering Basic Results: The Enrollment # in the protocol section conflicts with the # of participants Started in the ...

JohnsHopkinsU (SOM, SON)– Anthony Keyes, Nidhi Atri, Prince Nuamah registerclinicaltrials@jhmi.edu Oncology (SKCCC)– Monica Owens (Jhcccro@jhmi.edu) JHSPH– Miye Schakne (mschakne@jhsph.edu) Kennedy ...

NIH Final Rule September 16, 2016 Federal Register Notice: HHS Final Rule Federal Register Vol. 81, No 183, September 21, 2016 ...

Legacy Studies When entering Basic Results for legacy studies (i.e. studies starting 2007 and earlier) with limited data accessibility or older ...

Program highlights: 2.5 FTEs of dedicated staffing Nidhi Atri, M.D. Prince Nuamah, M.D. Anthony Keyes, MBA, PMP Statistical expertise Provided ...

Why Register and Report? Commitment to research participants Scientific validity/transparency Ethical standards Responsible stewardship of federal funds Required by law (FDAAA) * NEW* Required for any ...

ICMJE requires trial registry at or before first patient enrollment as a condition for publication. Source: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html The Responsible Party (RP) for ...

The Responsible Party (RP) for a clinical trial must register the trial and submit results information. An RP can be: The ...

Final Rule Federal Register Notice: HHS Final Rule Federal Register Vol. 81, No 183, September 21, 2016 Federal Register Notice: ...

When to submit Basic Results? No later than 12 months after (Primary) Completion Date. Primary Completion Date FDAAA [Required by for records ...