OCRA is FSU’s central administrator for ClinicalTrials.gov (CT.gov) a web-based resource that provides researchers, healthcare professionals, patients, their family members and the public with easy access to information on federally and non-federally supported clinical studies on a wide range of diseases and conditions in the United States and globally.
We can advise you on whether your clinical study needs to be registered on the CT.gov website, provide initial account setup and assist with updating and managing your account throughout the life cycle of your study. Clinical trials that involve FDA-regulated medical devices, drugs or biological product for a disease or condition must be registered on CT.gov. In addition, all NIH-funded interventional clinical trials must be registered. Finally, for any clinical trial funded by a federal department or agency, a copy of an IRB-approved consent form must be posted on a publicly available federal website, such as CT.gov or Regulations.gov.
Why is OCRA’s assistance important? The penalty for noncompliance is $13,237 with an additional $13,237-per-day fine if your study does not come into compliance within 30 days of notification by CT.gov. Also, non-compliance with the consent posting requirement may result in suspension of a study. Moreover, investigators and their universities can face termination of NIH grants as well as jeopardize future grant applications for noncompliance.
Finally, the International Committee of Medical Journal Editors (ICMJ) requires all clinical trials be registered as a condition of consideration for publication. A large majority of academic journals that are not members of the ICMJ are following its policy.
Information on ClinicalTrials.gov is provided and updated by the Principal Investigator of the clinical trial. Studies should be submitted to the website (i.e., registered) prior to enrollment of the first subject, and the information on the site is updated throughout the duration of the study.
The Final Rule for Clinical Trials Registration and Results Information 42 CFR Part 11 clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain trials to ClinicalTrials.gov, in accordance with FDAAA 801.
- If you do not have an account with ClinicalTrials.gov, you will need to contact OCRA for an initial account setup. Please allow 24 hours for this process to be completed.
- When registering a study on ClinicalTrials.gov, the "Sponsor" is Florida State University and the "Responsible Party" is the PI of the study. The PI can designate an individual (PRS User) to register the trial(s) and complete registration information. However, the PI is responsible for ensuring the information entered is accurate.
- Study registration should be completed on ClinicalTrials.gov before the first subject is enrolled.