Georgia Tech Policy and Procedure on Registering an Investigator-Initiated Clinical Trial or NIH funded Clinical Trial in ClinicalTrials.gov
ClincalTrials.gov allows the registration of trials that:
- are required to register under FDAAA 801 and the Final Rule (42 CFR part 11); or,
- are funded by the NIH and qualify as a clinical trial under the NIH definition
NIH Definition of a Clinical Trial
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
NIH applications/proposals involving clinical trials with due dates on or after January 25, 2018 must be submitted to an FOA or request for proposal (RFP) that explicitly states it will accept clinical trials.
Special Considerations for Training, Fellowship, and Career Development Awards
Institutional Training awards do not support clinical trials (with the exception of some D43 and K12 awards).
The NIH encourages fellows to receive training in clinical research, however, NIH supported fellows are not permitted to conduct a clinical trial independently.
Career Development awards may support either independent clinical trials or a mentored research training experience, depending on the FOA.
Georgia Institute of Technology Process for Registering on ClinicalTrials.gov
The “Sponsor” of the study is responsible for registering the trial in a public registry such as ClinicalTrials.gov. The Sponsor of industry-initiated and funded multi-center studies is the pharmaceutical or medical device company whose protocol you are following. For investigator- initiated studies from our faculty, Georgia Tech is considered the Sponsor and the Institute is therefore responsible for registering those studies. The Institute is a registered Sponsor at ClinicalTrials.gov. Kelly Winn and Scott Katz from ORIA’s Regulatory Affairs, are the designated administrators for the Institute’s ClinicalTrials.gov account.
The process for registering individual studies is described below. Remember, this pertains only to investigator-initiated studies.
- A study must have been submitted to the IRB for review prior to registry although IRB approval will not be provided until the ClinicalTrials.gov NCT number has been received.
- Georgia Tech’s IRB does not review the data registered for a given trial. This review is performed by the Institute administrators for Georgia Tech’s ClinicalTrials.gov account. However, ultimate responsibility for record accuracy lies with the Principal Investigator (PI) providing the requested details within Clinical Trails section of the IRB application.
- An individual user account will need to be established at ClinicalTrials.gov by the Institute administrators for the Principal Investigator (PI) of the study and designees requiring record access. Send an e-mail to email@example.com or firstname.lastname@example.org providing the user’s name, department, telephone number, and e-mail address. The user account will be created within ClinicalTrials.gov and within a very few minutes of the user account set-up, the new user will receive an e-mail from ClinicalTrials.gov providing the login details and temporary password.
- The Institute administrators will enter specific information about the study that has been acquired from the IRB human subjects protocol application. The complete data set is described in the following document (ClinicalTrials.gov Database Requirements Document). All of the information on this document is taken directly from the ClinicalTrials.gov website.
- Once the information is entered and released by the Institute administrators, ClinicalTrials.gov will perform a system validation and quality assurance review. For protocol records this usually occurs within 2 to 5 days of release. For records containing results, this process may take up to 30 days. After completion of their review, ClinicalTrials.gov will assign an NCT number and make the record (or updates) publicly available for viewing. Until this occurs, no one outside of Georgia Tech can see the record or updated information. A study is not considered to be registered until the QA process has been completed and the NCT number has been assigned. Please allow adequate time for this process. In order to qualify for publication consideration, enrollment shall not begin until this entire process has been completed.
- The Principal Investigator is responsible for maintaining the accuracy of the information on the registered trial. This includes updating the information as appropriate, minimally every 6 months or whenever a significant change occurs, and noting when enrollment ceases. This information should be provided directly to the Institute administrators.
Please do not hesitate to contact Kelly Winn (404-385-2175) or Scott Katz (404-385-5208) should you have any questions about these important requirements.