Clinical Trials FAQs
To answer this question accurately, consider the following:
Sponsor: NIH defines clinical trials broadly. If the study is NIH-funded, determine if your research fits this definition. If so, registration on Clinicaltrials.gov is required.
“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.”
Use of a Drug, Device, or Biologic in human subjects: this activity is likely FDA regulated, subject to Food and Drug Administration Amendments Act (FDAAA) of 2007 and will require registration.
Publications: Is it possible that your journal editors require registration on Clinicaltrials.gov? Check for publication policies such as this http://icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
Check publisher’s requirements early. It is possible that some will require registration and confirmation of an National Clinical Trial (NCT) Identifier number prior to publication. Check for publication policies such as this http://icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
An Applicable Clinical Trial utilizes research with human subjects AND a drug, device, or biologic. Applicable Clinical Trials may require FDA oversight and have stringent requirements for registration and reporting under the Food and Drug Administration Amendments Act (FDAAA) of 2007. An interactive flow chart about this definition is available from NIH at this link: https://grants.nih.gov/ClinicalTrials_fdaaa/ACTs_under_FDAAA.htm
The current NIH Clinical Trial definition is, “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.” (Reference NIH NOT-OD-15-015 found here https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html). Notice that a study does not require use of a drug, device, or biologic to fit under the NIH definition.
User accounts are established by the PRS administrator at the site where the trial is registered. PIs can reach a PRS administrator for Purdue by contacting irb@purdue.edu. IRB approval and training in Good Clinical Practices (GCP) is required prior to registration for all studies. Check our “Getting Started” page for more information and tips.
Start with IRB approval. Once you have received approval for the study at the site, you will have accurate information to begin registering the trial. Check our “Getting Started” page for more information and tips.
Start by utilizing the resources found on the Clinicaltrials.gov website. In particular, the Protocol Registration Data Element Definitions and Expanded Access Data Element Definitions documents are helpful to first-time users. See https://clinicaltrials.gov/ct2/help/for-manager for resources.
Most trials require at least annual updates in the Clinicaltrials.gov system.
For Purdue studies, the Responsible Party should be listed as the Principal Investigator (PI). PIs should review the expectations associated with this role on the Clinicaltrials.gov registration materials.