Clinical Trials
The Office of Regulatory Affairs suggests the following practices as the optimal strategy for Purdue University investigators to meet proposal and regulatory requirements concurrently when registering a federally-sponsored study in Clinicaltrials.gov.
Study the definitions of “Applicable Clinical Trial” and “Clinical Trial”.
- Applicable Clinical Trial Definition: https://grants.nih.gov/ClinicalTrials_fdaaa/ACTs_under_FDAAA.htm
- NIH Clinical Trial Definition: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html
Tips:
- Regardless of funding source, Applicable Clinical Trials with a drug, device or biologic, may require a submission to the US Food and Drug Administration (FDA) or other appropriate international regulatory body.
- If the investigator conducting the study is not a Purdue University faculty member (such as a physician), an agreement between the parties must exist. Please contact Purdue Sponsored Program Services (SPS) Contracting first to begin a clinical trial agreement before proceeding with a clinical trial.
If your study meets the definition of “Applicable Clinical Trial” or “Clinical Trial”, and will be submitted to a federal sponsor, you may need additional text to add to your grant proposal.
Complete the required sections on clinical trials when writing federal grant proposals. Follow the directions found in the grant solicitation or request for proposal. Your submission materials (to NIH or other sponsor), should include required sections about:
- Protection of human subjects (required for all human subject research)
- Data Safety Monitoring Plan (for any clinical trials)
Registration plan for Clinicaltrials.gov (for any clinical trials)
Shortly after proposal submission, begin the application to the Institutional Review Board (IRB).
Submit the IRB application early. You may not register on the Clinicaltrials.gov site if your study has not been approved by the Purdue IRB. Go to www.irb.purdue.edu to submit your application.
Tip: Be certain that the consent form and other relevant application materials contains a statement that tells participants that the research results will be uploaded to Clinicaltrials.gov.
Be certain all staff who are responsible for study coordination, data collection and data management, complete online training.
Training is administered by the CITI program. Please see the Training link at the sidebar for directions. All staff will need to complete the following courses.
- Protection of human subjects
Good Clinical Practice (for both Drugs and Devices)
If you receive an award from a federal sponsor for a clinical trial, begin registration at Clinicaltrials.gov within 21 days of the onset of the study.
- If the Principal Investigator has an existing account, begin registration. For new accounts or password resets, contact evprpregulatory@purdue.edu.
- Good Clinical Practice training must be completed prior to registering on the Clinicaltrials.gov website.
- Be certain to list the “Responsible Party” as the Principal Investigator of the study.
- To fulfill sponsor requirements, Clinicaltrials.gov results must be updated annually. In many cases, the requirement for updating results will coincide with annual reporting duties to NIH.
- Check publisher’s requirements early. It is possible that some will require registration and confirmation of an National Clinical Trial (NCT) Identifier number from Clinicaltrials.gov prior to publication.
