Getting Started

Responsibilities for Principal Investigators Conducting Clinical Trials

The EVPRP Research Regulatory Compliance Office suggests the following practices as the optimal strategy for Purdue University investigators to meet proposal and regulatory clinical trial requirements concurrently.

  • Study the definitions of “Applicable Clinical Trial” and “Clinical Trial” and determine if they relate to the proposed research.
  • During preparation of proposal submission materials (to NIH or other sponsor), be certain to author and submit the 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). Be certain that the consent form and other relevant application materials contains a statement that says state the research results will be uploaded to Clinicaltrials.gov. (Note, that in the case of an Applicable Clinical Trial with a drug, device or biologic, the trial may require a submission to the FDA
  • Be certain all staff “who are responsible for study coordination, data collection and data management,” complete online training (citiprogram.org) in these courses:
    • Protection of human subjects
    • Good Clinical Practice (for Clinical Trials)
  • If the sponsor issues an award for the proposed Clinical Trial, begin registration at Clinicaltrials.gov.
    • For new accounts or password resets, contact evprpregulatory@purdue.edu
    • If the lab has an existing account, begin registration, listing the Responsible Party as the Principal Investigator of the study.
  • To fulfill sponsor requirements,
    • PIs must complete registration at Clinicaltrials.gov no later than 21 calendar days
    • Clinicaltrials.gov results must be updated annually. In most cases, the requirement for updating results will coincide with annual reporting duties to NIH.