Auditing Your Site’s Vendors, and Other Pointers for PIs Who are New to Research

When taking on sponsored clinical research projects at their study sites, principal investigators (PIs) both new to, and experienced with, such activity may want to prepare for the eventuality of having a study audited by the U.S. Food and Drug Administration (FDA) by, among many other steps, performing their own audits of the quality of any vendors whose services will touch the studies.

This safeguard against possible study complications originating from the actions of persons not even based at the site, but capable of drawing criticism from an FDA auditor in terms of impact on the safety of study participants, could include PI-driven audits of data collection technology/service providers, of caterers providing meals for subjects, and even of the institutional review boards used to provide ethics approval of studies.

Such was the suggestion of an attendee at today’s session on “So, You Want to Be an Investigator: The Other Side of the Coin,” presented at the ACRP 2016 Meeting & Expo in Atlanta, Ga. by Charles Pierce, MD, PhD, FCP, CPI, medical director for Pierce One Consulting; Norbert Clemens, MD, PhD, CPI, director of clinical operations for MetaCure Germany GmbH; and Randall Stoltz, medical director of a Phase I unit for Covance.

According to the presenters, signing the FDA’s Form 1572 is the PI’s commitment in writing that she/he will be responsible for the study in question, including following the federal guidelines for the protection of the human subjects involved, interaction with the institutional review board(s) involved, and adhering to the details of the Investigational New Drug application to the FDA regarding adverse event reporting, record keeping, and being audit ready.

Through the 1572, the PI commits to the FDA to:

  • Personally conduct or supervise the investigation in accordance with the protocol (to the letter)
  • Ensure that all associates, colleagues, and employees assisting in the study conduct know their obligations
  • Comply with all requirements/obligations, including preparation and maintenance of study records
  • Inform the study participant of the investigational nature of the study
  • Ensure that the informed consent process is clear and valid and all IRB requirements are met
  • Accurately report all adverse events to the sponsor
  • Read and understand the investigator’s brochure

Aided by enthusiastic audience interaction in a roundtable format, the presenters addressed many other factors that play into the PI’s role in clinical studies and how it differs from everyday clinical practice.

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