To ensure the highest quality clinical research, the University of Utah Clinical Trials Office (CTO) and Department of Pediatrics are committed to helping our Principal Investigators (PI) to have a thorough understanding of investigator responsibilities, such as proper informed consent procedures, eligibility criteria requirements, and adverse event reporting.
CTO coordinators and staff assist the PI in understanding local, State and Federal regulations, guidelines, and certification requirements, including IRB, conflict of interest disclosure, CITI Biomedical Human Subjects Protection and Good Clinical Practices certifications, and the FDA regulations and guidelines for conduct and implementation of the study protocol.
Statement Of Investigator – FDA Form 1572
If the sponsor and the investigator agree that the study should be placed at the investigator’s site, the sponsor representative will request that the investigator review and sign Form FDA 1572, Statement of Investigator.
By signing this form, the investigator enters into a legally binding contract with the FDA.
The sponsor is the conduit for transmitting this information to the FDA. By signing this form, the investigator assumes full responsibility for the study, attests that he/she has read the Investigator’s Brochure, and agrees to conduct the study according to the protocol and FDA regulations.
Principal Investigator (PI) Checklist
To successfully execute your clinical research study and ensure proper PI oversight:
- Train research staff on protocol
- Oversee tasks delegated to research staff
- Regularly meet with the study team (recommend weekly)
- Oversee the recruitment process
- Oversee study procedures and review source data and case report forms (CRFs)
- Adhere to FDA Form 1572- Statement of Investigator
- Timely resolve data queries
- Comply with protocol & timely report adverse events
- Annually complete and comply with Collaborative Institutional Training Initiative (CITI), Good Clinical Practice (GCP), and Human Subjects Protection (HSP) trainings
Good Clinical Practice (GCP) Overview
The International Council for Harmonisation (ICH) E6 Guideline is titled Good Clinical Practice (GCP). This GCP document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors, and IRBs.
Clinical trials should be conducted in accordance with the ethical principles originating in the Declaration of Helsinki and consistent with GCP and the applicable regulatory requirements.
Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society as a whole. A trial should be initiated and continued only if the anticipated benefits justify the risks.
The rights, the safety, and the well-being of the human subjects are the most important considerations and should prevail over interests of science and society.
Available nonclinical and clinical information about the investigational product should be adequate to support the proposed clinical trial.
Clinical trials should be scientifically sound, described in a clear and detailed protocol.
A trial should be conducted in compliance with the protocol that has received prior Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approval.
Medical care given to, and medical decisions made on behalf of, trial subjects should always be the responsibility of a qualified physician.
J. Michael Dean, MD, MBA
Associate Dean for Clinical Research Professor Vice Chairman for Research Department of Pediatrics Director, Clinical Trials Office Chief, Division of Pediatric Critical Care University of Utah School of Medicine