What are the responsibilities of a Principal Investigator?

The Principal Investigator (PI) is an individual who assumes full responsibility for a research study, including but not limited to, the oversight and training of research assistants, administration of informed consent, and protecting participant confidentiality.

What are the roles of PI according to ICH GCP?

PI Commitments: Adequacy of Resources

  • Ensure that all trial-related medical decisions are made by an investigator who is a qualified physician.
  • Provide adequate medical care for participants who experience adverse events.
  • Notify the participant’s primary physician of his/her participation (as appropriate)

What are the responsibilities of an investigator in clinical research?

Investigators are responsible for supervising the proper handling, administration, storage, and destruction of investigational agents (ie, drug accountability). Although these tasks can be delegated to an appropriately qualified individual, the investigator maintains ultimate responsibility.

What is the role of a Principal Investigator on a grant?

A Program Director/Principal Investigator (PD/PI) is defined as the individual(s) judged by the applicant organization to have the appropriate level of authority and responsibility to direct a project supported by a grant. PI(s) are responsible for directing the project, intellectually and logistically.

What is the sponsor’s responsibility?

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols …

Which responsibilities are covered under ICH GCP E6?

ICH E6 requires sponsors to implement a “quality management system” from trial design to trial conduct to close-out. A well-designed protocol is the most important tool for ensuring human subject protection and high-quality data (FDA 2011).

Which of the following are the responsibilities of the principal investigator PI of a study quizlet?

The Principal Investigator (PI) is ultimately responsible for assuring compliance with applicable University IRB policies and procedures, DHHS Federal Policy Regulations, and FDA regulations and for the oversight of the research study and the informed consent process.

What should the principal investigator do before starting the trial?

In addition, the PI also agrees to conduct the trial according to the written protocol, obtain approval of the institutional review board (IRB) prior to initiating the trial and at any time the protocol is amended, maintain adequate records of the trial, protect subjects through the informed consent process, and notify …

What it means to be a Principal Investigator?

Listen to pronunciation. (PRIN-sih-pul in-VES-tih-GAY-ter) The person(s) in charge of a clinical trial or a scientific research grant. The principal investigator prepares and carries out the clinical trial protocol (plan for the study) or research paid for by the grant.

Where do principal investigators work?

Federal funding In the context of a clinical trial a PI may be an academic working with grants from NIH or other funding agencies, or may be effectively a contractor for a pharmaceutical company working on testing the safety and efficacy of new medicines.

What are the roles and responsibilities of sponsor in clinical trials?

Generally, a sponsor is responsible for: Selecting the investigator(s) Providing investigator(s) with the necessary information to conduct the clinical trial. Ensuring proper monitoring of the clinical study.