Principal investigator roles and responsibilities in clinical research

Clinical Investigator Responsibilities

principal investigator roles and responsibilities in clinical research

SOCRA Review: Investigator Roles and Responsibilities in Clinical Research

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The Principal Investigator is responsible for the management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships. Additionally, the Principal Investigator is responsible for the direction and oversight of compliance, financial, personnel, and other related aspects of the research project and for coordination with school, department, and central administration personnel to assure research in is conducted in accordance with federal regulations and university and sponsoring agency policies and procedures. The Principal Investigator reports to a designated official such as a dean, department head, or division chief. Sponsored Program Administration General Administrative Coordinates with school, department, and central administration personnel to help ensure that sponsored research and related activities are in accordance with federal regulations and university and sponsoring agency policies and procedures. Administers and oversees research and all related activities.

When conducting a clinical trial, it is important that clinical investigators successfully meet all research expectations, including regulatory requirements and the Guidelines for Good Clinical Practice. Clinical investigators face challenges during the conduct of clinical trials that are distinctly different from those encountered during the routine practice of medicine. Many of these challenges stem from regulatory requirements, the Guidelines for Good Clinical Practice GCP and the rigorous nature of clinical trials. When conducting a clinical trial, it is important that clinical investigators successfully meet all research expectations. A clinical investigator's primary responsibility is to conduct research that contributes to generalizable knowledge while protecting the rights and welfare of human participants. It is important to conduct research in an ethical manner.

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Jump to navigation. PIs leaving the institution are responsible for notifying the IRB well in advance of their departure so that they can make arrangements to either close the study or name another appropriately qualified individual currently at the institution to serve as the PI. Note: The IRB reviews and holds student research projects to the same standards as human subject research conducted by faculty or staff. IRB approval or exemption must be obtained prior to initiating any research activity under IRB oversight. Failure to obtain IRB approval for research with human subjects may preclude the use of the previously collected data and could result in other institutional sanctions. As a general condition for the approval of a research study, the IRB holds the principal investigator of the study responsible for ensuring that:.

Principal Investigator PI A Principal Investigator is the primary individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research. These faculty are not responsible for the conduct of the project, are not a signatory to an MOU, and normally do not share in the return of indirect cost, unless specified in the MOU. Faculty participants may participate in the research, may collect salary, and may have a role in publications. Being granted PI and Co-PI status is a privilege granted to eligible University personnel who meet the criteria identified below. All persons granted PI and Co-PI authority must accept all of the responsibilities associated with the application for and administration of awarded sponsored projects.



Chapter 4 - Roles and Responsibilities of Investigators and Research Staff

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Principal Investigator Roles and Responsibilities

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4 COMMENTS

  1. Javiera M. says:

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  2. Arthur B. says:







  3. Feebpanapme says:

    roles are those of the Sponsor and Principal Investigator, as defined by Good Clinical studies. Discuss the roles and responsibilities of other individuals and .

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