Principal Investigator (PI) Oversight Task

References

"Principal Investigator (PI) Oversight/Staff Roles and Responsibilities." UCLA's Clinical and Translational Science Institute (CTSI) ResearchGO
- QUOTE: ... To ensure clinical research staff are qualified by relevant, substantiated education and training to recognize the fundamental principles of clinical research in order to safely and ethically carry out their responsibilities, and those responsibilities delegated to them by the Principal Investigator.
  This Standard Operating Procedure (SOP) applies to personnel involved in the conduct of clinical trials at the University of Michigan. It is common practice for Principal Investigators (PIs) to delegate certain clinical trial related tasks to employees, colleagues, and/or other third parties. This SOP may also apply to individuals or entities not under the direct supervision of the investigator. The management of the financial aspects of conducting a clinical trial is not within the scope of this SOP. ...

(Padala et al., 2020) ⇒ Prasad R. Padala, Ashlyn M. Jendro, and Kalpana P. Padala. (2020). “Conducting Clinical Research During the COVID-19 Pandemic: Investigator and Participant Perspectives.” JMIR public health and surveillance, 6(2).
- QUOTE: ... As the medical landscape changes daily with the coronavirus disease (COVID-19) pandemic, clinical researchers are caught off-guard and are forced to make decisions on research visits in their ongoing clinical trials. Although there is some guidance from local and national organizations, the principal investigator (PI) is ultimately responsible for determining the risk-benefit ratio of conducting, rescheduling, or cancelling each research visit. The PI should take into consideration the ethical principles of research, local/national guidance, the community risk of the pandemic in their locale, staffing strain, and the risk involved to each participant, to ultimately decide on the course of action. While balancing the rights and protection of the human subject, we seldom examine patients’ views and opinions about their scheduled research visit(s). ...

(Sauber & Sfera, 2019) ⇒ Chris Sauber, and Dan Sfera. (2019). “The Comprehensive Guide To Clinical Research: A Practical Handbook For Gaining Insight Into The Clinical Research Industry.” Amazon Digital Services LLC - KDP Print US. ISBN:9781090349521
- QUOTE: ... The CRC is employed by the PI or the research clinic that the PI either owns, works for, or represents. The main responsibility of a clinical research coordinator is ensuring that the protocol, GCP, and all regulations are being followed appropriately and that the PI is managing sufficient safety oversight over the status of the clinical trial participants. ...