What is the Expectation for PI Oversight of Home Nursing Activities?

Posted in Process Improvement

The FDA recently updated their Good Clinical Practice Inquiries and Responses 2017-2021. This Q&A publication is based on the questions submitted to the FDA via gcpquestions@fda.hhs.gov.

In response to multiple questions related to PI oversight of home nursing activities, the FDA responses have referenced the Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects which states that the investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience to perform the delegated task. The guidance (Section III.A.4.) further states that the investigator is responsible for supervising the study tasks performed by this staff, even though they are not in his/her direct employ during the conduct of the study. The reference to the guidance makes clear the FDA expectation of PI oversight for home nursing activities.

There can be significant challenges associated with PI oversight of home nursing staff, especially if the home nursing company is contracted directly by the sponsor. In the responses noted above, the FDA recommended that the investigator discuss the study with the sponsor to ensure an understanding of the role of the home nursing service and the expectations of the investigator for supervising the conduct of the study, delegating study-related tasks, ensuring adequate training, and oversight of the study. The investigator and the sponsor should agree on a plan to help the investigator meet his/her responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations. The plan should be documented to allow the PI to evidence the oversight in case of inspection – if it wasn’t documented, was it done?

WCG Avoca Quality Consortium (AQC) Members have access to resources to support documentation of PI oversight in the Site Quality section of the Knowledge Center, including SQMS 03 – Proactive Quality Framework for Sites Investigator Responsibilities.

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Karen Harvey

Senior Director, Avoca Quality Consortium

WCG Avoca

Published: March 2023