Roles and Responsibilities of Study Members

Overview

These resources provide guidance on the roles and responsibilities for study teams conducting clinical and translational research. Many of these resources focus on the responsibilities you accept if you take on the role of principal investigator. Some do also outline roles and responsibilities for other research staff.


Links

U-M Resources

Research and Ethics Compliance – Operations Manual – Roles and Responsibilities of Investigators and Research Staff
The office of Research Ethics & Compliance described the roles and responsibilities of investigators and research staff in their operations manual.

IRBMED – Investigator Responsibilities
IRBMED provides guidance regarding investigator responsibilities according to the Food and Drug Administration, Office of Human Research Protections, and University of Michigan.

MICHR SOP – Principal Investigator (PI) Oversight / Staff Roles and Responsibilities
MICHR has created a core set of clinical trial Standard Operating Procedure (SOP) templates that provide standard, high-level guidance and can be customized by research study teams to accommodate department or individual study requirements.

FDA

The following links provide information about FDA regulations regarding study implementation.

Guidance for Industry Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects

FDA 1572 – Statement of Investigator

Instructional Supplement

Frequently Asked Questions – Statement of Investigator

Office for Human Research Protections

Investigator Responsibilities FAQs
This page lists frequently asked questions regarding investigator responsibilities.


Questions and Disclaimer

If you have questions about any of the resources on this page, please contact the sponsoring office directly. MICHR is not responsible for the content of these resources.

Resources on this page may not be an exhaustive list. If you know of other resources in this category, please let us know using the "Suggest a Resource" link at the bottom of the page.

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