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Guidance

Investigator Responsibilities

IRBMED
Apr 17, 2012 9:45 am
Copy Generated on: March 28, 2023, 11:44 pm
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  • Department of Health and Human Services

    Food and Drug Administration

    • Adverse Event Reporting to IRBs (Also see the UM Required Reporting)
    • Form FDA 1572, Frequently Asked Questions--Statement of Investigator
    • Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigator

    Office of Human Research Protections

    • Adverse Event and Unanticipated Problem Reporting (Also see the UM Required Reporting)
    • FAQs
  • University of Michigan

    • Human Research Protection Program, Operations Manual Part 6, Roles and Responsibilities of Investigators and Research Staff
    • Required Reporting: Adverse Events, Other Reportable Information and Occurences, and Unanticipated Problems Involving Risks to Subjects and Others

     

     

    Created 4/17/2012

     

Units: Institutional Review Boards (IRBMED)
Topic: Investigator & Study Team Responsibilities
Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: bpsea@umich.edu
Last Updated: May 10, 2018 1:00 PM

Guidance by Topic / Unit

Investigator & Study Team Responsibilities
Institutional Review Boards (IRBMED)

See Also

Accessing Medical Records
Protocol Deviations, Exceptions, Violations
Reports to or from Oversight Agencies, Boards, Committees, etc. (e.g., DSMB, FDA)
Complaints from Subject or Others about a Research Study
AHRQ: Mandatory Use of Data Safety and Monitoring Plans

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Office of Research
University of Michigan Medical School
1301 Catherine Street SPC 5624
Ann Arbor, MI 48109

North Campus Research Complex (NCRC)
2800 Plymouth Road Building 520, 3rd Floor
Ann Arbor, MI 48109-2800

Phone: 734-615-1332
Fax: 734-615-9458
Email: ummsresearch@umich.edu

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