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Guidance

Record Keeping Guidelines

Approval Date: March 8, 2021 2:00 pm

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Guidance

De-identified Data Sets

Approval Date: September 9, 2020 10:15 pm

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Guidance

FDA guidance – General, Drug and Biologicals, Medical Devices, and FDA operations

Approval Date: November 2, 2020 3:15 pm

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Guidance

Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments

Approval Date: August 14, 2023 10:30 am

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Guidance

External Adverse Event (AE) Reporting

Approval Date: August 14, 2015 12:30 pm

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Guidance

Responsibility for REP Oversight and Compliance

Approval Date: February 17, 2017 10:45 am

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Guidance

International Research

Approval Date: February 19, 2016 10:30 am

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Guidance

Humanitarian Use Device Requirements for U-M Physicians & Investigators

Approval Date: November 17, 2023 11:00 am

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Guidance

Investigator Responsibilities

Approval Date: April 17, 2012 9:45 am