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Guidance

Unanticipated Problems Involving Risks to Subjects or Others

Approval Date: April 16, 2015 2:30 pm

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Guidance

Federal Exemption Categories

Approval Date: December 13, 2024 1:00 pm

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Guidance

International Council for Harmonisation: Good Clinical Practice (ICH-GCP)

Approval Date: February 22, 2021 12:00 am

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Guidance

Other Reportable Information or Occurrence (ORIO)

Approval Date: October 27, 2023 11:15 am

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Templates

Specialty Informed Consent Templates

Approval Date: April 15, 2024 9:00 am

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Guidance

Adverse Event Reporting

Approval Date: June 11, 2018 8:00 am

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Guidance

Exempt Human Subjects Research

Approval Date: March 31, 2025 10:30 am

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Informational

Handling Patient Data General Security Guidelines

Approval Date: November 22, 2017 12:00 pm