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Policies

Statement of Practice: External Adverse Event Reports & Unanticipated Problems

Approval Date: February 18, 2015 12:00 pm

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Guidance

Blood Draw Guidance

Approval Date: January 3, 2022 10:00 pm

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Guidance

Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required Reporting

Approval Date: June 11, 2018 10:00 am

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Guidance

Study-Specific Adverse Event (AE) Reporting Plans

Approval Date: July 22, 2020 2:30 am

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Guidance

Certification Preparatory to Research

Approval Date: August 31, 2020 2:45 pm

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Guidance

Decedents

Approval Date: August 10, 2020 2:15 pm

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Guidance

Limited Data Sets

Approval Date: August 10, 2020 2:30 pm

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Guidance

Research Involving Genetic, Genomic, and/or DNA Collection or Analysis

Approval Date: September 13, 2023 1:00 pm