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Certification Preparatory to Research
Limited Data Sets
Decedents
Seeking Reconsent from Research Participants
Study-Specific Adverse Event (AE) Reporting Plans
FAQ: Repository application (REP)
Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required Reporting
Adverse Event Reporting
Deception and Concealment
FDA Expanded Access Program at the University of Michigan
G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Certification Preparatory to Research

Updated on:

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Limited Data Sets

Updated on:

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Decedents

Updated on:

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

FAQ: Repository application (REP)

Updated on:

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Adverse Event Reporting

Updated on:

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Deception and Concealment

Updated on: