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Protocol Resources
International Council for Harmonisation: Good Clinical Practice (ICH-GCP)
FAQ: Repository application (REP)
Handling Patient Data General Security Guidelines
IRB Standard Operating Procedures
Other Reportable Information or Occurrence (ORIO)
External (non-UM) Study Team Members
FDA Expanded Access Program at the University of Michigan
Certificates of Confidentiality
Responsibility for REP Oversight and Compliance

Topic: Investigator & Study Team Responsibilities

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

Protocol Resources

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:

S
SOPs
Standard Operating Procedures (SOPs) are step-by-step, detailed descriptions of how specific procedures are performed.

IRB Standard Operating Procedures

Updated on:

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

External (non-UM) Study Team Members

Updated on:

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

Certificates of Confidentiality

Updated on: