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Protocol Resources
International Council for Harmonisation: Good Clinical Practice (ICH-GCP)
Federal Exemption Categories
Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents
IRB Standard Operating Procedures
FDA Expanded Access Program at the University of Michigan
Certificates of Confidentiality
Research Involving Genetic, Genomic, and/or DNA Collection or Analysis
Prisoners in Research
Assent of Children in Research

Topic: Regulations & Policies (Federal, State & Local)

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.

Federal Exemption Categories

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.

Certificates of Confidentiality

Updated on:

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

Prisoners in Research

Updated on:

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

Assent of Children in Research

Updated on: