Resources and Tools

Root Cause Analysis Resources:

5 Whys

Problem Solving Tool
Download

Fishbone Diagram

Brainstorming Tool
Download

Internal & External Resources

UM Resources

HSRO

UDisclose Information

University Hotline

RIC Help Forms

Research Policies


External Resources

 

Clinical Research Training

FDA: Training & Education

Validation Center

CITI Program

NIH Research & Training

CDER Learn

What is Ethics in Research & Why is it Important? 

 

Ethical Codes & Research Standards

Declaration of Helsinki

Nuremberg Code

Belmont Report


Regulations & Policy

FDA 21 CFR 

FDA CDER (Drugs) 

FDA-Device 

FDA CBER (Biologics) 

ICH Good Clinical Practices (GCP) 

Office of Research Subject Protection (OHRP) 

ClinRegs: Aggregation of clinical research regulations from around the globe 

 

Professional Organizations

Society of Clinical Research Association (SoCRA) 

Association of Clinical Research Professionals (ACRP)

Regulatory Affairs Professionals Society (RAPS)

Health Care Compliance Association

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