Clinical Research Coordinator Resources
Updates in Clinical Research
Ethics in Clinical Research
- Belmont Report (Common Rule)
- Declaration of Helsinki, updated 2013
- Nuremburg Code
Human Subjects Protection / Good Clinical Practice Training
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HSR and GCP Online Training (CITI Program at the University of Miami)
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Guidance for Industry, E6 (R2) Good Clinical Practice: Consolidated Guidance
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National Institutes of Health, Human Subjects Protection
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FDA Office of Good Clinical Practice
Human Subjects Protection Regulations
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21 CFR, Part 50, Protection of Human Subjects
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45 CFR, Part 46, Protection of Human Subjects
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45 CFR, Part 46, Subpart D, additional protections for children
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21 CFR, Part 56, IRB
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21 CFR, Part 50 Subpart D, additional safeguards for Children
Running Clinical Trials
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FDA resources
- FDA GCP/Clinical Trial Guidance documents
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Guidance for Industry: Financial Disclosure by Clinical Investigators
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Guidance for Clinical Investigators, Sponsors, and IRBs : Determining whether human research studies can be conducted without an IND
Adverse Event Reporting
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MedWatch: FDA Safety Information and Adverse Event reporting Program
Source Documentation
Importance of Monitoring
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Guidance for Industry - Guideline for the Monitoring of Clinical Investigation
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Guidance for Industry - A risk-based approach to monitoring
Association of Rheumatology Health Professionals
Information on Certification
Ongoing Clinical Trials in Pediatric Rheumatology
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CenterWatch: Ongoing Clinical Trials in Rheumatology
What are Biologics and Biosimilars and How are they Regulated?
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Guidance for Industry: Biosimilars