Study Conduct Resources
Ethics in Clinical Research
- Belmont Report
- Declaration of Helsinki, updated 2013
- Nuremberg Code
Human Subjects Protection / Good Clinical Practice Training
- HSR and GCP Online Training (CITI Program at the University of Miami)
- Guidance for Industry, E6 (R2) Good Clinical Practice: Consolidated Guidance
- National Institutes of Health, Human Subjects Protection
Human Subjects Protection Regulations
- Common Rule (pre-2018 Requirements)
- Revised Common Rule (2018 Requirements)
- Exemptions (2018 Requirements)
- 21 CFR, Part 50, Protection of Human Subjects (Informed Consent)
- 45 CFR, Part 46, Subpart D, additional protections for children
- 21 CFR, Part 56, IRB
- 21 CFR, Part 50 Subpart D, additional safeguards for Children (updated link)
Running Clinical Trials
- FDA resources
- FDA GCP/Clinical Trial Guidance documents
- Guidance for Industry: Financial Disclosure by Clinical Investigators
- Guidance for Clinical Investigators, Sponsors, and IRBs : Determining whether human research studies can be conducted without an IND
- ICH E11: Clinical Investigation of Medicinal Products in the Pediatric Population
- Budget webinar for Industry studies
- ICH E8(R1) General Considerations for Clinical Studies
- PORTICO – Clinical Trials Toolkit
Adverse Event Reporting
- MedWatch: FDA Safety Information and Adverse Event reporting Program
Source Documentation
- Useful FDA forms
- Good documentation practice in clinical research
- Guidance for Industry – Electronic Source Data in Clinical Investigations
- 21 CFR Part 11, Electronic Records; Electronic Signatures
- ALCOA
Importance of Monitoring
- NIH Policy for Data and Safety Monitoring
- Guidance for Industry – Guideline for the Monitoring of Clinical Investigation
- Guidance for Industry – A risk-based approach to monitoring