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

• 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
• PHRP
• FDA Office of Good Clinical Practice

Human Subjects Protection Regulations

• 21 CFR, Part 50, Protection of Human Subjects
• 45 CFR, Part 46, Protection of Human Subjects
• 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

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

Adverse Event Reporting

• MedWatch: FDA Safety Information and Adverse Event reporting Program

Source Documentation

• Regulations and Guidelines for Source Documentation
• Overused and Inappropriate Use of notes to File Article
• Useful FDA forms

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

Association of Rheumatology Health Professionals

• Membership benefits

Information on Certification

• Society of Clinical Research Associates
• Association of Clinical Research Professionals

Ongoing Clinical Trials in Pediatric Rheumatology

• CenterWatch: Ongoing Clinical Trials in Rheumatology
• Clinical Trials.gov
  

What are Biologics and Biosimilars and How are they Regulated?

• Definition - 21 CFR Subchapter F, Subpart A 600.3 (h)
• 21 CFR 600 Biologics
• Biologics Guidances
• Guidance for Industry: Biosimilars