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Overview

Training Topics

Key Benefits

Trainer

Price/Registration

6 Modules/Webinar Sessions:
  • Good Clinical Practices and Compliance Issues: Practical GCP
  • Risk Management in Clinical Trials for Physicians: FDA audits, client inspections, troubleshooting
  • Recruitment Issues in Clinical Trials - Advertising, Data-mining, Referrals and Social Media Practices
  • Compliance with Sunshine Act for Clinical Investigators
  • How to Withstand an FDA Audit of Your Site
  • Clinical Trial Budget, Invoice, Contracts, and other Practical Issues

Areas/Topics Covered in Clinical Site FDA-Compliant Training
  • Responsibilities of the Investigator and the site staff per FDA
  • SOPs needed for a clinical site
  • GCP and Good documentation practices
  • Best practices for patient recruitment & Retention
  • Best business practices for dealing with sponsors
  • Best practices for social media usage by doctors and staff
  • IRBs, Informed Consent, Confidentiality and Privacy 
  • Social media strategies to handle patient recruitment
  • Sunshine act, HIPAA and Hitech Rules for Clinical
  • Customized content per your specific needs and concerns
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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com

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