Clinical Trials Data Disclosure & Data Transparency

  • Strategies to anonymize & release patient level data
  • Compliance issues and challenges with clinical data disclosure and transparency requirements
  • Title VIII of FDAAA Final Rule and complimentary NIH policy, EMA Policy 0070, ICMJE requirements
  • Regulations to share patient-level data and international registries
  • Anonymize data sharing standards at the local and global level
  • Patient engagement via lay summary documents in clinical trials
  • New anticipated USA & EU regulatory reforms
  • Protect patient level data privacy and preservation of regulatory integrity while sharing patient-level data

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