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Statistical Modeling for Quality Risk Assessment of Clinical Trials: Follow-Up at the Era of Remote Auditing.

Björn KoneswarakanthaTimothé Ménard
Published in: Therapeutic innovation & regulatory science (2022)
Continuous surveillance of the identified risk factors and resulting risk estimates could be used to complement remote QA strategies for clinical trials and help to manage audit targets and audit focus also in post-pandemic times.
Keyphrases
  • clinical trial
  • risk factors
  • risk assessment
  • sars cov
  • coronavirus disease
  • phase ii
  • public health
  • open label
  • human health
  • double blind
  • heavy metals
  • phase iii
  • randomized controlled trial