How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant 2013

  • 22 Mar 2013
  • Webinar

Description

Topics
  • What are Protocol "Deviation" and other terms / categories
  • The Primacy of the study Protocol
  • The Regulatory requirements for handling protocol deviations and violations
  • The many cause of protocol deviations
  • How to define and handle instances of PNF
  • The importance of documentation of protocol deviations as well as violations
  • What is the basis of the difference between a "Deviation" and a "Violation"
  • What is the reason different IRBs define deviations and violations differently
Who should Attend
  • Clinical Research Scientists (PKs, Biostatisticians,)
  • Principal Investigators / Sub-investigators
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • Safety Nurses
  • QA / QC auditors and staff
  • Recruiting staff
  • Clinical Research Data managers

Past Events

Important

Please, check "How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Quality assurance, Security & Safety
Health & Medicine: Healthcare, Hospitals & Clinics

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