The Importance Of Protocol Deviations and Violations to Subject Safety and Data Integrity Will Surprise You


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With the increasing frequency of real-time FDA audits, the importance of the seriousness and frequency of evidence of "Not following the Protocol" has gained increasing importance. Deviations and Violations from the agreed upon protocol may very well affect the scientific validity of the research. For this reason, a well-written protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollment is a key element in having deviation free study conduct. A major challenge is to know the differences between and differing significances of "Deviations" and "Violations". This must be clearly understood by all persons involved in the conduct of clinical research studies. Protocol Deviations and Violations are one of the most common problems identified by FDA Investigators and is a main reason for the rejection of clinical data from a particular site or even a study. Forewarned is forearmed

Course Objective

Protocol Deviations and Violations are one of the most common problems identified by FDA Investigators and is a main reason for the rejection of clinical data from a particular site or even a study. Forewarned is forearmed. Deviations and Violations from the agreed upon protocol may very well affect Subject and Public safety in addition to the scientific validity of the research.
For this reason, a well-written protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollment is a key element in having deviation free study conduct. If and when a deviation or violation of the protocol is found, meaning that the protocol was not followed (PNF) it must be reported, reviewed and acted upon for Corrective and Preventative Action (CAPA). Also, the differences between and differing significance of "Deviations" and "Violations" must be clearly understood by all persons involved in the conduct of clinical research studies.

Course Outline

  • How to know when the protocol is not followed (PNF)?
  • What is the difference between a deviation and a violation?
  • Importance of the "Protocol" in the number of deviations occurring
  • How to ensure that the protocol will be followed exactly?
  • What is in the Regs about following the protocol?
  • When may the Investigator make changes in the protocol?
  • What are the causes of Protocol Deviations and Violations?
  • How are Protocol Deviations managed?
  • Examples of Protocol Violations and Deviations

Target Audience

  • Principal Investigators and sub investigators
  • Clinical Research Scientists (PKs, Bio-statisticians, ...)
  • Research managers
  • Safety Nurses
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • Recruiting staff
  • QA / QC auditors and staff
  • Study Monitors
  • Clinical Research
  • Data managers.
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