Defining and Managing Protocol Deviation/Violation/Exception

Instructor: Calin Popa
Product ID: 704953
Training Level: Intermediate
  • Duration: 90 Min
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This webinar will teach you how to downsize the risk of noncompliance during the development of a clinical trial by helping you to understand, correct and prevent potential protocol deviations/violations.

Why Should You Attend:

With the growth of the Pharmaceutical and Biotechnology industry, audits get more and more frequent. The complexity of the investigational products and of the clinical trial protocols amplified the risks for noncompliance. Noncompliance in clinical trials and misreporting of clinical trial results that took place in the last years made the regulatory bodies to multiply the number of audits. On the other part, the sponsors also multiplied the audits from their part in the idea to try to downsize the risk of noncompliance during the trial.

This presentation will help you to understand, correct and prevent potential protocol deviations/violations.

Areas Covered in the Webinar:

  • ICH guidelines and Good Clinical Practice (GCP)
  • Differences between protocol deviations/violations/exceptions
  • Understanding compliance
  • Most frequent audit findings
  • Finding Protocol deviations/violations
  • Developing a CAPA plan

Who Will Benefit:

  • Clinical trial sponsors study team
  • CROs study team
  • Study managers, Clinical team leads, CRAs
  • Principal investigators, site managers and study coordinators
  • New Clinical Research Coordinators (1-2 years)
  • New Principal Investigators
  • Regulatory Compliance Associates and Managers
Instructor Profile:
Calin Popa

Calin Popa
Founder and President, Advanced Clinical Research Services Inc

Calin Popa, MD, CCRA is the Founder and President of Advanced Clinical Research Service Inc. a Canadian clinical research consulting company that provides training to FDA and Health Canada regulated industries.

He conducted visits for Pre-Study Site Qualification, Initiation, Monitoring and Close-Out for the purpose of compliance review, drug accountability, site management, safety review, training site personnel, and to assure the integrity of clinical data. Conducted visits to train new CRAs (sign-off visits) and performed online training for CRAs and site staff regarding regulatory compliance and Electronic Data Capture. He holds the CCRA certification from and is an active member of the Association of Clinical Research Professionals.

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