Protocol Deviations: Calculated Risk or Risk to be Managed?
Noncompliance with protocols (Protocol Deviations or PDs) is always one of the top five common findings in audits and regulatory inspections. There is a global inconsistency in protocol deviation definitions, classification, management and reporting.
While PDs are inevitable during clinical research, deviations from the protocol can result in harm to subjects, biased or inaccurate results, and possible rejection of all or part of the trial data by the sponsor or regulatory authorities. Can this risk be managed or even minimized?
This 90-minute course contains information drawn globally from industry experts within the DIA Good Clinical Practice and Quality Assurance community, an industry-wide survey, and presentations with discussions at various industry meetings. All participants will receive a copy of the DIA White Paper on “The Life-cycle and management of protocol deviations.”
This course will answer the following questions:
- What are industry best practices regarding protocol deviations?
- How can I minimize protocol deviations?
- How can I manage protocol deviations prospectively?
After attending this interactive live session, you will be able to:
- Define and classify protocol deviations
- Develop a Protocol Deviation Handling Plan
- Begin to minimize the risk of PDs
This course will be of benefit anyone working in a clinical/GCP regulated environment on a global or domestic scale. Those with responsibility for monitoring clinical trials, project management, quality assurance, regulatory affairs, etc. will find this course particularly useful.
Maryrose Petrizzo is a Senior Consultant at Halloran Consulting Group, Inc. She has over 17 years of experience in clinical quality leadership, global auditing, due diligence, and acquisitions. Maryrose is skilled in developing and improving quality processes, and influencing clinical teams towards a state of inspection readiness. She has developed and provided internal training on Inspection Readiness and managed large global clinical audit programs.
Prior to joining Halloran, Maryrose was Manager of Global Clinical Quality at Boston Scientific, where she was responsible for the Clinical organization’s inspection readiness training program, site audits, and vendor audits. In this role, she facilitated FDA/Regulatory agency inspections, and developed quality assurance policies and procedures. More recently, Maryrose was the Manager of Global Clinical Services and Vendor Management at Allergan, where she was responsible for vendor qualification assessments, risk analyses, and vendor outsourcing plans. She has also held clinical quality positions at AstraZeneca, Centocor,/Johnson & Johnson, and Covance.
Maryrose earned a Bachelor of Science in Chemistry from the College of St. Elizabeth in Morristown, NJ, and a Master of Science in Pastoral Care and Counseling from Neumann University in Aston, PA.