FDA Inspection Lessons Learned: Lack of Trial Oversight

Why Should You Attend:

Failure to personally conduct or supervise the clinical investigation is a frequent finding in regulatory inspections, and one that highlights the risk to participant safety in clinical trials. Principal investigators (PI) are required to provide adequate oversight of all clinical research activities at their sites, whether the activity is conducted by the PI or by a delegated member of the study team. Unfortunately, this isn’t always the case.

This webinar will identify the regulatory requirements for investigator oversight and delegation, as well as examine examples from actual warning letters citing trial oversight inadequacies. Appropriate corrective and preventive actions (CAPAs) will be discussed, equipping learners with solutions to avoid common trial oversight consequences and ultimately avoid inspection findings.

Attendees are encouraged to share their experiences as participants discuss methods and tools to aid in compliance through appropriate techniques for the trial oversight.

Learning Objectives:

• Identify regulatory requirements for appropriate delegation of duties and investigator oversight
• Critically assess the number of major and critical 2012 inspection findings related to trial oversight
• Employ steps to prevent major and critical inspections findings related to trial oversight
• Formulate corrective actions to resolve the major and critical inspection findings related to trial oversight

Areas Covered in the Webinar:

• Most Frequent Findings Related to Inadequate Oversight
• Possible Reasons for Non-Compliance
• Root Cause Analysis
• Corrective and Preventive Action

Who Will Benefit:

• Principal Investigator
• CRC
• Monitor (CRA)
• Regulatory Affairs/Compliance
• Trainer/Educator
• Investigator
• Auditor/Inspector

Instructor Profile:

Janet Ellen Holwell is an independent consultant specializing in maximizing excellence in CGP quality, compliance and training for both sites and industry. She works contractually with sponsors, CROs, academic medical centers, site investigators and their personnel to provide training and mentoring in the clinical research process, specializing in ICH-GCP compliance and quality oversight. She prepares clients for inspections/audits as well as helps them write effective CAPAs and SOPs, develop quality plans and create internal QA processes.

Ms. Holwell began her career as a clinical research coordinator in academia over 30 years ago. Prior to transitioning to industry, she managed a clinical pharmacology unit at Columbia Presbyterian Medical Center in New York City overseeing all operations. She was an instructor in good clinical practice (GCP) and helped develop the first GCP program in an academic institution. Prior to her position in quality management with Pfizer, she held positions as a clinical research associate, site selection specialist, study manager with oversight of vendor CRAs, clinical operations quality lead and trainer for several pharmaceutical companies.

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