Laboratory Investigations Relating to Sample Re-Analysis

Why Should You Attend:

Unexpected results in acceptable assays usually reflexively trigger calls for re-analysis by clinical managers or non clinical study directors. Before re-analysis is initiated compromising the sample, investigators must rule out pre-analytical errors, mislabeling, misdosing, delayed or accelerated sampling, subject variables (concurrent meds, fasting compromised, etc). This session will discuss several suggested procedures, hopefully avoiding unnecessary re-analysis. If re-analysis is still indicated at the end of the investigation, this session will suggest procedures.

Areas Covered in the Seminar:

• FDA restriction and guidance covering sample re-analysis.
• Establishment of complaint handling program.
• What constitutes valid re-analysis.
• CRM/CRA/Medical Officer Requests for re-analysis.
• Pre-analytical errors and investigations.
• Analytical errors and investigations.
• Post analytical errors and investigations.

 Edward O’Connor, PhD, is a consultant supporting Bioanalytical method development, validation and application to non clinical and clinical sample analysis. His background includes directing these efforts at a number of CROs including Tandem Labs, TherImmune, Covance, Oread and Mason Research as well as Biotechs MedImmune, Biogen and Elusys.