Laboratory Investigations Relating to Sample Re-Analysis
About This Event
This webinar on laboratory investigation will provide guidance on procedures used in investigating unexpected results for non-clinical and clinical trials and will discuss several suggested procedures, avoiding unnecessary 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.
Event Details:
Date: September 06, 2012
Time: 10:00 AM-11:00 AM PDT
Cost: $199 per attendee per computer terminal
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