Laboratory Investigations Relating to Sample Re-Analysis: Covering the basics before being called ou (Laboratory Training)
|Event Date/Time: Nov 19, 2010||End Date/Time: Nov 19, 2010|
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.