Laboratory Monitoring. And the role of PPD. Kevin Ryan Division of AIDS. Estelle Piwowar-Manning HPTN Central Laboratory. History: Early experience with several HPTN trials underscores the need for additional attention to laboratory QC / QA activities Philosophy:
And the role of PPD
Kevin RyanDivision of AIDS
Estelle Piwowar-ManningHPTN Central Laboratory
Early experience with several HPTN trials underscores the need for additional attention to laboratory QC / QA activities
HPTN studies will benefit if we can identify problems early that could jeopardize the integrity of study endpoint data and of lab data related to patient safety
Maximize the reliability of laboratory data
How will the PPD lab visits compare with visits by Central Laboratory personnel?
PPD staff will confirm that key lab records are present, kept current, and are reviewed by HPTU lab managers as scheduled
PPD staff will not conduct lab training, proficiency testing, personnel certification, assay troubleshooting, instrument certification, calibration, or other functions retained by the Central Laboratory
What kinds of documentation will be monitored? Laboratory personnel?
What time requirements are involved? Laboratory personnel?
What must the HPTU lab staff do?
What is the outcome of lab monitoring? Laboratory personnel?
Why?The goal is to identify QC/QA problems early, to help maximize the reliability of study endpoint data and of lab data related to patient safety
How?PPD will monitor lab QC/QA documentation (e.g. procedures, equipment, personnel, LDMS)
When?Lab visits will coincide with regularly scheduled PPD clinical monitoring visits
Then what?HPTU, DAIDS, & CL staff will discuss problems & plan solutions
Special thanks to: Laboratory personnel?