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Laboratory Monitoring

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:

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Laboratory Monitoring

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  1. Laboratory Monitoring And the role of PPD Kevin RyanDivision of AIDS Estelle Piwowar-ManningHPTN Central Laboratory

  2. History: Early experience with several HPTN trials underscores the need for additional attention to laboratory QC / QA activities Philosophy: 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 Goal: Maximize the reliability of laboratory data Laboratory Monitoring – the role of PPD .

  3. 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 Laboratory Monitoring – the role of PPD .

  4. What kinds of documentation will be monitored? • Laboratory procedure documentation examples: • Written SOPs • Study protocols & revisions • Quality control logs • Equipment documentation examples: • Inventory • Maintenance, repair & calibration records • Personnel documentation examples: • Records of training & proficiency testing • Safety-related documents • LDMS: • System check • Test of specimen location Laboratory Monitoring – the role of PPD .

  5. What time requirements are involved? • Lab visits scheduled to coincide with PPD clinical monitoring visits • We anticipate a lab visit to take approximately a half day • Regular attention to QA / QC practices during routine performance of lab duties will minimize time needed for the lab visit itself Laboratory Monitoring – the role of PPD .

  6. Laboratory Monitoring – the role of PPD . What must the HPTU lab staff do? • Collect the required documentation • Provide the monitor with a place to work • Provide access to laboratory space & equipment • Be available for questions

  7. What is the outcome of lab monitoring? • PPD lab report goes to DAIDS • Information shared with Central Laboratory • HPTU, DAIDS, & CL discussion: • Review problem areas (if any) • Schedule corrective steps • Assist in identifying resources • Schedule Central Lab re-visit (if needed) Laboratory Monitoring – the role of PPD .

  8. Laboratory Monitoring – the role of PPD .Summary: 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

  9. Special thanks to: Laboratory Monitoring – the role of PPD . • PPD: • Kathy Canaday • Jenny Scott • Jason Ezzele • DAIDS: • Pam Scanlan • Elaine Matzen • Patricia D’Souza • Mike Pensiero

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