Transcript No Slide Title

Laboratory Monitoring
And the role of PPD
Kevin Ryan
Division of AIDS
Estelle Piwowar-Manning
HPTN Central Laboratory
Laboratory Monitoring – the role of PPD
.
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
.
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
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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
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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
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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
Laboratory Monitoring – the role of PPD
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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
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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
Laboratory Monitoring – the role of PPD
Special thanks to:
• PPD:
• DAIDS:
• Kathy Canaday
• Pam Scanlan
• Jenny Scott
• Elaine Matzen
• Jason Ezzele
• Patricia D’Souza
• Mike Pensiero
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