HPTN 035
Phase II/IIb Safety and Effectiveness Study of the
Vaginal Microbicides BufferGel and 0.5% PRO2000/5 Gel (P) for the Prevention
of HIV Infection in Women
Laboratory
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Operational Memos
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Plasma Archive at Study Exit (09 Jun 2007)
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Regulatory notes to file (01 Jun 2006)
- The Central Lab needs to be informed
as quickly as possible of any instrument problems/failures, QC and
reagent problems. SCHARP, FHI and the CL need to be made aware
whenever your site puts in place any back up measures (such as using
back-up labs and equipment or other sites' labs), switches in
reagents or kits, or updates normal ranges or toxicity grading based
on a change of lab/instrument, reagent, or kit. SCHARP has QC checks
in place that may need to be amended based on this information.
Please inform the Network Lab, SCHARP, and FHI within 24 hours of
any such changes and provide the start dates of these measures to
ensure that all necessary QC checks can be updated.
Some reagent
changes may require re-evaluation of your site's normal ranges and
toxicity grading. For example, if your PT reagent changes or
has a differing ISI value, you will need to revalidate your ranges.
If you have any questions regarding a normal range change, please
contact the Network Laboratory (networklab@hptn.org).
- Please ensure that your back up lab
is providing you with a result form that lists the testing
laboratories information, patient information, specimen date,
reference ranges, and any critical value information.
5% Blood Reference Image
Click on the thumbnail image below to see a full-size image of a tube
containing 5% blood as a comparison for when to reject a urine specimen
for testing for GC/CT on the ProbeTec.
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