MTN 037 Laboratory Training Ratiya Pamela Kunjara Na Ayudhya MTN LC Magee-Womens Research Institute Pittsburgh, PA

Introduction Overview of Lab Testing Timing of Specimen Collection Highlights for Specimen Handling LDMS Tracking Sheets LDMS Reconciliation Reports

Overview of Lab Testing Assay Collection Requirements VST 1 SCR VST 2 ENR VST 3,5,7 Dose VST 4,6,8 24hr post VST 41,61,81 (4a/6a/8a) 48hr post PH Pharyngeal GC/CT Local lab requirements X « URINE Urine GC/CT Urine hCG   BLOOD CBC/diff/plt AST/ALT/Creatinine (Creatinine only) HIV-1 and HIV-2 serology X (Vst 8 only) Syphilis Serology Coagulation (PT/INR) Plasma Archive/Storage 10mL EDTA tube - process within 4 hours Plasma PK 10mL EDTA tube - process within 8 hours ♦ X Required, « As indicated, ♦ pre-dose, 1, 2, 3, 4, 5-6 and 24hrs

Overview of Lab Testing  PELVIC NAAT for GC/CT/TV Local lab requirements X « Vaginal Fluid for PK Weighed dacron swab in white top cryovial - freeze within 2 hours   ⌂ RECTAL Rectal swab for HPV Qiagen Digene Female Swab Specimen Kit - freeze ≤-70°C Rectal NAAT for GC/CT Rectal Fluid for PK Weighed sponge in 5mL cryovial - freeze within 2 hours Rectal Fluid for PD X (PD only) Rectal Enema for PD/PK 50ml conical tube - refrigerate and process within 8 hours Rectal Biopsies (3) for PK Weighed biopsies in clear top cryovial - freeze within 2 hours Rectal Biopsy (1) for Histology Biopsy in orange top cryovial with Formalin Rectal Biopsies (3) for PD 15ml conical tube with transport media - process within 15-30 mins Rectal Biopsies (2) for Archive Biopsy in green top cryovial - freeze within 2 hours X Required, « As indicated, ⌂ Randomized to 0.5-1, 1.5-3, 3.5-5, or 24 hrs

Timing of Specimen Collection Dosing Visit Blood draws - 1, 2, 3, and 4 hr +/- 15min window | 1hr | |2hr| |3hr | |4hr| | 5-6hr | |0.5-| | 1.5-3hr | | 3.5-5hr | 1hr Rectal Samples have no window; must be within range Blood and rectal 24hr and 48hr post-dose +/- 4hr window Pre Dose 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 30 min increment

Highlights of Specimen Handling Specimens with short time limits Rectal biopsies for PD 30 mins All other samples 2 hours or more Specimens weights required Vaginal fluid swab (SWB) for PK Rectal fluid sponge (SPG) for PK Rectal fluid sponge (SPG) for PD Rectal biopsies for PK (3) and archive (2)

LDMS Tracking Sheets Plasma Archive samples are collected at enrollment only. If a participant seroconverts, plasma for storage should be collected. Plasma for PK must be processed within 8 hrs of collection. Pay attention when batching samples to be sent to the lab at dosing visits.

LDMS Tracking Sheets For all PK and PD samples, timepoints must be entered into LDMS. When entering PK/PD timepoint into LDMS use the upper limit of the range. For example: 0.5-1hr would be entered as 1 hr.

LDMS Reconciliation Reports Types of Reports Discrep_CRFOnly Look at these reports Discrep_LDMSOnly together Discrep_partial_match Mismatched codes LDMS_errors Incorrect codes Site Lab Report Date Last LDMS Export PTID Specimen Type CRF Visit Code LDMS Visit Code CRF Date LDMS Date CRF Timepoint LDMS Timepoint Discrepancy Additional Discrepancy Description Affected Global Specimen IDs Corrective action Submitted by Pittsburgh 414 26MAR2018 24MAR2018 702-62199-3 Plasma - PK 3.1 3 13MAR2018 0 PRE Lab Data-CRF Specimen Collection Visits Don't Match   AC60HL2D-01, AC60HL2D-02, AC60HL2D-03, AC60HL2D-04, AC60HL2D-05 60 MIN JC60HL2L-01, JC60HL2L-02, JC60HL2L-03, JC60HL2L-04

Questions? www.mtnstopshiv.org MTN 037 SSP Pam Kunjara Section 10 Laboratory Considerations Pam Kunjara pkunjara@mwri.magee.edu 412-641-6393