1 MTN-003 Training Specimen Labeling and Preparation for Entry into LDMS

2 Specimen Labeling Each original specimen collection container must be labeled with a SCHARP-provided PTID Label –Urine collection cups, blood collection tubes, gram stain slides, etc. Some MTN-003 specimen containers will also need a Time Collected Label –Endo-cervical and vaginal swabs, plasma for PK testing

3 Two PTID Label sizes are used in VOICE –Large PTID Labels are used for all specimens except gram stain slides –Small PTID Labels are used for gram stain slides MTN-003 PTID Labels Large Label Small Label V:____.__ DATE: ___/_____/___ (VOICE) dd MMM yy VST:____.__ ___/_____/___ dd MMM yy ( VOICE)

4 On both sizes of PTID labels, write in the visit code and specimen collection date To ensure adhesion, make sure the container/slide is clean, dry and at room temperature before affixing label Use Word files (macros) to print PTID labels (PTID will need to be typed in before labels are printed) Use large or small label stock, depending on size of label that best fits the container/slide. MTN-003 PTID Labels

5 Add to specimens requiring a collection time –Endo-cervical and vaginal swabs, plasma for PK Do not place over or obscure PTID label Print labels directly from PDF file (no need to use a macro since there is no participant- specific information printed on this label) Use small size label stock MTN-003 Time Collected Labels Time _ _ : _ _ hh mm (VOICE)

6 MTN-003 Label Supply SCHARP will provide blank label stock (two sizes, large and small) to be used for PTID Labels and Time Collected Labels Sites can order more blank label stock by using the VOICE CRF Request Form SCHARP will also provide Word files (macros) that can be used to create PTID Labels - One macro for large PTID labels - One macro for small PTID labels

7 MTN-003 LDMS Specimen Tracking Sheet A non-DataFax form (1 page) supplied by SCHARP and included in CRF visit packets Documents specimens to be entered into LDMS –does not document all specimens collected at a visit, just those that will be temporarily stored on-site and later shipped off-site Includes spaces to record PTID, visit code, specimen collection date, and for some specimens, time of collection Also has space to document number of tubes/specimens collected

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9 Clinic Staff Preparation of LDMS Specimens Gather all of the participant’s specimens that will be entered into LDMS Obtain the VOICE LDMS Specimen Tracking Sheet completed for the participant Review the Tracking Sheet to verify all specimens present are recorded properly on the sheet (make sure visit code, collection date, and collection time on labels match what is recorded on the Tracking Sheet) Deliver Tracking Sheet and specimens to the LDMS entry lab

10 LDMS Staff Entry of Specimens into LDMS Enter information as recorded on the LDMS Tracking Sheet into LDMS Contact clinic staff if you have questions about the Tracking Sheet and/or specimens Once the specimens are entered into LDMS, record the LDMS data entry date and LDMS staff entry initials on the tracking sheet

11 Questions???