MTN-003 Training

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MTN-003 Training

• Specimen Labeling and Preparation for Entry into
  LDMS

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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

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MTN-003 PTID Labels

• 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

Large Label
Small Label
300-99999-9
VST____.__ ___/_____/___dd MMM
yy
(VOICE)
300-99999-9 V____.__ DATE ___/_____/___(VOICE)
dd MMM yy
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MTN-003 PTID Labels

• 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.

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MTN-003 Time Collected Labels

• 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

Time _ _ _ _
hh
mm (VOICE)
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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

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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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Clinic Staff Preparation of LDMS Specimens

• Gather all of the participants 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

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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

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Questions???