MTN-003 Training
Specimen Labeling and Preparation
for Entry into LDMS
1
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
2
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 V:____.__
DATE: ___/_____/___
(VOICE)
3
dd
MMM
yy
300-99999-9
VST:____.__
___/_____/___
dd
MMM
(VOICE)
yy
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.
4
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 participantspecific information printed on this label)
• Use small size label stock
Time
__:__
hh
mm
(VOICE)
5
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
6
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
7
8
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
9
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
10
Questions???
11