Lab Processing Grid: Template & Instructions for CRU protocols

Purpose: To collect and verify information for Physician Orders and CRU Flowsheet development

  1. Study team: Completes the processing gridsections Test Name, Time Points, and Processed by (unshaded sections of table on page 2 of this document).
  2. Most of this information is found in the protocol and lab manual.
  3. Include only research specimens that might be collected on CRU.
  4. Complete sections in RED with study specific information, N/A if information not applicable
  5. It may be necessary to contact the sponsor for additional information/clarifications.
  6. Sendprocessing grid to CP.
  7. CP:Completes and returns to Study team.
  8. Once CP and study team have completed review, study team sends grid to CRU.
  9. CRU:
  10. Reviews and asks for clarifications/corrections if needed.
  11. Sends processing grid to HL builders, if applicable.
  12. Adds information from processing grid to CRU flowsheets.
  13. Study team: Obtains actual research kit and provides to CRU as soon as possible.
  14. CRU: Verifies the information provided on this form with the research kit.
  15. Study team: If a new protocol, amendment, lab manual or other change affects the lab processing grid, please begin at Step 1; edit this form using track changes and submit all documents until approved.

Example of what would be submitted to CRU

Test Name/ Collection device
(Team to complete) / Time
Points
(Team to complete) / Invert/
Clot time
(CP to complete) / Centrifuge
Settings
(CP to complete) / Volume of aliquots /
storage container information
(CP to complete) / Storage
Temp
(CP to complete) / Other processing/
storage information
(CP to complete) / Processed by
(Team to complete)
Dinaciclib PK:4mL red top serum tube / Cohort 1:
C1D1: predose, 30 min, 1hr, 4hr, 8hr post dose.
C1D15, C2+D1 predose. / 5x
30min / 15min
3000rpm
25°C / Aliquot serum equally into (2) 1 mL cryovials labeled Dinaciclib PK / -80°C / Protect from light. Must be processed within 1 hour. / CRU
MK-333 PK: 4mL purple top EDTA tube / Cohort 2:
C1D1: predose, 30 min, 1hr, 4hr, 8hr post End of
MK-333 Infusion. / 8-10x
N/A / 15min
1500g
4°C / Aliquot 1.0mL of plasma into
(2) 1 mL cryovials labeled MK-2206 PK / -80°C / Place tubes on ice. Centrifuge within 30 min. of draw. / CRU
PD: 6mL purple top EDTA tube / All Cohorts:
C1D1 predose / N/A / N/A / NA / Room
temp / Call 263-5369 to pick up and process. / CP

Protocol Title:

CCC Nbr (e.g. UW Number): ______CRU Protocol #______

Prepared/Revised by / Date / Protocol Version Date / Lab Manual Version Date
Test Name/ Collection device / Time
Points / Invert/
Clot time / Centrifuge
settings / Volume of aliquots /
storage container information / Storage
temp / Other processing/storage information / Processed by
Test Name: #mL color/tube type / #x
#min / #min
#rpm/g
#°C / #mL fluid type into
(# )container type and volume /label info / Room Temp,
Refrigerate,
-20°C or
-80°C / add additional processing/storage info here / CRU or CP
Test Name: #mL color/tube type / #x
#min / #min
#rpm/g
#°C / #mL fluid type into
(# )container type and volume /label info / Room Temp,
Refrigerate,
-20°C or
-80°C / add additional processing/storage info here / CRU or CP
Test Name: #mL color/tube type / #x
#min / #min
#rpm/g
#°C / #mL fluid type into
(# )container type and volume /label info / Room Temp,
Refrigerate,
-20°C or
-80°C / add additional processing/storage info here / CRU or CP
Test Name: #mL color/tube type / #x
#min / #min
#rpm/g
#°C / #mL fluid type into
(# )container type and volume /label info / Room Temp,
Refrigerate,
-20°C or
-80°C / add additional processing/storage info here / CRU or CP

To add additional rows: highlight bottom row, right click, and select “Insert-Insert Rows Below”

CRU Lab Processing Template1Version Date: 12/12/17