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Laboratory Tests and Results Module: Round 3

The CTMS workgroup for the Laboratory Test/Results CRF Module began by focusing and analyzing work from Clinical Data Interchange Standards Consortium (CDISC) Clinical Data Acquisition Standards Harmonization (CDASH). Section 5.12. Laboratory Test Results* was reviewed and used as a template for variables to include in this module. After partitioning and consideration of the CDASH fields, the workgroup added variables from the cancer community CRF inventory.

Downloads

Laboratory Test Results NCI CRF Standards created on October 19th, 2018

Laboratory Test Results NCI CRF Standards created on June 21st, 2016

Laboratory Test Results NCI CRF Standards created on October 30th, 2014


Changes made from September 5th, 2014 to October 19, 2018

ModuleCDECDE Public IDChange
Laboratory Test Results
2003746

LabTest CDE 2003746 - Added PVs

  1. Copper, Urine
  2. Cytomegalovirus (CMV) Antibody, Serum
  3. Epstein-Barr Virus (EBV), Nuclear Antibody, IgM, Serum
  4. Hepatitis B Core (HBC) Antibody, IgG and IgM Total, Serum
  5. HIV (Human Immunodeficiency Virus) 1/2 Plus O, Antibody, Serum
  6. HIV1, Nucleic Acid Testing (NAT), Serum
  7. RPR (Rapid Plasma Reagin), Plasma
  8. Short Tandem Repeat Chimerism, Donor, Clusters of Differentiation 8 (CD8), %, Blood
  9. Short Tandem Repeat Chimerism, Donor, Clusters of Differentiation 4 (CD4), %, Blood
  10. Testosterone, Free, Serum
  11. West Nile Virus Antibody, IgG and IgM, Serum
  12. West Nile Virus, PCR, Serum

Lab Test Unit of Measure UCUM Codes CDE 2787947 –Added PV

  1. umol
Laboratory Test ResultsLab Test2003746

LabTest CDE 2003746 - Added PVs

  1. Bence Jones Protein, Electrophoresis, 24 hour, Urine
  2. Bence Jones Protein, Electrophoresis, Urine
  3. Beta 1 Globulin, Protein Electrophoresis, Serum
  4. Beta 2 Globulin, Protein Electrophoresis, Serum
  5. BK Virus, Polymerase Chain Reaction (PCR), Quantitative, Copies/mL, Blood
  6. Bromide, Serum
  7. Carbamazepine, Serum
  8. Carbon Dioxide, Partial Pressure, mmHg, Arterial Blood
  9. Clostridium tetani toxoid Antibody, IgG, Serum
  10. Cytomegalovirus, DNA, Polymerase Chain Reaction, Throat
  11. Cytomegalovirus, DNA, Polymerase Chain Reaction, Urine
  12. Denosumab, Serum
  13. Felbamate, Serum
  14. Fosphenytoin, Serum
  15. Glucose, Estimated Average, Blood
  16. HLA Antibody Screen, Blood
  17. IL-17, Serum
  18. Kappa/Lambda Immunoglobulin Free Light Chain Ratio, Serum
  19. Ki67, %, Tissue
  20. Lactate, Blood
  21. Light Chain Ratio, Urine
  22. Methotrexate, CSF
  23. Myoglobin, Urine
  24. Nucleated Red Blood Cell (NRBC) Count, %, Blood
  25. Oxcarbazepine, Serum
  26. Oxygen, Partial Pressure, mmHg, Arterial Blood
  27. Phenobarbital, Serum
  28. Polio Virus Antibody, Serum
  29. Primidone, Serum
  30. Reverse Triiodothyronine (T3), Free, Mass Spectrometry, Serum
  31. Thyrotropin Receptor Antibody, Serum
  32. Thyroxine (T4), Free, Mass Spectrometry, Serum
  33. Triiodothyronine (T3), Free, Mass Spectrometry, Serum
  34. Troponin I, Blood
  35. Urine M protein in mg/ 24 hrs
  36. Zinc, Serum



Status

status diagram showing pilot status

Metrics

CRF Stars:  Working Group Membership

* Represents Working Group Leads

No.

First Name

Last Name

Affiliation

1

Stephanie

Clabo

ACRIN

2

Donald

Connelly

University of Minnesota

3

Mary

Cooper

SAIC

4

Stephen

Dorian

RTOG

5

Rhonda

Facile

CDISC

6

Charlotte

Furey

Exelixis

7

David

Hillman

Mayo - NCCTG

8

Rebecca

Hills

University of Washington

9

Bob

Lanese (L)

Case Western

10

Mary

Lenzen

Octagon Research Solutions

11

Erik

Lickerman

Daedalus Software

12

Ruby

Lin

NCI CBIIT

13

Raymond

Lord

West Michigan Cancer Center

14

Riki

Ohira

Booz Allen Hamilton

15

Susan

Pannoni

City of Hope

16

Vikram

Purohit

Booz Allen Hamilton

17

Dianne

Reeves

NCI CBIIT

18

Anne

Ryan

NCI DCP

19

Julie

Smiley

Genzyme

20

Kim

Truett

CDISC

21

Joe

Uhimov

NCI TerpSys

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