The following list of data fields have been identified as being critical to accurate outcome analyses. These fields are audited for each recipient selected for audit. The table below is a summary of many of the critical data points grouped by data field type. Critical fields are regularly reviewed and updated; therefore, the list below includes the critical fields for the most current revisions of the forms. Since the audit process reviews data reported over four years (including older form revisions), critical fields reviewed as part of the audit may differ from the summary below. For a complete list of current data collection forms (including form numbers and names) visit the CIBMTR website.

Field Form(s)
Primary Disease for CT
Date of Diagnosis 2402
Primary disease for which the CT was performed, including classification / subtype 2402
Predisposing condition 2402
Prior HCT or CT 2011, 4000
Indication for CT 4000
Infusion date Appears on multiple CIBMTR forms
Laboratory studies, cytogenetic abnormalities, molecular markers, and immunohistochemical stains assessed at diagnosis 2011, 2018, 2402
Laboratory studies, cytogenetic abnormalities, and molecular markers, assessed in-between diagnosis and start of systemic therapy 2402
Laboratory studies, cytogenetic abnormalities, molecular markers, immunohistochemical stains, and flow cytometry assessed prior to CT 2011, 2018, 2402
Histologic transformation (date of transformation and disease classification 2018
Product and Infusion Data
Is this the first application of cellular therapy (non-HCT)? 4000
Did NMDP/Be the Match facilitate the procurement, collection, or transportation of the product? 4000
Date of infusion 4006, 4100
Product name 4000, 4003, 4006, 4100
Product cell type 4000, 4003
Genetic modification of product 4000
Product identification (including cell product ID, batch number, lot number) 4000, 4006
Cell counts (total number of cells administered, lymphocytes (unselected) administered), CD4+ lymphocytes administered, CD8+ lymphocytes administered, natural killer cells (NK cells) administered) 4006
Total volume infused 4006
Total number of products infused 4000, 4003
Concomitant therapy 4006
Where was the cellular therapy product manufactured / processed? (pharmaceutical / biotech company) 4003
In what setting is this cell therapy product infusion being planned? 4000
Consent
IRB-approved consent for submitting
research
4000
Participation in a cellular therapy clinical trial (study sponsor, sponsor name, etc.) 4000
Clinical status of recipient
Karnofsky / Lansky score 4000
ECOG score 2018
Dialysis immediately prior to the start of the preparative regimen 4000
Prior malignancy 4000
Comorbidities 4000
Systemic Therapy Prior to CT and Lines of Therapy
Lymphodepleting therapy prior to infusion (drug, dose, date started) 4000
GVHD
Acute GVHD developed 4100
Chronic GVHD developed / persisted 4100
Date of maximum overall grade of chronic GVHD 4100
Post-CT Disease Therapy
Subsequent transplant / cellular therapy 4100, 2111
Therapy / intervention given in reporting period 2111, 2118
Disease Status
Disease status at diagnosis and prior to systemic therapy including remission status 2402
Laboratory studies prior to preparative regimen (monocyte, blasts, etc.) 2011
Best response to CT and date best response first began 2111, 2118
Best response: Clinical / hematologic assessment 2111, 2118
Best response and disease assessment at the time of evaluation: Molecular, flow, cytogenetic, FISH, and cytogenetics 2111, 2118
Disease detected by clinical / hematologic assessments 2111
Current disease status and date assessed 2111, 2118
Recipient Status
Date of actual contact with recipient 4100
Survival status 4100
Pregnant at any time in reporting period (recipient or recipient’s female partner) 4100
Date of death and cause of death 4100, 2900
Peripheral Blood Count Recovery
Evidence of initial hematopoietic recovery and date 4100
ANC subsequent decline after recovery 4100
Platelet recovery ≥ 20 × 109/L 4100
Infection
Development of clinically significant infection since date of last report 4100
Organism, infection site, date of diagnosis 4100
Toxicities
Cytokine Release Syndrome (CRS) (diagnosis date, therapy, symptoms, resolution) 4100
Neurotoxicity (date of onset, symptoms, resolution, therapy, CARTOX-10 / ICE score) 4100
Hypogammaglobulinemia (date of onset, therapy, resolution) 4100
Tumor lysis syndrome (date of onset and grade 4100
Other toxicity (date of onset) 4100
Development of grade 3 or 4 organ toxicity 4100
C-reactive protein level 4100
Other
New malignancy, myelodysplastic, myeloproliferative disease or disorder 4100

Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. In addition to documenting the changes within each manual section, the most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.

Date Manual Section Add/Remove/Modify Description
8/10/2020 Appendix O: Cellular Therapy Critical Fields Add Appendix O: Cellular Therapy Critical Fields released.
Last modified: Aug 10, 2020

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