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. |
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