Last modified:
Mar 19, 2015
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- Getting Started
- General Instructions
- Recipient Assignment, Indication, and Information Manuals
- Transplant Essential Data (TED) Manuals
- 2400: Pre-TED
- Q1 – 23: Recipient Information
- Q24 – 43: Hematopoietic Cellular Transplant (HCT) and Cellular Therapy
- Q44 – 82: Donor Information
- Q83 – 86: Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)
- Q87 – 120: Comorbid Conditions
- Q121 – 135: Pre-HCT Preparative Regimen (Conditioning)
- Q136 – 144: Additional Drugs Given in the Peri-Transplant Period
- Q145 – 147: GVHD Prophylaxis
- Q148 – 150: Planned Post-HCT Disease Therapy Planned as of Day 0
- Q151: Prior Exposure: Potential Study Eligibility
- 2402: Disease Classification
- Q1-2: Primary Disease for HCT / Cellular Therapy
- Q3-95: Acute Myelogenous Leukemia
- Q96-163: Acute Lymphoblastic Leukemia
- Q164-167: Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms
- Q168-178: Chronic Myelogenous Leukemia
- Q179-258: Myelodysplastic Diseases
- Q259-371: Myeoloproliferative Diseases
- Q372-378: Other Leukemia
- Q379-396: Hodgkin and Non-Hodgkin Lymphoma
- Q397-443: Multiple Myeloma / Plasma Cell Disorder
- Q444-445: Solid Tumors
- Q446-448: Severe Aplastic Anemia
- Q449-450: Inherited Bone Marrow Failure Syndromes
- Q451-487: Hemoglobinopathies
- Q488-495: Disorders of Immune System
- Q496-497: Inherited Abnormalities of Platelets
- Q498-500: Inherited Disorders of Metabolism
- Q501-505: Histocytic Disorders
- Q506-509: Autoimmune Diseases
- Q510-511: Tolerance Induction Associated with Solid Organ Transplant
- Q512: Other Disease
- 2450: Post-TED
- Q1 – 6: Survival
- Q7 – 13: Subsequent Transplant
- Q14 – 16: Initial ANC Recovery
- Q17 – 18: Initial Platelet Recovery
- Q19 – 44: Graft versus Host Disease (Allogeneic Only)
- Q45 – 47: Liver Toxicity Prophylaxis
- Q48 – 49: Veno-occlusive disease (VOD) / Sinusoidal obstruction syndrome (SOS)
- Q50 – 56: Infection
- Q57 – 64: New Malignancy, Lymphoproliferative or Myeloproliferative Disorder
- Q65 – 83: Chimerism Studies (Cord Blood Units, Beta Thalassemia, and Sickle Cell Disease Only)
- Q84 – 106: Disease Assessment at the Time of Best Response to Infusion
- Q107 – 111: Post-Infusion Therapy
- Q112 – 122: Relapse or Progression Post-Infusion
- Q123 – 126: Current Disease Status
- 2400: Pre-TED
- Comprehensive Baseline & Follow-up Manuals
- 2000: Recipient Baseline
- Q1-3:Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)
- Q4-22: Organ Function Prior to the Preparative Regimen (Conditioning)
- Q23-34: Hematologic Findings Prior to the Preparative Regimen (Conditioning)
- Q35-38: Infection
- Q39-85: Pre-HCT Preparative Regimen (Conditioning)
- Q86-103: Additional Drugs Given in the Peri-Transplant Period
- Q104-117: Socioeconomic Information
- 2004: Infectious Disease Markers
- 2005: Confirmation of HLA Typing
- 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion
- 2100: Post-Infusion Follow-Up
- Q1-5: Vital Status
- Q6-12: Granulopoiesis / Neutrophil Recovery
- Q13-16: Megakaryopoiesis / Platelet Recovery
- Q17 – 25: Growth Factor and Cytokine Therapy
- Q26 – 35: Current Hematologic Findings
- Q36 – 51: Immune Reconstitution
- Q52 – 69: Chimerism Studies
- Q70 – 80: Engraftment Syndrome
- Q81 – 130: Acute Graft vs. Host Disease (GVHD)
- Q131 – 200: Chronic Graft vs. Host Disease (GVHD)
- Q201 – 207: Current GVHD Status
- Q208 – 223: Infection Prophylaxis
- Q224 – 247: Infection
- Q248 – 309: Organ Function
- Q310: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder
- Q311 – 334: Functional Status
- Q335 – 338: Subsequent HCT
- 2900: Recipient Death
- 2000: Recipient Baseline
- Comprehensive Disease-Specific Manuals
- 2010/2110: Acute Myelogenous Leukemia (AML)
- 2011/2111: Acute Lymphoblastic Leukemia (ALL)
- 2012/2112: Chronic Myeloid Leukemia (CML)
- CML Response Criteria
- 2012: CML Pre-Infusion Data
- Q1-17: Disease Assessment at Diagnosis
- Q18-83: Laboratory Studies at Diagnosis
- Q84-185: Pre-HCT or Pre-Infusion Therapy
- Q186-191: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
- Q192-252: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
- Q253-256: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
- 2112: CML Post-Infusion Data
- 2013/2113: Chronic Lymphocytic Leukemia (CLL)
- CLL Response Criteria
- 2013: CLL Pre-Infusion
- Q1-21: Disease Assessment at Diagnosis
- Q22-73: Laboratory Studies at Diagnosis
- Q74-148: Pre-HCT or Pre-Infusion Therapy
- Q149-191: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
- Q192-193: Disease Status at the Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
- 2113: CLL Post-Infusion
- Q1-3: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy
- Q4-26: Disease Assessment at the Time of Best Response
- Q27-42: Post-HCT / Post-Infusion Planned Therapy
- Q43-88: Disease Relapse or Progression Post-HCT / Post-Infusion
- Q89-113: Disease Status at the Time of Evaluation for This Reporting Period
- 2014/2114: Myelodysplastic Syndrome (MDS)
- MDS Response Criteria
- 2014: Myelodyplastic Syndrome (MDS) Pre-Infusion
- Q1: Subsequent Transplant of Cellular Therapy
- Q2-17: Disease Assessment at Diagnosis
- Q18-47: Diagnostic Studies (Measured Prior to First Disease Treatment)
- Q48-81: IPSS-R Prognosis Score
- Q82-156: Pre-HCT / Pre-Infusion Therapy
- Q157-193: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
- Q194-208: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen
- 2114: Myelodysplastic Syndrome (MDS) Post-Infusion
- 2015/2115: Juvenile Myelomonocytic Leukemia (JMML)
- JMML Response Criteria
- 2015: JMML Pre-HCT
- Q1-6: Clinical Features at Diagnosis
- Q7-48: Laboratory Values at Diagnosis
- Q49-62: Pre-HCT Therapy
- Q63-64: Transformation
- Q65-91: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen
- Q92-93: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen
- 2115: JMML Post HCT
- 2016/2116: Plasma Cell Disorders (PCD)
- Multiple Myeloma Response Criteria
- Plasma Cell Leukemia Response Criteria
- POEMS Response Criteria
- Amyloidosis Response Criteria
- 2016: PCD Pre-Infusion
- Q1-2: Disease Assessment at Diagnosis
- Q3-60: Diagnostic Studies (Measured Prior to Any Disease Treatment)
- Q61-124: Amyloidosis Organ Involvement at Diagnosis
- Q125-156: POEMS Syndrome Assessment at Diagnosis
- Q157-187: Pre-Infusion Therapy
- Q188-254:Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
- Q255-289: Amyloidosis Organ Involvement at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
- Q290-295: POEMS Syndrome Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
- 2116: PCD Post-Infusion
- Q1-2: Disease Specificity
- Q3-53: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy
- Q54-109: Organ Parameters of Amyloidosis at the Time of Best Response
- Q110-141: POEMS Syndrome Assessment at the Time of Best Response
- Q142-210: Post-Infusion Therapy
- Q211-252: Disease Status at the Time of Evaluation for this Reporting Period
- Q253-311: Current Status of Amyloidosis for this Reporting Period
- Q312 – 343: Current Status of POEMS Syndrome for This Reporting Period
- 2018/2118: Hodgkin and Non-Hodgkin Lymphoma
- Lymphoma Response Criteria
- 2018: LYM Pre-Infusion
- Q1-55: Disease Assessment at Diagnosis
- Q56-68: Laboratory Studies at Diagnosis
- Q69-81: Assessment of Nodal and Organ Involvement at Diagnosis
- Q82-139: Disease Assessment at Transformation
- Q140-152: Laboratory Studies at Transformation
- Q153-165: Assessment of Nodal and Organ Involvement at Transformation
- Q166-223: Pre-HCT Therapy
- Q224-233: Disease Assessment at the Failure of the 1st Line of Therapy (DLBCL only)
- Q234-288: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
- 2118: LYM Post-Infusion
- 2019/2119: Waldenström’s Macroglobulinemia (WM)
- Waldenstrom’s Macroglobulinemia Response Criteria
- 2019: WM Pre-HCT
- Q1-2: Disease Assessment at Diagnosis
- Q3-23: Clinical Features Present at Diagnosis
- Q24-75: Laboratory Studies at Diagnosis
- Q76-120: Pre-HCT Therapy
- Q121-150: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen
- Q151-152: Disease Status at Last Evaluation Prior to the Preparative Regimen
- 2119: WM Post-HCT
- 2026/2126: Neuroblastoma
- 2028/2128: Aplastic Anemia
- 2029/2129: Fanconi Anemia / Constitutional Anemia
- 2030/2130: Sickle Cell Disease (SCD)
- 2030: SCD Pre-Infusion
- Q1: Subsequent Transplant or Cellular Therapy
- Q2-5: Disease Classification at Diagnosis
- Q6-18: Transfusion Therapy
- Q19-21: Iron Therapy
- Q22-26: Pulmonary Assessments
- Q27-37: Cardiovascular Assessments
- Q38-46: Hepatic Assessments
- Q47-51: Renal Assessments
- Q52-56: Splenic Assessments
- Q57-61: Acute Chest Syndrome
- Q62-64: Pain
- Q65-67: Avascular Necrosis
- Q68-76: Central Nervous System
- Q77-85: Other Symptoms
- Q86-92: Disease Modifying Therapies
- Q93-119: Other Laboratory Studies
- Q120-121: Reason for Transplant
- 2130: SCD Post-Infusion
- Q1-5: Physical Assessments
- Q6-8: Transfusion Therapy
- Q9-13: Pulmonary Assessments
- Q14-30: Cardiovascular Assessments
- Q31-37: Renal Assessments
- Q38-42: Splenic Assessments
- Q43: Acute Chest Syndrome
- Q44-46: Pain
- Q47-49: Avascular Necrosis
- Q50-58: Central Nervous System
- Q59-66: Other Symptoms
- Q67-73: Disease Modifying Therapies
- Q74-100: Other Laboratory Studies
- Q101: Disease Status
- 2030: SCD Pre-Infusion
- 2031/2131: Immune Deficiencies (ID)
- 2033/2133: Wiskott-Aldrich Syndome (WAS)
- 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP)
- 2034: XLP Pre-HCT
- Q1-23: Disease Assessment at Diagnosis
- Q24-32: History of Epstein Barr Virus (EBV) Infection
- Q33-51: Assessment of Immunologic Function at Diagnosis
- Q52-104: Disease Assessment between Diagnosis and the Start of the Preparative Regimen
- Q105-130: Disease Status at Last Evaluation Prior to the Start of the Preparative Regimen
- 2134: XLP Post-HCT
- 2034: XLP Pre-HCT
- 2037 / 2137 Leukodystrophies
- 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH)
- 2039: HLH Pre-HCT
- Q1-22: Disease Assessment at Diagnosis
- Q23-47: Clinical Features and Laboratory Studies at Diagnosis
- Q48-58: Disease Assessment Between Diagnosis and the Start of the Preparative Regimen
- Q59-74: History of Infection at Any Time Prior to the Preparative Regimen
- Q75-107: Pre-HCT Therapy
- Q108-127: Clinical Features and Laboratory Studies At Last Evaluation Prior to the Start of the Preparative Regimen
- 2139: HLH Post-HCT
- 2039: HLH Pre-HCT
- 2057/2157 Myeloproliferative Neoplasms (MPN)
- MPN Response Criteria
- 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion
- Q1: Subsequent Transplant
- Q2-10: Disease Assessment at Diagnosis
- Q11-40: Diagnostic Studies (Measured Prior to First Disease Treatment)
- Q41-54: DIPSS Prognosis Score
- Q55-212: Pre-HCT / Pre-Infusion Therapy
- Q213-254: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
- Q255-261: Disease Assessment at the Last Evaluation Prior to the Preparative Regimen / Infusion
- 2157: Myeloproliferative Neoplasm (MPN) Post-Infusion
- 2058/2158: Thalassemia
- 2058: Thalassemia Pre-Infusion
- Q1: Subsequent Transplant or Cellular Therapy
- Q2 – 26: Thalassemia Diagnosis
- Q27 – 52: Donor Related Information
- Q53 – 59: Transfusion Therapy
- Q60 – 62: Hepatic Assessments
- Q63 – 67: Cardiac Assessments
- Q68: Renal Assessments
- Q69 – 74: Additional Iron Overload Assessments
- Q79 – 83: Additional Hematologic Labs
- Q84 – 94: Specify Existing Organ Impairments
- Q95 – 101: Disease Modifying Therapy
- 2158: Thalassemia Post-Infusion
- Q1 – 15: Post-Infusion Disease Testing
- Q16 – 17: Transfusion Therapy
- Q18 – 29: Treatment
- Q30: Splenic Assessments
- Q31 – 54: Hepatic Assessments
- Q55 – 63: Cardiac Assessments
- Q64 – 66: Renal Assessments
- Q67 – 81: Additional Iron Overload Assessments
- Q82 – 90: Additional Hematologic Labs
- Q91 – 102: Specify Existing Organ Impairments
- Q103 – 110: Disease Modifying Therapies
- 2058: Thalassemia Pre-Infusion
- Cellular Therapy Manuals
- 4000: Cellular Therapy Essential Data Pre-Infusion
- Q1-17: Recipient Data
- Q18-32: Cellular Therapy and HCT History
- Q33-57: Product Identification
- Q58-77: Indication for Cellular Therapy
- Q78-84: Lymphodepleting Therapy Prior to Cellular Therapy
- Q85-88: Toxicity Prophylaxis
- Q89-102: Hematologic Findings Prior to Lymphodepleting Therapy
- Q103-105: Functional Status
- Q106-123: Comorbid Conditions
- 4003: Cellular Therapy Product
- 4006: Cellular Therapy Infusion
- 4100: Cellular Therapy Essential Data Follow-Up
- Q1: Product
- Q2-6: Survival
- Q7-12: Subsequent Cellular Infusions
- Q13-15: Best Response to Cellular Therapy
- Q16-24: Peripheral Blood Count Recovery
- Q25-31: Disease Relapse or Progression
- Q32-42: Current Hematologic Findings
- Q43: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder
- Q44-68: Persistence of Cells
- Q69-79: Graft vs. Host Disease
- Q89-202: Toxicities
- Q204-213: Infection
- Q214-215: Pregnancy Status
- 4000: Cellular Therapy Essential Data Pre-Infusion
- Gene Therapy Manuals
- Infection & Miscellaneous Manuals
- 2046 / 2146: Fungal Infection
- 2047 / 2147: Hepatitis Serology
- 2149: Respiratory Virus Post-Infusion Data
- 2150: Viral Infection Diagnosis and Treatment Form
- 2540: Tepadina® Supplemental Data
- 2541: Inotuzumab Ozogamacin (Besponsa™) Supplemental Data
- 2542: Mogamulizumab Supplemental Data Collection
- 2543: Mylotarg™ Supplemental Data Collection
- 2553: VOD/SOS
- 2565: Sanofi Mozobil Supplemental Data
- 3500: Subsequent Neoplasms
- 3501: Pregnancy Form
- Appendices
- Appendix A: Abbreviations and Definitions
- Appendix B: Glossary of Terms
- Appendix C: Cytogenetic Assessments
- Appendix D: How to Distinguish Infusion Types
- Appendix E: Definition of a Product
- Appendix F: Response Evaluation Criteria in Solid Tumors (RECIST)
- Appendix G: Tracking Disease Status for Multiple Myeloma
- Appendix H: MDS/MPN Subtypes
- Appendix I: Ethnicity and Race
- Appendix J: Reporting Comorbidities
- Appendix K: Key Fields
- Appendix L: Karnofsky/Lansky Performance Status
- Appendix M: HCT Critical Data Fields
- Appendix N: Drug Classification
- Appendix O: Cellular Therapy Critical Fields