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2542: Mogamulizumab Supplemental Data Collection

Infection & Miscellaneous Manuals » 2542: Mogamulizumab Supplemental Data Collection

The Mogamulizumab Supplemental Data Collection Form (Form 2542) is designed to support a retrospective and prospective, multicenter, observational registry of patients treated with mogamulizumab alone or in combination, within one year prior to allogeneic hematopoietic…

2543: Mylotarg™ Supplemental Data Collection

Infection & Miscellaneous Manuals » 2543: Mylotarg™ Supplemental Data Collection

The Mylotarg™ Supplemental Data Collection Form (Form 2543) is designed to support a retrospective and prospective, multicenter, observational registry of patients with Acute Myeloid Leukemia (AML) treated with Mylotarg™ alone or in combination in regimen prior to…

Q4-7: Product Collection

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion » Q4-7: Product Collection

*NOTE: Multiple collections versus multiple products This form collects information for a single product. PBSC collected from a single mobilization event (a mobilization event is the planned administration of growth factors or systemic therapy designed to enhance stem…

Q6 -12: Product Collection

Gene Therapy Manuals » 2003: Gene Therapy Product » Q6 -12: Product Collection

*Multiple collections versus multiple products The Gene Therapy Product (2003) form collects the information for a single product. PBSC cells collected from a single mobilization event (a mobilization event is a planned administration of growth factors or systemic…

Q13-15: Collection Procedure

Cellular Therapy Manuals » 4003: Cellular Therapy Product » Q13-15: Collection Procedure

This section applies to Autologous products only. If this was an allogeneic product, continue with the “Cell Product Manipulation” section. Question 13-14: Specify the method of product collection: Specify how the product was collected: Bone marrow aspirate: a…

Q75-100: Apheresis Collection

Infection & Miscellaneous Manuals » 2565: Sanofi Mozobil Supplemental Data » Q75-100: Apheresis Collection

Question 75-76: Did the recipient receive blood transfusions (RBCs) during this apheresis collection? Report “Yes” if the recipient received blood transfusions during this apheresis collection. Also, indicate the number of units of RBCs transfused during the…

Q4-56: Pre-Collection Therapy Given to Enhance Product Collection

Infection & Miscellaneous Manuals » 2565: Sanofi Mozobil Supplemental Data » Q4-56: Pre-Collection Therapy Given to Enhance Product Collection

Question 4: Was pre-collection chemotherapy given to enhance product collection? Report “Yes” and go to question five if there was pre-collection chemotherapy given to enhance product collection. If “No”, go to question 12. Question 5: Specify where…

Q1-3: Pre-Collection Therapy

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion » Q1-3: Pre-Collection Therapy

This section of the HCT Infusion (2006) form captures pre-collection therapy information regarding the donor’s mobilization or priming; this section of the form is not completed for cord blood units or products from NMDP donors. Question 1: Did the donor…

General Guidelines for Completing Forms

General Instructions » General Guidelines for Completing Forms

Fields Requiring a Date For fields that require a date, if an exact date is not known use the process listed below. This process should be used only if the dates fit within the logical timeframe of the form (i.e. contact date, diagnosis date, relapse date, etc). To…

Q1-17: Recipient Data

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q1-17: Recipient Data

Question 1: Ethnicity The recipient’s ethnicity is automatically populated based on the value reported in the CRID assignment tool in FormsNet3. Verify the recipient’s ethnicity is correct. If an error is noted, correct the error in the CRID assignment tool and…

2012: CML Pre-Infusion Data

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2012: CML Pre-Infusion Data

Chronic myelogenous leukemia (CML) is a slow-progressing cancer of the myeloid white blood cells. It is characterized by the increased proliferation of immature white blood cells (granulocytes) with damaged DNA, or blasts, which accumulate in the blood and bone marrow.…

2112: CML Post-Infusion Data

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data

Chronic myelogenous leukemia (CML) is a slow-progressing cancer of the myeloid white blood cells. It is characterized by the increased proliferation of immature white blood cells (granulocytes) with damaged DNA, or blasts, which accumulate in the blood and bone marrow.…

Transplant Essential Data (TED) Manuals

Transplant Essential Data (TED) Manuals

The Transplant Essential Data (TED) Manual section contains information on the successful completion of TED forms. The Pre-TED Manual has several links to disease specific response criteria which can be found in the Comprehensive Disease Specific Manual…

2565: Sanofi Mozobil Supplemental Data

Infection & Miscellaneous Manuals » 2565: Sanofi Mozobil Supplemental Data

The Sanofi Mozobil Supplemental Data Collection Form (Form 2656) is designed to support a prospective, multicenter, observational registry of myeloma recipients undergoing hematopoietic progenitor cell mobilization and peripheral blood stem cell collection for upfront…

Q1-7: Recipient Death Data

Comprehensive Baseline & Follow-up Manuals » 2900: Recipient Death » Q1-7: Recipient Death Data

Question 1: Date of Death Report the date the recipient died. Confirm that the date matches the last date of actual contact reported on the Post-Infusion Follow-Up (2100) form or Cellular Therapy Essential Data Follow-Up (4100) form. If the death occurred at an…

2540: Tepadina® Supplemental Data

Infection & Miscellaneous Manuals » 2540: Tepadina® Supplemental Data

Tepadina® Supplemental post-HCT Data Collection Form, Form 2540, must be completed for recipients who are enrolled onto CIBMTR study SC17-03. This is a multi-center, prospective, observational post-authorization long-term study of the use of thiotepa as part of a…

2149: Respiratory Virus Post-Infusion Data

Infection & Miscellaneous Manuals » 2149: Respiratory Virus Post-Infusion Data

In an effort to collect data on the impact of the COVID-19 (SARS-CoV-2) pandemic on our transplant and cellular therapy recipients, CIBMTR released the Respiratory Virus Post-Infusion Data (2149) Form. This form captures information regarding the diagnosis, treatment,…

Q1 – 5: Leukodystrophies Post-Infusion Data

Comprehensive Disease-Specific Manuals » 2037 / 2137 Leukodystrophies » 2137: Leukodystrophies Post-Infusion » Q1 – 5: Leukodystrophies Post-Infusion Data

!Hereditary diffuse leukoencephalopathy (HDLS): If the primary disease for infusion is HDLS, manually select this option from question 1. This option will not auto populate at this time. Question 1: For which type of leukodystrophy was the infusion…

Appendix M: HCT Critical Data Fields

Appendices » Appendix M: HCT Critical Data Fields

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…

2046: Fungal Infection Pre-Infusion Data

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2046: Fungal Infection Pre-Infusion Data

Fungal infections are significant opportunistic infections affecting transplant patients. Because these infections are quite serious, it is important to collect additional information on them. The Fungal Infection Pre-Infusion Data Form (Form 2046) captures…

2146: Fungal Infection Post-Infusion Data

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2146: Fungal Infection Post-Infusion Data

The Fungal Infection Post-Infusion Data Form (Form 2146) captures information regarding the diagnosis, treatment, and response to treatment of fungal infections diagnosed after receiving a HCT or cellular therapy. This form must be completed when one of the fungal…

4100: Cellular Therapy Essential Data Follow-Up

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up

This form must be completed for all recipients of cellular therapy (non-HCT), including post-HCT “DCI / DLI” infusions. For recipients of hematopoietic cellular transplants, complete the appropriate HCT follow-up form. The Post-Cellular Therapy Essential Data…

2541: Inotuzumab Ozogamacin (Besponsa™) Supplemental Data

Infection & Miscellaneous Manuals » 2541: Inotuzumab Ozogamacin (Besponsa™) Supplemental Data

Inotuzumab Ozogamicin Supplemental pre-HCT Data Collection Form, Form 2541, must be completed for recipients who are enrolled onto CIBMTR study SC17-10. The study will evaluate safety outcomes post-HCT in patients with B-cell precursor ALL who have been treated with…

4000: Cellular Therapy Essential Data Pre-Infusion

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion

This form must be completed for all recipients of cellular therapy (non-HCT) with or without a prior HCT. Recipients of CAR T cells, donor lymphocyte infusions, tumor-infiltrating lymphocytes, cytotoxic T cells are common cellular therapies that should be reported…

Appendix A: Abbreviations and Definitions

Appendices » Appendix A: Abbreviations and Definitions

Appendix A provides definitions of common manual abbreviations and United States abbreviations. Common Manual Abbreviations YYYY: 4 digit year MM: 2 digit month DD: 2 digit day AHOP: Adult, Hematology, Oncology or Pediatric Unit (select only one) ALLO:…

Appendix I: Ethnicity and Race

Appendices » Appendix I: Ethnicity and Race

Ethnicity Ethnicity is the heritage or nationality of a group, but it is not connected to a specific race. For the purposes of the NMDP Consent for Participation Form and general NMDP work, ethnicity is viewed as an environmental influence on a person, versus a…

Q83-88: Data from Post-HSCT Follow-Up Form (2100)

Infection & Miscellaneous Manuals » 2540: Tepadina® Supplemental Data » Q83-88: Data from Post-HSCT Follow-Up Form (2100)

Questions 83-88 refer to data reported on form 2100, Q441-615, please ensure data reported here matches with form 2100. Questions 83-85: In the transplant physician’s judgment, were any of the disorders / impairments reported on the form 2100 a direct result of…

Q8-21: Product Transport and Receipt

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion » Q8-21: Product Transport and Receipt

Question 8: Was this product collected off-site and shipped to your facility? If the product was shipped to the transplant center or contracted lab from an off-site collection center, select “yes.” In general, the “yes” option will be used for unrelated…

Recipient Assignment, Indication, and Information Manuals

Recipient Assignment, Indication, and Information Manuals

Find information for the 2804: CIBMTR Research ID Assignment Form, 2814: Indication for CRID Assignment Form, and 2820: Recipient Contact Information Form in the navigation of the table of contents. The 2804 and 2814 forms are required to receive a CRID for a new…

2150: Viral Infection Diagnosis and Treatment Form

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form

The CMV / EBV / ADV / HHV-6 / BK Viral Infection Diagnostic Form captures information regarding the diagnosis, treatment, and status of the following infections: Cytomegalovirus (CMV) Epstein-Barr Virus (EBV) Adenovirus (ADV) Human Herpes Virus 6 (HHV-6) BK Virus…

Q379-396: Hodgkin and Non-Hodgkin Lymphoma

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q379-396: Hodgkin and Non-Hodgkin Lymphoma

Hodgkin lymphoma (HL or Hodgkin disease) is a cancer of the immune system that is marked by the presence of a type of cell called the Reed-Sternberg cell. The two major types of Hodgkin lymphoma are classical Hodgkin lymphoma (90-95% of cases) and nodular…

2018/2118: Hodgkin and Non-Hodgkin Lymphoma

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma

Hodgkin lymphoma (HL or Hodgkin disease) is a cancer of the immune system that is marked by the presence of a type of cell called the Reed-Sternberg cell. The two major types of Hodgkin lymphoma are classical Hodgkin lymphoma (90-95% of cases) and nodular…

Q17 – 25: Growth Factor and Cytokine Therapy

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q17 – 25: Growth Factor and Cytokine Therapy

!The Growth Factor and Cytokine Therapy section can only be completed on the 100-day follow-up form. These questions will not be answered for all subsequent reporting periods. *Combined Follow-Up In scenarios where a cellular therapy was given after an HCT and this…

Q18-32: Cellular Therapy and HCT History

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q18-32: Cellular Therapy and HCT History

Question 18: Is this the first time the recipient is being treated using a cellular therapy (non-HCT)? This is defined as the first application of a cellular therapy the recipient ever receives, not the first application the recipient receives at your facility. The…

Q1 – 61: Clinical and Laboratory Characteristics at Diagnosis

Comprehensive Disease-Specific Manuals » 2026/2126: Neuroblastoma » 2026: Neuroblastoma Pre-Infusion » Q1 – 61: Clinical and Laboratory Characteristics at Diagnosis

Question 1: What was the date of diagnosis of Neuroblastoma? Neuroblastoma is typically diagnosed by histopathologic findings from tumor tissue samples or a bone marrow biopsy. Tumor marker analyses can provide diagnostic assistance. The date of diagnosis should be…

Q24 – 43: Hematopoietic Cellular Transplant (HCT) and Cellular Therapy

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q24 – 43: Hematopoietic Cellular Transplant (HCT) and Cellular Therapy

Question 24: Is a subsequent HCT planned as part of the overall treatment protocol (not as a reaction to post-HCT disease assessment) (For autologous HCTs only) If, at the time of the current HCT, a second (tandem transplant) or subsequent HCT is planned according to…

Q23-47: Clinical Features and Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2039: HLH Pre-HCT » Q23-47: Clinical Features and Laboratory Studies at Diagnosis

*Report findings prior to any treatment of the primary disease for which the HCT is being performed. Question 23: Anemia (Hgb < 9 g/dL): Indicate if the recipient had anemia at diagnosis or prior to the start of treatment for HLH. Anemia is defined as hemoglobin less…

Q153-165: Assessment of Nodal and Organ Involvement at Transformation

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q153-165: Assessment of Nodal and Organ Involvement at Transformation

All values reported in questions 153-165 must reflect testing / evaluations performed prior to any treatment for the histology specified in question 84. If testing / evaluation was not done near the time of transformation (within approximately 30 days) and prior to the…

Q69-81: Assessment of Nodal and Organ Involvement at Diagnosis

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q69-81: Assessment of Nodal and Organ Involvement at Diagnosis

All values reported in questions 69-81 must reflect testing / evaluations performed prior to any treatment for the histology specified in question 1. If testing / evaluation was not done near the time of diagnosis (within approximately 30 days) and prior to the…

Q164-167: Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q164-167: Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms

Questions 164-165: Specify other acute leukemia classification Indicate the other acute leukemia disease classification at diagnosis. If the subtype is not listed, report as “other leukemia” and specify the reported disease. Acute undifferentiated leukemia is a…

Q48-58: Disease Assessment Between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2039: HLH Pre-HCT » Q48-58: Disease Assessment Between Diagnosis and the Start of the Preparative Regimen

Question 48: Were central nervous system (CNS) abnormalities found on computed topography (CT or CAT) or magnetic resonance imaging (MRI) scans? Indicate if radiology (CT, CAT, and/or MRI) performed on the recipient between diagnosis and the start of the preparative…

Q52-104: Disease Assessment between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT » Q52-104: Disease Assessment between Diagnosis and the Start of the Preparative Regimen

Question 52: Was HLH present? HLH is an abnormal proliferation of macrophages and histiocytes that leads to the phagocytosis of healthy circulating blood cells. Indicate if the patient developed HLH at any time after diagnosis but prior to the start of the preparative…

Q65 – 83: Chimerism Studies (Cord Blood Units, Beta Thalassemia, and Sickle Cell Disease Only)

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q65 – 83: Chimerism Studies (Cord Blood Units, Beta Thalassemia, and Sickle Cell Disease Only)

*Chimerism Studies This section relates to chimerism studies from allogeneic HCTs using cord blood units, or for allogeneic HCT recipients whose primary disease is beta thalassemia or sickle cell disease only. If this was an autologous HCT, an allogeneic HCT using a…

Q42-130:Clinical Features Assessed between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2033: WAS Pre-HCT » Q42-130:Clinical Features Assessed between Diagnosis and the Start of the Preparative Regimen

Infections identified between Diagnosis and the Start of the Preparative Regimen Specify the presence of all clinically significant infections identified between diagnosis and the start of the preparative regimen. For the purposes of this form, clinically significant…

Q51-115: Clinical Features Assessed Between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2031: ID Pre-HCT » Q51-115: Clinical Features Assessed Between Diagnosis and the Start of the Preparative Regimen

Infection Identified between Diagnosis and the Start of the Preparative Regimen Specify the presence of all clinically significant infections identified between diagnosis and the start of the preparative regimen. Only report an organism once, even if it was identified…

General Instructions

General Instructions

The General Instructions section of the Forms Instruction Manual contains several sections meant to aid in forms completion. Introduction Key Fields & Signature Lines General Guidelines for Completing Forms Manual Updates: Sections of the Forms Instruction Manual…

2000: Recipient Baseline

Comprehensive Baseline & Follow-up Manuals » 2000: Recipient Baseline

A transplant center designated as a Comprehensive Report Form center will submit data on the Pre-TED Form, followed by either the Post-TED Form or the Comprehensive Report Forms. The type of follow-up form used for a specific recipient is determined by the CIBMTR’s…

Q108-127: Clinical Features and Laboratory Studies At Last Evaluation Prior to the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2039: HLH Pre-HCT » Q108-127: Clinical Features and Laboratory Studies At Last Evaluation Prior to the Start of the Preparative Regimen

Question 108: Anemia (Hgb < 9 g/dL): Indicate if the recipient had anemia at the last evaluation prior to the start of the preparative regimen. Anemia is defined as hemoglobin less than 9 g/dL. Select “yes,” “no,” or “unknown.” Question 109: Degranulation…

Key Fields & Signature Lines

General Instructions » Key Fields & Signature Lines

Key Fields Accuracy of the Key Fields is essential for ensuring that: Data are being reported for the correct recipient. Outcomes data accurately reflects appropriate transplant type and product for each transplant center. Data are being shared with the correct…

Appendix E: Definition of a Product

Appendices » Appendix E: Definition of a Product

The intention of this appendix is to define the term product and provide several examples of infusions using single and multiple products. This appendix will also provide direction with regard to reporting product infusion on the CIBMTR Infusion Form 2006. The…

Q3-12: Cell Product Source

Cellular Therapy Manuals » 4003: Cellular Therapy Product » Q3-12: Cell Product Source

Question 3-4: Date of cell product collection Report if the date of cell product collection is Known or Unknown. If the date of cell product collection is Known, report the date (YYYY-MM-DD) in question 4. If the date of cell product collection is Unknown, continue…

Q89-113: Disease Status at the Time of Evaluation for This Reporting Period

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q89-113: Disease Status at the Time of Evaluation for This Reporting Period

Question 89-90: Were tests for molecular markers performed (e.g. PCR)? If testing for molecular markers was performed during the reporting period, report “yes” and report the sample collection date of the most recent testing performed during the reporting period…

Q93-119: Other Laboratory Studies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q93-119: Other Laboratory Studies

Questions 93 – 94: Was hemoglobin electrophoresis performed? Indicate if hemoglobin electrophoresis studies were performed prior to the start of the preparative regimen / infusion. If hemoglobin electrophoresis studies were performed, report Yes and provide the date…

2900: Recipient Death

Comprehensive Baseline & Follow-up Manuals » 2900: Recipient Death

The Recipient Death Data (Form 2900) captures cause of death data fields for recipients on the on the Comprehensive Report Form and Cellular Therapy Essential Data follow-up tracks. The leading cause of post-transplant mortality is persistent, recurrent, or relapsed…

Q57-74 Mobilization Agents

Infection & Miscellaneous Manuals » 2565: Sanofi Mozobil Supplemental Data » Q57-74 Mobilization Agents

Question 57-74: Specify mobilization agents used Mobilization drugs are used to increase the number of hematopoietic progenitor cells in the recipient’s peripheral blood prior to collection by apheresis. Report “Yes” for any mobilization drugs given as part of…

2006: Hematopoietic Stem Cell Transplant (HCT) Infusion

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion

Centers must complete the Form 2006 for each product when the recipient is assigned to the Comprehensive Report Form track. Centers must also complete the Form 2006 for the following product types when the recipient is assigned to the Transplant Essential Data…

2113: CLL Post-Infusion

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion

The Chronic Lymphocytic Leukemia Post-Infusion Data Form is one of the Comprehensive Report Forms. This form captures CLL-specific post-infusion data such as: disease assessment at the time of best response to HCT or cellular therapy, laboratory studies at the time of…

Appendix O: Cellular Therapy Critical Fields

Appendices » Appendix O: Cellular Therapy Critical Fields

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…

4003: Cellular Therapy Product

Cellular Therapy Manuals » 4003: Cellular Therapy Product

This form must be completed for all products for recipients of non-HCT cellular therapy (including post-HCT “DCI / DLI” infusions). For recipients of hematopoietic cellular transplants (HCT), complete the Hematopoietic Stem Cell Transplant (HCT) Infusion (2006)…

2028: Aplastic Anemia Pre-Infusion

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2028: Aplastic Anemia Pre-Infusion

This section of the CIBMTR Forms Instruction Manual is intended to be a resource for completing the Aplastic Anemia Pre-Infusion Data Form (Form 2028 – Revision 3). *Email comments regarding the content of the CIBMTR Forms Instruction Manual to:…

Q36 – 51: Immune Reconstitution

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q36 – 51: Immune Reconstitution

!The Immune Reconstitution section can only be completed on the 100-day, 6-month, 1 year, and 2 year follow-up forms. These questions will be skipped for all subsequent reporting periods. These questions are intended to determine whether the recipient recovered their…

2115: JMML Post HCT

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2115: JMML Post HCT

This form must be completed for all recipients randomized to the Comprehensive Report Form (CRF) track whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as Myelodysplastic (MDS)/myeloproliferative (MPN) diseases and question 480…

2400: Pre-TED

Transplant Essential Data (TED) Manuals » 2400: Pre-TED

*The Pre-TED Form is now required for all transplants, including subsequent transplants on the comprehensive report form track. All transplant centers participating in the CIBMTR must submit a Pre-TED (2400) Form for each allogeneic (related or unrelated)…

Q33-57: Product Identification

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q33-57: Product Identification

Question 33: Are any of the products associated with this course of cell therapy genetically modified? Genetically modified products include any product that was manipulated to alter its gene expression through the insertion of different genes or editing of genes. An…

2100: Post-Infusion Follow-Up

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up

A transplant center designated as a Comprehensive Report Form center will submit data on the Pre-TED and Pre-TED Disease Classification Forms, followed by either the Post-TED Form or the Comprehensive Report Forms. The type of follow-up forms required for a specific…

2003: Gene Therapy Product

Gene Therapy Manuals » 2003: Gene Therapy Product

This form must be completed for all products for Gene Therapy recipients. All patients receiving a Gene Therapy product will be placed into the CRF track. For TED only reporting centers, Form 2003 will also need to be completed. The Gene Therapy Product (2003)…

Q224 – 247: Infection

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q224 – 247: Infection

Infections occur frequently in transplant patients. The following questions are intended to capture detailed information on clinically significant infections diagnosed during the reporting period. A single infection may be found on multiple cultures or at multiple…

Q44 – 82: Donor Information

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q44 – 82: Donor Information

Question 44: Multiple donors? Indicate if cells from multiple different donors (multiple CBUs, combinations of other products from different donors) are to be used for this HCT. If Yes, continue with question 45. If No, continue with question 46. For example,…

Q74-100: Other Laboratory Studies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q74-100: Other Laboratory Studies

Questions 74 – 75: Was hemoglobin electrophoresis performed? Indicate if hemoglobin electrophoresis studies were performed since the date of last report. If hemoglobin electrophoresis studies were performed, report Yes and provide the date of the most recent…

2814: Indication for CRID Assignment

Recipient Assignment, Indication, and Information Manuals » 2814: Indication for CRID Assignment

The Indication for CRID Assignment (Form 2814) collects information to initiate CIBMTR reporting on appropriate research or data collection forms. This form must be completed for the first indication requiring the individual to register for a CIBMTR Research ID (CRID).…

Historical Manual Updates

Getting Started » Historical Manual Updates

Welcome to the CIBMTR Forms Instruction Manual. The Table of Contents on the left side of the screen is for navigational purposes; if you are on a mobile device you may find the Table on Contents on the top of the page. General Instructions provides useful general…

2118: LYM Post-Infusion

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion

Complete this form for recipients whose primary disease, reported on the Disease Classification Form (Form 2402), is Hodgkin Lymphoma (HL) or non-Hodgkin Lymphoma (NHL). One exception is Waldenstrom’s macroglobulinemia / lymphoplasmacytic lymphoma, for which, a…

2018: LYM Pre-Infusion

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion

Complete this form for recipients whose primary disease, reported on the Disease Classification Form (Form 2402), is Hodgkin Lymphoma (HL) or non-Hodgkin Lymphoma (NHL). One exception is Waldenstrom’s macroglobulinemia / lymphoplasmacytic lymphoma, for which, a…

Q1-2: Primary Disease for HCT / Cellular Therapy

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q1-2: Primary Disease for HCT / Cellular Therapy

*Disease Classification Questions The newest versions of the TED Forms use the World Health Organization (WHO) disease classifications. The Disease Classification questions contain all of the established WHO disease types and subtypes. The “other, specify” category…

2018 Manual Updates

Getting Started » Historical Manual Updates » 2018 Manual Updates

December 2018 November 2018 October 2018 September 2018 August 2018 July 2018 June 2018 May 2018 April 2018 March 2018 February 2018 January 2018 Updates made during the current calendar year are included below. For updates prior to 2018, click on the subtopic…

2119: WM Post-HCT

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2119: WM Post-HCT

This form must be completed for all recipients randomized to the Comprehensive Report Form (CRF) track whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as Non-Hodgkin lymphoma and the subtype is reported as Waldenström’s…

Q1-3: Mobilization

Infection & Miscellaneous Manuals » 2565: Sanofi Mozobil Supplemental Data » Q1-3: Mobilization

Question 1-2: Did the recipient stay at a temporary location closer to the collection center for mobilization? (e.g., hotel) Report “Yes” for question one if the recipient stayed at a temporary location closer to the collection center for mobilization. If the…

2126: Neuroblastoma Post-Infusion

Comprehensive Disease-Specific Manuals » 2026/2126: Neuroblastoma » 2126: Neuroblastoma Post-Infusion

The Neuroblastoma Post-HCT Data Form is one of the Comprehensive Report Forms. This form captures neuroblastoma (NEU) post-HCT data for the reporting period. This form must be completed for all recipients whose primary disease, as reported on the Pre-TED Disease…

Q195-198: Disease Status at Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data » Q195-198: Disease Status at Time of Evaluation for this Reporting Period

Question 195: What was the disease status? Report the recipient’s disease status at the time of evaluation for this reporting period. Ensure the disease status is consistent with the international working group criteria provided in the in CML Response Criteria…

Q21-22: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2115: JMML Post HCT » Q21-22: Disease Status at the Time of Evaluation for this Reporting Period

Question 21: What was the disease status? Indicate the disease status of JMML as of the last evaluation during the reporting period. See JMML Response Criteria for disease status definitions. The center does not need to repeat all disease-specific assessments…

Q78-79: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2019/2119: Waldenström’s Macroglobulinemia (WM) » 2119: WM Post-HCT » Q78-79: Disease Status at the Time of Evaluation for this Reporting Period

Question 78: What is the current disease status? Indicate the disease status of WM or LPL at last evaluation during the reporting period. See WM Response Criteria for disease status definitions. The center does not need to repeat all disease-specific assessments…

Q1: Product

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q1: Product

Question 1: Name of Product: (for most recent cell therapy infusion) *If your center considers this to be a Donor Lymphocyte Infusions (DLI), as reported on the Pre-CTED (4000) form, product name will not be auto-populated. Select Other product for the product name.…

2114: Myelodysplastic Syndrome (MDS) Post-Infusion

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2114: Myelodysplastic Syndrome (MDS) Post-Infusion

This form must be completed for all recipients who are randomized to the Comprehensive Report Form (CRF) track and whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as “Myelodysplastic Syndrome (MDS) (50)” The Myelodysplastic…

2402: Disease Classification

Transplant Essential Data (TED) Manuals » 2402: Disease Classification

The Disease Classification Form is required for all transplants, including subsequent transplants on the comprehensive report form track and cellular therapy infusions when the indication is malignant hematologic disorder, non-malignant disorder or solid tumor. All…

2110: AML Post-Infusion

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2110: AML Post-Infusion

The Acute Myelogenous Leukemia Post-Infusion Data Form (Form 2110) is one of the Comprehensive Report Forms. This form captures AML-specific post-infusion data such as: the recipient’s best response to HCT or cellular therapy, cytogenetic and molecular findings at…

Q87-90: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion » Q87-90: Disease Status at the Time of Evaluation for this Reporting Period

Question 87: What is the current disease status? (by CT (radiographic) criteria) Indicate the current disease status, based on radiographic criteria, using the international working group criteria provided in LYM Response Criteria section of the Forms Instruction…

2553: VOD/SOS

Infection & Miscellaneous Manuals » 2553: VOD/SOS

The Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome (SOS) Form, Form 2553, must be completed when VOD / SOS has been reported to have developed on the 100 Day Post-HCT Data Form (F2100) or the 100 Day Post-TED Form (Form 2450). Additionally, a Six Month…

3500: Subsequent Neoplasms

Infection & Miscellaneous Manuals » 3500: Subsequent Neoplasms

The Subsequent Neoplasms (3500) form must be completed when a new malignancy is reported on a Post-HCT Follow-Up (2100) or Cellular Therapy Essential Data Follow-Up Form (4100) form. Reported new malignancies should be different than the disease / disorder for which…

2026: Neuroblastoma Pre-Infusion

Comprehensive Disease-Specific Manuals » 2026/2126: Neuroblastoma » 2026: Neuroblastoma Pre-Infusion

The Neuroblastoma Pre-HCT Data Form (Form 2026) is one of the Comprehensive Report Forms. This form captures neuroblastoma specific pre-HCT data such as: the recipient’s clinical and laboratory findings at the time of diagnosis and prior to the start of the…

2111: ALL Post-Infusion

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2111: ALL Post-Infusion

The Acute Lymphoblastic Leukemia Post-Infusion Data Form (Form 2111) is one of the Comprehensive Report Forms. This form captures ALL-specific post-infusion data such as: the recipient’s best response to HCT or cellular therapy, cytogenetic and molecular findings at…

Q1-13: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2010: AML Pre-Infusion » Q1-13: Disease Assessment at Diagnosis

Question 1: Is the disease (AML) therapy related? (not MDS / MPN) Agents such as radiation or systemic therapy used to treat other diseases (e.g., Hodgkin lymphoma, non-Hodgkin lymphoma, and breast cancer) can damage the marrow and lead to a secondary malignancy such…

Q63-64: Transformation

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2015: JMML Pre-HCT » Q63-64: Transformation

Question 63: Did transformation to acute myelogenous leukemia (AML) occur? Indicate if the recipient’s disease transformed to AML between initial diagnosis and the start of the preparative regimen. Approximately 10-15% of JMML cases will transform to AML.…

Q1-31: Infection Episode

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form » Q1-31: Infection Episode

Question 1: Organism This field is auto-populated to match the virus reported on the Post-HCT Follow-Up Data Form (Form 2100). Review the value to ensure it is accurate. A Viral Infection Diagnostic Form will come due for each CMV, EBV, ADV, HHV-6, and BK virus…

Q67 – 81: Additional Iron Overload Assessments

Comprehensive Disease-Specific Manuals » 2058/2158: Thalassemia » 2158: Thalassemia Post-Infusion » Q67 – 81: Additional Iron Overload Assessments

Questions 67 – 68: Serum iron A serum iron test is used to determine how much iron is in the serum. If the serum iron level is lower than normal, it indicates the body’s iron stores are low (iron deficiency). If the serum iron level is higher than normal, it could…

2013: CLL Pre-Infusion

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion

The Chronic Lymphocytic Leukemia Pre-Infusion Data Form is one of the Comprehensive Report Forms. This form captures CLL-specific pre-infusion data such as: disease assessment at diagnosis, laboratory studies at diagnosis, pre-infusion treatment for CLL, most recent…

2046 / 2146: Fungal Infection

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection

Fungal infections are significant opportunistic infections affecting transplant recipients. Because these infections are quite serious, it is important to collect additional information on them. Fungal infection specific forms (Form 2046 and 2146) collect more…

Q310: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q310: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder

*Combined Follow-Up In scenarios where both HCT and cellular therapy forms are being completed, duplicate questions will exist between the Cellular Therapy Essential Data Follow-Up (4100) form and the Post-HCT Data (2100) or Post-Transplant Essential Data (2450) form.…

Q43-88: Disease Relapse or Progression Post-HCT / Post-Infusion

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q43-88: Disease Relapse or Progression Post-HCT / Post-Infusion

Question 43: Was a disease relapse or progression detected since the date of last report? Refer to the international working group criteria provided in CLL Response Criteria section of the Forms Instructions Manual for more information on how to determine recurrence…

2017 Manual Updates

Getting Started » Historical Manual Updates » 2017 Manual Updates

December 2017 November 2017 October 2017 September 2017 August 2017 July 2017 June 2017 May 2017 April 2017 March 2017 February 2017 January 2017 !Hyperlinks Please note, hyperlinks on this page will not work for any manual sections which have been retired and / or…

2128: Aplastic Anemia Post-HCT

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2128: Aplastic Anemia Post-HCT

The Aplastic Anemia Post-HSCT Data Form is one of the Comprehensive Report Forms. This form captures aplastic anemia-specific post-HSCT disease assessment data for the reporting period. This form must be completed for all recipients whose primary disease, as reported…