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2820: Recipient Contact Information

Recipient Assignment, Indication, and Information Manuals » 2820: Recipient Contact Information

The Recipient Contact Information Form 2820 collects contact information on recipients who have agreed to be contacted directly by the CIBMTR for the purpose of inviting them to participate in research activities. If the recipient is a minor, contact information for…

Q1 – 23: Recipient Information

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q1 – 23: Recipient Information

Question 1: Date of Birth The date of birth is automatically populated based on the value reported in the CRID Assignment tool in FormsNet3. Verify that the date of birth is correct. If an error is noted, correct the CRID Assignment tool and verify that the date of…

Q6-8: Transfusion Therapy

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q6-8: Transfusion Therapy

Questions 6 – 7: Were red blood cell transfusions administered since the date of last report? Red blood cell (RBC) transfusions are often given as supportive care to lower hemoglobin S for recipients with Sickle Cell Disease (SCD). Indicate if the recipient…

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…

Q6-18: Transfusion Therapy

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q6-18: Transfusion Therapy

Question 6: Were any red blood cell (RBC) transfusions administered? Red blood cell (RBC) transfusions are often given as supportive care to lower hemoglobin S for recipients diagnosed with Sickle Cell Disease (SCD). If the recipient received any RBC transfusions…

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…

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…

Q6-12: Granulopoiesis / Neutrophil Recovery

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q6-12: Granulopoiesis / Neutrophil Recovery

!This 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. Absolute neutrophil recovery (ANC) recovery is defined as an ANC of ≥ 500/mm3 (or ≥ 0.5 ×…

Q6 – 52: Clinical Status Post-Infusion

Comprehensive Disease-Specific Manuals » 2037 / 2137 Leukodystrophies » 2137: Leukodystrophies Post-Infusion » Q6 – 52: Clinical Status Post-Infusion

*Clinical Status Post-Infusion The Clinical Status Post-Infusion section can only be answered for the six-month and annual reporting periods. This section will be disabled for the Day 100 reporting period. Questions 6 – 7: Was the total neurologic function scale…

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…

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…

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…

Q19-21: Iron Therapy

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q19-21: Iron Therapy

Question 19: Was iron chelation therapy received at any time? Iron chelation therapy is used to prevent or reduce iron overload. Examples include Deferoxamine (Desferal) and Deferasirox (Jadenu, Exjade). Select Yes if iron chelation therapy was performed at any time…

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…

Q1-21: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion » Q1-21: Disease Assessment at Diagnosis

*Subsequent Infusion If this is a report of a second or subsequent transplant or cellular therapy, check “yes” under the Subsequent Transplant or Cellular Therapy section of the form and continue with question 149. Questions 1-2: What was the date of diagnosis of…

Q51-105: Clinical Status of Recipient Post-HCT

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2133: WAS Post-HCT » Q51-105: Clinical Status of Recipient Post-HCT

Question 51: Did the recipient experience any types of bleeding (since the date of last report)? Due to WAS-associated thrombocytopenia, bleeding episodes are frequently observed. Indicate whether the recipient experienced any types of bleeding since the date of last…

Q104-117: Socioeconomic Information

Comprehensive Baseline & Follow-up Manuals » 2000: Recipient Baseline » Q104-117: Socioeconomic Information

Question 104: Is the recipient an adult (18 years of age of older) or emancipated minor? Indicate if the recipient is 18 years of age or older, or if under 18, has been declared an emancipated minor by law. An emancipated minor is a child who has been granted the…

Q1-9: Serological Evidence of Hepatitis Exposure / Infection – Recipient

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2147: Hepatitis Serology Post-HCT » Q1-9: Serological Evidence of Hepatitis Exposure / Infection – Recipient

Question 1: Hepatitis B core antibody (HBcAb) The total hepatitis B core antibody refers to both IgG and IgM antibodies produced by the body in response to the presentation of the core antigen by liver cells. Since core antigen is present only in infected liver cells…

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,…

Q7-26: History of Antiviral Therapy for Hepatitis – Recipient

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q7-26: History of Antiviral Therapy for Hepatitis – Recipient

Question 7: Did the recipient receive therapy for hepatitis prior to HCT? Hepatitis antiviral therapy is intended to prevent progression of the disease and minimize sequelae of infection. The National Institutes of Health (NIH) in the United States recommends…

Q1-6: Serological Evidence of Prior Hepatitis Exposure / Infection – Recipient

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q1-6: Serological Evidence of Prior Hepatitis Exposure / Infection – Recipient

Question 1: Specify and/or confirm previous Hepatitis B surface antigen (HBsAg) testing performed and reported on the Form 2000 – Recipient Baseline Data The hepatitis B surface antigen is a protein expressed on the surface of the hepatitis B virus. Its presence in…

Q1-3:Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)

Comprehensive Baseline & Follow-up Manuals » 2000: Recipient Baseline » Q1-3:Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)

*Infusion Without a Preparative Regimen Questions 1-3 must be answered even if no preparative regimen was given. Question 1: Does the recipient have a history of smoking cigarettes? The intent of this question is to determine the recipient’s history of smoking,…

Q144-170: Donor/Infant Demographic Information

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion » Q144-170: Donor/Infant Demographic Information

The Donor Demographic Information section (questions 144-170) is to be completed for all non-NMDP allogeneic donors / CBUs. If the stem cell product was from an NMDP donor or an autologous donor, continue with the signature lines at the end of the form. Question 144:…

Q83 – 86: Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q83 – 86: Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning)

Question 83: What scale was used to determine the recipient’s functional status? The CIBMTR uses the Karnofsky / Lansky scale to determine the functional status of the recipient immediately prior to the start of the preparative regimen. The Karnofsky Scale is…

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…

Q1-5: Vital Status

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q1-5: Vital Status

The date of actual contact with the recipient to determine medical status for this follow-up report is based on a medical evaluation conducted by a clinician with responsibility for the recipient’s care. Report the date of the medical evaluation performed closest to…

Q1 – 6: Survival

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q1 – 6: Survival

The date of actual contact with the recipient to determine medical status for this follow-up report is based on a medical evaluation conducted by a clinician with responsibility for the recipient’s care. Report the date of the medical evaluation performed closest to…

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…

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)…

2137: Leukodystrophies Post-Infusion

Comprehensive Disease-Specific Manuals » 2037 / 2137 Leukodystrophies » 2137: Leukodystrophies Post-Infusion

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

Q2-3: Survival

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q2-3: Survival

Question 2: Date of actual contact with the recipient to determine medical status for this follow-up report: Enter the date of actual contact with the recipient to evaluate medical status for this follow up report. In general, the date of contact closest to the…

Q201 – 207: Current GVHD Status

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q201 – 207: Current GVHD Status

Question 201: Are symptoms of GVHD still present on the date of actual contact (or present at the time of death)? This question refers to any symptoms of GVHD (acute and / or chronic) observed during the reporting period. This section of the form must be completed if…

2450: Post-TED

Transplant Essential Data (TED) Manuals » 2450: Post-TED

Transplant centers participating in the CIBMTR must submit a Post-TED Form for recipients who meet any of the following criteria: Recipient receives a transplant at a United States center designated as a TED-only center. Recipient receives a transplant at a United…

Q19 – 44: Graft versus Host Disease (Allogeneic Only)

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q19 – 44: Graft versus Host Disease (Allogeneic Only)

!Autologous Transplants If this was an autologous HCT, continue with the Liver Toxicity Prophylaxis section of the form. The graft-versus-host disease section should only be completed for allogeneic HCTs. Graft versus Host Disease (GVHD) is an immunological phenomenon…

Q12-20: Peripheral Blood Count Recovery

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q12-20: Peripheral Blood Count Recovery

!Questions 12 – 15 can only be completed on the 100 day and 6 month follow-up forms. These questions will be disabled for all subsequent reporting periods. Combined follow up In scenarios where an HCT was given after a cellular therapy and this form is now being…

Q311 – 334: Functional Status

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q311 – 334: Functional Status

!The Functional Status section will only be answered on the day 100 form. Centers will not be able to complete this section for any subsequent reporting periods. Question 311: Was the intent to complete the HCT procedure (conditioning, infusion, and period of recovery…

Q1 – 6: Current Hematologic Parameters

Comprehensive Disease-Specific Manuals » 2029/2129: Fanconi Anemia / Constitutional Anemia » 2129: Fanconi Anemia / Constitutional Anemia Post-HCT » Q1 – 6: Current Hematologic Parameters

Question 1: Was the recipient red blood cell (RBC) transfusion independent since the date of the last report? Indicate if the recipient was RBC transfusion independent for the entire reporting period. Some discretion may be required if the recipient received a…

2030: SCD Pre-Infusion

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion

SCD Pre-Infusion Data The Sickle Cell Disease (SCD) Pre-Infusion Data Form (Form 2030) is one of the Comprehensive Report Forms. This form captures SCD-specific pre-infusion data such as: disease classification at diagnosis, transfusion status prior to the start of…

Q1-6: Functional Status

Infection & Miscellaneous Manuals » 3501: Pregnancy Form » Q1-6: Functional Status

!If the female recipient or the male recipient’s female partner is pregnant at the time of submitting this form (created on-demand) or is pregnant on the reported contact date for the current reporting period (created as a result of reporting a pregnancy on the…

Q3-35: Hematologic Findings

Infection & Miscellaneous Manuals » 2540: Tepadina® Supplemental Data » Q3-35: Hematologic Findings

Questions 3-35: Hematologic Findings !Questions 3-35 can only be completed on the 100 day follow-up form. These questions will be skipped for all subsequent reporting periods. These questions are intended to determine the hematological status of the recipient after…

Q67-73: Disease Modifying Therapies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q67-73: Disease Modifying Therapies

Question 67: Were disease modifying therapies given or stopped since the date of last report? Indicate if the recipient received any disease modifying therapies (see question 68 for a list of common disease modifying therapies) or if the recipient discontinued a…

Getting Started

Getting Started

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…

Q21-35: Post-HCT or Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion » Q21-35: Post-HCT or Post-Infusion Therapy

!Post-Infusion Therapy Prior versions of the lymphoma post-infusion manuals have instructed centers to report treatment for persistent disease in the same data fields as treatment for relapse / progression. The current version of the manual instructs centers to report…

Q124 – 127: Current Disease Status

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q124 – 127: Current Disease Status

!Malignant Diseases Only Only complete the Current Disease Status section if the HCT being reported was given to treat a malignant disease. If the HCT being reported was given to treat a non-malignant disease, leave these questions blank. FormsNet3SM should enable /…

2130: SCD Post-Infusion

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion

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

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…

Q20-30: Current Assessment of Immunologic Fuction Post-HCT

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2134: XLP Post-HCT » Q20-30: Current Assessment of Immunologic Fuction Post-HCT

Question 20: Did the recipient receive supplemental intravenous immunoglobulins (IVIG)? IVIG is a product made from pooled human plasma that primarily contains IgG. It is used to provide immune-deficient recipients with antibody function to prevent infection.…

Q43-49: Treatment of Infection

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2146: Fungal Infection Post-Infusion Data » Q43-49: Treatment of Infection

Question 43: Did the recipient receive any therapy between 7 days prior to the date of infection diagnosis and the date of contact for this reporting period? Report “Yes” if the recipient received any antifungal treatment from seven days prior to the date of…

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…

Q1-25: Disease Assessment at the Time of Assessment for This Reporting Period

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2128: Aplastic Anemia Post-HCT » Q1-25: Disease Assessment at the Time of Assessment for This Reporting Period

Questions 1 – 2: Was the recipient red blood cell (RBC) transfusion independent for the entire reporting period? Indicate if the recipient was RBC transfusion independent for the entire reporting period. Some discretion may be required if the recipient received a…

Q43-98: Therapy

Infection & Miscellaneous Manuals » 2553: VOD/SOS » Q43-98: Therapy

Treatment for VOD/SOS is generally intended to normalize flow through the hepatic vessels by resolving the central venous and sinusoidal obstruction and preventing fibrosis. Supportive therapies such as hypertransfusions may also be started to improve renal and…

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…

3501: Pregnancy Form

Infection & Miscellaneous Manuals » 3501: Pregnancy Form

This form captures information regarding a female recipient’s or a male recipient’s female partner’s pregnancy. This form must be completed when a pregnancy is reported on a Cellular Therapy Essential Data Follow-Up (4100) Form. The Pregnancy (3501) Form will…

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…

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…

Q20-63: Pre-HCT or Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2011: ALL Pre-Infusion » Q20-63: Pre-HCT or Pre-Infusion Therapy

The FormsNet3SM application allows questions 28-63 to be reported multiple times. Complete these questions for each line of therapy administered on or after the date of diagnosis of ALL and prior to the start of the preparative regimen (or prior to infusion if no…

Q51-76: Therapy

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form » Q51-76: Therapy

Question 51: Did the recipient receive any therapy between 7 days prior to the date of infection diagnosis and the date of contact for this reporting period? Report “Yes” if the recipient received any antiviral medication between seven days prior to the date of…

Q70 – 80: Engraftment Syndrome

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q70 – 80: Engraftment Syndrome

!The Engraftment Syndrome section can only be completed on the 100-day follow-up form. These questions will be skipped for all subsequent reporting periods. Questions 70 – 71: Did engraftment syndrome occur? Engraftment syndrome typically occurs during neutrophil…

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…

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…

Q60-79: Graft vs. Host Disease

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q60-79: Graft vs. Host Disease

*Autologous Infusions Questions 60-77 should be completed for allogeneic infusions only. If this was an autologous infusion, continue to the “Toxicities” section. Combined follow up In scenarios where both HCT and cellular therapy forms are being completed, there…

Appendix D: How to Distinguish Infusion Types

Appendices » Appendix D: How to Distinguish Infusion Types

This appendix includes definitions of Hematopoietic Stem Cell Transplant (HCT), Cellular Therapies, Supplemental Infusions, and Autologous Cells Given for Graft Failure. For more information see Table 1. Table 1. Distinguishing Infusion Types* *A preparative…

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…

Q248 – 309: Organ Function

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q248 – 309: Organ Function

Links within section: Q248 – 261:Pulmonary Function Q262 – 267: Liver Toxicity Prophylaxis and Function Q268 – 279: Thrombotic Microangiopathy Q280 – 309: Other Organ Impairment / Disorder Pulmonary Function *Bacterial, Viral, and Fungal Pneumonia Report…

Q13-16: Megakaryopoiesis / Platelet Recovery

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q13-16: Megakaryopoiesis / Platelet Recovery

!The megakaryopoiesis / platelet recovery 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. The following questions refer to initial platelet recovery…

Q183-184: Pregnancy Status

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q183-184: Pregnancy Status

*Questions 183-184 This section focuses on fertility. This is an important section due to the possibility of some genetically modified cells persisting and possible transmission to the fetus. If a pregnancy is reported, complete the Pregnancy (3501) Form to answer…

Q52 – 69: Chimerism Studies

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q52 – 69: Chimerism Studies

*Autologous Transplants If this was an autologous HCT, continue with the Engraftment Syndrome section starting with question 108. Chimerism testing and graft-versus-host disease sections should only be completed for allogeneic HCTs. *Syngeneic Transplants If this was…

Q99-112: Maximum Severity

Infection & Miscellaneous Manuals » 2553: VOD/SOS » Q99-112: Maximum Severity

The following section is intended to capture the maximum severity of VOD/SOS during the current reporting period. If this form is being completed for the six month follow-up report the maximum values obtained during the current reporting period. Do not report values…

Q71-77: Transfusion Status from Diagnosis to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2028: Aplastic Anemia Pre-Infusion » Q71-77: Transfusion Status from Diagnosis to the Start of the Preparative Regimen / Infusion

Question 71: Were red blood cell transfusions received? Red blood cell (RBC) transfusions are often given as supportive care to re-establish baseline hemoglobin counts for recipients diagnosed with aplastic anemia. If the recipient received any RBC transfusions…

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…

Q101: Disease Status

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q101: Disease Status

Question 101: What is the status of sickle cell disease at the time of this report, or at the time of death? Report the status of the recipient’s sickle cell disease based on the Hb S and clinical symptoms at the time of evaluation, or death, for this reporting…

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,…

Q11-19: Post-HCT Therapy

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2115: JMML Post HCT » Q11-19: Post-HCT Therapy

Question 11: Was any therapy given for relapsed, persistent, or progressive disease since the date of last report? Indicate if the recipient received treatment for relapsed JMML during the current reporting period. Do not report therapy given for maintenance (to…

Q7 – 13: Subsequent Transplant

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q7 – 13: Subsequent Transplant

Question 7: Did the recipient receive a subsequent HCT since the date of last report? Indicate whether the recipient received a second (or third, etc.) hematopoietic stem cell infusion. Hematopoietic stem cells are defined as mobilized peripheral blood stem cells,…

Q154-163: Hospital Stay

Infection & Miscellaneous Manuals » 2553: VOD/SOS » Q154-163: Hospital Stay

The following questions are only completed for 100 Day follow-up forms. If this VOD/SOS Form is being completed for the six month follow-up, skip this section and submit the form (or continue to signature line if submitting a paper form). Question 154: Was the intent…

Q1-10: Infection Diagnosis

Infection & Miscellaneous Manuals » 2149: Respiratory Virus Post-Infusion Data » Q1-10: Infection Diagnosis

Question 1: Date of Infection Diagnosis The reported date of COVID-19 (SARS-CoV-2) diagnosis must match the diagnosis date reported on the corresponding follow-up form. Report the date the sample was collected for the first test which confirmed the diagnosis. The…

2020 Manual Updates

Getting Started » Historical Manual Updates » 2020 Manual Updates

January 2020 February 2020 March 2020 April 2020 May 2020 June 2020 July 2020 August 2020 October 2020 December 2020 Updates made during the current calendar year are included below. For updates prior to 2020, click on the subtopic corresponding to the year of…

Q64-99: Post-HCT / Post-Infusion Planned Therapy

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data » Q64-99: Post-HCT / Post-Infusion Planned Therapy

Question 64: Was therapy given since the date of last report for reasons other than relapse or progressive disease? (Include any maintenance and consolidation therapy.) Indicate if the recipient received treatment post-Infusion for reasons other than relapse,…

2133: WAS Post-HCT

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2133: WAS 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 Wiskott-Aldrich Syndrome under “disorders of the immune system.” The…

Q77-85: Other Symptoms

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q77-85: Other Symptoms

*Priapism: Questions 77 – 78 are applicable to only biologically male recipients. Question 77: Did one or more episodes of priapism occur? (to be answered for males only) Priapism is defined as prolonged erection of the penis, usually without sexual arousal. …

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

Question 310: Did a new malignancy, myelodysplastic, myeloproliferative, or lymphoproliferative disease / disorder occur that is different from the disease / disorder for which the infusion was performed? (Include clonal cytogenetic abnormalities, and post-transplant…

Q25-41: Therapy

Infection & Miscellaneous Manuals » 2149: Respiratory Virus Post-Infusion Data » Q25-41: Therapy

Question 25 : Did the recipient receive any therapy? For the initial form, report “Yes” if the recipient received therapy to treat the respiratory virus infection from 7 days prior to and up to 14 days after the diagnosis date reported in question 1. For the…

Q62-64: Pain

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q62-64: Pain

Question 62: Have vaso-occlusive pain episodes occurred that required hospitalization or treatment within the last 2 years? (treatment that is in a hospital or clinic setting) Vaso-occlusive pain, sometimes called a pain crisis, is a common painful complication of…

Q57-61: Acute Chest Syndrome

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q57-61: Acute Chest Syndrome

Question 57: Has acute chest syndrome (ACS) occurred in the last two years? Acute chest syndrome (ACS) is a term used to identify symptoms of chest pain, cough, fever, decreased oxygen (hypoxia), and lung infiltrates. Due to the sickling nature of red blood cells as a…

Q65 – 84: Chimerism Studies (Cord Blood Units, Beta Thalassemia, and Sickle Cell Disease Only)

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q65 – 84: 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…

Q44-46: Pain

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q44-46: Pain

Question 44: Has vaso-occlusive pain occurred requiring hospitalization or treatment? (treatment that is in a hospital or clinic setting since the date of last report) Vaso-occlusive pain, sometimes called a pain crisis, is a common painful complication of sickle cell…

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…

Q1-22: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2039: HLH Pre-HCT » Q1-22: Disease Assessment at Diagnosis

Question 1: Is this recipient a registered participant in the United States Immunodeficiency Network (USIDNET)? The United Stated Immunodeficiency Network (USIDNET) is a research consortium studying primary immune deficiencies. They maintain a registry of primary…

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…

Q18-37: Antiviral Therapy for Hepatitis

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2147: Hepatitis Serology Post-HCT » Q18-37: Antiviral Therapy for Hepatitis

This section is related to antiviral therapy given to the recipient. Question 18: Was therapy given for hepatitis since the date of the last report (or, if this is the first post-HCT report, since diagnosis)? Hepatitis antiviral therapy is intended to prevent…

Q449-450: Inherited Bone Marrow Failure Syndromes

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q449-450: Inherited Bone Marrow Failure Syndromes

*Note: Primary Disease for Infusion: If the recipient was diagnosed with an inherited bone marrow failure syndrome and developed MDS or AML, report the primary disease for infusion as MDS or AML, respectively. Questions 449: Specify the inherited bone marrow failure…

Q1-25: Infection Episode

Infection & Miscellaneous Manuals » 2046 / 2146: Fungal Infection » 2046: Fungal Infection Pre-Infusion Data » Q1-25: Infection Episode

Question 1: Organism This field is auto-populated to match the fungus reported on the Baseline Form (Form 2000). Review the value to ensure it is accurate. A Fungal Infection Pre-Infusion Data Form will come due for each applicable infection reported on the Baseline…

Q142 – 176: Familial History of Disease

Comprehensive Disease-Specific Manuals » 2029/2129: Fanconi Anemia / Constitutional Anemia » 2029: Fanconi Anemia / Constitutional Anemia Pre-HCT » Q142 – 176: Familial History of Disease

Questions 142 – 148: Were any other genetically related family members affected? Indicate Yes or No if any other genetically related family members have been diagnosed with Fanconi Anemia. This includes a sibling, cousin, parent, aunt / uncle, or other…

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…

2047: Hepatitis Serology Pre-HCT

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT

The Hepatitis Serology Pre-HCT Data, Form 2047, will come due when any of the following IDMs are reported as “positive” on the Form 2000, Recipient Baseline Data: Hepatitis B surface antigen Hepatitis B core antibody Hepatitis B DNA Hepatitis C…

Q86-92: Disease Modifying Therapies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q86-92: Disease Modifying Therapies

Question 86: Were disease modifying therapies given? (excludes blood transfusions) Indicate if the recipient received disease modifying therapies (see question 87 for a list of common disease modifying therapies) at any time between diagnosis and the start of 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…

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)…

Q17 – 18: Initial Platelet Recovery

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q17 – 18: Initial Platelet Recovery

!Initial Platelet Recovery The Initial Platelet Recovery 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. Optional for Non-U.S. Centers The following…

Q14 – 16: Initial ANC Recovery

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q14 – 16: Initial ANC Recovery

!Initial ANC Recovery The Initial ANC Recovery questions 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. Question 16 must be answered on all follow-up…