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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…

Q22-26: Pulmonary Assessments

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q22-26: Pulmonary Assessments

Questions 22 – 23: Were pulmonary function tests (PFT) performed? (If PFT tests were conducted we ask that you attach the most recent report) Indicate if pulmonary function tests (PFTs) were performed prior to the start of the preparative regimen / infusion. If…

Q35-38: Infection

Comprehensive Baseline & Follow-up Manuals » 2000: Recipient Baseline » Q35-38: Infection

Question 35: Did the recipient have a history of clinically significant fungal infection (documented or suspected) in the 6 months prior to the start of the preparative regimen? Fungal infections play a major role in the clinical outcome of a transplant recipient. The…

Q22-40: Product Processing / Manipulation

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion » Q22-40: Product Processing / Manipulation

Question 22: Was the product thawed from a cryopreserved state prior to infusion? If any portion of the product was thawed prior to this infusion, select “yes” and continue with question 23. If the product was never cryopreserved, select “no” and continue…

Q22-73: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2013: CLL Pre-Infusion » Q22-73: Laboratory Studies at Diagnosis

All values reported in questions 22-73 must reflect testing performed prior to any treatment of CLL/SLL/PLL. If testing was not performed near the time of diagnosis and prior to the initiation of treatment, the center should report unknown for that value. An exception…

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 – 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…

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,…

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…

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:…

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…

Q38-42: Splenic Assessments

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q38-42: Splenic Assessments

*NOTE: Splenic Assessments Questions 38 – 42 will only be applicable for the 100-day, 6-month, 1 year, and 2-year follow-up periods. Questions 38 – 42 will be disabled for annual reporting > 2 years. Question 38: Was splenic function assessed? Evaluation of…

Q27-42: Post-HCT / Post-Infusion Planned Therapy

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q27-42: Post-HCT / Post-Infusion Planned Therapy

Question 27: 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,…

Q38-46: Cell Product Analysis

Cellular Therapy Manuals » 4003: Cellular Therapy Product » Q38-46: Cell Product Analysis

*This section applies only to products that are not commercially available. If a commercially available product (e.g., Kymriah® or Yescarta®, TecartusTM, BreyanziTM, Abecma®) or pre-commercial product was selected in question one, continue to question…

Q30 – 68: Product Analysis (All Products)

Gene Therapy Manuals » 2003: Gene Therapy Product » Q30 – 68: Product Analysis (All Products)

*Reporting Multiple Instances of Product Analysis To report multiple instances of product analysis, complete questions 30-68 by adding additional instances in FormsNet3SM Question 30: Specify the timepoint in the product preparation phase that the product was…

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…

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…

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…

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…

Q31-41: Laboratory Studies at the Time of Evaluation for This Reporting Period

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2134: XLP Post-HCT » Q31-41: Laboratory Studies at the Time of Evaluation for This Reporting Period

Questions 31-32: Serum ferritin Indicate whether serum ferritin level was “known” or “unknown” during the reporting period. If “known,” report the value and unit of measure documented on the laboratory report in question 32. If there are multiple values…

Q2-5: Disease Classification at Diagnosis

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q2-5: Disease Classification at Diagnosis

*Note: When reporting data on the Sickle Cell Disease (SCD) Pre-Infusion Data Form (Form 2030 – Revision 3), report all findings at any time prior to the start of the preparative regimen, unless otherwise specified. If no preparative regimen was given, report all…

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…

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…

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…

Q35-54: History of Antiviral Therapy for Hepatitis – Donor

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology » 2047: Hepatitis Serology Pre-HCT » Q35-54: History of Antiviral Therapy for Hepatitis – Donor

Complete questions 35-54 for allogeneic transplants only; if donor information is unknown, leave the data field blank. Complete all data fields for which relevant donor information is documented and available to the CIBMTR center completing the form. Question 35: Did…

Q38-46: Hepatic Assessments

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q38-46: Hepatic Assessments

Question 38: Was a liver MRI conducted? Indicate if a liver MRI was conducted at any time between diagnosis and the start of the preparative regimen / infusion. If a liver MRI was performed, report Yes. If multiple liver MRIs were performed, report the most recent…

Q31-47: Optional Antigen Reporting

Comprehensive Baseline & Follow-up Manuals » 2005: Confirmation of HLA Typing » Q31-47: Optional Antigen Reporting

Questions 31-33: Number of C antigens provided Indicate if one or two HLA-C antigens were tested. If one antigen was tested, report the first antigen specificity in question 32 and continue with question 34. If two antigens were tested, report the first antigen…

Providing Feedback

Getting Started » Providing Feedback

For each manual section, an opportunity to provide feedback is offered at the bottom of the page. Select “Was this helpful?” with “yes” and “no” options; note that identifying information is not attached to your vote. To add a specific comment, it will be…

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…

2134: XLP Post-HCT

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2134: XLP 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 “disorders of the immune system” and question 628 as X-Linked…

2139: HLH Post-HCT

Comprehensive Disease-Specific Manuals » 2039/2139: Hemophagocytic Lymphohistiocytosis (HLH) » 2139: HLH Post-HCT

The Hemophagocytic Lymphohistiocytosis Post-HCT Data Form is one of the Comprehensive Report Forms. This form captures HLH-specific Post-HCT data such as the disease assessment since the date of the last report. This form must be completed for all recipients…

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…

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…

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…

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…

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…

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…

2131: ID Post-HCT

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2131: ID Post-HCT

The Immune Deficiency Post-HCT Data Form is one of the Comprehensive Report Forms. This form captures ID-specific post-HCT data such as: laboratory studies post-HCT, clinical features assessed post-HCT, Post-HCT treatment, and status of hematologic engraftment. This…

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…

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…

2011: ALL Pre-Infusion

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

The Acute Lymphoblastic Leukemia Pre-Infusion Data Form (Form 2011) is one of the Comprehensive Report Forms. This form captures ALL-specific pre-infusion data such as: the recipient’s hematologic findings at the time of diagnosis and prior to the start of the…

Q11-40: Diagnostic Studies (Measured Prior to First Disease Treatment)

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion » Q11-40: Diagnostic Studies (Measured Prior to First Disease Treatment)

Report findings prior to any first treatment of the primary disease for which the HCT / cellular therapy is being performed. If the recipient’s MPN transformed, report the studies from the original diagnosis. If multiple studies were performed prior to the start of…

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…

2116: PCD Post-Infusion

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion

The Plasma Cell Disorder Post-HCT Data Form is one of the Comprehensive Report Forms. This form captures plasma cell disorder (PCD) post-HCT data such as: disease assessment at the time of best response, hematologic and organ parameters at the time of best response,…

Q18-83: Laboratory Studies at Diagnosis

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2012: CML Pre-Infusion Data » Q18-83: Laboratory Studies at Diagnosis

All values reported in questions 18-83 must reflect testing performed prior to any treatment of CML. If testing was not performed near the time of diagnosis and prior to the initiation of treatment, report unknown for that value. If the exact date of sample…

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…

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…

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…

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…

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…

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…

2157: Myeloproliferative Neoplasm (MPN) Post-Infusion

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2157: Myeloproliferative Neoplasm (MPN) 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 “Myeloproliferative Neoplasm (MPN) (1460)”. The…

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…

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…

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…

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…

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…

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.…

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…

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…

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…

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…

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…

2047 / 2147: Hepatitis Serology

Infection & Miscellaneous Manuals » 2047 / 2147: Hepatitis Serology

Hepatitis is a general term referring to non-specific inflammation of the liver, which can be caused by multiple conditions, including viral infection. This form is intended to capture information regarding two forms of viral hepatitis infections, Hepatitis B and…

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 ×…

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 /…

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…

Appendix H: MDS/MPN Subtypes

Appendices » Appendix H: MDS/MPN Subtypes

The following MDS / MPN subtypes are used on the Pre-TED Disease Classification (2402) Form, AML Pre-Infusion (2010), the MDS Pre-Infusion (2014) Form, and the MPN Pre-Infusion (2057) Form.1 Myelodysplastic Syndrome (MDS) Subtypes Myelodysplastic Syndrome with…

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…

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…

2005: Confirmation of HLA Typing

Comprehensive Baseline & Follow-up Manuals » 2005: Confirmation of HLA Typing

For transplants using an NMDP donor or cord blood unit, the donor’s HLA typing is reported on NMDP Form 22 (Confirmation of Donor HLA Typing) and the recipient’s HLA typing is reported on NMDP Form 117 (Final Recipient HLA Typing). In all other situations, the…

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…

Q1-43: Laboratory Studies Post-HCT

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2131: ID Post-HCT » Q1-43: Laboratory Studies Post-HCT

To be completed in conjunction with a form 2100 – 100 Days Post-HCT Data, 2200 – Six Months to Two Years Post-HCT Data, or Form 2300 – Yearly Follow-Up for Greater than Two Years Post-HCT Data. Information reported here should reflect the date of last contact as…

Q16-37: Cell Product Manipulation

Cellular Therapy Manuals » 4003: Cellular Therapy Product » Q16-37: Cell Product Manipulation

*This section applies only to products that are not commercially available. If a commercially available product (e.g., Kymriah®, Yescarta®, TecartusTM, BreyanziTM, Abecma®) or pre-commercial product was selected in question one, continue to question 38. *This…

Appendix B: Glossary of Terms

Appendices » Appendix B: Glossary of Terms

General Terms absolute neutrophil count (ANC) Neutrophils are a type of white blood cell that helps protect the body from infection. The number of neutrophils in a recipient’s blood is used to track recovery after chemotherapy or HSCT. In some types of HSCT, 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…

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…

Q1-40: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2110: AML Post-Infusion » Q1-40: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Question 1: What was the best response to HCT or cellular therapy since the date of the last report? (Include response to any therapy given for post-HCT / post-infusion maintenance or consolidation, but exclude any therapy given for relapsed, persistent or progressive…

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.…

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:…

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…

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,…

Q1-2: 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…

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…

Q35-59: Persistence of Cells

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q35-59: Persistence of Cells

!This section pertains to the evaluation of persistence of a cellular product in the recipient and only applies to genetically-modified cellular therapy products. Question 35: Were tests performed to detect persistence of the cellular product since the date of last…

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…

Q1-72: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2114: Myelodysplastic Syndrome (MDS) Post-Infusion » Q1-72: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy

Best response is based on response to the HCT or cellular therapy infusion, but does not include response to any therapy given for disease relapse or progression post-HCT or post-cellular therapy. When determining the best response to HCT or cellular therapy infusion,…

POEMS Response Criteria

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » POEMS Response Criteria

General Reporting Guidelines Use the POEMS response criteria when determining the disease status for POEMS. Immunofixation (IFE) and immunoelectrophoresis (IEP) are essentially measuring the same thing and either may be used to determine CR. Electrophoresis (SPEP…

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…

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…

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…

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,…

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…

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…

Q33-51: Assessment of Immunologic Function at Diagnosis

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT » Q33-51: Assessment of Immunologic Function at Diagnosis

Report findings from immune function studies at the time of diagnosis; if multiple studies were performed, report the initial values. Question 33: NK cell function Natural killer (NK) cells are cytotoxic lymphocytes implicated in viral response and tumor…

Q1-63: Disease Assessment at the Time of Best Response

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data » Q1-63: Disease Assessment at the Time of Best Response

Question 1: What was the best response to HCT or cellular therapy since the date of the last report? (include response to any therapy given for post-HCT maintenance or consolidation, but exclude any therapy given for relapsed, persistent, or progressive disease) The…

Q36-86: Disease Relapse or Progression Since the Date of Last Report

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion » Q36-86: Disease Relapse or Progression Since the Date of Last Report

Question 36: Did the recipient experience a relapse or progression since the date of the last report? (by any method) Relapse / progression may be detected by imaging assessments (CT, PET, MRI) as well as molecular, cytogenetic, and clinical / hematologic methods.…

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…

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…

Q77: Infection Status at the Time of Evaluation for this Reporting Period

Infection & Miscellaneous Manuals » 2150: Viral Infection Diagnosis and Treatment Form » Q77: Infection Status at the Time of Evaluation for this Reporting Period

Question 77: What was the infection status at the time of evaluation for this reporting period? Report the status of the viral infection on the date of contact for this reporting period (refer to the corresponding follow-up form) based on the primary care provider’s…