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 background information for successfully completing forms.

2804/2814: CRID Assignment and Indication provides explanatory text used to generate a CIBMTR Research ID (CRID) and report the indication.

Transplant Essential Data (TED) Manuals provides explanatory text for each question found on the TED forms.

Comprehensive Baseline & Follow-up Forms Manuals provides explanatory text for each question on the Baseline, Follow-up, IDMs, HLA, and Infusion forms.

Comprehensive Disease Specific Manuals provides explanatory text and additional information for disease indications requiring CIBMTR reporting.

Cellular Therapy Manuals provides explanatory text for completing pre-infusion, infusion, and post-infusion forms

Infection & Miscellaneous Manuals provides explanatory text for manuals such as the Hepatitis Serology, VOD / SOS, and Myelofibrosis CMS Study forms.

Appendices provide additional information beyond the scope of the other manuals.

Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. In addition to documenting the changes within each manual section, the most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.

Date	Manual Section	Add/Remove/Modify	Description
4/30/2025	4100: Cellular Therapy Essential Data Follow-Up	Add	Added new warning box above question 47: Effective April 30th, 2025, report only toxicities (e.g. CRS, neurotoxicity, etc.) that are directly attributed to the CAR-T product / infusion. It is no longer required to report any toxicity regardless of causality. Treatment given post-infusion may have the effect of re-activating the product and inducing toxicities (e.g. CRS), these toxicities should NOT be captured in this section of the form. Contact CIBMTR Center Support with questions.
4/30/2025	4100: Cellular Therapy Essential Data Follow-Up	Remove	Removed the blue note box above question 47: Report any observed toxicity or infection that occurs post-infusion in this reporting period, regardless of causality and whether or not treatment was administered. The intent is to capture all toxicities diagnosed after the cellular therapy infusion. Although treatment given post-infusion may have the effect of re-activating the product and inducing toxicities (e.g. CRS), these toxicities should still be captured in this section of the form.
4/19/2025	2013: CLL Pre-Infusion	Add	Disease Assessment at the Last Evaluation and CLL to NHL Transformations blue note box added to Q105: Disease Assessments at the Last Evaluation and CLL to NHL Transformations: When CLL has transformed to NHL, the disease assessment at the last evaluation section will be disabled.
4/19/2025	3501: Pregnancy Form	Add	Version 2 of the 3501 Pregnancy Form section of the Forms Instructions Manual released. Version 2 corresponds to revision 3 of the Form 3501.
4/19/2025	2400: Pre-TED	Add	Gene therapy examples 6 and 7 added to Q75: Example 6 (single product): a single mobilization event, even when collected over several days Example 7 (single product): A recipient may require multiple mobilizations, and possibly multiple manufacturing steps, for the final product intended for infusion. It should be considered a single gene therapy product, regardless of how many mobilizations or steps required for manufacturing.
4/19/25	Q12-14: Best Response to Cellular Therapy	Add	Added blue box above question 13: If a subsequent cellular therapy was given for disease relapse / progression and the F4000 was made NRQ, the best response prior to the relapse/ progression should be reported.
4/19/2025	MDS Post-HCT	Modify	Correct typo in Q229: Indicate if the recipient’s disease status was assessed by any other assessment at the time of evaluation for this reporting period. Indicate “yes” if the disease status was assessed by other assessment at the time of evaluation for this reporting period, report the date of assessment in question 230, and specify the name of the other assessment in question 231. Indicate “no” if the disease status was not assessed by other assessment at the time of best response evaluation for this reporting period and continue with question 233.
4/19/2025	2013: CLL Pre-Infusion	Modify	Clarification: Systemic symptoms or B symptoms (also known as constitutional symptoms) include unexplained fever > 38˚ C (100.4˚ F), night sweats, and / or unexplained weight loss of >10% of body weight in six months before treatment diagnosis. Specify if the recipient had B symptoms within six months prior to the diagnosis. If it is unclear if symptoms were present within six months prior to the diagnosis, seek physician clarification.
4/19/2025	2100:Post-Infusion Follow-Up Form	Add	Instructions clarified when to report Yes or No for coronary artery disease: Indicate if the recipient experienced a cardiac impairment or disorder. Review the list below to determine if the condition should be reported as cardiac impairment / disorder. Refer to Table 5. Cardiac Impairments for an overview of when to report the impairment. If Yes, report the onset date, specify if the impairment / disorder, and answer any other applicable questions. If the cardiac impairment or disorder is an arrhythmia, cardiomyopathy, unstable angina, hypertension requiring treatment, pericarditis, coronary artery disease (CAD), or heart valve disease, use the following guidelines to determine when to report Yes or No:
4/19/2025	2157: Myeloproliferative Neoplasm (MPN) Post-HCT	Modify	Correct typo in Q272: Indicate if the recipient’s disease status was assessed by any other assessment at the time of evaluation for this reporting period. Indicate “yes” if the disease status was assessed by other assessment at the time of evaluation for this reporting period, report the date of assessment in question 273, and specify the name of the other assessment in question 274. Indicate “no” if the disease status was not assessed by other assessment at the time of best response evaluation for this reporting period and continue with question 276.
4/19/2025	Reporting Instructions Overview: Contact Dates – Subsequent Infusions and Contact Dates	Add	Example 4 added: The recipient had a subsequent auto transplant for graft failure and death occurred in the same reporting period. The recipient has their first transplant on 3/1/2023 and a subsequent auto transplant for the indication of graft failure/insufficient hematopoietic recovery on 4/15/2023 and death occurred on 5/20/2023. Report the Day 100 contact date as the date of death, 5/20/2023.
4/19/2025	Reporting Instructions Overview: Contact Dates – Subsequent Infusions and Contact Dates	Add	Subsequent Cell Therapy and Death blue box added: Subsequent Cell Therapy and Death: For a subsequent cellular therapy, if the Cellular Therapy Essential Data Pre-Infusion (4000) is requested via CIBMTR Center Support to be made “NRQ”, the death and subsequent infusion can be reported on the same form.
4/19/2025	Reporting Instructions Overview: Contact Dates – Subsequent Infusions and Contact Dates	Add	Example 9 added: The recipient had a subsequent non-genetically modified cellular therapy and death occurred in the same reporting period. The recipient has their first transplant on 1/21/23 and a non-genetically modified cellular therapy infusion on 2/15/23. Death occurred on 3/1/23. Report the Day 100 contact date as the date of death, 3/1/23
4/19/2025	2014: Myelodysplastic Syndrome (MDS) Pre-Infusion	Add	ET or PCV to MDS Transformation and Disease Assessments at Diagnosis blue note box added above Q2: ET or PCV to MDS Transformation and Disease Assessments at Diagnosis: If MDS transformed from ET or PCV, report assessments from the time of the MDS transformation. Do not report assessments from the time of ET or PCV diagnosis.
4/19/2025	2402: Disease Classification	Add	ET or PCV to MDS Transformation and Disease Assessments at Diagnosis blue note box added above Q201: ET or PCV to MDS Transformation and Disease Assessments at Diagnosis: If MDS transformed from ET or PCV, report assessments from the time of the MDS transformation. Do not report assessments from the time of ET or PCV diagnosis.
3/6/2025	2037: Leukodystrophies Post-Infusion	Add	New blue note box above question 45: Neurocognitive Assessment (3503) Form: The Neurocognitive Assessment Form will only come due for recipients enrolled in CIBMTR study CS20-51 when a neurocognitive test was administered.
3/6/2025	2137: Leukodystrophies Post-Infusion	Add	New blue note box above question 45: Neurocognitive Assessment (3503) Form: The Neurocognitive Assessment Form will only come due for recipients enrolled in CIBMTR study CS20-51 when a neurocognitive test was administered.
2/20/2025	3505: Transfusion	Add	New blue note box above question 1: Zyntelgo®, For the 100d follow up form, include the last RBC transfusion given prior to discharge from the hospital post-infusion.
2/20/2025	3505: Transfusion	Add	New blue note box above question 6: Zyntelgo®, Report only the first and last platelet transfusion in the reporting period.
1/28/2025	2814: Indication for CIBMTR Data Reporting	Modify	Added new floating text to the non-cellular therapy option: Indicate whether the individual will be receiving an Infusion (e.g., hematopoietic cellular transplant (HCT), gene therapy, cellular therapy), Marrow toxic injury, or Non-cellular therapy (e.g., study enrollment, chemotherapy, immunotherapy, etc.).
1/28/2025	2814: Indication for CIBMTR Data Reporting	Remove	Removed the red warning box: Non-cellular Therapy: There are currently no active studies for this option. If this seems to be incorrect, submit a CIBMTR Center Support ticket
1/28/2025	2814: Indication for CIBMTR Data Reporting	Add	New blue note box added: CMS Innovation Center’s Cell and Gene Therapy (CGT) Access Model for Sickle Cell Disease (SCD) Select “non-cellular therapy” when completing this form for the first time for a CRID to be enrolled in the CMS Innovation Center’s Cell and Gene Therapy (CGT) Access Model for Sickle Cell Disease (SCD). Contact CIBMTR Center Support with any questions.
1/24/2025	3507: Solid Tumor Response	Add	Version 1 of the Solid Tumor Response section of the Forms Instructions Manual released. Version 1 corresponds to revision 1 of the Form 3507.
1/24/2025	2059 Solid Tumor Pre-Infusion	Add	Version 1 of the Solid Tumor Pre-Infusion section of the Forms Instructions Manual released. Version 1 corresponds to revision 1 of the Form 2059.
1/24/2025	2554: CMS Registration	Add	Version 1 of the CMS Registration section of the Forms Instructions Manual released. Version 1 corresponds to revision 3 of the Form 2554.
1/24/2025	2402: Disease Classification	Remove	Instructions in Q180 updated: CIBMTR captures the classification of ambiguous lineage and other myeloid neoplasms based on the World Health Organization (WHO) 2022. Indicate the other acute leukemia disease classification at diagnosis. If the subtype is not listed, report as Other acute leukemia of ambiguous lineage or myeloid neoplasm and specify the reported disease. Acute undifferentiated leukemia is a type of AML characterized by immature predominating cells that cannot be classified. Biphenotypic, bilineage, or hybrid leukemias have characteristics representative of both myeloid and lymphoid lineages. Mast cell leukemia is characterized by an increased number of tissue mast cells in the peripheral blood.
1/24/2025	2402: Disease Classification	Add	Myelodysplastic/myeloproliferative neoplasm with neutrophilia and Disease Status added above Q195 and Q390: Myelodysplastic/myeloproliferative neoplasm with neutrophilia and Disease Status: As of October 2024, atypical CML is captured as an MDS and the disease classification is reported as Myelodysplastic/myeloproliferative neoplasm with neutrophilia. The disease status for Myelodysplastic/myeloproliferative neoplasm with neutrophilia will be reported in the Other Leukemia section of the form.
1/24/2025	ALL Response Criteria	Add	Relapse Criteria blue box added for clarification: Relapse Criteria: The Disease presence determined by a physician upon clinical assessment criteria is not if there is only disease detected by MRD or other methods of assessment (i.e., molecular, cytogenetics, flow cytometry). In order to report relapse, disease must be detected by clinical / hematologic assessments.
1/24/2025	AML Response Criteria	Add	Relapse Criteria blue box added for clarification: Relapse Criteria: The Disease presence determined by a physician upon clinical assessment criteria is not if there is only disease detected by MRD or other methods of assessment (i.e., molecular, cytogenetics, flow cytometry). In order to report relapse, disease must be detected by clinical / hematologic assessments.
1/24/2025	2130 SCD Post-Infusion	Modify	Abdominal Girth red warning box above Q2 updated: p(banner important). Abdominal girth and Blood Pressure: Abdominal girth and blood pressure are is currently disabled and cannot be answered at this time.
1/24/2025	2100:Post-Infusion Follow-Up Form	Remove	Instructions in Q48 updated: Lymphocyte analyses are often performed post-HCT to evaluate the reconstitution of the immune system. Certain lymphocyte groups repopulate earlier than others post-HCT. If lymphocyte testing was performed, select all lymphocytes tested during the reporting period and answer the subsequent questions as follows. CD3 (T cells) CD4 (T helper cells) CD8 (cytotoxic T cells) CD19 (B lymphocyte cells) CD20 (B lymphocyte cells) CD56 (natural killer (NK) cells) If lymphocyte testing was not completed during the reporting period, select No lymphocyte analyses performed.
1/24/2025	2018: LYM Pre-Infusion	Add	Richter’s transformation blue note box added above Q166: Richter’s Transformation: If completing the form for a recipient whose disease has undergone Richter’s transformation prior to infusion, only report therapy administered since the transformation to lymphoma on the Lymphoma Pre-Infusion (2018) Form. Any therapy given prior to transformation will be reported on the CLL Pre-Infusion (2013).
1/24/2025	4101: Post-Cellular Therapy Follow-Up	Add	New blue note box above question 21: There are currently no commercially available persistence tests for the commercially available BCMA CAR-T products (e.g. Abecma, Carvykti. You may select No for the question Were tests performed to detect persistence of the cellular product since the date of last report?.
1/24/2025	4101: Post-Cellular Therapy Follow-Up	Modify	Modified blue note box above question 21: There is a are currently no commercially available persistence tests for the commercially available CD19+ CAR-T products (e.g. Kymriah, Yescarta, Tecartus, Breyanzi , Abecma, Carvykti). You may still select No for the question Were tests performed to detect persistence of the cellular product since the date of last report? but please confirm if your site is using the new persistence test.
1/24/2025	2028: Aplastic Anemia Pre-Infusion	Add	Instructions updated to clarify leukodepleted and leukoreduced can be used interchangeably: Red blood cells may be leukodepleted (may also be documented as leukoreduced) to prevent post-transfusion complications by reducing the number of WBCs transfused. This information is typically found within the “blood blank” or “transfusion history” information. Report Yes if any of the red blood cells administered between diagnosis and the start of the preparative regimen / infusion were leukodepleted or leukoreduced. If none of the red blood cells administered between diagnosis and the start of the preparative regimen were leukodepleted or leukoreduced, report No. If it is not known if the red blood cells were leukodepleted or leukoreduced, seek clarification from the blood bank. If it cannot be determined if leukodepleted or leukoreduced red blood cells were administered prior to the start of the preparative regimen, report Unknown.
1/24/2025	2100:Post-Infusion Follow-Up Form	Add	Instructions updated how to report the work status in Q408: Select the work status that best describes the recipient’s current or most recent employment during this reporting period. If the recipient is Retired, specify their retirement status. If the recipient’s status is anything other than Full time, indicate if the recipient claimed and received medical disability due to any illness.
1/24/2025	2100:Post-Infusion Follow-Up Form	Remove	Update diabetes / hyperglycemia requiring chronic treatment description to match Table 8 in Q341 – 349: Endocrine Impairments Diabetes / hyperglycemia requiring chronic treatment: high blood glucose levels. Diabetes / hyperglycemia should only be reported if insulin and / or oral medication is required for treatment. Diabetes / hyperglycemia controlled through diet and exercise should not be reported. Only select this option if the recipient developed diabetes / hyperglycemia requiring treatment post-infusion. Do not report this disorder if the recipient had a diagnosis and was on treatment prior to infusion.
1/24/2025	2005: Confirmation of HLA Typing	Modify	Updated when the 2005 form comes due: Non-NMDP unrelated donor Non-NMDP unrelated cord blood unit Related cord blood unit HLA matched related donor HLA mismatched related donor Recipient of any of the donor types listed above Match siblings/syngeneic recipients and donors participating in the Related HCT Specimen Repository Recipient of HLA identical
1/24/2025	AML Response Criteria	Add	Example 1 and 2 updated to further clarify 0% blasts in the blood is required to report CR for recipients with MDS / MPN who transformed to AML with residual MDS / MPN: Example 1: A recipient who transformed from MDS to AML received AML induction therapy. A bone marrow biopsy was performed post-induction and showed remission; however, there was still evidence of dysplasia present. The recipient did not receive additional therapy and went to transplant. In this scenario, the pre-transplant disease status may be reported as “CR” if all AML criteria are met in addition to having 0 % blasts in the peripheral blood. Example 2: A recipient who transformed from primary myelofibrosis to AML achieved remission following induction therapy and went to transplant. During the Day 100 reporting period, a bone marrow biopsy was performed and myelofibrosis was present. In this case, the post-transplant disease status may still be reported as “CR” if all AML criteria are met in addition to having 0 % blasts in the peripheral blood.
1/24/2025	2402: Disease Classification	Add	ET or PCV to MDS Transformation blue box added above Q198: ET or PCV to MDS Transformation: In the rare event MDS transformed from ET or PCV, report Yes there was a predisposing condition, the condition as Other condition and specify as ET or PCV. Do not report there was a disease transformation below.
1/24/2025	2402: Disease Classification	Add	ET and PCV added as possible other predisposing conditions to report in Q199: A list of entities that would fall into the Other condition category include: ETV6-related familial thrombocytopenia, ANKRD26-related familial thrombocytopenia, SRP72-related familial aplastic anemia / MDS, MBD4-related familial leukemia, Bloom Syndrome, Noonan Syndrome, Neurofibromatosis, Downs Syndrome, ATG2B/GSKIP duplication (chromosome 14q32.2), MECOM-associated syndrome , Essential thrombocythemia (ET), Polycythemia vera (PCV).
1/124/2025	2402: Disease Classification	Modify	CALR Testing blue box updated above Q292: If CALR testing was performed and positive but the lab report does not specify the type, select Not done for CALR 1 and CALR 2, and Positive Not done for Not defined.
1/24/2025	2113: CLL Post-Infusion	Add	Clarification where MRD treatment is reported: Systemic therapy, radiation, withdrawal of immunosuppression, and/or other treatments may be administered for persistent, relapsed, or progressive disease. Additionally, therapy for measurable residual disease (MRD) may also be administered. Indicate if the recipient received treatment post-infusion for measurable residual disease (MRD), persistent, relapsed, or progressive disease in the current reporting period.
1/24/2025	2113: CLL Post-Infusion	Add	Clarified where MRD treatment is reported: Report the date when treatment for measurable residual disease (MRD), persistent, relapsed, or progressive disease was started in the current reporting period. If multiple treatments were started in the reporting period, report the date of the first treatment.
1/24/2025	2113: CLL Post-Infusion	Add	Instructions clarified to report not report MRD treatment with maintenance / consolidation: Indicate if the recipient received treatment post-infusion for reasons other than treatment for measurable residual disease (MRD), relapse, progressive, or persistent disease during the current reporting period. Recipients generally receive a HCT / cellular therapy under a specific protocol which defines radiation and / or systemic therapy to be given post-infusion, along with prophylactic medication as well as any systemic therapy, radiation, and / or other treatments to be administered post-infusion as planned (or maintenance) therapy. Planned (maintenance or consolidation) therapy is given to assist in prolonging remission. Planned therapy may be described in a research protocol or standard of care protocol and these should be referred to when completing this section. If post-infusion therapy is given as prophylaxis or maintenance for recipients in CR consider this ‘planned therapy,’ even if this was not documented prior to infusion. Do not include any treatment administered as a result of relapse, progression, or persistent disease. Indicate if therapy was given for reasons other than measurable residual disease (MRD), relapse, progressive, or persistent disease in the current reporting period.
1/24/2025	2113: CLL Post-Infusion	Add	Instructions added on how to report the best response when not in CR pre-infusion and persistent disease detected post-infusion: Use the following guidelines to determine how to report the best response when the recipient is not in CR pre-infusion and persistent disease was detected post-infusion: If the first assessments complete post-infusion are consistent with persistent disease and treatment for persistent disease was not started, report the best response as Stable disease and the assessment date as the first assessments showing stable disease. If the first assessments completed post-infusion are consistent with persistent disease and treatment for persistent disease was started, report the best response as Stable disease and the assessment date as the last assessments prior to initiating persistent disease treatment.
1/24/2025	Appendix C: Cytogenetics	Add	Chimerism Methods of Assessment section and Table 1. Chimerism Methods added to Chimerism and Cytogenetics section
1/24/2025	Appendix L: Karnofsky / Lansky Performance Status	Modify	Version 2 of Appendix L: Karnofsky / Lansky Performance Status released with the Winter 2025 Quarterly release

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