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 |
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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: |
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.
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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 |
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.
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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 |
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
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1/24/2025 | 2005: Confirmation of HLA Typing | Modify | Updated when the 2005 form comes due:
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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:
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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 |
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:
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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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