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 |
---|---|---|---|
3/13/2024 | 2100:Post-Infusion Follow-Up Form | Add | Instructions added on when to use the medication toxicity for liver impairment in Q275: Medication toxicity: If the liver abnormality (i.e., abnormal LFT values) is associated with drug initiation, abnormalities improve with cessation, and / or there are no other causes for the changes. |
3/13/2024 | 2400: Pre-TED | Modify | The red warning box above Q147 updated to clarify this section is now disabled and will be updated with the next revision of the Pre-TED (2400) form. |
3/13/2024 | 4000: Cellular Therapy Essential Data Pre-Infusion | Modify | Updated instructions in Q9 to clarify RCI-BMT is now known as CIBMTR CRO Services: If the study sponsor is reported as BMT-CTN, CIBMTR CRO Services (formerly RCI-BMT), USIDNET, COG, PedAL, or Investigator initiated, specify the ClinicalTrials.gov identification number. The letters “NCT” do not need to be included in the field. I |
3/13/2024 | 4000: Cellular Therapy Essential Data Pre-Infusion | Modify | Updated hyperlink in Q8 for CIBMTR CRO Services: https://cibmtr.org/CIBMTR/Studies/Research-Programs/Clinical-Trials-Support/CRO-Services |
3/13/2024 | 4000: Cellular Therapy Essential Data Pre-Infusion | Modify | Updated instructions in Q8 to clarify RCI-BMT is now known as CIBMTR CRO Services: For the infusion being reported on this form, indicate if the recipient is a registered participant with BMT-CTN, CIBMTR CRO Services (formerly RCI-BMT), USIDNET, COG, a Corporate / Industry trial, EudraCT, UMIN, an investigator-initiated trial and/or another clinical trial sponsor, regardless if that sponsor uses CIBMTR forms to capture outcomes data. |
3/8/2024 | General Instructions | Add | General Number Reporting Guidelines added to the General Guidelines for Completing Forms subsection |
3/8/2024 | 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion | Add | Omidubicel and Orca-T Products blue box added above Q35: Omidubicel and Orca-T Products If the product is Omidubicel, select Ex vivo expansion for the first product and Other manipulation for the second product – specify the manipulation as ‘Negative fraction.’ If the product is Orca-T, report the manipulation as CD34 enriched. |
3/8/2024 | 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion | Add | Omidubicel and Orca-T Products blue box added above Q34: Omidubicel and Orca-T Products If the product is Omidubicel or Orca-T, select Yes the product was manipulated. |
3/8/2024 | 2400: Pre-TED | Add | Omidubicel and Orca-T Products blue box added above Q76: Omidubicel and Orca-T Products: If the product is Omidubicel, report the number of products intended to achieve hematopoietic engraftment as two and complete two HCT Product and Infusion (2006) forms. If the product is Orca-T, report the number of products intended to achieve hematopoietic engraftment as one and complete one HCT Product and Infusion (2006) forms and two Cellular Therapy Product (4003) forms. |
3/8/2024 | 2400: Pre-TED | Add | Omidubicel and Orca-T Products blue box added above Q75: Omidubicel and Orca-T Products: If the product is Omidubicel, report the number of products from the donor as two. If the product is Orca-T, report the number of products from the donor as three. |
3/8/2024 | 2400: Pre-TED | Add | Omidubicel and Orca-T Products blue box added above Q47: Omidubicel and Orca-T Products: If the product is Omidubicel or Orca-T, report No, the product was not genetically modified. |
3/8/2024 | 2400: Pre-TED | Add | Omidubicel and Orca-T Products blue box added above Q45: Omidubicel and Orca-T Products: If the product is Omidubicel, report the product type as CBU. If the product is Orca-T, report the product type as BM. |
3/8/2024 | 2400: Pre-TED | Add | Omidubicel and Orca-T Products blue box added above Q42: Omidubicel and Orca-T Products: If the product is Omidubicel or Orca-T, select No for multiple donors. |
3/7/2024 | 2199: Donor Lymphocyte Infusion | Modify | Added text for clarification of therapy timepoint: This question is intended to capture if the recipient |
2/23/2024 | 2402: Disease Classification | Add | Instructions updated in Q408 to clarify Deauville scores should not be determined without physician / radiologist clarification: Report whether the five-point PET score is known. This information is typically documented in the PET report. Consult the appropriate transplant physician if the results are unclear. If Known, report the score. Otherwise, report Unknown. If the PET scan result is only documented as an ‘X’, report this as Unknown. If multiple scores are documented, report the highest. If a score is not documented within the PET (or PET/CT) scan, report Unknown or work with the physician / radiologist to determine if a score can be reported. Do not determine Deauville scores without seeking physician / radiologist clarification. |
2/21/2024 | 2400: Pre-TED | Add | ATG / Campath blue note box added above Q106 |
2/13/2024 | 2100:Post-Infusion Follow-Up Form | Remove | Update the Corticosteroids blue note box above Q121 for clarification: Corticosteroids are captured differently depending on whether they are used topically or systemically. Use the following guidelines when determining how to report corticosteroids used to treat acute GVHD: Topical Creams for Skin: Do not report topical ointments or creams used to treat skin GVHD including corticosteroid creams such as Triamcinolone or Hydrocortisone. Other Topical Treatments: Certain corticosteroid treatments Systemic Treatments: Systemic administration of corticosteroids, including use of prednisone and dexamethasone, should be reported in Select systemic treatment used to treat acute GVHD). |
2/13/2024 | 2402: Disease Classification | Add | Instructions updated in Q408 to clarify Deauville scores should not be determined without physician / radiologist clarification: Report whether the five-point PET score is known. This information is typically documented in the PET report. Consult the appropriate transplant physician if the results are unclear. If Known, report the score. Otherwise, report Unknown. If the PET scan result is only documented as an ‘X’, report this as Unknown. If multiple scores are documented, report the highest. If a score is not documented within the PET (or PET/CT) scan, work with the physician / radiologist to determine if a score can be reported. Do not determine Deauville scores without seeking physician / radiologist clarification. |
2/12/2024 | POEMS Response Criteria | Add | Urine Immunofixation and Electrophoresis blue box added for clarification: Urine Immunofixation and Electrophoresis: The sample for the urine immunofixation and electrophoresis criteria must be a 24-hour urine and not a random urine. |
2/12/2024 | Multiple Myeloma Response Criteria | Add | Urine Immunofixation and Electrophoresis blue box added for clarification: Urine Immunofixation and Electrophoresis: The sample for the urine immunofixation and electrophoresis criteria must be a 24-hour urine and not a random urine. |
2/12/2024 | Plasma Cell Leukemia Response Criteria | Add | Urine Immunofixation and Electrophoresis blue box added for clarification: Urine Immunofixation and Electrophoresis: The sample for the urine immunofixation and electrophoresis criteria must be a 24-hour urine and not a random urine. |
2/12/2024 | 2900: Recipient Death | Add | Instructions for when ‘autopsy pending’ is reported were updated: If Autopsy pending, the form will not go to complete (CMP) status until the autopsy results are reported. The form may be submitted with question 2 as Autopsy pending, but the form will remain in saved (SVD) status until it is updated with the results. Once the autopsy results are known, update question 2, and the Primary cause of death, if applicable, to ensure all pertinent causes of death are reported, then resubmit in order to complete the form. All pertinent causes of death should be reported on the second Recipient Death Data (2900) form. |
2/12/2024 | 2402: Disease Classification | Add | Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in the Laboratory Studies at Diagnosis of MDS blue box: Report laboratory results closest to the diagnosis date and prior to the start of first treatment of the primary disease for which the HCT is being performed. If the recipient’s MPN transformed, report the studies from the original diagnosis. |
2/12/2024 | 2402: Disease Classification | Add | Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis in the Laboratory Studies at Diagnosis of MPN blue box: Report laboratory results closest to the diagnosis date and prior to the start of first treatment of the primary disease for which the HCT is being performed. If the recipient’s MPN transformed, report the studies from the original diagnosis. |
2/12/2024 | 2402: Disease Classification | Add | Instructions clarified when to report more than one heavy / light chain in Q415 Indicate the heavy and / or light chain type for the recipient’s disease. Select all that apply. More than one heavy and / or light chain type should only be selected for recipients diagnosed with biclonal multiple myeloma. |
1/26/2024 | 2100:Post-Infusion Follow-Up Form | Add | Example 7 added to Q1: Example 7. The recipient had a subsequent auto transplant for graft failure: The recipient has their first auto transplant on 3/1/23 and a subsequent auto transplant for the indication of graft failure/insufficient hematopoietic recovery on 4/15/23. What to report: 100 Day Date of Contact: The date of contact reported will be appropriate to the reporting period since a new Pre-TED (2400) / Disease Classification (2402) is not required for auto rescues. |
1/26/2024 | 2450: Post-TED | Add | Example 7 added to Q1: Example 7. The recipient had a subsequent auto transplant for graft failure: The recipient has their first auto transplant on 3/1/23 and a subsequent auto transplant for the indication of graft failure/insufficient hematopoietic recovery on 4/15/23. What to report: 100 Day Date of Contact: The date of contact reported will be appropriate to the reporting period since a new Pre-TED (2400) / Disease Classification (2402) is not required for auto rescues. |
1/26/2024 | 2542: Mogamulizumab Supplemental Data Collection | Add | Version 2 of the 2542: Mogamuluizumab Supplemental Data Collection section of the Forms Instruction Manual released. Version 2 corresponds to revision 2 of the Form 2542. |
1/23/2024 | 4101: Post-Cellular Therapy Follow-Up | Add | Added the text in red: CAR-T cells that target antigens (e.g., CD19) on B-cells do not distinguish between cancerous and normal B-cells. As result, the recipient can develop B-cell aplasia (low number or absence of B-cells). B-cell aplasia can be used as a surrogate to track persistence of the product. If the recipient has B-cell aplasia, then the product may still be present. Examples include (but not limited to) “cellular immunology report”, “lymphocyte subsets”, or “B-cell panel” of applicable tests that will show B-cell populations. |
1/19/4 | 4100: Cellular Therapy Essential Data Follow-Up | Add | Added text in red to the first blue box above question 12: If the primary disease reported is Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Hodgkin Lymphoma (HL), Non-Hodgkin Lymphoma (NHL), or Multiple Myeloma (MM) and there is a corresponding disease form, best response is not reported on this form. |
1/16/2024 | 4100: Cellular Therapy Essential Data Follow-Up | Add | Added the following text to question 85: Lower scores are associated with a higher level of encephalopathy. Report the lowest score of any evaluation from the reporting period. Unable to complete assessment should be selected when an assessment was started and couldn’t be finish for any reason or the recipient couldn’t perform the evaluation. This should be used rarely since evaluations may be given multiple times a day. |
1/15/24 | 4101: Post-Cellular Therapy Follow-Up | Modify | Added the text in red: Many cellular therapies are designed to target a specific tumor antigen(s). One mechanism of resistance to these cellular therapies includes antigen escape. This occurs when disease relapses and the tumor develops partial or complete loss of the tumor antigen. This may be determined by testing (e.g. T-cell subset profile) on the blood and/or bone marrow showing absence of the tumor antigen targeted by the cellular therapy they received. Common testing methods are listed in question 6. Example 1: A recipient has a CD19 expressing disease prior to the cell therapy infusion, such as acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL). The recipient is given a CD19-directed CAR T-cell therapy, achieves a CR then relapses. At the time of relapse, the T-cell subset profile shows the absence of CD19 B Cells. This means the leukemia/lymphoma cells no longer express CD19. |
1/15/2024 | 4100: Cellular Therapy Essential Data Follow-Up | Modify | Added the text in red: Disease relapse or progression can be documented by a variety of methods including molecular, flow cytometry, cytogenetic/fluorescent in situ hybridization (FISH), radiographic or hematological/clinical. The intent is to captures any new relapse or progression event that occurred in the reporting period, not just the initial relapse or progression. Report Yes if any new disease relapse or progression was detected by any one of the methods in the current reporting period and report the first date (YYYY-MM-DD) of the relapse or progression detected. |
1/12/24 | 4000: Cellular Therapy Essential Data Pre-Infusion | Remove | Removed the red warning box regarding clinical trials from question 9: |
1/12/24 | 4000: Cellular Therapy Essential Data Pre-Infusion | Remove | Removed the red warning box regarding clinical trials from question 8: |
1/10/2024 | Appendix D: How to Distinguish Infusion Types | Modify | Added definitions for genetically modified vs not genetically modified cellular therapy products. |
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