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
4/14/2021 AML Response Criteria Add Transfusion independent clarification added for CR and CRi: Transfusion independent (a minimum of eight weeks without platelet or red blood cell transfusion)
3/25/2021 2100: Post-HCT Follow-Up Add Clarification added on when to use the “previously reported” option for platelet recovery (questions 13 and 16).
3/22/2021 2402: Disease Classification Add Added the following instruction for question 405:
The Durie-Salmon stage is only required if the recipient’s I.S.S. stage at diagnosis cannot be determined and is not reported in questions 415-416.
3/17/2021 4000: Cellular Therapy Essential Data Pre-Infusion Modify Clarification added to the blue note box about reporting co-morbidities within 6 months of the cellular therapy: Please report co-morbidities that occurred were detected within six months of the cellular therapy, which is different than HCT reporting. The 6 month rule applies to assessments that need to be performed in order to determine if a comorbidity is present (i.e., PFT for pulmonary, liver values for hepatic, creatinine for renal, BMI for obesity, etc.). If the co-morbidity is denoted as “ANY history”, the 6 month rule does not apply.
3/9/2021 2900: Recipient Death Add Primary Cause of Death blue note box added above question 4: Primary Cause of Death: Report the primary cause of death based on the physician’s determination. If the cause of death is unclear, seek physician clarification to determine the appropriate cause of death/
3/9/2021 2804: CIBMTR Research ID Assignment Form Add Added the following instructions to question 10: Indicate the detailed race of the recipient. If this recipient has reported that they are more than one detailed race, check each detailed race indicated in the list below that applies. If the race detail is not documented or is not known, select “unknown.”
3/9/2021 2804: CIBMTR Research ID Assignment Form Remove Removed the following instructions from question 9: Indicate the recipient’s race. If this recipient has reported that they are more than one race, check each race indicated in the list below that applies. The race groups provided are specific to the United States. If the recipient is White, Southeast Asian, or Pacific Islander, but a more specific Race Detail is not available, report the patient is “Other [White, Southeast Asian, or Pacific Islander respectively].
3/9/2021 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion Add Product Processing blue note box added above question 33: Product Processing: Wash and dilution, both which generally apply to cord blood units, are now included as processing options, though they may not be classified as such by laboratories. If dilution is performed as part of washing, dilution should not need be reported. Only report the primary procedure. See the Steps in Manipulation note box below.
3/8/2021 2400: Pre-TED Modify Blue note box above questions 102-111 updated: Complete questions 102 – 111 using the results measured within four weeks prior to the closest to the start of the preparative regimen. If the assessment was performed multiple times, report the closest value to the start of the preparative regimen. The following are considered biomarkers according to the augmented HCT comorbidity index.
3/8/2021 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion Add The following information was added to question 153: It should be noted for cord blood unit transplants that almost all units are screened, or the infant is screened, for potentially transplantable genetic diseases. This may be documented as a ‘hemoglobin screen,’ which evaluates for sickle cell and/or thalassemia, both of which are hemoglobinopathies.
3/8/2021 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion Add Instructions on how to report the date of product analysis, depending on if the the product was analyzed multiple times and examples 1 – 3 were added to question 42.
3/8/2021 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion Add Added the following statement to question 41: The At Infusion timepoint should include values reflective of the product infused regardless of when the analysis occurred. Since all products are analyzed prior to cryopreservation, the At Infusion timepoint would be applicable for these cell counts. Depending on the product type and your center’s practice, viability may be assessed closer to the time of infusion.
3/8/2021 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion Add Example 1 added to questions 2-3: Example 1: The donor was mobilized with Granix (tbo-Filgrastim) prior to the start of collection. Since this is a biologic medical product that is highly similar to Neupogen, this would be captured under G-CSF.
3/8/21 Appendix E: Definition of a Product Modify Graphic below the “Single Product vs Multiple Products” was added and examples 1 – 5 were update.
3/3/2021 2047/2147: Hepatitis Serology Removed Removed the following instructions as they are inaccurate: This form will also come due if a recipient received cells from a donor who was reported as “reactive” on the Form 2004, Infectious Disease Markers:
  • Hepatitis B surface Antigen
  • Hepatitis B core Antibody
  • Hepatitis C Antibody
3/3/2021 2047/2147: Hepatitis Serology Removed Removed the following instructions as they are inaccurate: Because viral hepatitis can be transmitted from the donor to the recipient via hematopoietic stem cell transplantation, this form will also be triggered when any of the following IDMs are reported as “reactive” on the Form 2004, Infectious Disease Markers:
  • Hepatitis B surface Antigen
  • Hepatitis B core Antibody
  • Hepatitis C Antibody
3/3/2021 2450: Post-TED Add Example F added above question 84, under the header “Disease Assessments at the Time of Best Response:” A recipient receives a transplant on 1/1/2020 for IgA Kappa Multiple Myeloma in stable disease. During the 100 Day reporting period, the first set of myeloma labs on Day 29, 1/30/2020, show progressive disease. Myeloma labs repeated on Day 60 and Day 100 also showed disease progression. As a result, therapy is planned to be given, starting in the 6-month reporting period, on Day 110. The best response to HCT for the Day 100 reporting period would be reported as “Not in complete remission – disease detected” and report “Yes,” clinical / hematologic assessments were performed with the Day 100 myeloma labs, as this is the most recent testing in the reporting period. In cases where the first assessment post-HCT shows progression, report the last assessment prior to the start of treatment. If treatment doesn’t start until the next reporting period, report the last assessment in the current reporting period.
1/25/2021 2400: Pre-TED Modify Added clarification to the main page of this manual regarding the edit capabilities of the form due to the release of the Consent Tool on 1/25/2021.
1/25/2021 2402: Disease Classification Modify Added clarification to the main page of this manual regarding the edit capabilities of the form due to the release of the Consent Tool on 1/25/2021.
1/25/2021 4000: Cellular Therapy Essential Data Pre-Infusion Modify Added clarification to the main page of this manual regarding the edit capabilities of the form due to the release of the Consent Tool on 1/25/2021.
1/22/2021 3501: Pregnancy Form Add Version 1 of the 3501 Pregnancy Form section of the Forms Instructions Manual released. Version 1 corresponds to revision 2 of the Form 3501.
1/22/2021 4100: Cellular Therapy Essential Data Follow-Up Modify Version 6 section of the Forms Instruction Manual released. Version 6 corresponds to revision 6 of the Form 4100.
1/22/2021 4006: Cellular Therapy Infusion Modify Version 5 of the 4006: Cellular Therapy Infusion section of the Forms Instruction Manual released. Version 5 corresponds to revision 5 of the Form 4006.
1/22/2021 4003: Cellular Therapy Product Modify Version 4 of the 4003: Cellular Therapy Product section of the Forms Instruction Manual released. Version 4 corresponds to revision 4 of the Form 4003.
1/22/2021 4000:Cellular Therapy Essential Data Pre-Infusion Modify Version 5 of the 4000: Cellular Therapy Essential Data Pre-Infusion section of the Forms Instruction Manual released. Version 5 corresponds to revision 7 of the form 4000.
1/22/2021 2400: Pre-TED Modify Version 7 of the 2400: Pre-TED section of the Forms Instruction Manual released. Version 7 corresponds to revision 8 of the Form 2400.
1/21/2021 2820: Recipient Contact Information Modify Instruction text updated: This question should be answered ‘yes’ if the recipient has given permission to be directly contacted by CIBMTR for research as indicated on the Pre-TED F2400 consent tool. This will allow CIBMTR to contact the patient and invite them to participate in PRO data collection or other research studies.
1/11/2021 2402: Disease Classification Add Clarification added on how to report the number of lines of therapy prior to infusion when there is a prior infusion and / or transformation along with examples 1 and 2: A single line of therapy refers to any agents administered during the same time period with the same intent (induction, consolidation, etc.). If a recipient’s disease status changes resulting in a change to treatment, this should be considered a new line of therapy. Additionally, if therapy is changed because a favorable disease response was not achieved, this should be considered a new line of therapy. Report the total number of lines of therapy received since the original lymphoma diagnosis up until the start of the preparative regimen / infusion, regardless of if the recipient has received a prior infusion. Indicate how many lines of therapy the recipient received prior to the start of the preparative regimen / infusion.
Example A: A recipient received a line of induction and achieved CR. However, following induction, the recipient relapsed and received a line of re-induction with no response. After re-induction, the recipient transformed, received a different line of re-induction followed by consolidation and achieved CR2 prior to HCT. This would be considered as four separate lines of therapy and the total number of lines of therapy reported in this example would be “3+ lines.” Example B: A recipient received a line of induction, achieved CR, and then went to HCT. Post-transplant, the recipient transformed, received a line of re-induction followed by a line of consolidation and achieved CR2 prior to the second HCT. In this scenario, the recipient received three lines of therapy and “3+ lines” would be reported.
1/7/2021 4100: Cellular Therapy Essential Data Follow-Up Add Clarified when to report hypogammaglobulinemia, how to report date of onset and date of resolution. Several examples have been added.
Last modified: Apr 14, 2021

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