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.
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.
|5/12/2021||4100: Cellular Therapy Essential Data Follow-Up||Add||Added new example 4 for hypogammaglobulinemia resolution date when testing is not exactly at 3 months.|
|5/7/2021||4000: Cellular Therapy Essential Data Pre-Infusion||Add||Instructions added to question 108 on how to report psychiatric comorbidity: The presence of any mood, anxiety, or other psychiatric disorder requiring continuous treatment during the last four weeks. Examples include, but are not limited to, depression, anxiety, Attention-Deficit Disorder (ADD), Attention-Deficit Hyperactivity Disorder (ADHD), bipolar disorder, and schizophrenia requiring psychiatric consult or treatment in the last 4 weeks. Do not report a psychiatric comorbidity if therapy was given “as needed” for any mood, anxiety, or other psychiatric disorder|
|5/6/2021||2000: Recipient Baseline||Add||Question 2 updated with instructions on how to report use of naswar or paan: Indicate the recipient’s smoking and / or chewing tobacco use from the options listed. Select “chewing tobacco” if the recipient has a history using naswar and / or paan. If “cigarettes” is selected, continue with question 3.|
|5/6/2021||2100: Post-HCT Follow-Up||Modify|| The following instructions were updated for question 661 were updated: Select the category that best describes the recipient’s current occupation. If the recipient is a student, check “student.” If the recipient is younger than school-aged, check “under school age” and continue with question 665. If “other” is selected, report the recipient’s occupation in question 662. Only one work status may be reported. If a recipient has multiple possible occupations during the current reporting period, report the highest level of work being performed. For example, full time work would be reported over part time work and part time work would be reported over being a student. If the recipient is not currently employed on the date of contact or not employed at any time during the current reporting period, check the box that best describes his / her last job
|5/6/2021||2450: Post-TED||Add||The following instructions were added to question 1 for date of contact and subsequent infusion: Date of Contact & Subsequent Infusion If the recipient has a subsequent infusion (HCT or cellular therapy), the date of contact will depend on the type of subsequent infusion. If the subsequent infusion is an HCT or genetically modified cellular therapy (e.g. CAR-T), report the date of contact as the day before the preparative regimen / systemic therapy begins for the subsequent infusion. If no preparative regimen / systemic therapy is given, report the date of contact as the day before the subsequent infusion. In these cases, actual contact on that day is not required, and the day prior to the initiation of the preparative regimen (or infusion, if no preparative regimen / systemic therapy) should be reported. This allows every day to be covered by a reporting period but prevents overlap between infusion events. If the subsequent infusion is a non-genetically modified (e.g. DLI) cellular therapy infusion, report the date of contact as appropriate to the reporting period.|
|5/6/2021||2400: Pre-TED||Add||Clarification added to question 55 that a 2004 and 2005 form will not come due when the product is facilitated by NMDP|
|5/6/2021||2450: Post-TED||Modify||Updated the question numbers in the red warning box above question 108|
|5/5/2021||2100: Post-HCT Follow-Up||Modify|| The following instructions were updated for questions 486 – 487: Indicate whether the recipient received endotracheal intubation or mechanical ventilation (invasive positive pressure ventilation)
|5/5/2021||2130: SCD Post-Infusion||Add||The Bedside Schwartz equation was added to questions 36 -37 to calculate the GFR for pediatric recipients.|
|5/5/2021||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Add||The following instructions were added for buffy coat enriched for question question 33: Buffy coat enriched: Buffy coat enrichment is performed to reduce/remove mature erythrocytes and plasma. Buffy coat enrichment performed as part of the cryopreservation process should not be reported as product processing.|
|5/5/2021||2006: Hematopoietic Stem Cell Transplant (HCT) Infusion||Add||Red warning box added above quetion 33: Product Processing as Part of Cryopreservation: Product processing performed as part of the cryopreservation process should not be reported as a separate process. For example, plasma reduction / removal performed as part of the cryopreservation process should not be reported as product processing.|
|5/5/2021||Plasma Cell Leukemia Response Criteria||Add||The following criteria was added for relapse: Appearance of any other sign of progression such as: Development of new soft tissue plasmacytomas or bone lesions (osteoporotic fractures do not constitute progression), Hypercalcemia (> 11mg/dL), Decrease in hemoglobin of ≥ 2 g/dL not related to therapy or other non-myeloma-related conditions, Rise in serum creatinine by 2 mg/dL or more from the start of therapy and attributable to myeloma, Hyperviscosity related to serum paraprotein|
|5/5/2021||Plasma Cell Leukemia Response Criteria||Modify||The response criteria for CR, VGPR, and PR were re-formatted and split between measurable and non-measurable disease.|
|5/5/2021||Plasma Cell Leukemia Response Criteria||Add||Confirmatory Assessments for PCL red warning box added: Questions often arise about how to report a disease response when the recipient meets all criteria for a disease response at a given timepoint (i.e., pre-infusion, 100-day date of contact, 6 month date of contact, etc.) and the confirmatory assessment is performed within the next timepoint. In this case, the disease response should be reported at the timepoint in which it was first observed (not the timepoint in which it was confirmed). Please note, this may require updating a previously submitted form. Review the examples below for further clarification.|
|5/5/2021||Plasma Cell Leukemia Response Criteria||Add||Urine Studies blue note box added: In order to report a Stringent Complete Response (sCR) or Complete Response (CR), urine studies MUST be performed and agree with the international myeloma working group (IMWG) criteria provided above. As long as the negative serum electrophoresis and immunofixation studies have been confirmed, only one set of negative urine studies needs to be documented to report sCR or CR.|
|4/28/2021||Appendix J: Reporting Comorbidities||Add||Updated the table “What not to report” for psychiatric comorbidity when treatment is given “as needed.”|
|4/28/2021||2400: Pre-TED||Add||Clarification added on how to report a psychiatric comorbidity when treatment is given “as needed”: The presence of any mood, anxiety, or other psychiatric disorder requiring continuous treatment during the last four weeks. Examples include, but are not limited to, depression, anxiety, Attention-Deficit Disorder (ADD), Attention-Deficit Hyperactivity Disorder (ADHD), bipolar disorder, and schizophrenia requiring psychiatric consult or treatment in the last 4 weeks. Do not report a psychiatric comorbidity if therapy was given “as needed” for any mood, anxiety, or other psychiatric disorder.|
|4/28/2021||2450: Post-TED||Remove|| The instructions for questions 116 – 117 were updated by removing the following: Form options are arranged alphabetically. Indicate which systemic therapy agents were administered during the current reporting period for
|4/28/2021||MPN Response Criteria||Add||For CR, Myelofibrosis CR, and PR, neutrophilic precursors clarification added: Neutrophilic precursors* reduced to ≤ 2% (*neutrophilic precursors include myeloblasts, promyelocytes, myelocytes, & metamyelocytes)|
|4/28/2021||2130: SCD Post-Infusion||Modify||Instructions on when to report not applicable for questions 74 – 75 were updated: If RBC transfusion(s) were given within four weeks prior of the hemoglobin electrophoresis, report Not applicable and go to question 89.|
|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
|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.
|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
|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:
|3/3/2021||2047/2147: Hepatitis Serology||Removed|| Removed the following instructions as they are inaccurate:
|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
|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.
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.|
Need more help with this?
Don’t hesitate to contact us here.