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
3/3/2021 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: Mar 03, 2021

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