Getting Started

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
2/20/23	4100 Post-CTED	Modify	Updated the applicable response options for non-malignant disease in Table 1: Complete Response, Partial Response, or No Response Normalization of organ function, Partial normalization of organ function, No response, Worsening of organ function
2/16/2023	2100:Post-Infusion Follow-Up Form	Add	Examples of immunosuppression added to Q208
2/16/2023	2118: LYM Post-Infusion Data	Add	Instructions for best response by PET clarified (Q85): Indicate the best response to the line of therapy using the international working group metabolic criteria provided in LYM Response Criteria section of the Forms Instruction Manual. Report “Not assessed” if the recipient’s primary disease is a non-PET avid lymphoma or a PET scan was not performed after the initiation of the line of therapy being reported and prior to the initiation of any new therapy.
2/16/2023	2450: Post-TED	Modify	Examples updated for Q1: Example 8. The recipient had a subsequent non-genetically modified cellular therapy. The recipient has their first transplant on 1/21/15 and a non-genetically modified (e.g. DLI) (excludes DLI) cellular therapy infusion on 2/15/15. There was no lymphodepleting therapy administered. Example 9. The recipient had a subsequent Donor Lymphocyte Infusion (DLI). The recipient has their first transplant on 1/21/2215 and receives a DLI on 2/27/2022. There was no lymphodepleting therapy administered prior to the DLI. What to report: 100 Day Date of Contact: The date of contact reported will be appropriate to the reporting period. Do not complete the follow up form early. Combined follow up will not be applied, a single F2199 is required for each DLI in the reporting period, then HCT reporting continues.
2/16/2023	2100:Post-Infusion Follow-Up Form	Modify	Examples updated for Q1: Example 8. The recipient had a subsequent non-genetically modified cellular therapy. The recipient has their first transplant on 1/21/15 and a non-genetically modified (e.g. DLI) (excludes DLI) cellular therapy infusion on 2/15/15. There was no lymphodepleting therapy administered. Example 9. The recipient had a subsequent Donor Lymphocyte Infusion (DLI). The recipient has their first transplant on 1/21/2215 and receives a DLI on 2/27/2022. There was no lymphodepleting therapy administered prior to the DLI. What to report: 100 Day Date of Contact: The date of contact reported will be appropriate to the reporting period. Do not complete the follow up form early. Combined follow up will not be applied, a single F2199 is required for each DLI in the reporting period, then HCT reporting continues.
2/15/2023	2400: Pre-TED	Remove	Instructions for reporting the height prior to prep were updated: Report the recipient’s height just prior to the start of the preparative regimen. The intent of this question is to determine the height used when calculating preparative regimen drug doses. This height is usually documented on the transplant orders (for radiation and/or systemic therapy) or admitting orders. Report height to the nearest whole centimeter or inch (round up if 0.5 or greater).
2/15/2023	2100:Post-Infusion Follow-Up Form	Add	Clarification added on how to report the mucositis grade: Mucositis requiring therapy: inflammation and ulceration of mucous membranes that line the digestive tract, usually due to chemotherapy and radiotherapy. Specify the grade as 0 (none), I (mild) – oral soreness, erythema, II (moderate) – oral erythema, ulcers, solid diet tolerated, III (severe) – oral ulcers, liquid diet only, or IV (life-threatening – oral ulcers, oral alimentation impossible in question 304. The highest grade in the reporting period should be reported. Do not report mucositis which did not require treatment or intervention during the reporting period.
2/15/2023	4100 Post-CTED	Add	The ‘No Documentation of Contact Date’ red warning box added above Q2: No Documentation of Contact Date The contact date data field cannot be left blank and is required to be reported. In cases where the recipient passed away and there is no documentation to report the date of death, the guidelines for reporting estimated dates must be used.
2/15/2023	2900: Recipient Death	Add	The ‘No Documentation of Contact Date’ red warning box added above Q1: No Documentation of Contact Date The contact date data field cannot be left blank and is required to be reported. In cases where the recipient passed away and there is no documentation to report the date of death, the guidelines for reporting estimated dates must be used.
2/15/2023	2100:Post-Infusion Follow-Up Form	Add	The ‘No Documentation of Contact Date’ red warning box added above Q1: No Documentation of Contact Date The contact date data field cannot be left blank and is required to be reported. In cases where the recipient passed away and there is no documentation to report the date of death, the guidelines for reporting estimated dates must be used.
2/15/2023	2450: Post-TED	Add	The ‘No Documentation of Contact Date’ red warning box added above Q1: No Documentation of Contact Date The contact date data field cannot be left blank and is required to be reported. In cases where the recipient passed away and there is no documentation to report the date of death, the guidelines for reporting estimated dates must be used.
2/15/2023	2450: Post-TED	Add	Instruction updated to include a radiologic assessment may be reported for the current disease stats assessment date: If the current disease status is Complete remission, report the date of the most disease specific clinical / hematologic or radiologic assessment performed within approximately 30 days of the contact date. If the current disease status is Not in complete remission – disease detected, report the most recent clinical / hematologic or radiologic assessment performed in the reporting period that detects disease. If the current disease status is Not in complete remission – no disease detected but incomplete evaluation to establish CR, report the last clinical / hematologic (color-red) or radiologic assessment performed in the reporting period.
2/14/2023	2450: Post-TED	Modify	Clarification added on when to use the Previously reported option: The Previously reported option should only be used if the same malignancy has already been reported on a Subsequent Neoplasms (3500) form that was made do on demand. See examples below. If it is unclear whether or not to use of this option, contact CIBMTR Center Support if there are questions. Example 1. A recipient developed a new malignancy at Day +68 and is reported at the time the Day 100 Post-Infusion Follow-up (2450) form is completed. In this scenario, report Yes, the recipient developed a new malignancy, and a Subsequent Neoplasms (3500) form will be completed to report the new malignancy information. For all future reporting periods, select No. Example 2. A recipient developed a new malignancy during the seven-year reporting period and the transplant center decided to create the Subsequent Neoplasms (3500) form as an unscheduled form in FormsNet3SM to report the new malignancy information immediately since a Post-Infusion Follow-Up for seven-year reporting period will not come due. When the eight-year Post-Infusion Follow-Up (2450) form is completed, Previously reported, will be reported since a prior Subsequent Neoplasms (3500) form has already been submitted for the new malignancy. Example 3. A recipient was diagnosed with basal cell skin cancer on the neck in the one-year reporting period and two months later, within the same reporting period, there was a diagnosis of basal cell located on the nose. The lesion on the nose is not considered a metastasis from the neck, but a new discreet lesion. Report Yes, there was a new malignancy on the Post-HCT Follow-Up (2450), and a single Subsequent Neoplasms (3500) form will come due to report one of the basal cell malignancies. Create a second Subsequent Neoplasms (3500) form to report the other basal cell malignancy as these are discreet episodes. If the new malignancy, lymphoproliferative disorder, or myeloproliferative disorder was reported in a prior reporting period, select Previously reported.
2/8/23	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Updated the text in the blue box below question 121: Serologic tests should be completed during the pre-HCT work-up phase, or approximately one month prior to the start of the preparative regimen. If a recipient tests positive for Hepatitis B core antibody (Anti HBc), Hepatitis B surface antigen (HBsAg), Hepatitis B NAAT, Hepatitis C antibody (Anti HCV), and/or Hepatitis C NAAT serologic tests, also complete the HEP Form (Form 2047). If a recipient tests positive for HIV antibody or HIV NAT serologic tests, also complete the HIV Form (Form 2048).
2/7/2023	4100 Post-CTED	Modify	Added CarvyktiTM to the red warning box below question 180: This question will enable only if the commercially available product Kymriah®, BreyanziTM, Abecma®, or CarvyktiTM is selected in question 1 and can only be completed on the 100 day and 6 month follow-up forms.
2/3/2023	4100 Post-CTED	Modify	Clarified what should not be reported as CRS therapy, highlighting the follow text in a blue box: Supportive care treatments should not be reported as treatment for CRS. Examples of what not to report as other therapy include, but are not limited to, acetaminophen (Tylenol®) albumin, antibiotics, IV fluids, or any brand name or specific corticosteroids administered.
1/27/2023	2450: Post-TED	Add	Red warning box regarding reporting persistent GVHD for the Day 100 reporting added for Q38: Persistent GVHD and Day 100 Reporting Period: Previously, reporting Yes for Did chronic GVHD persist since the date of last report was not an applicable option for the Day 100 reporting period. However, if there was a prior infusion, the recipient developed chronic GVHD in the last reporting period of the previous infusion and chronic GVHD persisted into the Day 100 reporting period of the current infusion, report Yes, chronic GVHD persisted since the date of last report.
1/27/2023	2450: Post-TED	Add	Red warning box regarding reporting persistent GVHD for the Day 100 reporting added for Q19: Persistent GVHD and Day 100 Reporting Period: Previously, reporting Yes for Did acute GVHD persist since the date of last report was not an applicable option for the Day 100 reporting period. However, if there was a prior infusion, the recipient developed acute GVHD in the last reporting period of the previous infusion and acute GVHD persisted into the Day 100 reporting period of the current infusion, report Yes, acute GVHD persisted since the date of last report.
1/27/2023	2100:Post-Infusion Follow-Up Form	Add	Red warning box regarding reporting persistent GVHD for the Day 100 reporting added for Q136: Persistent GVHD and Day 100 Reporting Period: Previously, reporting Yes for Did chronic GVHD persist since the date of last report was not an applicable option for the Day 100 reporting period. However, if there was a prior infusion, the recipient developed chronic GVHD in the last reporting period of the previous infusion and chronic GVHD persisted into the Day 100 reporting period of the current infusion, report Yes, chronic GVHD persisted since the date of last report.
1/27/2023	2100:Post-Infusion Follow-Up Form	Add	Red warning box regarding reporting persistent GVHD for the Day 100 reporting added for Q96: Persistent GVHD and Day 100 Reporting Period: Previously, reporting Yes for Did acute GVHD persist since the date of last report was not an applicable option for the Day 100 reporting period. However, if there was a prior infusion, the recipient developed acute GVHD in the last reporting period of the previous infusion and acute GVHD persisted into the Day 100 reporting period of the current infusion, report Yes, acute GVHD persisted since the date of last report.

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CIBMTR®(Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®/Be The Match® and the Medical College of Wisconsin