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.
|2/1/2019||Cellular Therapy Manuals||Modify|| Added clarification (in red below):
What cellular therapies to report and when:
|1/25/2019||4003: Cellular Therapy Product||Modify||Version 2 of the 4003: Cellular Therapy Product section of the Forms Instruction Manual released. Version 2 corresponds to revision 2 of the Form 4003.|
|1/25/2019||2900: Recipient Death||Modify||Version 3 of the 2900: Recipient Death section of the Forms Instructions Manual released. Version 3 corresponds to revision 4 of the Form 2900.|
|1/25/2019||2018: LYM Pre-Infusion||Modify||Version 4 of the 2018: Lymphoma Pre-Infusion Data section of the Forms Instruction Manual released. Version 4 corresponds to revision 5 of the Form 2018.|
|1/24/2019||4100: Cellular Therapy Essential Data Follow-up||Modify|| Added examples (in red below) in question 33 on when to use “previously reported” option:
If a new malignancy is reported, please complete the Subsequent Neoplasms Form 3500 to answer questions specific to the new malignancy. The option of ‘Previously reported’ should only be used if the same new malignancy instance has already been reported on a F3500. See examples below. If there is a question regarding use of this option, please contact your CIBMTR CRC.
Example 1. Recipient develops a new malignancy at day +68. It is reported at the time the 100-day form 4100 is completed. Question 33 should be answered as ‘yes’ and the form 3500 should be completed to report all new malignancy information.
Example 2. Recipient develops a new malignancy at day +68 and had received a commercial CAR-T product. Per protocol, the new malignancy should be reported at the time of knowledge of the new malignancy. The form 3500 should be created as an unscheduled form in FormsNet3 and completed in a timely manner. No other new malignancy develops during the 100-day reporting period. When the 100-day form 4100 is completed, question 33 should be answered as ‘previously reported’.
Example 3. Recipient develops a new malignancy at day +68 and had received a commercial CAR-T product. Per protocol, the new malignancy should be reported at the time of knowledge of the new malignancy. The form 3500 should be created as an unscheduled form in FormsNet3 and completed in a timely manner. Another new malignancy develops at day +100. It is decided to report the 2nd new malignancy on the 100-day form 4100 since it is due. Question 33 should be answered as ‘yes’ to create another form 3500.
|1/17/2019||4100: Cellular Therapy Essential Data Follow-Up||Modify|| Added (in red below) clarification on how hypogammaglobulinemia is documented:
Report the date (YYYY-MM-DD) in question 126 when the hypogammaglobulinemia was documented by either a physician/health care provider or determined by lab results. If the hypogammaglobulinemia continues from a prior reporting period, report the original diagnosis date as the onset date and override the error.
Example 1. The recipient developed hypogammaglobulinemia at day +22 which was reported on the 4100 day 100 form. The lab results continue to show IgG levels < 600 mg/dl during the 6 month reporting period. Report the original diagnosis date on the 4100 6 month form and override the error.
|1/17/2019||4000: Cellular Therapy Essential Data Pre-Infusion||Remove|| Removed the following blue note box instruction (struck out below) for questions 250 to 252 functional status. Functional status should be reported for every indication.