Critical Forms
CIBMTR has identified the below forms as Critical. These forms capture critical data, such as infusion, donor type and disease classification. If these forms are completed close to the actual infusion date, the subsequent forms triggered by critical forms will come due in a timelier manner. Forms completed in a timely manner will ensure specific study data, severe adverse infusion events, and product complaints, as well as data for participating registries, cord blood banks, and apheresis/collection centers are more readily available for use.
Requirements
- Critical Forms On Time: Complete* ≥ 50%* of forms with the due dates in the current trimester by the due date listed in FormsNet3
- Critical Forms Due During the Previous Trimester: Complete ≥98% of forms with due dates in the previous trimester by the end of the current trimester
| Forms | Form Due Date (April 2021 FN Release) |
|---|---|
| Indication for CRID Assignment Form (2814) | CRID Registration Date + 30 days |
| Pre-TED (2400) | Infusion Date + 30 days |
| Disease Classification (2402) | Infusion Date + 30 days |
| HCT Infusion Form (2006) | Infusion Date + 45 days |
Study Supplemental Forms
Participation in prospective studies is voluntary and requires a commitment from the transplant center Medical Director. If a center elects to participate in a study that requires additional (supplemental) forms to collect specific study data, CPI requirements will apply to these supplemental forms. In general, study supplemental forms should be submitted by the due date in FormsNet3 whenever possible.
Requirements
- Centers will be required to complete 100% of theses forms by the end of the trimester following the due date to meet CPI standards.
| Forms | Visit | Form Due Date (July 2021 FN Release) |
|---|---|---|
| BMT CTN 1702 Enrollment Form (2532) | n/a | Enrollment Date + 30 days |
| BMT CTN 1702 Donor Testing Form (2533) | n/a | Evaluability Determination + 180 days |
| BMT CTN 1702 Monthly Update Form (2534) | 1 Month | Evaluability Determination + 30 days |
| 2 Month | Evaluability Determination + 60 days | |
| 3 Month | Evaluability Determination + 90 days | |
| 4 Month | Evaluability Determination + 120 days | |
| 5 Month | Evaluability Determination + 150 days | |
| 6 Month | Evaluability Determination + 210 days | |
| BMT CTN 1702 Adverse Event Form (2535) BMT CTN 1702 Off Study Form (2536) BMT CTN 1702 Protocol Deviation / Violation Form (2537) |
n/a | Submission Date |
| Tepadina® Supplemental Data Collection Form (2540) | 100 day | Infusion Date + 130 days |
| 6 month | Infusion Date + 225 days | |
| 1 year, 2 year | Anniversary Date + 45 days | |
| 3, 4, 5 year | Anniversary Date + 60 days | |
| Inotuzumab Ozogamicin (Besponsa™) Supplemental Data Collection Form (2541) | n/a | Infusion Date + 30 days |
| Mogamulizumab (Poteligeo) Supplemental Data Collection Form (2542) | 100 day | Infusion Date + 130 days |
| 6 month | Infusion Date + 225 days | |
| 1 year, 2 year | Anniversary Date + 45 days | |
| Gemtuzumab Ozogamicin (Mylotarg ™) Supplemental (2543) | n/a | Administration Date |
| Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome (SOS) Supplemental Data Collection Form (2553) |
100 day | Infusion Date + 130 days |
| 6 month | Infusion Date + 225 days | |
| CMS Registration Form (2554) | n/a | Infusion Date + 30 days |
| CMS – MF Myelofibrosis Eligibility Form (2555) | n/a | Infusion Date + 30 days |
| Myelofibrosis Pre-HCT Supplemental Data (2556) | n/a | Infusion Date + 30 days |
| CMS-SCD Sickle Cell Disease Eligibility Form (2558) | n/a | Infusion Date + 30 days |
The following forms are currently excluded from CPI: Forms 2008, 2800, 2801, and 5000-5002.
Other Forms
For all other forms not classified as critical or study supplemental forms, CIBMTR monitors completion rates for two trimesters after the form’s due date.
Requirements
- Centers will be required to complete 95% of these forms by the end of the trimester following the due date to meet CPI standards.
| Forms | Form Due Date (April 2021 FN Release) |
|---|---|
| Eligibility (2500) Patient Contact (2820) |
Infusion Date + 30 days |
| Pre- CTED | Infusion Date + 30 days |
| CT Product Form (4003) CT Infusion Form (4006) |
Infusion Date + 45 days |
| Gene Therapy Product (2003) | Infusion Date + 45 days |
| Baseline (2000) Infectious Disease Markers (2004) HLA Typing (2005) Pre-Infusion Disease / Infection (2010-2058) |
Infusion Date + 60 days |
| 100 Day Follow-up (2450, 2100, 4100) 100 Day Post-Infusion Disease / Infection Forms (2110-2158) 100 Day Chimerism Form (2451) |
Infusion Date + 130 Days |
| 6 Month Follow-up (2450, 2100, 4100) 6 Month Post-Infusion Disease / Infection Forms (2110-2158) 6 Month Chimerism Form (2451) |
Infusion Date + 225 days |
| 1 Year Follow up, 2 Year Follow-up (2450, 2100, 4100) 1 Year Post-Infusion, 2 Year Post-Infusion Disease / Infection Forms (2110-2158) 1 Year, 2 Year Chimerism Form (2451) |
Anniversary Date + 45 days |
| 3+ Year Follow-up (2450, 2100, 4100) 3+ Year Post-Infusion Disease, Infection Forms (2110-2158) |
Anniversary Date + 60 days |
| Secondary Neoplasm Form (3500) Pregnancy Form (3501) |
Event Date + 30 days |
| Death Form (2900) | Death Date + 30 days |
| Donor Lymphocyte Infusion Form (2199) | Date Reported + 30 days |
Query Resolution
Queries may be placed on missing data or to verify inconsistent data, or when clarification and/or documentation is needed to confirm the reported data. Whenever possible, query resolution should occur within six weeks after placement of the query.
Requirements
- Resolve ≥95% of queries placed in the previous trimester.
Query Resources
- Query Functionality Overview
- Query Resolution Instructions
- How to Run a CPI List for Queries
- Queries eLearning