Below is a table summarizing the forms included in CPI and their respective due dates.
Critical Forms
As of September 2021, US centers will be required to complete 95% of these forms by the due date and 98% of these forms by end of the trimester following the due date in order to meet CPI Standards.
| Forms | UPDATED Due Date (April 2021 FN Release) |
|---|---|
| Indication 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 |
Non-Critical Forms
As of September 2021, US centers will be required to complete 95% of these forms by end of the trimester following the due date in order to meet CPI Standards.
| Forms | UPDATED Due Date (April 2021 FN Release) |
|---|---|
| Eligibility (2500) Patient Contact (2820) |
Infusion Date + 30 days |
| Pre-CTED (4000) | Infusion Date + 30 days |
| CT Product Form (4003) CT Infusion Form (4006) |
Infusion Date + 45 days |
| Baseline (2000) Infectious Disease Markers (2004) HLA Typing (2005) Pre-Infusion Disease / Infection (2010-2057) |
Infusion Date + 60 days |
| 100 Day Follow-up (2450, 2100, 4100) 100 Day Post-Infusion Disease / Infection Forms (2110-2157) 100 Day Chimerism Form (2451) |
Infusion Date + 130 Days |
| 6 Month Follow-up (2450, 2100, 4100) 6 Month Post-Infusion Disease / Infection Forms (2110-2157) 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 (2110-2157) 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 (2110-2157) |
Anniversary Date + 60 days |
| Secondary Neoplasm Form (3500) Pregnancy Form (3501) |
Event Date + 30 days |
| Death Form (2900) | Death Date + 30 days |
Study Supplemental Forms
As of September 2021, US centers will be required to complete 100% of these forms by end of the trimester following the due date in order to meet CPI Standards.
| Forms | Visit | CURRENT Due Date | UPDATED Due Date (coming with July 2021 FN Release) |
|---|---|---|---|
| BMT CTN 1702 Enrollment Form (2532) | n/a | Enrollment Date + 30 days | No Change |
| BMT CTN 1702 Donor Testing Form (2533) | n/a | Enrollment Date + 30 days | Evaluability Determination + 180 days |
| BMT CTN 1702 Monthly Update Form (2534) | 1 Month | Evaluability Determination + 30 days | No Change |
| 2 Month | Evaluability Determination + 60 days | No Change | |
| 3 Month | Evaluability Determination + 90 days | No Change | |
| 4 Month | Evaluability Determination + 120 days | No Change | |
| 5 Month | Evaluability Determination + 150 days | No Change | |
| 6 Month | Evaluability Determination + 210 days | No Change | |
| 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 | No Change |
| Tepadina® Supplemental Data Collection Form (2540) | 100 day | Infusion Date + 160 days | Infusion Date + 130 days |
| 6 month | Infusion Date + 270 days | Infusion Date + 225 days | |
| 1 year, 2 year | Anniversary + 90 days | Anniversary Date + 45 days | |
| 3, 4, 5 year | Anniversary + 45 days | Anniversary Date + 60 days | |
| Inotuzumab Ozogamicin (Besponsa™) Supplemental Data Collection Form (2541) | n/a | Infusion Date + 60 days | Infusion Date + 30 days |
| Mogamulizumab (Poteligeo) Supplemental Data Collection Form (2542) | 100 day | Infusion Date + 160 days | Infusion Date + 130 days |
| 6 month | Infusion Date + 270 days | Infusion Date + 225 days | |
| 1 year, 2 year | Anniversary + 90 days | Anniversary Date + 45 days | |
| Gemtuzumab Ozogamicin (Mylotarg ™) Supplemental (2543) | n/a | Administration Date | No Change |
| Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome (SOS) Supplemental Data Collection Form (2553) |
100 day | Infusion Date + 160 days | Infusion Date + 130 days |
| 6 month | Infusion Date + 270 days | Infusion Date + 225 days | |
| CMS Registration Form (2554) | n/a | Infusion Date | Infusion Date + 30 days |
| CMS – MF Myelofibrosis Eligibility Form (2555) | n/a | Infusion Date | Infusion Date + 30 days |
| Myelofibrosis Pre-HCT Supplemental Data (2556) | n/a | Infusion Date | Infusion Date + 30 days |
| CMS-SCD Sickle Cell Disease Eligibility Form (2558) | n/a | Infusion Date | Infusion Date + 30 days |
The following forms are currently excluded from CPI:
Form numbers: 2008, 2800, and 2801
Form numbers: 5000 – 5002
Last modified:
Jul 07, 2021