Updates to validations, question enabling/disabling and form generation occur on a monthly basis and are tentatively scheduled for the 4th Friday of the month.
August 2026 (To Be Released August 21, 2026)
| Form_Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| F4006 r7 | Q13 | Validation (Modify) | IF Core: Product name IS EQUAL TO ANY ANITOCAB, ARLOCAB, RAPCAB, RELMACAB, TABELEC, ZAMTOCAB, ZEVORCAB, LETETRESGENE, LISOCABTAGENE, ORVACABTAGENE, OTH, OTHR, NO_PROD_NAME OR Core: Treatment Path for the current event IS EQUAL TO 1 THEN Q13 Total number of cells administered MUST BE ANSWERED IF Core: Product name IS EQUAL TO ANY AFAMITRES, ANITOCAB, ARLOCAB, CILTACABTAGENE, IDECABTAGENE, LETETRESGENE, LIFILEUCEL, OBECAB, RAPCAB, RELMACAB, TABELEC, ZAMTOCAB, ZEVORCAB, LISOCABTAGENE, ORVACABTAGENE, TISAGENLECLE, OTH, OTHR, NO_PROD_NAME OR Core: Treatment Path for the current event IS EQUAL TO 1 THEN Q15 Specify the cell type(s) administered MUST BE ANSWERED |
IF Core: Product name IS EQUAL TO ANY ARLOCAB, RAPCAB, RELMACAB, TABELEC, ZAMTOCAB, ZEVORCAB, LETETRESGENE, LISOCABTAGENE, ORVACABTAGENE, OTH, OTHR, NO_PROD_NAME OR Core: Treatment Path for the current event IS EQUAL TO 1 THEN Q13 Total number of cells administered MUST BE ANSWERED Q15 IF Core: Product name IS EQUAL TO ANY AFAMITRES, ARLOCAB, CILTACABTAGENE, IDECABTAGENE, LETETRESGENE, LIFILEUCEL, OBECAB, RAPCAB, RELMACAB, TABELEC, ZAMTOCAB, ZEVORCAB, LISOCABTAGENE, ORVACABTAGENE, TISAGENLECLE, OTH, OTHR, NO_PROD_NAME OR Core: Treatment Path for the current event IS EQUAL TO 1 THEN (15) Specify the cell type(s) administered MUST BE ANSWERED |
Remove Antio-cel from validation as Kite does not provide cell dose information on the CoC |
| F2400 r11 | Q42 | Validation (Add) | IF AND ONLY IF Q42 Was this donor used for any prior HCTs? IS EQUAL TO No AND Q41 Did NMDP facilitate the procurement, collection, or transportation of the product? IS EQUAL TO No THEN Q57 Has the donor signed an IRB / ethics committee (or similar body) approved consent form to donate research blood samples to the NMDP / CIBMTR? MUST BE ANSWERED | For scenarios when subsequent transplant reported but first time donor has been used. Question should be unanswered for when reporting on 2nd+ infusion with same donor |
July 2026 (Released July 24, 2026)
| Form_Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| F3505 r1 | Q6 | Validation (Add) | N/A | Q6 Were any platelet transfusions administered? Will only be required for CS22-24 and CS20-55 studies, and will not be required for the SC24-08 study | Burden reduction – platelet questions are not needed for SC24-08 CMMI |
| F2402 r10 | Validation (Modify) | IF AND ONLY IF (501) Specify the multiple myeloma/plasma cell disorder (PCD) classification IS EQUAL TO ANY (MM, MM_NONSEC) AND (1) Date of diagnosis of primary disease for infusion: IS ANSWERED AND (2) What was the primary disease for which the infusion was performed? IS ANSWERED AND Interactive: 2402R10 PCD IS EQUAL TO false) THEN (524) I.S.S. stage MUST BE ANSWERED. IF AND ONLY IF (501) Specify the multiple myeloma/plasma cell disorder (PCD) classification IS EQUAL TO ANY (MM, MM_NONSEC) AND (1) Date of diagnosis of primary disease for infusion: IS ANSWERED AND (2) What was the primary disease for which the infusion was performed? IS ANSWERED AND Interactive: 2402R10 PCD IS EQUAL TO false) THEN (525) R-I.S.S. stage MUST BE ANSWERED |
IF AND ONLY IF (501) Specify the multiple myeloma/plasma cell disorder (PCD) classification IS EQUAL TO ANY (MM, MM_NONSEC) AND (1) Date of diagnosis of primary disease for infusion: IS ANSWERED AND (2) What was the primary disease for which the infusion was performed? IS ANSWERED AND Interactive: 2402R10 PCD IS EQUAL TO false) AND (518) Serum albumin: IS NOT ANSWERED OR (519) Serum β2-microglobulin: IS NOT ANSWERED) THEN (535) I.S.S. stage MUST BE ANSWERED. IF AND ONLY IF (501) Specify the multiple myeloma/plasma cell disorder (PCD) classification IS EQUAL TO ANY (MM, MM_NONSEC) AND (1) Date of diagnosis of primary disease for infusion: IS ANSWERED AND (2) What was the primary disease for which the infusion was performed? IS ANSWERED AND Interactive: 2402R10 PCD IS EQUAL TO false ) AND (516) LDH: IS NOT ANSWERED OR (524) Were cytogenetics tested (karyotyping or FISH)? IS EQUAL TO ANY (N, U) OR (525) Were cytogenetics tested via FISH? IS EQUAL TO ANY (N, U) THEN (536) R-I.S.S. stage MUST BE ANSWERED |
Burden reduction – when labs and karyotype are reported, user does not need to also answer ISS and R-ISS questions (they are calculated from labs and karyotype). Questions in this section were also reordered to create a better user experience |
June 2026 (Released June 17, 2026)
| Form_Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| F2450 r9 | Q34 | Validation (Modify) | If Core: Selective TED IS NOT EQUAL TO SEL_TED AND Visit IS EQUAL TO ANY (100D, 6M) THEN Q34 Was specific therapy used to prevent liver toxicity? MUST BE ANSWERED | If Core: Selective TED IS NOT EQUAL TO SEL_TED AND Visit IS EQUAL TO ANY (100D, 6M) AND Core: Treatment PATH for the current event IS EQUAL TO 1 THEN Q34 Was specific therapy used to prevent liver toxicity? MUST BE ANSWERED | Question disabled for subsequent CT events |
| Q96 | Validation (Add) | If and only if Core: Selective TED IS NOT EQUAL TO SEL_TED AND ( Core: Treatment Path for the current event IS EQUAL TO 1 AND Core: Event disease IS EQUAL TO ANY ALL, AML, AML_ANLL, CML, HL, NHL, MDS, MPN, OAL, OL, OTH_LEUK, PCD, STU ) THEN Q96 What is the current disease status? MUST BE ANSWERED | If Core: Selective TED IS NOT EQUAL TO SEL_TED AND (( Core: Treatment Path for the current event IS EQUAL TO 1 OR CORE: Current Event Track IS EQUAL TO STND_FUP_TED) AND Core: Event disease IS EQUAL TO ANY ALL, AML, AML_ANLL, CML, HL, NHL, MDS, MPN, OAL, OL, OTH_LEUK, PCD, STU ) THEN Q96 What is the current disease status? MUST BE ANSWERED | Question enabled for subsequent CT events when the CT is randomized to the Standard Follow-up TED track | |
| Validation (Modify) | IF AND ONLY IF Core: Selective TED IS NOT EQUAL TO SEL_TED AND ( Core: Treatment Path for the current event IS EQUAL TO 1 AND Core: Event disease IS EQUAL TO ANY ALL, AML, AML_ANLL, CML, HL, NHL, MDS, MPN, OAL, OL, OTH_LEUK, PCD, STU ) THEN Q96 What is the current disease status? MUST BE ANSWERED | IF AND ONLY IF Core: Selective TED IS NOT EQUAL TO SEL_TED AND ( Core: Treatment Path for the current event IS EQUAL TO 1 AND Core: Event disease IS EQUAL TO ANY ALL, AML, AML_ANLL, CML, HL, NHL, MDS, MPN, OAL, OL, OTH_LEUK, PCD, STU ) AND Core: Disease_Cde is NOT EQUAL to MGRS THEN Q96 What is the current disease status? MUST BE ANSWERED | There are no established criteria to assess disease status for MGRS | ||
| F2100 r9 | Q46 | Validation (Add) | If Visit IS EQUAL TO ANY (100D, 6M, 1Y, 2Y) THEN Q46 Were supplemental intravenous immunoglobulins (IVIG) received? MUST BE ANSWERED | If Visit IS EQUAL TO ANY (100D, 6M, 1Y, 2Y)AND Core: Treatment PATH for the current event IS EQUAL TO 1 THEN Q46 Were supplemental intravenous immunoglobulins (IVIG) received? MUST BE ANSWERED | Question disabled for subsequent CT events |
| Q237 | Validation (Add) | Q237 Did the recipient develop Systemic Inflammatory Response Syndrome (SIRS)? MUST BE ANSWERED | If Core: Treatment PATH for the current event IS EQUAL to 1 THEN Q237 Did the recipient develop Systemic Inflammatory Response Syndrome (SIRS)? MUST BE ANSWERED | ||
| Q239 | Validation (Add) | Q239 Did the recipient develop septic shock? MUST BE ANSWERED | If Core: Treatment PATH for the current event IS EQUAL to 1 THEN Q239 Did the recipient develop septic shock? MUST BE ANSWERED | ||
| F4100 r10 | Q22 | Validation (Add) | Q22 Was a subsequent autoimmune disorder diagnosed? MUST BE ANSWERED | If Core: Treatment PATH for the current event IS EQUAL to 2 OR (Core: Treatment PATH for the current event IS EQUAL to 1 AND CORE: Patient event donor type IS Auto) THEN Q22 Was a subsequent autoimmune disorder diagnosed? MUST BE ANSWERED | Question disabled for subsequent Allo HCT events |
May 2026 (Released May 15, 2026)
| Form_Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| F2016 r5 | Q192 | Validation (Modify) | Q192 Plasma cells in blood by morphologic assessment MUST BE ANSWERED. | IF Form 2402 R10: Sequence Number: IS NOT ANSWERED THEN Q192 Plasma cells in blood by morphologic assessment MUST BE ANSWERED. IF Form 2402 R9: Sequence Number: IS ANSWERED THEN Q192 Plasma cells in blood by morphologic assessment MUST BE ANSWERED. |
Plasma cells in blood by morphologic assessment is captured on F2402 r10, thus will be disabled on F2016. |
| F2016 r5 | Q193 & Q194 | Validation (Modify) | IF AND ONLY IF Q192 Plasma cells in blood by morphologic assessment = Known, THEN Q193 % value MUST BE ANSWERED. IF AND ONLY IF Q192 Plasma cells in blood by morphologic assessment = Known, THEN Q194 Plasma cells in blood by morph assess value MUST BE ANSWERED. |
IF AND ONLY IF Q192 Plasma cells in blood by morphologic assessment = Known, THEN Q193 % value MUST BE OPTIONAL. IF AND ONLY IF Q192 Plasma cells in blood by morphologic assessment = Known, THEN Q194 Plasma cells in blood by morph assess value) MUST BE OPTIONAL. IF AND ONLY IF Q192 Plasma cells in blood by morphologic assessment = Known, THEN ANY (Q193 % value, Q194 Plasma cells in blood by morph assess value) MUST BE ANSWERED. |
Centers only have to answer one or the other, not both of these child questions, based on what is reported on their source documentation. |
| F2400 r11 | Validation (Add) | If Q32 “Specify donor” = ALLO-UNRELATED and Q41 “Did NMDP facilitate the procurement, collection, or transportation of the product?” = yes and GRID is not answered, then Q45 “Registry Donor ID” must be answered. If Q41 “Did NMDP facilitate the procurement, collection, or transportation of the product?” = yes and GRID is not answered, then Q49 “Donor Date of Birth” is optional. If Q41 “Did NMDP facilitate the procurement, collection, or transportation of the product?” = yes and GRID is not answered, then Q53 “Donor sex” is optional. If Q41 “Did NMDP facilitate the procurement, collection, or transportation of the product?” = yes and GRID is not answered, then Q47 “Registry or UCB Bank ID” must be equal to any (4364, 2197, 6681, 3146, 4993, 6887, 8339, 4131, 4460, 5451, 8196, 4068, 5070, 4307, 3034, 4381, 5971, 8714, 9778, 2329, 5509, 6933, 6517). |
Enabling more fields for NMDP facilitated donors that do not use GRID. |
April 2026 (Released April 24, 2026)
| Form_Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| 2400 r11 | Q41 | Validation (Add) | If Q41 “Did NMDP facilitate the procurement, collection, or transportation of the product?” is equal to yes and GRID is not answered, then Q47 “Registry or UCB Bank ID” must be equal to any (4364, 2197, 6681, 3146, 4993, 6887, 8339, 4131, 4460, 5451, 8196, 4068, 5070, 4307, 3034, 4381, 5971, 8714, 9778, 2329, 5509, 6933, 6517) | Enabling more fields for NMDP facilitated donors that do not use GRID | |
| 2402 r10 | Q115 | Validation (Modify) | If Q115 “What was the disease status?” is equal to any (1CR, 2CR, GE3CR), then Q117” Date CR first achieved:” must be answered | If Q115 “What was the disease status?” is equal to 1CR, then Q117 “Date CR first achieved:” must be answered | Q117 is only answered for 1st CR |
| Smart Navigation (Add) | If Q115 “What was the disease status?” is equal to 2nd complete remission, then go to Q119 “Specify the method(s) that was used to assess measurable residual disease status” else go to Q128 “Specify ALL classification” | Q117 is not necessary for 2nd CR. Q119 should be completed when the disease status is 2nd CR. | |||
| 2028 r3 | Q59 | Validation (Modify) | If and only if Q59 “Was therapy given?” is equal to yes, then Q69 “Was there recurrent disease following this line of therapy?” must be answered | If Q59 “Was therapy given?” is equal to yes and Q67 “Best Response to line of therapy” is equal to (Complete, Partial), then Q69 “Was there recurrent disease following this line of therapy?” must be answered | Data quality improvement |
| 4000 r11 | Q7 – 10, Q39 & Q41 | Validation (Modify) | If and only if core “Recipient Age At Transplant” is less than 18, then Q7 “Is the recipient an emancipated minor?” must be answered If core “Recipient Age At Transplant” is greater than or equal to 18 or Q7 “Is the recipient an emancipated minor?” is equal to yes, then Q8 “Specify the recipient’s current relationship status” must be answered Q9 “What is the highest degree or level of school that the recipient has completed?” must be answered Q10 “Is the recipient covered by health insurance?” must be answeredt |
If and only if core “Recipient Age At Transplant” is less than 18 and core “Intl. Domestic Code” is equal to “D,” then Q34 “Is the recipient an adult (18 years of age or older) or emancipated minor?” must be answered If core “Recipient Age At Transplant” is greater than or equal to 18 or Q7 “Is the recipient an emancipated minor?” is equal to yes and core “Intl. Domestic Code” is equal to “D,” then Q8 “Specify the recipient’s current relationship status” must be answered If and only if core “Intl. Domestic Code” is equal to “D,” then Q39 “What is the highest educational grade the recipient completed?” must be answered If and only if core “Intl. Domestic Code” is equal to “D,” then Q41 “Is the recipient covered by health insurance?” must be answered |
Align with CT forms |
| 2400 r11 | Q23, Q27 & Q28 | Validation (Modify) | If Q23 “Sponsor” is equal to any (BMT_CTN, RCI_BMT, PIDTC) and core “Intl. Domestic Code” is equal to “D,” then Q27 “Protocol ID” must be answered If Q23 “Sponsor” is equal to any (BMT_CTN, RCI_BMT, PIDTC) and core “Intl. Domestic Code” is equal to “I,” then Q27 “Protocol ID” must be optional If and only if Q27 “Protocol ID” is answered, then Q28 “Subject ID:” must be answered If Q23 “Sponsor” is equal to any (BMT_CTN, RCI_BMT, PIDTC, USIDNET, COG, OTHR), then Q28 “Subject ID:” must be optional |
Q23 “Sponsor” is equal to BMT_CTN, then Q27 “Protocol ID” must be answered If Q23 “Sponsor” is equal to any (RCI_BMT, PIDTC) and core “Intl. Domestic Code” is equal to “D” then Q27 “Protocol ID” must be answered If Q23 “Sponsor” is equal to any (RCI_BMT, PIDTC) and core “Intl. Domestic Code” is equal to “I,” then Q27 “Protocol ID” must be optional If Q27 “Protocol ID” is equal to any (1507, 1903, 1904, 1905, 2001, 2203, 2207, 2303), then Q28 “Subject ID:” must be answered If Q27 “Protocol ID” is equal to any (CRO10_CBA, CRO16_NTCD, CRO17_CD33, CRO17_CSIDE, CRO_ABA3, CRO_ACCEL, CRO_MEAS, CRO_OPTIM, CRO_PRES1, CRO_TRANS, COG_1732, COG_1831, COG_2020SC, COG_2031, OTHR_COG), then Q28 “Subject ID:” must be optional |
Data quality improvement |
March 2026 (Released March 27, 2026)
| Form_Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| F2029R2, F2030R5, F2031R3, F2033R3, F2034R3, F2035R3, F2035R2, F2036R2, F2038R2, F2039R3, F2040R2, F2044R2 and F2055R2 | Validation (Modify) | Diagnosis date is reported on F2402 and the pre-infusion CRF forms for congenital diseases | Diagnosis date questions disabled on these CRF forms. Validations dependent on diagnosis date will now use the diagnosis date core field. |
Data quality improvement | |
| F4003 r6 | Q1 | Validation (Modify) | IF Core: Product name = AFAMITRES, ANITOCAB, ARLOCAB, LETETRESGENE, LIFILEUCEL, OBECAB, RAPCAB, RELMACAB, TABELEC, ZAMTOCAB, ZEVORCAB, AXICABTAGENE, BREXUCABTAGENE, CILTACABTAGENE, IDECABTAGENE, LISOCABTAGENE, ORVACABTAGENE, or TISAGENLECLE, THEN Q1 Is the product out of specification? MUST BE ANSWERED | IF Core: Product name = AFAMITRES, ANITOCAB, ARLOCAB, LETETRESGENE, LIFILEUCEL, OBECAB, RAPCAB, RELMACAB, TABELEC, ZAMTOCAB, ZEVORCAB, AXICABTAGENE, BREXUCABTAGENE, CILTACABTAGENE, IDECABTAGENE, LISOCABTAGENE, ORVACABTAGENE, or TISAGENLECLE AND Core: Treatment Path for the current event IS EQUAL TO 2 THEN Q1 Is the product out of specification? MUST BE ANSWERED | Q1 should not be answered for co-infusions |
| F4003 r6 | Q7 | Validation (Modify) | IF Core: Product name = OTHER or NO_PROD_NAME THEN Q7 Where was the cellular therapy product manufactured / processed? MUST BE ANSWERED | IF Core: Product name = OTHER or NO_PROD_NAME OR Core: Treatment Path for the current event IS EQUAL TO 1 THEN Q7 Where was the cellular therapy product manufactured / processed? MUST BE ANSWERED | Q7 should be answered for co-infusions |
| F4003 r6 | Q14 | Validation (Modify) | IF Core: Product name = OTHER or NO_PROD_NAME THEN Q14 Were the cells in the infused product selected/modified/engineered prior to infusion? MUST BE ANSWERED | IF Core: Product name = OTHER or NO_PROD_NAME OR Core: Treatment Path for the current event IS EQUAL TO 1 THEN Q14 Were the cells in the infused product selected/modified/engineered prior to infusion? MUST BE ANSWERED | Q14 should be answered for co-infusions |
| F4003 r6 | Q29 | Validation (Modify) | IF Core: Product name = ANITOCAB, ARLOCAB, RAPCAB, RELMACAB, TABELEC, ZAMTOCAB, ZEVORCAB, LETETRESGENE, LISOCABTAGENE, ORVACABTAGENE, OTH, OTHER or NO_PROD_NAME THEN Q13 Total number of cells administered MUST BE ANSWERED | IF Core: Product name = ANITOCAB, ARLOCAB, RAPCAB, RELMACAB, TABELEC, ZAMTOCAB, ZEVORCAB, LETETRESGENE, LISOCABTAGENE, ORVACABTAGENE, OTH, OTHR, or NO_PROD_NAME OR Core: Treatment Path for the current event IS EQUAL TO 1 THEN Q13 Total number of cells administered MUST BE ANSWERED | Q29 should be answered for co-infusions |
| F4006 r7 | Q13 | Validation (Modify) | IF Core: Product name = ANITOCAB, ARLOCAB, RAPCAB, RELMACAB, TABELEC, ZAMTOCAB, ZEVORCAB, LETETRESGENE, LISOCABTAGENE, ORVACABTAGENE, OTH, OTHER or NO_PROD_NAME THEN Q13 Total number of cells administered MUST BE ANSWERED | IF Core: Product name = ANITOCAB, ARLOCAB, RAPCAB, RELMACAB, TABELEC, ZAMTOCAB, ZEVORCAB, LETETRESGENE, LISOCABTAGENE, ORVACABTAGENE, OTH, OTHR, or NO_PROD_NAME OR Core: Treatment Path for the current event IS EQUAL TO 1 THEN Q13 Total number of cells administered MUST BE ANSWERED | Q13 should be answered for co-infusions |
| F4006 r7 | Q15 | Validation (Modify) | IF Core: Product name = AFAMITRES, ANITOCAB, ARLOCAB, CILTACABTAGENE, IDECABTAGENE, LETETRESGENE, LIFILEUCEL, OBECAB, RAPCAB, RELMACAB, TABELEC, ZAMTOCAB, ZEVORCAB, LISOCABTAGENE, ORVACABTAGENE, TISAGENLECLE, OTH, OTHR, or NO_PROD_NAME THEN Q15 Specify the cell type(s) administered MUST BE ANSWERED | IF Core: Product name = AFAMITRES, ANITOCAB, ARLOCAB, CILTACABTAGENE, IDECABTAGENE, LETETRESGENE, LIFILEUCEL, OBECAB, RAPCAB, RELMACAB, TABELEC, ZAMTOCAB, ZEVORCAB, LISOCABTAGENE, ORVACABTAGENE, TISAGENLECLE, OTH, OTHR, or NO_PROD_NAME OR Core: Treatment Path for the current event IS EQUAL TO 1 THEN Q15 Specify the cell type(s) administered MUST BE ANSWERED | Q15 should be answered for co-infusions |
| F2400 r11 | Q164 | Validation (Modify) | Q164 Planned start date of abatacept: MUST BE BETWEEN Event date and Event date: PLUS 7 DAYS | Q164 Planned start date of abatacept: MUST BE BETWEEN Event date: MINUS 1 DAYS and Event date: PLUS 7 DAYS | Abatacept is often given the day before infusion, not on the same date as the infusion. Updating this validation allows accurate start date entry without creating an error in on the form. |
| F4006 r7 | Q24 | Validation (Modify) | Q24 Did the recipient receive concomitant therapy? MUST BE ANSWERED | IF Core: Treatment Path for the current event IS EQUAL TO 2 THEN Q24 Did the recipient receive concomitant therapy? MUST BE ANSWERED | Q24 should not be answered for co-infusions |
| F2016 r5 | Validation (Modify) | IF Q1 Specify the multiple myeloma/plasma cell disorder (PCD) classification = Multiple myeloma-non-secretory (187) THEN Q13 What was the M-spike type? MUST BE NOT EQUAL TO No bands present. IF Q1 Specify the multiple myeloma/plasma cell disorder (PCD) classification = Multiple myeloma (178) THEN Q13 What was the M-spike type? MUST CONTAIN ANY (IGG_KAPPA, IGA_KAPPA, IGM_KAPPA, IGD_KAPPA, IGE_KAPPA, IGG_LAMBDA, IGA_LAMBDA, IGM_LAMBDA, IGD_LAMBDA, IGE_LAMBDA, IGG_HVY_CHN, IGA_HVY_CHN, IGM_HVY_CHN, IGD_HVY_CHN, IGE_HVY_CHN). IF Q1 Specify the multiple myeloma/plasma cell disorder (PCD) classification = Multiple myeloma-light chain only (186) THEN Q13 What was the M-spike type? MUST = ANY (KAPPA_LT_CHN, LAMBDA_LT_CHN). IF Q1 Specify the multiple myeloma/plasma cell disorder (PCD) classification = Multiple myeloma-light chain only (186) THEN Q13 What was the M-spike type? MUST = ANY (KAPPA_LT_CHN, LAMBDA_LT_CHN). IF AND ONLY IF Q12 Serum immunofixation = Known THEN Q13 What was the M-spike type? MUST BE ANSWERED. |
IF AND ONLY IF Q12 Serum immunofixation = Known THEN Q13 What was the M-spike type? MUST BE ANSWERED. Removed validations that restrict answers to Q13 based upon disease classification in Q1. | Aligns F2016 with F2402 |
February 2026 (Released February 20, 2026)
| Form_Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| F2114 R4 | Q219 | Floating Text (Add) | Q219 “Was disease detected via bone marrow examination?” | Q219 “Was disease detected via bone marrow examination? Report if the disease was assessed via bone marrow examination” | Data quality improvement |
| F2157 R1 | Q262 | Floating Text (Add) | Q262 “Was disease detected via bone marrow examination?” | Q262 “Was disease detected via bone marrow examination? Report if the disease was assessed via bone marrow examination” | Data quality improvement |
| F2006 R7 | Q43 | Floating Text (Add) | Q43 “Total volume of product received by center plus additives” | Q43 “Total volume of product received by center plus additives (report the volume infused)” | Data quality improvement |
| F2003 R2 | Q72 | Validation (Add) | No validation | Q72 “Date of manipulated product infusion” must be greater than or equal to event date | Providing date range for improved data quality. Q72 cannot be before the event date and in the event of multiple F2003s for an event “or equal to” was added |
| F2500 R3 | Q4 | Floating Text (Modify) | Q4 “Total number of lines of therapy received (between diagnosis and infusion)” | Q4 “Total number of lines of therapy received (between diagnosis and apheresis)” | Aligned to match Forms Instruction Manual |
| F2554 R3 | Q4 | Validation (Modify) | Q4 “Does the recipient have Medicare coverage?” must be answered | If Q1 “The recipient should be enrolled on the following study” is equal to Multiple Myeloma (17-CMS-MM), Myelofibrosis (16-CMS-MF), Sickle cell disease (17-CMS-SCD), then Q4 “Does the recipient have Medicare coverage?” must be answered | Medicare is not eligible for CGT Access Model and thus information is not necessary |
January 2026 (Released January 23, 2026)
| Form_Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| F2451 R3 | Q4-13 | Validation (Add) | Overrides are allowed on Q4-13 | Overrides are NOT allowed on Q4-13 | Improved data quality. If no donor cells are found in a chimerism study, 0% must be entered in the grid, rather than leaving these fields blank |
| F2400 R11 & F2000 R6 | Validation (Modify) | If F2400: Sequence Number: is not answered, then Q80 Dosing weight: must be answered If F2400: Sequence Number: is answered and Q39 Was a pre-HCT preparative regimen given = Yes, then Q80 Dosing weight: must be answered If F2400: Sequence Number: is not answered, then Dosing weight uom must be answered If F2400: Sequence Number: is answered and Q39 Was a pre-HCT preparative regimen given = yes, then Dosing weight uom must be answered |
If Q39 Was a pre-HCT preparative regimen given = yes, then Q80 Dosing weight: must be answered If Q39 Was a pre-HCT preparative regimen given = yes, then Dosing weight uom must be answered Removed these validations: If F2400: Sequence Number: is not answered, then Q80 Dosing weight: must be answered If F2400: Sequence Number: is not answered, then Dosing weight uom must be answered |
Dosing weight will be disabled on F2400 R11 and enabled on F2000 R6, where it will be collected for each drug. This change will improve the accuracy of dosing weight data. | |
| F2057 R1 | Q11, Q29, Q35 | Validation (Modify) | Several validations reference the diagnosis date as the date the diagnostic labs were drawn | References to the diagnostic date have been removed from validations for diagnostic lab draw dates. Validations now require that the lab draw date be before the systemic treatment start date, aligning with validations on similar forms. Previous validations have been removed and replaced with the following:
|
Diagnostic labs must be drawn before the start of systemic treatment, but they may occur either before or after the diagnosis date |
| F2199 R2 | Q1 | Validation (Modify) | Override is allowed on Q1 Donor ID | Override is NOT allowed on Q1 Donor ID | Donor information is required for proper analysis of allo boost information |
December 2025 (Released December 12th, 2025)
| Form_Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| F2400 R11 | Q178 | Validation (Modify) | Q178 “Specify if the recipient received any of the following” must be answered | If research is consent is equal to “Y, WAIVER, PND_AOM_Y,” then Q178 “Specify if the recipient received any of the following” must be answered | Question should only be answered for recipients providing appropriate consent |
| F2199 R2 | Q138 | Validation (Modify) | If Q6 “What is the primary indication?” is equal to “Insufficient hematopoietic recovery/graft failure,” then Q38 “What was the best response to the DCI?” must be be equal to “NR, NORM_BC, PART_NORM_BC” If Q6 “What is the primary indication? is equal to “gvhd_treatmnt, immune_reconst, infect_trtmt, INS_RECOV_GF, subopt_dnr_chim, REL_PROG_TRTMT, MRD_TRTMT,” then Q38 “What was the best response to DCI?” must be answered |
If Q6 “What is the primary indication?” is equal to “Insufficient hematopoietic recovery/graft failure” or is not answered, then Q38 “What was the best response to the DCI?” must be be equal to “NR, NORM_BC, PART_NORM_BC” If Q6 “What is the primary indication? is equal to “gvhd_treatmnt, immune_reconst, infect_trtmt, INS_RECOV_GF, subopt_dnr_chim, REL_PROG_TRTMT, MRD_TRTMT” or is not answered, then Q38 “What was the best response to DCI?” must be answered |
Best response will be collected for allo boosts when Q6 is not answered |
| Q6 | Validation (Modify) | If Q6 “What is the primary indication?” is equal to “MRD_TRTMT, REL_PROG_TRTMT,” then Q8 “Was therapy to treat disease given prior to the DCI?” must be answered | If Q6 “What is the primary indication?” is equal to “MRD_TRTMT, REL_PROG_TRTMT” or is not answered, then Q8 “Was therapy to treat disease given prior to the DCI?” must be answered | Question should be enabled for allo boosts | |
| F2015 R3 | Q7-14, 19-20, 32-48, 71-87 | Validation (Modify) | Q7-14, 19-20, 32-48, 71-87 are enabled | Q7-14, 19-20, 32-48, 71-87 should be disabled when F2402 R10 is revision of F2402 that is completed | CBC and cytogenetics are collected on F2402 R10 and no longer need to be collected on F2015 |
November 2025 (Released November 21st, 2025)
| Form_Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| F2138 r2 | Q20-22 | Floating Text (Add) | Q20-22 will be leveled out, no longer child questions of Q11 | To clearly show the intent is to capture testing done on a serum sample, not a CSF sample | |
| F2402 r10 | Q377 | Validation (Modify) | IF AND ONLY IF Q376 disease status = Hematologic improvement, then Q377 Specify cell lines examined to determine HI status must be answered | Q377 should not be answered if the disease subtype in Q309 is JMML | Q377 is not applicable to JMML (Juvenile Myelomonocytic Leukemia) |
| F2157 r1 | Q128 | Validation (Add) | Q128 must not be equal to “not applicable” | If all molecular markers tested are negative, then the parent question (Q117) should be answered as “No”, thus skipping Q128. | |
| F2034 r3 | Q3 & Q114 | Validation (Modify) | IF AND ONLY IF Is this the report of a second or subsequent transplant for the same disease? IS EQUAL TO No THEN Q3 What was the date of diagnosis? MUST BE ANSWERED. Q114 Serum ferritin MUST BE ANSWERED |
IF AND ONLY IF Is this the report of a second or subsequent transplant for the same disease? IS EQUAL TO No AND Date Received: IS LESS THAN OR EQUAL TO 2025-11-21 THEN Q3 What was the date of diagnosis? MUST BE ANSWERED. (Disable Q3) IF AND ONLY IF Date Received: IS LESS THAN OR EQUAL TO 2025-11-21 THEN Q114 Serum ferritin MUST BE ANSWERED. (Disable Q114) |
Disabling Q3 because it is a duplicate, this question is captured on F2402. Disabling Q114 (and child questions 115-116) because they are duplicates. These questions are captured on F2400 |
| F2056 r1 | Q5 | Validation (Modify) | IF AND ONLY IF Is this the report of a second or subsequent transplant for the same disease? = No, THEN Q5 MUST BE ANSWERED. | IF AND ONLY IF Is this the report of a second or subsequent transplant for the same disease? IS EQUAL TO No AND Date Received: IS LESS THAN OR EQUAL TO 2025-11-21 THEN (5) What was the date of diagnosis? MUST BE ANSWERED. (Disable Q5) |
Disabling Q5 because it is a duplicate, this question is captured on F2402. |
| F2039 r3 | Q3 | Validation (Modify) | IF AND ONLY IF Is this the report of a second or subsequent transplant for the same disease? = No, THEN Q3 MUST BE ANSWERED. | IF AND ONLY IF Is this the report of a second or subsequent transplant for the same disease? IS EQUAL TO No AND Date Received: IS LESS THAN OR EQUAL TO 2025-11-21 THEN Q3 What was the date of diagnosis? MUST BE ANSWERED. (Disable Q3) |
Disabling Q3 because it is a duplicate. This question is capture on F2402 |
| F2019 r3 | Q151 | Validation (Modify) | Q151 What was the disease status at the last evaluation prior to the preparative regimen? MUST BE ANSWERED | IF AND ONLY IF Received Date: IS LESS THAN OR EQUAL TO 2025-11-21 THEN Q151 What was the disease status at the last evaluation prior to the preparative regimen? MUST BE ANSWERED. (Disable Q151) |
Disabling Q151 because it is a duplicate. This question is capture on F2402 |
October 2025 (Released October 24th, 2025)
| Form Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| 2030 r5 | Q39 | Validation (Modify) | Q39 Cystatin-C must be answered | Q39 will be disabled | Questions will be disabled as F2400 r11 now captures information |
| 2000 r6 | Q39 | Validation (Modify) | If and only if Q39 “Was a pre-HCT preparative regimen given?” is equal to “yes,” then Q80 “dosing weight” must be answered | If and only if Q39 “Was a pre-HCT preparative regimen given?” is equal to “yes” and if date received is less than or equal to 2025-10-24, then Q80 “dosing weight” must be answered | |
| Q104 | Q104 “Is the recipient an adult (18 years of age or older) or emancipated minor?” must be answered | If date received is less than or equal to 2025-10-24, then Q104 “Is the recipient an adult (18 years of age or older) or emancipated minor?” must be answered | |||
| Q109 | Q109 “What is the highest educational grade the recipient completed?” must be answered | If date received is less than or equal to 2025-10-24, then Q109 “What is the highest educational grade the recipient completed?” must be answered | |||
| Q111 | Q111 “Is the recipient covered by health insurance?” must be answered | If date received is less than or equal to 2025-10-24, then Q111 “Is the recipient covered by health insurance?” must be answered | |||
| 4000 r10 | Q1 & Q2 | Validation (Modify) | If international center, then Q1 “Ethnicity” and Q2 “Race” are optional If US center, then Q1 “Ethnicity” and Q2 “Race” must be answered |
If international center and date received is less than or equal to 2025-10-24, then Q1 “Ethnicity” and Q2 “Race” are optional If US center and date received is less than or equal to 2025-10-24, then Q1 “Ethnicity” and Q2 “Race” are required |
Q1 & Q2 will be disabled as F2807 r1 collects information and is required for both international and US centers |
| 2010 r4 | Q10 | Validation (Modify) | If and only if “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is “no,” then Q10 “Did the recipient have a documented antecedent hematologic disorder?” must be answered | If and only if “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is “no” and date received is less than or equal to 2025-10-24, then Q10 “Did the recipient have a documented antecedent hematologic disorder?” must be answered | Q10-Q13 will be disabled as F2402 r10 now collects information |
| 2014 r4 | Q40 & Q177 | Validation (Modify) | If and only if Q1 “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is “no,” then Q40 “Were molecular tests for molecular markers performed?” must be answered If and only if “infusion primary disease” is equal to MDS, then Q177 “Were molecular tests for molecular markers performed?” must be answered |
If and only if Q1 “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is “no” and date received is less than or equal to 2025-10-24, then Q40 “Were molecular tests for molecular markers performed?” must be answered If and only if “infusion primary disease” is equal to MDS and date received is less than or equal to 2025-10-24, then Q177 “Were molecular tests for molecular markers performed?” must be answered If “primary disease” is AML and date received is greater than or equal to 2025-10-24, then Q177 “Were molecular tests for molecular markers performed?” must be answered |
Q40-Q47 and Q177-Q184 will be disabled as molecular markers at diagnosis and last evaluation are now collected on F2402 r10 when primary disease is MDS Molecular markers at last evaluation will still be collected on F2014 when the primary disease on F2402 is AML but a transformation has been reported |
| 2057 r1 | Q33 & Q233 | Validation (Modify) | If and only if Q1 “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is equal to “no,” then Q33 “Were molecular tests for molecular markers performed?” must be answered If and only if “Infusion primary disease” is equal to “MPN,” then Q233 “ Were molecular tests for molecular markers performed?” must be answered |
If and only if Q1 “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is equal to “no” and date received is less than or equal to 2025-10-24, then Q33 “Were molecular tests for molecular markers performed?” must be answered If and only if “Infusion primary disease” is equal to “MPN” and date received is less than or equal to 2025-10-24, then Q233 “Were molecular tests for molecular markers performed?” must be answered If and only if “Infusion primary disease” is equal to “AML” and if date received is greater than or equal to 2025-10-24, then Q233 “Were molecular tests for molecular markers performed?” must be answered |
Q33-Q40 and Q233-Q240 will be disabled as molecular markers at diagnosis and last evaluation are now collected on F2402 r10 when primary disease is MPN Molecular markers at last evaluation will still be collected on F2057 when the primary disease on F2402 is AML but a transformation has been reported |
| 2058 r2 | Q61 | Validation (Modify) | Q61 “Direct bilirubin” must be answered | If date received is less than or equal to 2025-10-24 then Q61 “Direct bilirubin” must be answered | Q61-Q63 will be disabled as direct bilirubin is now collected on F2402 r10 |
| 2012 r3 | Q253 & Q256 | Validation (Modify) | Q253 “What was the disease status?” must be answered Q256 “Date assessed” must be answered |
If date received is less than or equal to 2025-10-24, then Q253 “What was the disease status?” must be answered If date received is less than or equal to 2025-10-24, then Q256 “Date assessed” must be answered |
Q253-Q256 will be disabled as CML disease status is now collected on F2402 r10 |
| 2016 r5 | Q3, Q5 & Q7 | Validation (Modify) | If and only if “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is equal to “no,” then Q3 “Hemoglobin” must be answered If and only if “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is equal to “no,” then Q5 “Serum calcium” must be answered If and only if “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is equal to “no,” then Q7 “Serum creatinine” must be answered |
If and only if “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is equal to “no” and date received is less than or equal to 2025-10-24, then Q3 “Hemoglobin” must be answered If and only if “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is equal to “no” and date received is less than or equal to 2025-10-24, then Q5 “Serum calcium” must be answered If and only if “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is equal to “no” and date received is less than or equal to 2025-10-24, then Q7 “Serum creatinine” must be answered |
Q3-Q9 will be disabled as lab values are now collected on F2402 r10 |
| Q234 | Validation (Modify) | Q234 “Were cytogenetics tested?” must be answered | If and only if “Is this the report of a second or subsequent transplant or cellular therapy for the same disease?” is equal to “no,” then Q234 “Were cytogenetics tested?” must be answered | Q234-Q236 will be disabled as cytogenetics for subsequent infusions for MM/PCD will now be collected on F2402 r10 | |
| 2026 r2 | Q179, Q213, Q249 | Validation (Add) | If date received is greater than or equal to 2025-10-24, then Q179 “Specify the best response to chemotherapy” must not be equal to “very good partial response” or “minimal response” or “not evaluable” If date received is greater than or equal to 2025-10-24, then Q213 “Best response to line of therapy” must not be equal to “very good partial response” or “minimal response” or “not evaluable” If date received is greater than or equal to 2025-10-24, then Q249 “Specify the disease status immediately prior to the preparative regimen” must not be equal to “very good partial response” or “minimal response” or “not evaluable” |
Disease response options for neuroblastoma have been added to F2402 r10 and new validations/custom error messages will keep disease status consistent until neuroblastoma forms are updated | |
| 2126 r2 | Q1 | Validation (Add) | If date received is greater than or equal to 2025-10-24, then Q1 “Best response” must not be equal to “very good partial response” or “minimal response” or “not evaluable” |
September 2025 (Released September 26th, 2025)
| Form Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| F2402 r9 | Q416 | Modify | Radios button for answer options (single answer) | Check all that apply | Recent form revisions removed the combined light and heavy chain deposition disease option, but since patients may have both, answer fields will now be ‘check all that apply’ |
| F2116 r5 | Validation (modify) | If Q1 is equal to any (MM, MM_LT_CH, MM_NONSEC, PCL, SOL_PLASMA, SM, OSTEOSCL_POEMS, MGRS, OTH_PCL), then Q3 must be answered. If Q142 = yes AND Q1 is equal to any (MM, MM_LT_CH, MM_NONSEC, PCL, SOL_PLASMA, SM, OSTEOSCL_POEMS, MGRS, OTH_PCL) then Q163 must be answered. If Q1 is equal to any (MM, MM_LT_CH, MM_NONSEC, PCL, SOL_PLASMA, SM, OSTEOSCL_POEMS, MGRS, OTH_PCL), then Q251 must be answered |
If Q1 is equal to any (MM, MM_LT_CH, MM_NONSEC, PCL, SOL_PLASMA, SM, OSTEOSCL_POEMS, OTH_PCL), then Q3 must be answered. If Q142 = yes AND Q1 is equal to any (MM, MM_LT_CH, MM_NONSEC, PCL, SOL_PLASMA, SM, OSTEOSCL_POEMS, OTH_PCL), then Q163 must be answered. If Q1 is equal to any (MM, MM_LT_CH, MM_NONSEC, PCL, SOL_PLASMA, SM, OSTEOSCL_POEMS, OTH_PCL), then Q251 must be answered |
The validations have been updated to remove MGRS, since there is not disease response criteria |
August 2025 (Released August 22nd, 2025)
| Form_Revision | Question | Type of Change | Current | New | Rationale for Change |
|---|---|---|---|---|---|
| F2402 r4-9 | Validation (Modify) | If and only if “What was the primary disease for which the HCT / cellular therapy was performed?” is equal to “Histiocytic Disorders” and “Did the recipient have an active or recent infection with a viral pathogen?” is equal to “no,” then “Has the recipient ever been infected with PCP / PJP?” must be answered | If and only if “What was the primary disease for which the HCT / cellular therapy was performed?” is equal to “Histiocytic Disorders” then “Has the recipient ever been infected with PCP / PJP?” must be answered | PCP / PJP should be reported for all patients with Histiocytic Disorders | |
| F2400 r6-10 | Validation (Add) | If “NMDP facilitated” is not equal to “yes,” then “Registry” must not be equal to “U1CB” or “USA1” | Validation added to ensure correct registry or cord bank is reported | ||
| F2044 r2 | Q82 & Q115 | Validation (Modify) | Q82 (Date of evaluation prior to mobilization for stem cell collection) must be less than or equal to date of HSCT for which this form is being completed minus 120 days Q115 (Date CBC tested) must be less than or equal to date of HSCT for which this form is being completed minus 120 days |
Q82 (Date of evaluation prior to mobilization for stem cell collection) must be greater than or equal to date of HSCT for which this form is being completed minus 120 days Q115 (Date CBC tested) must be greater than or equal to date of HSCT for which this form is being completed minus 120 days |
Validation was incorrect and has been updated to match instructions on the form |
Additional Note: Question numbers were added in front of Donor ID field to every row in table that collects the percent of donor cells for each type of cells that were tested on F2451 r3
Last modified:
Aug 11, 2026