Form_Revision |
Question |
Type of Change |
Current |
New |
Rationale for Change |
---|
F2450r7 / F2100r4-8 |
Q16 (F2450) / Q18 (F2100) |
Validation (Add) |
“Not Applicable” available as answer option |
“Not Applicable” will NOT be allowed to be reported for 6M, 1Y, and 2Y reporting periods |
Consistency with ANC data capture update in April |
F4100r8/9 |
Q180 and 187 (r8) / Q153 and 160 (r9) |
Validation (Modify) |
If current treatment path is equal to 2, questions must be answered |
Disabled for combined follow-up when 2nd event is HCT |
Burden reduction |
F2450r7 / 2011r8 |
Q67 (F2450) / Q65 (F2100) |
|
Answer option reads “PCR (includes quantitative, real time, and fluorescent multiplex)” |
Option PCR changed to “Single nucleotide polymorphisms (SNPs) (includes quantitative PCR, real-time PCR, sequencing, other)” |
Updated for more inclusive data capture |
Form_Revision |
Question |
Type of Change |
Current |
New |
Rationale for Change |
---|
F2013 r3 |
Q3 |
Validation (Modify) |
If subsequent transplant or cell therapy, then Q3 is disabled |
Q3 must be answered for every transplant and cell therapy (regardless if subsequent or first) |
Provides disease status at latest assessment |
F2900 r5 |
|
Events & Actions |
If primary cause of death = COVID-19 OR contributing cause of death contains COVID-19, then a F2149 comes due |
As of November 2022, F2149 will not come due for TED track (except those enrolled in CTN 2101 study) |
F2149 is no longer collected for TED track |
F2000 r6 |
Q80 |
Validation (Modify) |
No decimal place available when entering dosing weight |
One decimal place available when entering dosing weight |
Exact dosing weight necessary to capture data accurately, especially in pediatric patients |
Form_Revision |
Question |
Type of Change |
Current |
New |
Rationale for Change |
---|
F2400 r9 |
Q91 |
Events & Actions |
5 instances allowed for COVID vaccine |
8 instances allowed for COVID vaccine |
Matches the most recent forms |
F2400 r9 |
Q6 |
Validation (Modify) |
If country of primary residence = United States, then zip/postal code must be answered |
If country of primary residence = United States OR US territories, then zip/postal code must be answered |
All US territories must have zip/postal codes reported |
F2400 r9 |
Q6 |
Validation (Add) |
N/A |
If Q6 country = any United States or US territory, then Q3 Ethnicity must not = N/A |
Ethnicity must be entered for all states and territories |
F2199 r1 |
Q9 |
Validation (Modify) |
If CBC result available is EQUAL TO lymphocytes, then lymphocyte value must be answered |
If CBC result available CONTAINS lymphocytes, then lymphocyte value must be answered |
If a CBC result has a lymphocyte value, then the value must be reported |
F2400 r10 |
Q20 |
Validation (Modify) |
If study sponsor = any (USIDNET, COG, PedAL), then subject ID must be answered |
If study sponsor = PedAL, then subject ID must be answered. If study sponsor = any other, then subject ID is optional |
Subject ID only needs to be answered if the study sponsor is PedAL |
Form_Revision |
Question |
Type of Change |
Current |
New |
Rationale for Change |
---|
F2400 r9 / F2402 r6 |
|
Events & Actions |
Currently NMDP related donors only get 2006 forms on TED track when repository consent = yes |
All NMDP related products will receive the 2006 form, regardless of repository consent |
All NMDP related products should receive the 2006 form |
F2100 r7 |
Q311 |
Smart Navigation (Modify) |
If Q311 = No, then go to Q315 |
If Q311 = No, then go to Q312 |
Date of discharge needs to be reported when procedure was planned to be inpatient. |
F2016 r5 |
Q177 |
Validation (Add) |
N/A |
Q177 must not be equal to Not Applicable |
Not a real scenario |
F2116 r5 |
Q160/Q187/Q208 |
Validation (Modify) |
If Q155 = Yes, then Q160 must be answered |
If Q158 is = to Known or Unknown, then Q160 must be answered |
Dose should be disabled until the radiation is stopped. If the patient receives therapy across multiple reporting periods, report the total dose all at once after the radiation is stopped |
Form_Revision |
Question |
Type of Change |
Current |
New |
Rationale for Change |
---|
F2814 r4 |
Q2 |
Validation (New) |
None |
Q2 Event date: MUST BE NOT EQUAL TO Core: Patient event dates OR Q2 Event date: MUST BE EQUAL TO Core: HSCT Date |
The CIBMTR is preventing a F2814 being completed for an event already created |
F2400 r9 |
Q23 |
Validation (Modify) |
If Q18 = yes AND Q49 = yes, then Q23 is optional |
If Q18 = yes AND Genetically Modified AND Q19 = Other sponsor OR Q21 = BMT CTN 1903 – HIV T Cell, then Q23 must be answered |
|
F2400 r9 / F2402 r6 |
|
Events & Actions |
None |
If Form Track = CRF AND F2402 Q451 = Transfusion dependent thalassemia, then Forms F2058 and F2158s will generate |
New disease specific form released in the Spring 2022 release |
F2402 r6 |
Q433 |
Validation (Modify) |
If Q427 = yes, then Q433 must be answered |
If Q428 = yes, then Q433 must be answered |
Validation was updated to be on the Q428, rather than Q427 |
F2450 r6 |
|
Events & Action |
If Visit ID = 100 Days and Q48 = Yes, then generate F2553 100 Days |
If Visit ID = 100 Days and Q48 = Yes, then generate F2553 100 Days AND enroll in study SP16-02 |
Study enrollment is open |
F2100 r6 |
|
Events & Action |
If Visit ID = 100 Days and Q498 = Yes, then generate F2553 100 Days |
If Visit ID = 100 Days and Q498 = Yes, then generate F2553 100 Days AND enroll in study SP16-02 |
Study enrollment is open |
F4100 r8 |
Q27 |
Validation (Modify) |
If Q25 = yes, then Q27 must be answered |
If Q1 = (Axicabtagene, Brexucabtagene, Ciltacabtegene, Idecabtegene, Lisocabtagene, Tisagenlecleucel), then Q27 must be answered |
|
F2116 r5 |
Q228 |
Validation (Modify) |
If Q1 = (AMYL, MGRS, OTH_PCL ) OR Q2 = (AMYL, MGRS), then Q228 must be answered |
Remove criteria for AMYL, MGRS. These questions should be “must be answered” for all. |
|
F2116 r5 |
Q230 |
Validation (Modify) |
If Q1 = (AMYL, MGRS) OR Q2 = (AMYL, MGRS), then Q230 must be answered |
Remove criteria for AMYL, MGRS. These questions should be “must be answered” for all |
|
F2116 r5 |
Q232 |
Validation (Modify) |
If Q1 = (AMYL, MGRS) OR Q2 = (AMYL, MGRS), then Q232 must be answered |
Remove criteria for AMYL, MGRS. These questions should be “must be answered” for all |
|
Form_Revision |
Question |
Type of Change |
Current |
New |
Rationale for Change |
---|
F2010 r4 |
Q83 |
Validation (Modify) |
Q83 Range for percent disease detected (in blood) must be between 0.001 and 4 |
Q83 Range for percent disease detected (in blood) must be between 0.001 and 99.999 |
Range is updated to be consistent with F2111 |
F2016 r5 |
Q237 |
Validation (Modify) |
If Q236 = Abnormalities identified, then Q237 must be answered |
disabled question for all |
ISCN string is not currently collected |
F2016 r5 |
Q243 |
Validation (Modify) |
If Q242 = Abnormalities identified, then Q243 must be answered |
disabled question for all |
ISCN string is not currently collected |
F4100 r8 |
Q4 |
Validation (Modify) |
If the F4000 Q54 = Outpatient and F4100 Visit is 100 days, then F4100 Q4 must be answered |
If F4000 Q54 = Outpatient, F4100 Visit is 100 days and Current event is Cellular Therapy, then Q4 must be answered |
Updated so only Cell Therapy events have to answer this question. Previous validation was requiring Q4 to be answered for HCT events that were a part of combined follow-up |
F4100 r8 |
Q27 |
Validation (Modify) |
Q27 must be answered |
If Q25 = Yes, then Q27 must be answered |
|
Form_Revision |
Question |
Type of Change |
Current |
New |
Rationale for Change |
---|
F2400 r9 |
Q17 |
Validation (New) |
None |
Q17 “Research Sample Recipient ID” cannot be equal to Q10 “RID” |
IDs cannot be the same |
F2400 r9 |
Q76 |
Validation (New) |
None |
Q76 “Research Sample Donor ID” cannot be equal to Q10 “RID” |
IDs cannot be the same |
F2400 r9 / F2402 r6 |
N/A |
Events & Actions |
If form track = CRF and (F2402 Q488 = NEUTD, GST2, HPST2 and Patient is alive), then F2056/2156 generates |
If form track = CRF and (F2402 Q488 = Chediak-Higashi syndrome, Griscelli syndrome type 2, Hermansky-Pudlak syndrome type 2, Other pigmentary dilution disorder and Patient is alive), then F2056/2156 generates |
Added ‘Other pigmentary dilution disorder’ to generate the disease specific forms |
F2402 r6 |
Q449 |
Validation (Modify) |
If Q2 = IBMFS, then Q449 must be answered (no override allowed) |
If Q2 = IMBFS, then Q449 must be answered |
An override can be used on Q449, as not all subtypes (e.g. other, specify) are listed. Centers can leave an override and specify the subtype in the override comment. |
F2014 r4 |
Q152 |
Validation (Modify) |
If (Q151 = CR, NR_SD, Prog from HI, Rel from CR) or (Q152 = HI-P, HI-N) or (Q153 = LTB, HTB), then Q154 must be answered |
If (Q151 = CR, NR_SD, Prog from HI, Rel from CR) or (Q152 contains either HI-P or HI-N) or (Q153 = LTB, HTB), then Q154 must be answered |
Q152 is a ‘check all that apply’; validation was updated to allow multiple options |
F2057 r1 |
Q208 |
Validation (Modify) |
Q208 date must be between the dates reported in Q186 and Q208 |
Q208 date must be between Q184 and Event date |
|
F2057 r1 |
Q210 |
Validation (Modify) |
Q210 date must be between the dates reported in Q186 and Q208 |
Q210 date must be between Q184 and Event date |
|
F2100 r7 |
Q254 |
Validation (New) |
None |
If Q254 contains (BLA, TRANSBRONCH_BIOP, OPEN_VATS, AUTOPSY, OTHR), then Q254 cannot contain No diagnostic tests done |
If a diagnostic method is selected, then it is not logical to also select ‘No diagnostic tests done’ |
F2116 r5 |
Q94 |
Validation (Modify) |
If 91 = HEP_RES, NR_SD, PD, then Q94 must be answered |
If 92 = Known, Unknown, then Q94 must be answered |
Updated to match the flow of the form and manual |
F2116 r5 |
Q95 |
Validation (Modify) |
If 91 = HEP_RES, NR_SD, PD, then Q95 must be answered |
If Q92 = Known, Unknown, then Q95 must be answered |
Updated to match the flow of the form and manual |
F2116 r5 |
Q218 |
Validation (Modify) |
If Q216 = Known, then Q218 must be answered |
If Q217 = any M-spike type (excluding ‘No bands present’), then Q218 must be answered |
|
F2116 r5 |
Q219 |
Validation (Modify) |
If Q216 = Known, then Q219 must be answered |
If Q217 = any M-spike type (excluding ‘No bands present’), then Q219 must be answered |
|