January 24Th, 2020 Release Highlights
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th January 24 , 2020 Release Highlights Forms to be released: • 2400 R6 – Pre-Transplant Essential Data • 2402 R4 – Disease Classification • 2000 R5 – Recipient Baseline Data • 2004 R5 – Infectious Disease Markers • 2005 R7 – Confirmation of HLA Typing • 2006 R5 – Hematopoietic Cellular Transplant (HCT) Infusion • 2450 R5 – Post-Transplant Essential Data • 2016 R4 / 2116 R4 – Plasma Cell Disorders (PCD) • 4000 R6 – Cellular Therapy Essential Data Pre-Infusion Form • 4100 R5 – Cellular Therapy Essential Data Follow-Up Form • 4003 R3 – Cellular Therapy Product • 4006 R4 – Cellular Therapy Infusion • 2542 R1* – Mogamulizumab Supplemental Data • 2500 R3 – Recipient Eligibility Form *indicates new form For information on high level changes to the forms, please select from the list below: Table of Contents Pre-Transplant Essential Data (2400) Summary .................................................................................... 2 Disease Classification (2402) Summary ................................................................................................ 7 Recipient Baseline Data (2000) Summary .......................................................................................... 10 Infectious Disease Markers (2004) Summary ..................................................................................... 13 Confirmation of HLA Typing (2005) Summary .................................................................................... 14 Hematopoietic Cellular Transplant (HCT) Infusion (2006) Summary .................................................... 15 Post-Transplant Essential Data (2450) Summary ................................................................................ 18 Plasma Cell Disorders (PCD) Pre- Infusion (2016) Summary ................................................................ 19 Plasma Cell Disorders (PCD) Post- Infusion (2116) Summary ............................................................... 25 Cellular Therapy Essential Data Pre-Infusion Form (4000) Summary ................................................... 31 Cellular Therapy Essential Data Follow-Up Form (4100) Summary ...................................................... 33 Cellular Therapy Product (4003) Summary ......................................................................................... 35 Cellular Therapy Infusion (4006) Summary ........................................................................................ 36 Mogamulizumab Supplemental Data (2542) Summary ....................................................................... 37 Recipient Eligibility Form (2500) Summary ......................................................................................... 38 Pre-Transplant Essential Data (2400) Summary Key Fields Removed Hospital and Unit fields from Key Fields • Confirmed they are not used in studies Event date has been moved from Q11 to the Key Fields • This is consistent with event date being in the Key Fields of other forms. Field is currently autopopulated from the F2814 Indication form and will be auto-populated in the Key Fields Recipient Information Section updated from “Recipient Data” to “Recipient Information” • Standardizes section titles between Recipient and Donor, section titles now match Ethnicity and Race in questions 3 & 4 will be moved to the CRID Assignment F2804 and will be autopopulated onto the F2400 • The field cannot be removed from the form since the research database does not receive F2804 data. We will collect ethnicity and race at the time of recipient registration to eliminate duplicative reporting on multiple forms • Changed Race to a ‘check all that apply’ list, instead of a multiple. There will be validations in FormsNet3 that will give an error if “unknown” is selected with any other option • Race detail list will filter based on option reported for Race o Example: if ‘white’ is reported for race, race detail will only show race details associated with ‘white’ • Added race detail option for ‘other black’ in Q5 Country of primary residence added to this section as Q6 (moved from the 2000) • Country list expanded to be the same option group as country of birth from F2804 (ISO country options) • State of residence added for residents of Brazil in Q7 • Province/territory of Residence added for residents of Canada in Q8 Added a field for NMDP RID in Q10, which will be auto-populated from the CRID Assignment F2804 • The NMDP RID is currently captured on the F2804, but is frequently missing for 2nd transplants, where the data manager must go back and update the F2804. By showing the field on the PreTED, it will serve as a data quality check. The field must still be updated on the F2804, which remains the ‘source of truth’ Recipient blood type and Rh factor have been moved from F2000 Baseline (Q6 & Q7) to the F2400 Pre-TED in questions 12 &13 • Review committee felt this is widely known information and should be collected on every patient Recipient consent questions 14-20 have been moved and consolidated: 2 • Updated text in Q14 to include “IRB / ethics committee (or similar body)” o More inclusive for international centers • The question “permission to be directly contacted for future research” updated to include “contacted by CIBMTR for...” and has been made a child question (Q15) of the research database consent question. A recipient cannot consent to future contact without also consenting to the research database. There will be just one date field collected instead of two separate ones. o Contact details will be collected on the Recipient Contact Information F2820 • The question regarding research sample submission has been moved from the F2006 (Q282) and made a child question of the research sample repository consent question. This will eliminate data quality errors having these questions split across two forms. Now seen as Q19. Adding PIDTC to the study sponsor option list to in Q22 facilitate randomization to CRF track for the PIDTC study Hematopoietic Cellular Transplant (HCT) and Cellular Therapy Moved HCT date (Q11) to the Key Fields section, renamed it “Event Date” • This is consistent with event date being in the Key Fields of other forms Moved prior Q13 regarding planned subsequent HCT to a parent Q26 • Still answered for autos only, now first question in section Updated text in Q12 from “Was this the first HCT for this recipient” to “Has the recipient ever had a prior HCT?” (now Q28) • Internal reviewers felt this wording makes the question more clear. It will change the meaning of the answer: a prior ‘no’ will now be a ‘yes’. The HPC source for the prior HCT was updated to a “check all that apply” in Q34. The option list for “reason for current HCT” (Q35) was harmonized with the F2450 Q9 “indication for subsequent HCT” • The option “planned second HCT, per protocol” has been updated to “Planned subsequent HCT, per protocol” o Covers scenarios where form is being completed for 3rd+ HCT Added questions 40- 45 to capture prior cellular therapies o These questions include: date of prior CT, institution, and source of the prior CT. Donor Information Changed how we collect the donor type: • Q48 “Specify donor” has been simplified to “Autologous”, “Allogeneic, related”, and “Allogeneic, unrelated” • Product has been moved higher up on form to Q49, updated to ‘check all that apply’ 3 • Added genetically modified (yes/no) Q51 • Moved question to specify related relationship higher up on form (Q53) o Consolidated relationship questions from F2006 and F2005 o Added ‘grandparent’ and ‘grandchild’ as options • Added back Q55 to capture degree of mismatch of related donor type o At the request of the Biostatisticians, used for high level comparison • Added Q56 to capture unrelated donor type (HLA match/mismatch) • Added Q57 to capture if “NMDP facilitated the product” • The combination of these questions will enable calculation of the donor type as listed on R5 (Auto, Auto CBU, NMDP, NMDP CBU, etc.) and will allow capture of NMDP Related HCTs. This format will simplify data entry of the form. • Donor and product type, and related donor type will be mandatory fields, no override allowed. Added field to capture new GRID (Global Registration Identifier for Donors) in Q63 Added option for “unknown” for Q64 “Is the CBU ID also the ISBT DIN” Donor blood type and Rh factor have been moved from the F2006 (Q253 & Q254) and consolidated into the Donor Information section in questions 73 & 74 Added “indeterminant” as an option for Donor CMV in Q75 Donor consent questions have been moved and consolidated to the Donor Information section • Updated Q76 text to include “IRB / ethics committee (or similar body)” o More inclusive for international centers • The question regarding research sample submission has been moved from the F2006 (Q284) and made a child of the research sample repository consent question. This will eliminate data quality errors having these questions split across two forms. Now seen as Q78. Auto HCT mobilization questions • Removed prior questions 53 and 54 that ask for number of mobilizations • Updated question about mobilization agents to “What agents were used to mobilize the autologous recipient for this HCT?” Options “G-CSF”, “Plerixafor (Mozobil)”, “Combined with chemotherapy” are needed for a corporate report. Now seen as Q82. • Included option for “Anti-CD20”. This will not be asked on F2006 Removed Q63 “was plerixafor give prior to prep reg?” Product processing / manipulation Questions 72-90 have been updated and consolidated, and moved to the F2006