1. Form Revision and Development
Tiffany Hunt, CCRP
Rachael Latchana, MPH
Stephanie Meyers
February 20, 2019

2. Understand the Form Revision Process
Objectives
Understand the Form Revision Process
Review 2019 Revisions
Objectives
Review the form revision process- there are have been changes since the last form revision talk in 2017
Take a look at the big changes coming in 2019

3. The Form Revision Process
Let’s start with the form revision process and the steps involved
Form revision is a complicated process. From the last time form revision was presented here, we completed a process improvement project that reviewed the process from start to finish and streamlined parts where we could. The result took us from a 22+ week process down to 12 weeks.
AML/ALL vs LYM

4. The form revision process
Step 1
Plan
Prepare
Revise
Review
Approve
Release
The form revision process
The first step is to plan

5. Plan Why revise a form? Time since last revision Upcoming studies
Updates or resolving issues
Updates from WHO
Requests from staff or centers
Every good process starts with planning. To determine which forms should be revised, we look at several factors: how long it’s been since the last revision, which forms may be utilized by upcoming studies, necessary updates of things that we know are out of date or new practices or resolving known issues, if disease classification updates from WHO and we take requests from staff or centers.

6. Plan Create a Roadmap Form Revision Core Team Obtain approval
Draft proposed schedule
Obtain approval
Scientific directors and senior leaders review and approve
Be flexible!
allow wiggle room for critical revisions, or new priority forms
Our form revision core team then creates a roadmap. The core team consists of the form revision product owners, data ops directors and a scientific director, who meets weekly. At one of those meetings, we will draft the schedule for the next year of form revisions. This roadmap is presented to the scientific directors and senior leaders for review and approval. There is always flexibility built in to allow for unforeseen critical revisions or new form creation that takes priority.

7. The form revision process
Plan
Step 2
Prepare
Revise
Review
Approve
Release
The form revision process

8. Prepare Announce revisions to the network Volunteer!
Includes scientific directors and centers
Volunteer!
Send form change suggestions
Meet with scientific director of working committee
After we have the roadmap, the work begins on the next form on the list8. An announcement will be sent to all of CIBMTR and the network announcing that revisions are beginning. We ask for volunteers and suggestions at this time. We also meet with the scientific director of the working committee who will be leading the meetings. Get their input and suggestions.

9. The form revision process
Plan
Prepare
Step 3
Revise
Review
Approve
Release
The form revision process

10. Revise Initial Review Committee (IRC)
Consists of field expert physicians, subject matter experts (SME), data managers, CIBMTR staff and other individuals
Weekly Meetings (4 weeks, 2 hours)
review the form(s) top to bottom, question by question
remove outdated questions, add new questions based on new technology/treatments, clarify problematic sections
Q&A Meeting
allow for data managers to pilot the forms
ensure source documents exist for requested data
We then assemble and meet with the initial review committee. This group consists of physicians who are experts in the field, other subject matter experts, data managers, and cibmtr staff. The group meets weekly, for 4 weeks, 2 hours each, to review the form top-to-bottom and question-by-question. This group is removing outdated questions, adding new questions based on new technology or treatments, and clarifying problematic issues.
After the 4 weeks of meetings, we allow a few weeks for the data managers to pilot the new form. We want to ensure that the questions being asked can be answered or that they make sense. This Q&A session allows data managers to voice concerns, raise issues, and seek clarification with the physicians and CIBMTR staff.

11. The form revision process
Plan
Prepare
Revise
Step 4
Review
Approve
Release
The form revision process

12. Review Internal Review
CIT review
Statistical review
Database review
Develop validations, identify potential problem areas, and discuss form development
Once the initial review committee is complete and there is a working draft, we continue the internal review. CIBMTR staff participate on the IRC and can provide input during the revision calls. We then meet with CIT, the statistical group and our database team. We develop validations based on previously known issues or suspected future issues, and identify potential problem areas of the new form.

13. Plan
Prepare
Revise
Review
Step 5
Approve
Release

14. Approve Scientific Director(s) Request volunteers for time studies
Review form drafts and change summaries
Review occurs at standing weekly meeting
Request volunteers for time studies
Assess form completion burdens
After IRC and internal reviews are done, we will have a working draft that we feel comfortable presenting for approval. The form draft goes to the scientific directors. This group will review the form drafts and change summaries and give feedback. We may have to make changes based on their input.

15. Approve OMB Approval Form 2400, 2402, 2004, 2005, 2006, and 2450
Long process (6+ months)
Post to the Federal Register: 60 day notice, 30 day notice
OMB review and approval
Approval by the Office of Management and Budget, b/c of paperwork reduction act

16. Post- Approval FormsNet3 Process Build new forms
Write/test validations
Define Events and Actions (logic for how forms come due)
Metadata work
AGNIS
Mappings
We pass it off then, to the next team where

17. Plan
Prepare
Revise
Review
Approval
Step 5
Release

18. Release New Forms Forms Instruction Manual Update / develop eLearnings
Announce to Network
Release forms prior to “Go Live” date
Forms Instruction Manual
Release updated manuals prior to “Go Live” date
Update / develop eLearnings

19. Finally…How can YOU help?
Submit form change suggestions
Submit at any time
Send to your CRC
Suggestions reviewed during the next revision
Volunteer
Participate on a form revision committee!
Important to have data managers involved

20. Finally…How can YOU help?
Time studies
We need your input on the length of time it takes to complete the forms
Important information for OMB process but also any revised forms
Please, please, please volunteer

21. Upcoming Revisions

22. The Core Forms
2400, 2402, 2000, 2004, 2005, 2006, 2450, 2804
Revision committees met May – July 2018 for 2400/2000, 2006
Internal review July – October 2018
Requires OMB approval (in process)
Scheduled for release in Summer 2019
Will be posted 2 months in advance for preview
This was a huge undertaking. We revised the pre-TED, Disease classification, Baseline, IDM, HLA, Infusion and Post-TED forms
Let’s take a closer look to what these changes are (a more in depth change summary can and will be provided with the form drafts)

23. Pre-TED (Form 2400) Revision Highlights *not a complete list
Fun Fact: Decreased total number of questions (357 to 142)
‘Check all that apply’ capability:
Race, race detail, country of residence, comorbidities, planned post-HCT therapy
Recipient Information section
Ethnicity, race, race detail
Collected on CRID assignment (Form 2804)
Auto-populated on Pre-TED
We added, removed and moved question around that resulted in the number of questions asked on the form dropping from 357 to 142

24. Pre-TED (Form 2400) Revision Highlights (cont.)
Hematopoietic Cellular Transplant (HCT) section
New cellular therapy (CT) history questions
Previous history of CT
All prior CT reported to CIBMTR
Place of prior CT
Does not require completion of a F4000
We added, removed and moved question around that resulted in the number of questions asked on the form dropping from 357 to 142

25. Pre-TED (Form 2400) Revision Highlights (cont.)
Donor Information section
Donor ID
Collect only on Pre-TED
Auto populate Forms 2004/2005/2006
Specify donor list condensed
Autologous, allogeneic related / unrelated
Product
NMDP
Genetically modified HCT products
Consolidated all donor-related questions from this and other forms
Lots of changes

26. Pre-TED (Form 2400) Revision Highlights (cont.)
Pre-HCT Preparative Regimen (Conditioning) section
Chemotherapy Drugs
Added ‘multiple’ capability to eliminate Yes/No for each drug
Updated drug list
Additional Drugs Given in Peri-Transplant Period section
NEW SECTION TO FORM
Used to report drugs given for both the preparative regimen and GVHD prophylaxis

27. Disease classification (F2402) Revision Highlights *not a complete list
New indications
“Tolerance induction associated with solid organ transplant”
“Recessive Dystrophic Epidermolysis Bullosa”
Cytogenetic results
Added a place holder question to allow for future submission of results
Cytogenetic abnormality list has been made ‘check all that apply’ (MDS/MPN, PCD)

28. Disease classification (F2402) Revision Highlights cont.
Inherited Abnormalities of Erythrocyte Differentiation or Function section
New questions added to capture beta thalassemia and sickle cell

29. Baseline (F2000) Revision Highlights*not a complete list
Fun Fact: Decreased total number of questions (264 to 118)
Recipient Demographics / Race / Clinical status
Moved country of primary residence, ethnicity, race, race detail, recipient blood type and Rh factor to pre-TED
Infection
Collect infections in 6 months prior to infusion
Pre-HCT Preparative Regimen (Conditioning) section
Chemotherapy Drugs
Added ‘multiple’ capability to eliminate Yes/No for each drug
Updated drug list

30. Baseline (F2000) Revision Highlights (cont.)
Additional Drugs Given in Peri-Transplant Period section
NEW SECTION TO FORM
Used to report drugs given for both the preparative regimen and GVHD prophylaxis
Socioeconomic Information
Will collect most recent works status
Updated insurance list

31. Infusion (F2006) Revision Highlights*not a complete list
Fun Fact: Decreased total number of questions (285 to 170)
Donor/cord blood unit identification
Donor Identification to be auto-populated on form in key fields
Product processing and manipulation
Consolidated questions from pre-TED to here
Removed whole section for Autologous products

32. Infusion (F2006) Revision Highlights (cont.)
Product analysis
Consolidated timepoints to “pre-cryopreservation” and “post thaw”
Expanded cell types (TNC, CD34, CD3/4/8) and
collect viability per cell type instead of overall viability
Product infusion
Clarified question “was the entire volume of received product infused”

33. Infusion (F2006) Revision Highlights (cont.)
Donor/Infant demographic information
Donor blood type/Rh factor moved to pre-TED
Biological relationship of donor to recipient
Removed and consolidated to the pre-TED
Transferable genetic or clonal abnormalities
Expanded option list

34. IDM and HLA (F2004 / F2005) Revision Highlights *not a complete list
Donor/cord blood unit identification
Donor Identification to be auto-populated on form in key fields
Form 2004
New question added to capture NAT testing for HBV
NAT testing for HIV-1 and HCV split
Removed questions for Anti-HTLV1, syphyllis, CMV, WNV, toxoplasmosis
Form 2005
Form will be collected for recipient and final donor only

35. Post-TED (F2450) Revision Highlights*not a complete list
‘Check all that apply’ capability:
Liver toxicity prophylaxis, post-HCT therapy, relapse or progression post-HCT therapy
GVHD
Added questions to capture organ staging since the date of the last report
Chimerism studies
Collecting chimerism data for beta thalassemia and sickle cell recipients

36. Post-TED (F2450) Revision Highlights (cont.)
Relapse or progression post-HCT
The intent of the F2450 has always been to capture the first relapse only
Updated question text to say “was the date of the first clinical/hematologic relapse or progression previously reported”
Removed “decreased chimerism” from the intervention given for relapse question

37. CRID Assignment Form (F2804) Revision Highlights
Demographics
Added recipient ethnicity, race and race detail
Will be auto-populated on pre-TED
Race will be ‘check all that apply’
Race detail list will automatically filter based on race selection

38. Plasma Cell Disorder Revision Highlights
Revising the forms 2016/2116 and the PCD section of the 2402
Capturing biclonal/triclonal scenarios
Capturing information on monoclonal gammopathy of renal significance (MRGS) and POEMS
Updated Amyloidosis sections
Fall release

39. Contact form (F2820)
Form will collect recipient contact details for use in:
CIBMTR observational research database: permission to contact for future CIBMTR research studies
BMT CTN studies for direct patient follow up
Additional future studies
Includes:
name
address
phone number

40. At this point, I feel like every center has participated in some way to this round of revisions. I’ve lost track of the full list, so thank you to everyone who has participated in any way.

41. Questions