CRC Interactive Presentation Stephanie Meyers and Amalia Hantke February 21, 2019 *There are no conflicts of interest to disclose.

Objectives Data Management Resources Form Status Subsequent Transplants Comorbidities Overview Duplicate CRID and Transfers Number of Products Common data clean-ups When to contact your CRC *Write any questions on the notecards on your desk/table.

Data Management Resources

Resources to Know Forms Instruction Manual Data Management Guide FormsNet3 Training Guide Conference Materials Newsletters & eBlasts Online Training Data Collection Forms Retired Forms

Resources to Know includes detailed instructions on how to answer questions for each form type #1 resource (and best friend) Forms Instruction Manual link https://www.google.com/search?q=joey+and+chandler+in+canoe&biw=1065&bih=834&tbm=isch&source=iu&ictx=1&fir=DSzbTy5FTfK01M%253A%252Cr7ROm1RCLKCYzM%252C_&usg=AI4_-kQEkFp03peiZgvYSlsHi-kgxLx9KQ&sa=X&ved=2ahUKEwjL0NTFkpbgAhUi7YMKHVTVDxwQ9QEwBHoECAAQDA#imgrc=CifTHMHRR2dejM:

Resources to Know Data Management Guide link includes detailed guidance on how/ when forms come due, data quality, CRF/TED level participation, etc. Data Management Guide link contains training for data submission into FN3 FormsNet3 Training Guide link view previous audio & visual Tandem/ TCT presentations Conference Materials link view pertinent news/ updates Newsletters & eBlasts link *Verbally say Comprehensive Research Form, Transplant Essential Data

Resources to Know educational opportunities available at any time Online Training link contains forms currently in use Data Collection Forms link contains archived forms an ECF must be completed to update non- editable form versions Retired Forms link Non-editable forms include AUD forms.

Contact Information CRC Find your center’s CRC here Assist with any questions related to CIBMTR data submission Cellular Therapy Coordinators CIBMTR-CellTherapy@mcw.edu Assist with specific cellular therapy questions NMDP Service Desk 763-406-3411, servicedesk@nmdp.org Help resolve complex issues regarding FN3/ Traxis access

How Forms Come Due Question #1 The Pre-TED forms were recently completed in FN3. Additional 2450 forms came due, but a Product F2006 was not generated. This product was from a Non-NMDP unrelated donor. Does the F2006 need to be completed? Note: The Pre-TED indicates the donor was not used for any prior HCTs. In addition, the recipient was ‘not approached’ to sign an IRB-approved consent form to donate research blood samples.

How Forms Come Due Question #1 Data Management Guide link How Forms Come Due View applicable instance info. Contact your CRC

How Forms Come Due Question #1

Form Status

Form Status Codes

Resolving Queries

Resolving Queries

Resolving Queries

Resolving Queries Question #1 When you have searched for forms in QRY status, view the query you want to resolve by… Clicking on the view error/query report, if available Going to the form change history Using either the edit form icon or the view error/query report icon, if available Clicking on the edit form icon as you normally would to update form data

Resolving Queries Question #1 When you have searched for forms in QRY status, view the query you want to resolve by… Clicking on the view error/query report, if available Going to the form change history Using either the edit form icon or the view error/query report icon, if available Clicking on the edit form icon as you normally would to update form data

Resolving Queries Question #2 What kind of forms can queries be placed on? Forms represented with a PDF Forms represented with an Edit icon All forms

Resolving Queries Question #2 What kind of forms can queries be placed on? Forms represented with a PDF Forms represented with an Edit icon All forms If a PDF form is in QRY status, please notify your CRC to resolve the issue. An ECF will be needed.

Subsequent Transplants

Process Follow the steps below to report a subsequent transplant in FN3 Do not create a new Indication F2814 Report on the appropriate follow-up form in FN3 Ensure the correct date of contact is captured New Pre-TEDs (F2400/ F2402) will be generated in FN3 Follow-up reporting on the prior HCT ends Follow-up reporting continues for the most recent HCT

Autologous Rescue Autologous cells infused for graft failure/ insufficient hematopoietic recovery Purely to reduce the reporting burden, new Pre-TEDs will not come due in FN3 Report subsequent Auto HCT Indication captured as graft failure/ insufficient hematopoietic recovery New Pre- TEDs are not generated Follow-up Reporting continues for the prior HCT

Subsequent Transplant Question #1 The recipient received a subsequent transplant. However the recipient did not sign consent to the research database for the prior auto transplant. No follow-up forms are due in FN3. How do you report this subsequent transplant? Create a new Indication F2814 Contact your CRC

Subsequent Transplant Question #1 The recipient received a subsequent transplant. However the recipient did not sign consent to the research database for the prior auto transplant. No follow-up forms are due in FN3. How do you report this subsequent transplant? Create a new Indication F2814 Contact your CRC

Comorbidities Overview

Comorbidities Overview Clinically significant co-existing disease/ organ impairment at the time of patient assessment prior to prep that may have an effect on HCT outcome Sorror Paper Forms Instruction Manual: F2400 & Appendix J

Comorbidities Question #1 Should a hepatic comorbidity be captured on the Pre-TED F2400? Preparative regimen on 8/19/2018 HCT on 8/24/2018 *FIX table so its aligned better

Comorbidities Question #1 Do not report a hepatic comorbidity in this case Although there are two high ALT values between Day -24 and the start of prep, the values are trending downward. The two values nearest to the start of the prep are normal.

Comorbidities Question #2 Should an infection comorbidity be captured on the Pre-TED F2400? Known rhinovirus/ enterovirus at the time of transplant Recipient receives only IVIG treatment prior to HCT

Comorbidities Question #2 Do not report an infection comorbidity in this case The recipient does not begin treatment prior to the prep and continue beyond Day 0 of HCT

Duplicate CRID and Transfers

When creating a CRID and this warning appears, If the potential match is at your center, you can do a CRID search. If the potential match is at a different center, please take a screenshot of this warning and send it to your CRC, who will inform you if the CRIDs are duplicates.

Potential Match at your Center To search within your own center for potential matches, go to the Recipient Tab Assign CRID Search/Edit CRID

Ways to Avoid Duplicate CRIDs Double check the recipient Medical History. Use the Search/Edit CRID tool The best way to search for a match is by ‘Gender’ and ‘Date of Birth’. This is in case of spelling errors in the name, extra information (i.e. middle name/initial), and/or a name change.

Potential Match with a Different Center Request contact information for the other center to confirm the CRIDs are for the same recipient Initiate a transfer, using the transfer form and send to the other center Send the completed form to your CRC to complete the process

Transfer Form (F2801) Reminders: Event date should be the most recent event at the ‘transferring from’ center. Always double check the DOB! Make sure all parts are legible for accurate data entry. The IUBMID and Team ID are either both answered OR are both ‘Not Applicable’. Once you see the F2801 is DUE in FormsNet3, please do not complete it. Our data entry team will complete this form.

Cellular Therapy Transfers HCT occurs at Center A, and CT occurs at Center B for the same recipient. Both centers will continue to do follow-ups for their respective infusions. New ability to have two centers report on the same CRID NO TRANSFER NEEDED Inform your CRC, who will collaborate with the Cell Therapy team Center A will report the HCT follow-ups Center B will report the CT follow-ups

Number of Products

Definition of Product Single Product Number of Products Single Product All of the following criteria must be met: Single donor/cell source Single mobilization method Single collection method One Multiple Products One or more of the following criteria must be met: Multiple donors/cell sources Multiple mobilization methods Multiple collection methods Multiple – one to represent each donor/cell source, mobilization method, and/or collection method *From Appendix E

Product Question #1 An auto donor receives Filgrastim and undergoes a 2-day collection. The yield is less than desired. Filgrastim is switched to Mozobil and donor undergoes another 2-day collection. The yield is still less than desired. After a 4 week rest, the donor receives both Filgrastim and Mozobil and undergoes a 2-day collection. Cells from all days of collection are infused. How many products?

*There is a change of mobilization after each collection. Product Question #1 3 Products! 1st product: Filgrastim 2nd product: Mozobil 3rd product: Filgrastim + Mozobil *There is a change of mobilization after each collection.

Product Question #2 Day 1-3: Mobilized with GCSF Day 4: Mobilized with GCSF and Plerixafor Day 5: Collection day, GCSF and Plerixafor are continued Day 6: Collection day, GCSF and Plerixafor are continued Day 7: Collection day How many products?

1 Product! Product Question #2 The medications stayed the same prior to the collection start and throughout the collection process.

Product Question #3 Day 1-3: Mobilized with GCSF Day 4: Collection, but poor cell count. Re-mobilized with GCSF and Plerixafor Day 5: Collection day, GCSF and Plerixafor are continued Day 6: Collection day, GCSF and Plerixafor are continued Day 7: Collection day How many products?

*The collection on day 4 resulted in a change of mobilization. Product Question #3 2 Products! 1st Product: GCSF (days 1-3) 2nd Product: GCSF and Plerixafor (days 4-6) *The collection on day 4 resulted in a change of mobilization.

Common Data Cleanups

Common Discrepancies Death date/contact date discrepancies Ethnicity and race Updating the CRID assignment form

Ethnicity and Race What’s wrong? Ethnicity should be consistent across all F2400s and past F2000 revisions Race should be consistent across all F2400s and F2000s Race details should be a subtype of the Race, according to Appendix I

Great News! Ethnicity and Race With the new revision of the 2400/2000, Ethnicity and Race will be reported on the F2804 and then auto-populated onto the F2400.

Date of Death and Contact Date What’s wrong? The date of death and the actual contact date on the appropriate follow-up form should be the same (F2900 and F2100). If they are not the same, additional follow-up forms continue to come due.

Updating the CRID Assignment Form (F2804) What’s wrong? When updating the CRID assignment form (F2804), the updated data does not auto-populate on forms that have previously been completed (i.e. F2400) Date of Birth Missing RID Gender

Updating the CRID Assignment Form (F2804) How to update the F2804

Updating the CRID Assignment Form (F2804) What to do after updating the F2804 Reprocess the F2400 Reprocess the F2000 *only retired versions (an ECF may be required) Reprocess all F2450s *only retired versions (an ECF may be required) Double check the update has transferred to the reprocessed form

When to Contact your CRC

You need a CPI forms DUE list. Should you contact your CRC?

Generate Forms Due List in FN3 CPI Forms Due List Contact Your CRC CRCs can provide the center with the forms due list and summary report upon request CRCs also provide the center with the forms due list and summary report at designated times throughout the trimester Generate Forms Due List in FN3 Navigate to “Center Forms Due” under the “Recipient” tab in FN3 Select “CPI Forms” Filter for the appropriate CPI Period Export to Excel Remember to remove any Auto infusions prior to 12/3/2007

CPI Forms Due List

Clear a Form A form has accidentally been opened in ‘edit’ mode and is now in SVD status. Should you contact your CRC? A form has accidentally been completed/ submitted for the incorrect CRID. Should you contact your CRC?

Clear a form in SVD status Contact Your CRC CRCs can clear a completed form CRCs can reset a LTF/SUR form Clear a form in SVD status Navigate to the form under the “Recipient” tab in FN3 Click the ‘edit form’ icon followed by the ‘clear form’ icon

Reporting Recipient Death Date of death was reported on the appropriate F2450, but the F2900 did not come DUE. Should you contact your CRC?

Reporting Recipient Death When the recipient is on the TED track, the Recipient Death Data F2900 will not come due in FN3. When the recipient is on the CRF track, the DOD reported on the F2900 must match the DOC reported on the appropriate follow-up F2100. F2100 DOC F2900 DOD

Links Forms Instruction Manual https://www.cibmtr.org/manuals/fim/1/en/topic/getting-started Data Management Guide https://www.manula.com/manuals/cibmtr/training-and-reference/1/en/topic/getting-started FormsNet3 Training Guide https://www.cibmtr.org/DataManagement/TrainingReference/FormsNet/Documents/FN3%20Training%20Guide%20AE.pdf Conference Materials https://www.cibmtr.org/Meetings/Materials/CRPDMC/Pages/-2018CRPDM.aspx Newsletters & eBlasts https://www.cibmtr.org/DataManagement/TrainingReference/DataMattersTrainingNewsletters/Pages/index.aspx Online Training https://www.cibmtr.org/DataManagement/TrainingReference/eLearning/Pages/index.aspx Data Collection Forms https://www.cibmtr.org/DataManagement/DataCollectionForms/Pages/index.aspx Retired Forms https://www.cibmtr.org/DataManagement/DataCollectionForms/Pages/Retired.aspx