Volume 1, Issue 2

The Quarterly Data Matters Newsletter will be sent out in January, April, July, and October.

Please do not unsubscribe from this newsletter. This is the CIBMTR's means of keeping you updated about FormsNet3, Forms Revision, and Center Support updates.

Center Support Updates

Change Effective Monday, March 23,2020:

All CIBMTR Center Support tickets will be automatically triaged to a Subject Matter Expert.

Triaging tickets to Subject Matter Experts will decrease the response turnaround time, and improve service.

For centers currently assigned a CRC, further clarification will be provided in the next few weeks regarding the specific tasks your CRC will assist your center with.

Pathology Report: Interpretation Assistance

Need help interpreting a report for CIBMTR reporting?

Best Practice

  1. Review report and CIBMTR form with your physician
  2. If desired, submit CSM Ticket for further clarification and/or confirmation. Include information from physician discussion.
  3. Document discussion and report on the form accordingly
  4. Upload de-identified report to FormsNet.

Note: Audit errors may be charged if physician clarification was not documented and data are reported incorrectly.

CPI Updates

Recipient CPI

COVID-19 Update:
We understand that data, including enrollment (CRID generation) may be sent to CIBMTR at a reduced rate, or not at all, during this pandemic. We ask that if your center is still submitting data, please prioritize the Transplant Center Specific Analysis (queries, data review, and follow-up) and Consecutive Transplant Audit (CTA) requests first. Effective March 23, 2020, CIBMTR suspended CPI requirements for this trimester for all product types. Please note, during this time, your center must still have current IRB or MHA/DTA documents on file with NMDP.

We will be continuing the normal schedule for CPI summary reports, including increased frequency of reports at the end of the trimester so you can track your results and other parts of CPI that are found on these reports.

You may have noticed some enhancements on your weekly CPI summary report recently. For your convenience we’ve highlighted in red the sections that are below the % required to pass CPI, thus requiring your attention.

At the bottom of your report, you’ll notice the CTA HCT tracker section is now live!

Please note: CTA HCT List Reviewed and Approved is considered not in good standing until the list is received and approved.

The Not Received is a reminder that you need to submit your list. Once the list is received and approved, you will see Good Standing listed.

Discrepancy lists will be posted to the portal this year, more information on retrieval will be coming.

CTA HCT Discrepancies Resolved and CTA HCT Queries Resolved will remain as TBD until the start of next trimester. At that time both will move to Not Complete until each are completed.

End of the trimester CPI memos will be posted to the portal Summer 2020. For your convenience your CPI memos will remain archived there for your center. More information on how to retrieve these memo’s will be coming soon.

We’ve officially rolled out NON US CPI to our Pilot Centers. Look for additional phases of NON US CPI in the coming months. Welcome and thank you for all your work!

Upcoming Form Releases

The next forms undergoing revision will be the Aplastic Anemia Pre and Post-Infusion forms, in addition to the “Severe Aplastic Anemia” and “Inherited Abnormalities of Erythrocyte Differentiation or Function” sections on the Disease Classification F2402. The content review meetings will begin in April. Please contact cibmtrformfeedback@nmdp.org if you would like to participate.

For more information about the upcoming releases or to comment on current form revisions, please contact: cibmtrformfeedback@nmdp.org

CIBMTR Forms Instruction Manual Updates

Several CIBMTR Forms Instruction Manual updates are currently in progress. The primary goal of manual updates is to increase clarification around a reporting instruction, update the instruction to capture necessary data and provide additional reporting examples to assist data management staff in reporting accurate data. In an effort to increase transparency in manual updates, each Data Matters Newsletter moving forward will include a section to review recent updates in the manual. In addition, the Historical Manual Updates section of the Forms Instruction Manual will be undergoing revision to more clearly outline manual updates and reporting instruction changes.

Upcoming Manual Updates – Spring 2020:

Pre-TED (2400) Form
Q80: Number of products infused – Reporting instruction changed from previous version of form and manual

Historically, if a recipient received additional growth factors during the same mobilization cycle (see example below), this would have been considered two products for the purposes of reporting on the CIBMTR forms. However, it is difficult to determine the effect of the first or second mobilizing agent when the collections are part of the same mobilization cycle. Therefore, for the purposes of CIBMTR reporting, when additional growth factors are given during the same mobilization cycle, this should now be considered one product. Only one 2006 form will come due for reporting.

Example: A G-CSF stimulated donor had a PBSC collection, but the cell count was poor. Plerixafor (Mozobil) was added as part of the mobilization and the donor was re-collected the following day. As the change in mobilization occurred during the same mobilization cycle, these collections are considered a single product.

Post-TED (2450) Form
Q78-100: Disease assessment at the time of best response – Treatment for progressive or persistent disease – Reporting instruction clarification added

The manual has been updated with clarification on what disease assessments should be reported on the form when a recipient’s best response to transplant is "Not in Complete Remission" and treatment for progressive or persistent disease is started. See below for clarification.

If the best response is “not in complete remission,” report the disease assessment using the following instructions:

  • If the recipient meets the criteria for progression and starts treatment, report the assessment at the time of best response prior to the disease progression.
  • If the recipient starts treatment for persistent disease, report the most recent assessment prior to the start of treatment. 
  • If no treatment for progressive or persistent disease was given, report the date of the most recent assessment in the reporting period.

Q106-116: Relapse or progression post-HCT – Reporting instruction changed from previous version of form and manual

The current Post-TED (2450) Form, R5 was updated with the Winter 2020 release. When the form was updated, the instruction for how to capture therapy given for relapsed, persistent, or progressive disease was changed. Previously, therapy given for relapse or progression was reported in each reporting period in which it was given. Moving forward, the updated version of the Post-TED (2450) Form will only capture treatment given for relapse or progression in the reporting period in which the first relapse/progression occurs. Questions capturing information about therapy or relapse will not be enabled on the subsequent Post-TED (2450) Forms.

For more information about the management of the CIBMTR Forms Instruction Manual or to comment on the current manual, please contact: CIBMTRFormsManualComments@nmdp.org


Clinical Data Validation

Critical Field Lists Update

Following the January 2020 Forms Revision release, Critical Field Lists are now available in the Audit Data section of the CIBMTR Portal for the following forms: 2400, 2402, 2450, 2005, and 2006.

Additional Critical Field Lists are still being updated for the following forms: 2004, 2000, 2402 (IEA section only), 2016, 2116, 4000, 4100, 4003, and 4006. We anticipate these remaining Critical Field Lists will be available on the Portal by the end of April.

Critical fields are those data fields that have been identified as being essential to the accurate completion of outcomes analyses. These fields will be audited for each recipient, though may differ based on disease and transplant type.

The Critical Fields Lists are useful tools for centers to ensure internal audits are better focused on those fields that determine the site’s Critical Field Error Rate (CFER) as part of the CIBMTR Audit program.

If you have any questions about the critical fields lists. please contact Jenna Umar at jhullerm@nmdp.org. Furthermore, if you do not have access to the Audit Data section, contact Jenna Umar at the email above, and access will be provided to you.

If you do not have general access to the CIBMTR Portal, submit a request via ServiceNow.

Donor, Apheresis, and Collection Center Updates

For Donor Centers:

As COVID 19 evolves and the difficulties and uncertainties of travel continue, the NMDP has had to utilize out of network centers to perform PBSC collections for donors unable to travel. As a result, the process for these “compassionate collections” is currently under review and will be updated, as needed.

It is wonderful how everyone is working so hard to ensure these collections move forward for the patients in need, while also ensuring the safety of each Donor remains a top priority!

2020 TCT Clinical Research Professional/Data Management Meeting

We had a great turn out for the TCT 2020 Clinical Research Professional/Data Management meeting in sunny Orlando Florida. Our meetings took place on February 18th and 19th and we had an average of 275 data professionals in attendance each day. 

Some speaker highlights were Cytogenetics, Data Transformation, Cellular Therapy and updates from our Customer Service Center and the Audit Team.  New this year were 3 pediatric breakout sessions on SCIDS, Fanconi Anemia and Neuroblastoma which were well attended and a big hit.

We are excited to announce this year’s award for best oral abstract went to Kayla Woodring whose presentation was titled: “Rebuilding a Data Management Team to Improve Program Efficiency and Clinical Compliance"
Oral abstracts were also presented by:
Nicolette Minas & Kathleen Ruehle – Presentation: “A Diamond in the Rough!”
Heliz Regina Neves & Cinthya Correa da Silva – Presentation: “Strategies to Increase the Number of Centers Reporting Data to CIBMTR”

On Feb 20th we held a new data manager onboarding session for approximately 35 preregistered data managers. The workshop included interactive activities such as registering a new CRID, understanding how forms come due, and how to use CIBMTR Portal applications such as Enhanced Data Back to Centers. Important topics for new data managers were presented including CPI, annual reports such as TCSA and CVDR, and how to respond to queries. We ended the day with disease overviews and hands on activities using disease trackers. It was a very productive and educational day for all.

Presentations from the Clinical Research Professional/Data Management meeting can be found on the CIBMTR website at: https://www.cibmtr.org/Meetings/Materials/CRPDMC/Pages/2020-Clinical-Research-Professionals--Data-Management.aspx

Special thanks to all staff and data professionals for completing the evaluations which we use to improve our meetings from year to year. Please SAVE the DATE for 2021. Our meeting will take place in Honolulu, Hawaii on February 9th and 10th.