In October 2016, the 2nd annual CIBMTR Cellular Therapy Registry Forum was held at the Coordinating Center in Minneapolis, MN. Representatives from the cellular therapy community, industry, and regulatory groups attended this 2-day event. Day one provided an overview of the cellular therapy world and where it is headed. Presentations were given by multiple centers on their practices, including updates from industry representatives such as Kite Pharma and Atara Biotherapeutics. The FDA and FACT provided an overview of the work their organizations are doing in-around cellular therapies. Day two of the forum focused on CIBMTR's Cellular Therapy data collection initiative. Data Managers from several centers, and CIBMTR Clinical Research Coordinators participated in this group to review the cellular therapy data collection forms in detail and answer other attendees' questions. This successful meeting marks another step forward for the CIBMTR Cellular Therapy Registry. 


CIBMTR® (Center for International Blood and Marrow Transplant  Research®) is a research collaboration between the National  Marrow Donor Program®/Be The Match® and Medical College of  Wisconsin.

FACT / CIBMTR Data Audit Collaboration
Beginning January 1, 2017, the Foundation for the Accreditation of Cellular Therapy (FACT) and CIBMTR will implement a collaborative program of data auditing designed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited programs. With this collaborative program:
  • FACT clinical inspectors will no longer perform a data audit during the on-site FACT inspection. This will eliminate the need for data sheets to be prepared only for FACT inspectors and allow the clinical inspector to focus on adequacy of corrective actions and quality improvement.
  • All verification of the accuracy of data against source data will be handled by the CIBMTR audit teams on site according to their current practices and schedules. The current CIBMTR process will not change.
  • The FACT / CIBMTR Data Audit Committee will review CIBMTR audit reports and corrective action plans to assess compliance with standards, implementation of effective corrective action, and improvements.
  • Timeliness and completeness of data submission will also be assessed by the Committee using CPI reports from the CIBMTR indicating "in good standing".
 
Programs submitting an Annual Report or Renewal Application to FACT after January 1, 2017, will find new questions related to this program on those reports. Programs that have already submitted renewal applications will notice there is no change in the upcoming inspection. Between now and January, there may be some overlap in processes.
 
CIBMTR audits will remain every four years as scheduled (unless you request and pay for an interim special audit). Your center will respond to these audits to the principal auditor as usual and according to the time frames defined by the CIBMTR. FACT will receive information from your center annually and manage the processes on an on - going basis, depending on the needs of the program. FACT on - site inspections will continue to occur every three years.
 
On - site, clinical FACT inspectors will have access to CIBMTR data audit information and reports. They will review documentation of internal data audits and implementation of corrective action plans. Ultimately, successful FACT accreditation will depend on satisfactory audit results.
 
If your center struggled with CIBMTR data audits in the past, you won't immediately lose your FACT accreditation. Initially, centers will be given a grace period to show improvement in critical field and random error rates. During this grace period, centers will be expected to learn from prior difficult audits, design appropriate investigations, implement effective corrective actions, and follow up to ensure the improvements are sustained. This new process is designed to help your center identify the issues that may be barriers to improvement and develop strategies to be successful.

For additional questions or comments, please contact heather.conway@unmc.edu.

BMT Tandem 2017
On behalf of CIBMTR and the rapidly expanding field of cellular therapies, we are pleased to invite you to attend our annual Clinical Research Professional/Data Managers' Conference, February 21 - 22, 2017. Come to this year's conference to hear what our speakers have to share about advancements in the field and their impact on our patients. Come to learn what is changing and its significance in the role you play. Come to contribute your thoughts and opinions to this direction. Lastly, come to meet people from all over our globe to make social connections while enjoying the spectacular Gaylord Palms Resort Convention Center. We look forward to seeing you!

Registration, housing and abstract submissions are open.   Home Page
   
Here are the session topics:

Tuesday, February 21
    • Breakfast with Dr. Mary Horowitz
    • CIBMTR Data Life Cycle
    • VOD
    • Cellular Therapy: Science, Process, and Forms
    • Chronic GVHD
    • Less Common Diseases
    • PANEL: Cytogenics and Molecular Markers
    • Hot Topics
    • Mentor's Reception
Wednesday, February 22
    • FACT/Audit Collaboration
    • RITN
    • PANEL: Best Practices for Centers
    • Oral Abstracts
    • Tools for Centers:  eDBtC and CPA
    • Forms Revision - Updates and Changes
    • AGVHD Reporting
    • Janet's Inbox
NEW Session -  Thursday, February 23 - International Data Manager's Open Forum


Forms scheduled for release in FormsNet3
CIBMTR is excited to announce that forms are scheduled for release in FormsNet on November 15th, 2016.  The revised forms include:
 
Forms
2013 - Pre-HCT CLL Disease Insert
2113 - Post-HCT CLL Disease Insert
 
In addition to the revised forms being released, the CLL forms and HLA Form 2005 will also be implemented for cellular therapy data collection.
 
Update: The revised Post-TED 2450, CRF Follow-up Form 2100, and Death Form 2900 have been delayed until the winter release. As a result, the transfer of reporting DCI data to the new cellular therapy data collection forms has also been delayed until that time.
 
If you have any questions about the upcoming release, please contact Marie Matlack mmatlack@nmdp.org or Janet Brunner jbrunner@mcw.edu.

MDS and MPN eLearning 
This module provides basic information about the pathophysiology of MDS and MPN, helps identify and organize key assessments used to track MDS and MPN, and will help the data manager understand how those assessments determine appropriate disease status for CIBMTR reporting.

In the Learning Center, Course Catalog, under CIBMTR Data Management  

HLA eLearning
If you have little to no knowledge of HLA,  this beginner's guide is for you. Simple terms are used to describe what HLA is, why it matters, and how to communicate HLA to donors, patients, and the general public. Figure out what all the fuss is about and what HLA is . . . for the rest of us!

In the Learning Center, Course Catalog, under HLA Search/Strategies

Multiple Myeloma eLearning
  • Module 1: "Basics of Multiple Myeloma" covers the basic pathophysiology and relevant disease assessments for multiple myeloma.
  • Module 2: "Reporting Myeloma Disease Status" is intended to help the Data Manager understand how those assessments determine appropriate disease status for CIBMTR reporting based on the international myeloma working group (IMWG) criteria. 

Both modules should be completed to finish the course.


In the Learning Center, Course Catalog, under CIBMTR Data Management

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