1. 10-CMSMDS-1 Study Training Slides
SUM07_1.ppt

2. Primary Study Objectives
Overview
Primary Study Objectives
To prospectively examine outcomes of allogeneic HCT in adults > 65 years of age with MDS to determine whether their outcomes are similar to those in younger patients
To provide a mechanism for coverage for patients with MDS who are Medicare beneficiaries under a CED (Coverage with Evidence Decision)

3. Overview of Study Requirements
Complete and submit the Center Verification of Participation form
Maintain IRB approval of Research Database Protocol and Consent
Consent eligible patients using the Research Database consent form
Submit paper registration form for each patient to be enrolled.
Study participants will be assigned to the CRF track
Completion of Form 2400 ( Pre-TED)

4. Center Verification
Return to CIBMTR-Mpls, the Center Verification form to confirm that your center is or is not participating in CMS-MDS study.
For participating centers, all patients registered to this study will be assigned to the CRF track.
This form can be either faxed or ed to:
Anne Dircks
(Fax)

5. IRB Approval Is IRB approval required for the CMS-MDS study plan?
It is required that each participating center maintain IRB approval of the Research Database Protocol and Consent
Submission of the 10-CMSMDS-1 study plan to your local IRB is not required but may be submitted if needed.

6. How to Consent Patients
All patients will be consented using the IRB approved Research Database study consent. There is not a separate consent form that is specific for the 10-CMSMDS-1.
Agreement to participate in the Research Database study also allows for eligible patients to enroll onto the 10-CMSMDS-1 study.

7. Registration Form
For all eligible patients who have signed consent, submission of the CMS-MDS paper registration form is required. The form can be found on the CIBMTR study page, and contains submission instructions.
The purpose of this form is to track study enrollment to ensure that all eligible patients are appropriately registered to the study.

8. Form 2400 (Pre-TED) Completion
To properly enroll a study patient, the following two fields on the Pre-TED form are required to be completed:
Under Recipient Identification-The RCI-BMT box must be checked, and the St ID# 10-CMSMDS-1 must entered in the specify field.
Consented to Research question should also be marked as Yes.
This will ensure that the patient is properly enrolled on to the CMS-MDS study and assigned to the CRF track.

9. Form 2400 Screen Shot Example
RECIPIENT IDENTIFICATION
CIBMTR recipient ID#: ______________________________________
ID assigned by: 􀂉CIBMTR 􀂉EBMT 􀂉Other __________________
􀂉BMT-CTN, St ID #:_______ 􀂉RCI-BMT, St ID #:_______ 􀂉NMDP 􀂉SCTOD
Consented for Research? 􀂉 Yes 􀂉 No
Consented for CIBMTR Related Specimen Repository? 􀂉Yes 􀂉No
Gender: 􀂉Male 􀂉Female DOB:___ ___ ___ ___ - ___ ___ - ___ ___
Y Y Y Y M M

10. CMS coverage
For information regarding Medicare claim policies and instructions, please go to the study webpage and look under “Guidance for Providers”

11. Study Related Materials
All study related materials can be found on the study web page at:

12. Sr. Clinical Research Specialist
Questions
For any study related questions, please contact
Anne Dircks
Sr. Clinical Research Specialist