10-CMSMDS-1 Study Training Slides SUM07_1.ppt
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)
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)
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 emailed to: Anne Dircks 612-884-8660 (Fax) firstname.lastname@example.org
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.
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.
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.
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. Form 2400 (Pre-TED) Completion
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
CMS coverage • For information regarding Medicare claim policies and instructions, please go to the study webpage www.cibmtr.org/HCTforMDS and look under “Guidance for Providers”
Study Related Materials All study related materials can be found on the study web page at: www.cibmtr.org/HCTforMDS
Questions • For any study related questions, please contact Anne Dircks Sr. Clinical Research Specialist 612.884.8209 email@example.com