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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

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Presentation Transcript
overview
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
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
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) [email protected]

irb approval
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
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
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.
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.

Form 2400 (Pre-TED) Completion
form 2400 screen shot example
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
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
Study Related Materials

All study related materials can be found on the study web page at:

www.cibmtr.org/HCTforMDS

questions
Questions
  • For any study related questions, please contact

Anne Dircks

Sr. Clinical Research Specialist

612.884.8209

[email protected]

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