Introduction to Research and Clinical Trials by hcj


									10-CMSMDS-1 Study
  Training Slides

          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

 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

Maintain IRB approval of Research Database Protocol and

Consent eligible patients using the Research Database
  consent form

Submit paper registration form for each patient to be

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)
               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

 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 Screen Shot Example

 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:___ ___ ___ ___ - ___ ___ -
 ___ ___
            CMS coverage
 For information regarding Medicare
  claim policies and instructions, please
  go to the study webpage and look
  under “Guidance for Providers”
   Study Related Materials

All study related materials can be found
 on the study web page at:
 For any study related questions, please
                Anne Dircks
      Sr. Clinical Research Specialist

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