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Orientation Guide

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Check to see if the following list of recommendations are included in your binder. ... consent form, and amendments. IRB correspondence (including e-mails) ... – PowerPoint PPT presentation

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Title: Orientation Guide


1
Orientation Guide
Research and Development VAMC- Houston
Modified Dated 07-11-2007
2
The Essential Binder
What is it, and why do I have to have one?
3
Binder
  • Purpose
  • Aids in monitoring
  • Documents qualifications of site and staff
  • Documents institutional approvals
  • Documents the story of what occurred throughout
    the trial process.

4
Binder
  • If you are on an industry sponsored study, you
    likely have one included in the startup package.
  • Check to see if the following list of
    recommendations are included in your binder.

5
Recommended binder contents
  • Protocol summary (investigators brochure)
  • Current consent form, and amendments
  • IRB correspondence (including e-mails) and
    especially approvals, amendments, and renewals
  • VA RD correspondence
  • Affiliated hospital correspondence I.E. TIRR
    approval
  • Case report forms
  • Investigational Drug Information Record 10-9012

6
Recommended binder contents
  • AE and SAEs
  • Curriculum Vitaes of all staff
  • Lab certification (to include VA if used)
  • Baylors Protection of Human Subjects
    certification for all staff should be kept in the
    binder
  • Reports of audit
  • IRB membership rooster

7
Binder
  • On investigator initiated or VA grants, etc. you
    likely have to create your own binder

8
Binder
  • Keep it orderly and use labeled dividers in
    chronological order
  • Keep it up-to-date!
  • Call Marilyn Crosby RN for assistance _at_
    713-794-8096 or email at mcrosby_at_bcm.edu or
    marilyn.crosby_at_va.gov
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