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Checklist/Guide for Investigators

CHECKLIST/GUIDE FOR INVESTIGATORS

***NOTE: Before review of new studies can occur the IRB Office must have on file for each Principal Investigator and Sub/Co Investigator involved in the research/studythe following:    

  • Current Curriculum Vitae (CV) or Resume,
  • A signed copy of the “Investigator’s Manual Compliance Acknowledgement” from the NGHS IRB:Investigator’s Manual.
  • A signedConflict of Interest statement, and
  • A copy of the NIH computer based training ‘Certificate of Completion’

When properly completed the IRB application form(s) and checklists facilitate review and timely approval by the IRB.  Careful preparation of the protocol and consent form can obviate the need for post-review modifications and the resultant delay in the approval process. 

Incomplete applications will be returned

 
NEW PROTOCOLS/PROPOSALS:
  • All questions/sections of the “Initial Review Application” completed
  • Supporting documents have been attached, including (as appropriate):
  • Complete Protocol Document
  • If applicable, Expedited/Facilitated Review Application
  • Research Proposal/Protocol Summary (if Protocol is more than 4 pages)
  • Consent Document (in NGHS IRB format) *****
  • Authorization Use/Disclosure PHI Document
  • Questionnaires
  • Interview guides
  • Investigators Brochure – required if research involves an investigational drug or device; package insert if FDA approved drug
  • Advertisements/Recruitment Materials (i.e. websites, print & broadcast)
  • Any other available appendices (e.g. schemas) 
 
NOTE:  If this study should be reviewed by specialty committees/departments, obtainprotocol approval beforesubmission to IRB (e.g. Radiation Therapy Dept.; Laboratory)
 
A copy of the application has been made for the investigators’ records

CONTINUING REVIEW (Previously Approved Protocols):
 
All questions/sectionsof Continuing-Review form completed
 
Supporting documents have been attached, including:

Protocol Summary

Copy of the most recent IRB approval letter

Copy of the last consent form signed (obliterate participants identity)

If applicable:

Expedited/Facilitated Review Application
  • A report summarizing information provided to the investigator via Safety Reports 
  • Appropriate appendices, for example:
    •  Grant Applications
    •  Investigator’s Brochure
    • Questionnaires
    • Interview Guides
    • Advertisements/Recruitment Materials (i.e. websites, print & broadcast)
                                                       
A copy of the application has been made for the investigators’ records 
Have Questions? Call (770) 219-9000
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