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Human Subjects Committee

New: Consultation and Pre-Review Services

Forms

 

   
Word
PDF
  
Revised
   

INITIAL SUBMISSION FORMS

   
 
 
 HOW TO SUBMIT TO THE HUMAN SUBJECTS COMMITTEE  
10/24/2008
 
PDF

New -
Special Instructions about Cancer-Related Studies

 
11/13/2008
Word Document
   Application for Full Committee Review of Human Subject Research
7/1/2009
Word
   Application for Expedited Review of Human Subject Research
5-15-2008
Word
   Application for Review of Retrospective Human Subject Research  
3-20-2009
Word
   Application for Exempt Review of Human Subject Research Instructions PDF
5-15-2008
Word
   Scientific Merit Review Template Instructions PDF
Word
   Application Addendum for Cancer and Cancer-Related Studies Instructions
Word
   Nursing Impact Form  
10-26-2007
Word Doc
   Supplemental Application for IND and IDE sponsors  
06-15-2007
Word Doc
   Application for Waiver of HIPAA Privacy Authorization Studies Using PHI  
Word
   Request to Rely on the Lawrence HSC  
Word
   Request for Determination of Not Human Subjects Research  
    GCRC Submission Process  
Word Doc
   Radiation Safety Form RS06 (required for all studies that involve any form of radiation or use of a radioisotope)   08-15-2008
 
    INFORMED CONSENT TEMPLATES  
       
  CHANGES AND UPDATES TO APPROVED STUDIES
    Request for Amendments:
    >> Recruitment/Retention Materials
    >> Change in Study Personnel or Study Sites
   

>> Investigator's Drug or Device Brochure

   

>> Protocol and Other Amendments

6/25/2009
     
    PROBLEM REPORTS
   
Problem Report A - Internal Adverse Drug Event
   
Problem Report B - External Adverse Drug Event
   
Problem Report C - Unanticipated Adverse Device Event
   
Problem Report D - Report of Non-Compliance 
   
Problem Report E - Study-Related Complaint
   
Problem Report F - Monitoring/Audit Report
   
Problem Report G - Incarceration of a Study Participant
   
Problem Report H - Breach of Confidentiality/Loss of Data
   
Problem Report I - Other Problems
   
Report of New Information
     
    CONTINUING REVIEW AND CLOSURES
Word Doc
   Continuing Review Form
10/30/2008
Word Doc
   Continuing Review Supplement for Cancer and Cancer-Related Studies Instructions
Word
   Protocol Summary
Word
   Closure Request Instructions PDF
04-05-2006
     

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