Case Report-Series -

• Case Report-Series (7-15)
  

Conflict of Interest -

• Conflict of Interest in Research (COI-R) (10-15)  
  

 Cooperative Group Long Term Follow Up Protocol -

• Cooperative Group LTFU Continuing Review (9-09).doc 

 Emergency/Compassionate Use -

• Emergency Use - Single Patient (11-11).doc 

Exempt Determination - 

• Exempt Determination (11-15)  
  

Generation, Use and Revisions of Policies and Procedures -

• Generation, Use and Revision of Policies and Procedures (1-10).doc 

 Guests at IRB Convened Meetings

• Guests (7-15) 

 HIPAA -

• HIPAA in Research (6-11).doc 
• HIPAA - General Information (7-15)
  

 Human Subject Protection Training -

• Human Subjects Training (3-16) - REVISED 3-16
  

 Humanitarian Use Device (HUD)

• Humanitarian Use Device (10-15)
  

 Informed Consent -

• Informed Consent (10-15)
  

 Key Personnel -

• Key Research Personnel (10-15)  
  

 Non-Compliance -

• Non-Compliance, Version 2-15 

 Non-English/Limited English Proficiency -

• Non-English-Limited English Proficiency Subjects (2-11).doc 

 Protocol Deviations/Violations -

• Protocol Deviations-Violations (1-10).doc 

 Reporting to External Agencies -

• Reporting to External Agencies (1-10).doc 

 Review Fees -

• Review Fees (10-15) 

Review of Clinical Investigations Involving Children

•  Review of Clinical Investigations Involving Children

Statement of Compliance

• Statement of Compliance (8-16)
  

Subject Concerns/Complaints -

• Subject Concerns-Complaints (1-10).doc 

 Unanticipated Problems/Adverse Events 

• Unanticipated Problem/Event (4-15)