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  Home For Research Subjects About the HRPP / IRB Contact Us Submitting a Protocol Maintaining IRB Approval

  Columbia University Human Research Protection Program

 
Regulations
  -   Federal
  -   State Law
Ethical Principles
Policies & Guidance
  -   Selected University Research Policies
  -   IRB Policies/Procedures/Guidance
   -   General: OHRP & FDA
   - International Standards
   -   Related Information
Education & Training
 Required Training:
  -   GCP / Human Subjects
  -   HIPAA (for Research)
  -   CITI Training (Research with Minors)
 Additional Training Opportunities:
  -   Monthly Investigator Meetings
  -   IRB 101
  -  

Annual Educational Conference

   -  

Other Web-Based Training

Frequently Asked Questions
Related Links
  -   CU IRB (Morningside Campus)
  - Columbia University - Research
  -   RASCAL
  -   Research Administration
   -   Clinical Trials Office
   

–  Research Pharmacy

   -   GCRC
   -   HIPAA Home Page
  - Radiation Safety Office
   -   AAHRPP
   -   OHRP
   -   FDA Guidance
   -   NYSPI IRB
   -   WIRB

 

News & Announcements


 4/28/2008
New HIPAA Policy and Procedures Released
1/24/2008  New Policy Released:  Reporting to the IRB of Unanticipated Problems Involving Risks
12/27/2007 IRB Review of Oral History Projects Policy is Released
12/26/2007 Updated Instructions for CITI Training
12/13/2007 New Policy Posted: Use of Publicly Available Datasets

                                                        more...


Information for Research Subjects
  • Research at Columbia University
  • What is the IRB?
  • Should I Participate in Research?
  • Studies Seeking Participants
About the HRPP / IRB
  • Purpose / Scope / Responsibilities
  • IRB Roster and Meeting Schedule
  • Quality Improvement Program
  • Compliance Oversight
  • Federalwide Assurance
Contact Us
 Submitting a Protocol
  • What Should Be Submitted to the IRB
  • Types of IRB Review
  • RASCAL Tutorial
  • Creating a New Protocol & More
    - User's Guide to the RASCAL IRB Module
  • Tips for Efficient Protocol Review
  • Resubmitting
  • Creating Consent Forms
Maintaining IRB Approval
  • Reporting Adverse Events
  • Modifying Your Protocol
  • Renewing Your Protocol
  • Other Reporting Requirements
    - Protocol Deviations & Violations
    - Interim Analysis / DSMB Reports
    - Suspension
  • Closing out a Project

 
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