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Education & Training
 Required Training:
  -   Human Subjects Protection
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  -   Research with Minors
  - Clinical Research Coordinators
 Additional Training Opportunities:
  -   Monthly Investigator Meetings
  -   IRB 101
  -  

Annual Educational Conference

  - RASCAL Workshops
   -  

Other Web-Based Training

Frequently Asked Questions
Related Links
  -   CU IRB (Morningside Campus)
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   -   Clinical Trials Office
   

–  Research Pharmacy

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Radiation Safety Office

External Links
   -   AAHRPP
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   -   NYSPI IRB
   -   OHRP
  - PRIM&R
   -   WIRB

 

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Have questions, suggestions, or concerns about research that involves human subjects? Use the IRB Staff Directory, Phone Tree, Office email address ("Ask the IRB" link), or suggestion box to contact us!

 

News & Announcements

Current list of CUMC IT certified systems:

https://secure.cumc.columbia.edu/cumcit/secure/security/scp_systems.html

7/30/2014

Monthly IRB- Researcher Meeting

Topic: Clinical Trials Office Resources & IRB Update

(including a review of deviations and violations)

 

**This session was rescheduled from July**

 

 

Featured Presenters:

Helen Kim, Pharm.D.

Executive Director, Clinical Trials Office

 

Brenda Ruotolo

Executive Director, Human Research Protection Office (IRBs)

Date: August 12, 2014

Time: 3:30 - 4:30pm

Location: Hammer Health Sciences Building, Room 312

RSVP: https://calendar.columbia.edu/sundial/webapi/register.php?eventID=72260

                                                        more...

Policy & Guidance Refresher

July/August 2014

Protocol Deviations and Violations

All deviations from and violations of Columbia IRB policies or IRB determinations, including departures from the requirement for adherence to the approved protocol, must be reported to the IRB.

• A protocol deviation is defined as a variation from the approved protocol for one subject or to address a temporary situation that is identified by the research team and approved by the IRB before implementation.

• A protocol violation is defined as a variation from the approved protocol that was implemented without prospective approval by the IRB (and was not implemented to avoid or minimize imminent harm*). Protocol violations may be considered as noncompliance with the federal regulations and institutional policies for the protection of human subjects. If the violation is noncompliance, the provisions of the IRB Noncompliance Policy will apply.

PGR Archive

 
 

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 Rosters and Meeting Schedule
  • Quality Improvement Program
  • Compliance Oversight
  • Federalwide Assurance
Contact Us
 Submitting a Protocol 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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