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Columbia University Human Research Protection Program
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Have questions, suggestions, or concerns about research that involves human subjects? Use the IRB Staff Directory or
Office email address ("Ask the IRB" link) to contact us!
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Visit the Morningside IRB Office on Wednesday’s
from 1:00-3:00 without an appointment*
When: Any Wednesday
Where: Studebaker Building
615 West 131st Street, 3rd Floor
(Building entrance is on W. 132nd Street due to construction)
Time: 1:00 pm – 3:00 pm
*Alternatively an appointment may be scheduled
by calling 212-851-7040. |
Current list of CUMC IT certified systems:
https://secure.cumc.columbia.edu/cumcit/secure/security/scp_systems.html |
| 5/6/2013 |
July-December 2013 IRB Submission Deadline and IRB Meeting Dates released |
| 3/18/2013 |
IRB 101: Human Subjects Research Protections & How to Submit a Protocol to the CU IRB-Morningside
Date: Wednesday, May 29, 2013
Time: 4:10-5:30
Location: Hamilton 503 |
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Policy & Guidance Refresher
May 2013
WITHDRAWAL OF SUBJECTS FROM FDA-REGULATED STUDIES
This guidance provides insights on how to best handle subjects who voluntarily drop-out from a clinical trial or are withdrawn from the study by the clinical investigator. It also helps to clarify FDA’s longstanding policy that data that has already been collected from subjects must be retained in the study data for the given clinical trial even if the subject voluntarily drops-out of the study. Based on the FDA’s October 2008 “Guidance for Sponsors, Clinical Investigators, and IRBs – Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials”, it provides additional guidance to the Columbia University “Informed Consent Policy”.
PGR Archive |
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Information for Research Subjects
- Research at Columbia University
- What is the IRB?
- Should I Participate in Research?
About the HRPP / IRB
- Purpose / Scope / Responsibilities
- IRB Roster and Meeting Schedule
- Quality Improvement Program
- Compliance Oversight
- Federalwide Assurance
Contact Us
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Submitting a Protocol
- RASCAL Tutorial
- Tips for Efficient Protocol Review
- Resubmitting
- Creating Consent Forms
Maintaining IRB Approval
- Modifying a Protocol
- Renewing a Protocol
- Other Reporting Requirements
-Adverse Events
-Protocol Deviations & Violations
-Interim Analysis / Safety Reports
-Suspension
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