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Regulatory Process

Thank you for approaching the Research Unit at the Center for Interventional Vascular Therapy (CIVT) at New York-Presbyterian Hospital (NYP), Columbia University Medical Center (CUMC). 

Contact Person:

Treena Williams

Regulatory Manager

212.305.3485

Tat2112@cumc.columbia.edu

Below is a description of our protocol submission process from initial proposal through study initiation at CUMC.  

1. Confidential Disclosure or NON-Disclosure Agreement (CDA/NDA):  If a CDA is required, please provide in WORD format and it will be forwarded to Columbia University’s Clinical Trials Office (CTO) for legal review, finalization and execution.  

2. Site Surveys/Questionnaires:  If any questionnaires need completion, please email to Treena Williams (taw2112@columbia.edu) with a cc to me. 

3. Site Qualification Visit:  If a visit to the site is needed, please email to schedule.

4. Clinical Trial Agreement (CTA) and Budget:  routed through the Clinical Trials Office. A legal representative and a finance officer will be in touch with you to negotiate, finalize and execute a clinical trial agreement including budget.  Please note that execution of the agreement is dependent upon receipt of IRB approval.  Columbia University encourages sponsors to have a master agreement as it significantly shortens contract negotiations for future studies.

5. Institutional Review Board (IRB) Approval:  CUMC has 4 separate IRB Boards that each meet twice per month (a meeting schedule is attached).  All interactions with the IRB are managed via a web-based electronic application (called RASCAL).  Upon receipt of study start-up documents (i.e. full study protocol, FDA approval letter (if applicable), template ICF), we will prepare the IRB submission, draft ICFs and HIPAA authorization.  A primary Clinical Research Coordinator (CRC) will be assigned close to the time of IRB approval.

6. Joint Radiation Safety Committee (JRSC) Approval:  With protocols that involve any form of radiation (cath lab procedure, x-ray or nuclear imaging, etc.), approval from JRSC is necessary.  This request will be completed concurrently with the IRB Submission. 

7. Spanish Translations:  We serve a large number of Spanish-only speaking patients.  Therefore, the informed consent, HIPAA form, and any other documents handed to patients need to be translated to Spanish.  We have a local translation center approved by the IRB to complete this task.

8. Regulatory Documents Required by Study Sponsors:  Please forward a listing of all required regulatory documents to Treena Williams (taw2112@columbia.edu) with a cc to me (for example, CAP/CLIA, lab normals, financial disclosures, CVs, medical licenses, etc.) 

9. Site Initiation Visit:  Once all regulatory requirements have been met, a site initiation visit should be scheduled.  Please contact our Clinical Manager, Kate Dalton (keb2114@columbia.edu) to schedule. 

10. Vendor Credentialing:  Any vendors coming in to NYP must register with Vendor Credentialing Services (VCS). The good news is that VCS handles the credentialing in several hospitals within the tri-state area and therefore many vendors have already registered.  If you have any questions beyond what VCS can provide, please contact NYP’s vendor credentialing system administrator in Procurement & Strategic Sourcing at vendorcred@nyp.org.

11. Useful Links: 

IRB Meeting Schedule-available at http://www.columbia.edu/cu/irb/about.html

FWA Information- http://www.columbia.edu/cu/irb/about.html

Vendor Credentialing Information http://www.vcsdatabase.com/

 

 


 

 
 
 
 

 

 

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Contact Us

Uptown

161 Ft. Washington Ave.
Herbert Irving Pavilion,
6th Floor
New York, NY 10032
212.305.7060

Midtown East

16 East 60th Street
New York, NY 10022
212.326.5745

Somers

CIVT–Westchester
Bailey Court
334 Route 100
Somers, NY 10589
914.277.4367
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