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


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 Jernise Hobbs and copy

3. Site Qualification Visit:  If a visit to the site is needed, please email Kate Dalton at 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 ( 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 ( 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

11. Useful Links: 

IRB Meeting Schedule-available at

FWA Information-

Vendor Credentialing Information







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