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).
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 (email@example.com) 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 (firstname.lastname@example.org) 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 (email@example.com) 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 firstname.lastname@example.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/