Clinical Trials for Investigators

Our mission is to facilitate quality clinical trial research - the effective and efficient evaluation of new pharmaceuticals and medical devices - by providing the Columbia University Irving Medical Center research community with comprehensive administrative services that help move trials quickly from initial proposal through contract execution. We assist with trials supported by federal and foundation grants and industry contracts, including investigator-initiated trials.

The CTO requires the following documents in order to properly negotiate the legal and budgetary items for a study:

  • Protocol
  • Draft informed consent form
  • Draft study budget
  • Draft study agreement

Please submit a new study for CTO contract and budget review, negotiation and execution by emailing [email protected].

If your study involves utilizing the services of other departments with Columbia University Irving Medical Center, forms are required for proper assessment of the costs involved. Please follow this link to the cost estimate forms.

Investigational device studies under an Food and Drug Administration (FDA)-issued Investigational Device Exemption (IDE) that begin with the letter “G”, as well as post-market approval studies of carotid stents or registries of carotid stents, must be submitted to the Medicare contractor, National Government Services (NGS) or Centers for Medicare and Medicaid Services (CMS), for a coverage decision prior to enrollment of subjects into the study.

Submission to NGS/CMS cannot occur until the protocol has received Institutional Review Board (IRB) approval and the contract for the study has been signed by all parties.

Prior to having the IRB approval documents and executed contract available, you can determine whether you need to submit a full application, or if you can use a short application. A full application includes documents that you can collect prior to having IRB approval, minimizing the time it will take for submission to NGS/CMS.

Visitors, including vendors and alumni, will no longer need to show proof of vaccination. Please click here for an update on the University's COVID Guidelines.

All HCIR (Health Care Industry Representative) who will be visiting NewYork-Presbyterian Hospital need to maintain a current membership with our third-party credentialing partner, Green Security. This is a requirement for conducting business with or at NewYork-Presbyterian Hospital. Examples of HCIRs include, but are not limited to: salespersons, service technicians, clinical trial monitors, consultants, educators, onsite service providers, contract workers, and language service providers.

Effective January 1st, 2024, NewYork-Presbyterian Hospital is live with Green Security. Symplr was phased out on March 1st, 2024 and as such, Green Security is the only accepted vendor credentialing platform. Since March 1, 2024, all NewYork-Presbyterian Hospital approvers have been able to utilize single-sign on with Green Security.

For further information or to register, please visit the Green Security website: https://www.greensecurityllc.com/.

For vendors who visit any NYP affiliated campus less than 12 times a year, please follow the Vendor Pass process. Vendor Pass is a NYP developed web application to replace HCIR attestation forms. To get started, the requesting NYP/CU/WC employee must submit a Vendor Pass on behalf of vendor visitor prior to visit here: https://vendorpass.nyp.org/login

  1. The NYP/CU/WC employee generates an attestation form at https://vendorpass.nyp.org/login and enters basic information on the vendor.

  2. The vendor receives an email to fill out questions.

  3. Based on the responses, the vendor is issued a pass that will only turn green on the day of, or the date range allocated for their visit.

  4. The NYP/CU/WC employee will receive an email once the pass is approved.

  5. On the day of the visit, the vendor must present the green pass to security on site in order to gain entrance to the facility.

For further assistance or inquiries, please contact the NYP HCIR Credentialing Administrator at: [email protected].

For guidance on remote monitoring, please follow this link.

Consent to Contact for Research (CCR) enables researchers to access and contact patients who indicate their willingness to be contacted for research, based on information in their medical records, without an initial connection through their treating physicians or medical director. 

Each study will need IRB approval in order to use the CCR registry.

To find more information about CCR, please click here.