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:
- 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.
Contractors and non-academic visitors with official business with Columbia who require access to our facilities will be permitted access so long as they meet the primary vaccination series mandate. Evidence of vaccination will need to be provided to their employer who will then attest to the vaccine status of these individuals. A separate proof of vaccination attestation will be utilized for persons in these categories that can be obtained by contacting [email protected] with the person’s name, company, and date of birth. In addition, persons in this category need to adhere to University guidelines in place. Please click here for the University's COVID Guidelines for Fall 2022 and At-A-Glance-COVID-19-Policies.
In addition to the above, if visitors require access to NewYork-Presbyterian (NYP) facilities, they will also need to comply with NYP's requirements for external vendors. Effective September 1, 2021, NYP will require all vendors that come onsite to be vaccinated against COVID-19 or to obtain a valid exemption. Please click here for more information.
In order to better fulfill its responsibility to protect confidentiality, security and safety, and promote infection control for its patients, employees and visitors, NYP has retained Symplr System (https://www.symplr.com/) to manage Health Care Industry Representative (HCIRs) credentialing for all of its facilities.
NYP prefers that clinical research monitors or other sponsor representatives complete the HCIR credentialing process through Symplr. However, if the attestation process is permitted by the applicable clinical trial agreement (CTA), NYP will admit monitors who have completed and signed its medical attestation form.
If permitted by the applicable CTA, please provide the attached HCIR Attestation Form to each monitor to complete and sign. The monitor will be responsible for obtaining approval of the form from the clinical department that he or she will be visiting at NYP and submitting it to NYP's HCIR Credentialing Administrator at [email protected]. To provide adequate processing time, it is preferred that the form be submitted at least three business days prior to the monitor’s scheduled appointment. Upon the monitor’s arrival, the monitor must present the signed attestation form at the appropriate Security desk in order to be permitted access to that campus. The monitor must carry the completed form with him or her whenever on-site at NYP.
For further assistance or inquiries, please contact the NYP HCIR Credentialing Administrator at: [email protected].