For Investigators

Protocol Submission to CTO

Instructions and Forms

Other Forms which you may need are provided for you as references. Please contact the appropriate department for further clarification.

Radiology Cost Estimate Form - Radiation Safety Review Form

Anesthesiology Cost Estimate Form

Ophthalmology Cost Estimate Form

Ophthalmology Cost Estimate Form

Pathology Form - Pathology IRB Review Form

Spanish Translation Center (STC)

The STC was established in 1996 by the CTO with the goals of enlarging the pool of potential study participants and reaching out to the Hispanic community. Their services include: (1) initial translations into Spanish, (2) modifications or renewals of pre-existing STC translations, and (3) reviews of translations done by external translators for all research-related documents (e.g, informed consent forms, HIPAA forms, brochures, newsletters, etc.).

Please email all applicable items are required to the Director of the STC:

1. For translation, IRB-approved English documents for initial translations or the PDF version of the IRB-approved English documents. For review, the Word version of the Spanish documents.

2. Name of the Sponsor.

3. ARC Chartstring

Magaly Garcia, MD, Director

mg1067@cumc.columbia.edu

 

NGS Determination

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

Submission to NGS cannot occur until the protocol has received 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.

NGS Instructions

 

Clinical Research Monitors and Access to NYPH and CUMC

In order to better fulfill its responsibility to protect confidentiality, security and safety, and promote infection control for its patients, employees and visitors, New York-Presbyterian Hospital has retained VCS (www.vcsdatabase.com) to manage Health Care Industry Representative (HCIRs) credentialing for all of its facilities.

The Hospital prefers that clinical research monitors or other sponsor representatives complete the HCIR credentialing process through VCS.  However, if the attestation process is permitted by the applicable clinical trial agreement (CTA), the Hospital will admit monitors who have completed and signed its medical attestation form.

If permitted by the applicable CTA, please provide the attached 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 the Hospital and submitting it to the hospital’s HCIR Credentialing Administrator at vendorcred@nyp.org.  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 the Hospital.

For further assistance or inquiries, please contact the New York Presbyterian HCIR Credentialing Administrator at: vendorcred@nyp.org.

 

Human Research Protection Office (HRPP) / Institutional Review Board (IRB)

http://www.cumc.columbia.edu/dept/irb/

Research in which people will be asked to participate cannot begin until it has been approved by an Institutional Review Board (IRB). This group of people often includes behavioral and social scientists, social workers, other professionals, and people from the local community. They all work together to make sure that human research is well planned and ethical.

The IRB decides, when approving studies, that it is reasonable to ask people whether they want to be involved. Both before and during the research study, the IRB serves to protect the rights and welfare of research participants. It makes sure that any risks in the research study are as small as possible. The IRB also reviews each study while it is going on to make sure volunteers continue to be protected.

Sponsored Projects Administration (SPA)

http://spa.columbia.edu/

Sponsored Projects Administration (SPA), formerly Research Administration, serves as a central resource to support the research community at Columbia University by providing guidance and stewardship for the researchers and administrators on all campuses.

Our mission is to provide excellent administrative support to investigators in their pursuit of research and other scholarly activities while ensuring compliance with federal, University and private sponsor regulations, terms and conditions.

SPA operates through delegation of authority from the University Board of Trustees as a unit of the Office of the Executive Vice President for Research.

Irving Institute for Clinical and Translational Research (CTSA)

http://irvinginstitute.columbia.edu/

Getting Columbia scientists to find novel ways to do collaborative and interdisciplinary research to accelerate the development of new diagnostics, treatments, and disease prevention approaches for human health is the goal of the Irving Institute for Clinical and Translational Research. Formerly the Irving Center for Clinical Research, the program evolved into the Irving Institute in October 2006 as one of the first 12 clinical and translational science centers funded by the National Institutes of Health. The Irving Institute has become a transformative agent for research innovation at Columbia and for the national consortium of 37 other CTSA — Clinical and Translational Science Award — recipients nationwide, including those that have joined the original 12. NIH aims to fund 60 centers. The Irving Institute, with 40 members and affiliated faculty, also receives substantial support from Herbert and Florence Irving.

Office of the Executive Vice President for Research (EVPR)

http://evpr.columbia.edu/

The Executive Vice President for Research, reporting directly to the President of the University, has overall responsibility for the University's research enterprise, encompassing a broad spectrum of research departments, institutes and centers in the natural and biomedical sciences, the social sciences and the humanities. Columbia has a long and distinguished history of discovery of new knowledge. The Office of the Executive Vice President for Research works to foster the continuation of those creative endeavors and to promote an environment that sustains the highest standards of scholarship, health and safety.

The Office establishes and administers the policies governing the conduct of research at the University and oversees the management of its research programs. It also assists investigators seeking external funding, promotes interdisciplinary research and awards seed money for early stage investigations. This page provides links to the nine separate units managed by the Office as well as to resources and policies to support students and scholars conducting research throughout the University.