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What would you like to do?
Submit a new study
Submit an Amendment
Submit a Confidential Disclosure Agreement (CDA)


 
Submit a new study – required documents and information

Contract and budget negotiation.  The Clinical Trials Office (CTO) negotiates contracts and budgets of clinical trials whose Principal Investigator has a primary appointment in the College of Physicians and Surgeons.  Research Administration negotiates contracts and budgets of clinical trials whose Principal Investigator has a primary appointment in the Mailman School of Public Health, the College of Dental Medicine, or the School of Nursing.

Step 1.  All sponsored research projects must first be registered through the RASCAL Grants & Contracts Module.  Log in to RASCAL, create a proposal, obtain a RASCAL "Proposal Trak ID" , e.g., "PT-AAAG1234", and upload to RASCAL the complete protocol, a draft budget, and a draft contract.

Step 2.  Review these questions, which will help the CTO process your study.

Step 3.  Complete CTO required forms.

•  Compliance Statement  (Preview form)

•  Questionnaire (v. 2008)  (Preview form)

•  Tax Exemption Certification (v. 2008)  (Preview form)

Step 4.  Complete these additional forms where applicable.

•   Research Pharmacy Cost Estimate Request Form    (Preview form)
The Research Pharmacy Cost Estimate Request Form allows the Research Pharmacy to provide investigators with a more accurate estimate of costs associated with the procurement and distribution of pharmaceuticals.  If your proposal does not require Research Pharmacy assistance — e.g., the proposed study is a device trial rather than a drug trial — continue to the Budget Worksheet and instructions for budget preparation.
Please note: investigators requiring cost estimates from the New York State Psychiatric Institute's Research Pharmacy should call the Contracts Department at (212) 305-3360.
 
•  Budget Worksheet and Instructions (Preview form)
The CTO Finance department must approve all budgets prior to contract execution. The budget worksheet and instructions are provided as a guide to improve discussions with this department. The CTO Finance Budgets team members are continually apprised of all changes in New York-Presbyterian Hospital ChargeMaster program and can assist investigators in using the appropriate fees.
•  Spanish Translation Request Form  (Preview form)
Use the Spanish Translation Request Form to send documents that require translation, modification, or review by the Spanish Translation Center.   Click here to read instructions.

Spanish Translation Center staff: click here to review requests.


 
Submit an Amendment – required documents and information
•   Submit an Amendment   (Preview form)
To amend an existing study already on file, you must provide the following documents and information:
–   Principal investigator name and contact information
–   CU IRB #
–   Abbreviated title
–   Sponsor name and contact information
–   Clinical Research Organization (CRO) name and contact information (if applicable)
–   Electronic copies of amendment and any amendment-related correspondence from sponsor


 
Submit a Confidential Disclosure Agreement (CDA)
•   Submit a CDA   (Preview form)
A Confidential Disclosure Agreement (CDA) is a legal contract that defines the terms and criteria used to assure that a study sponsor and Columbia University will maintain the confidentiality of study-related information — e.g., data, methods, and procedures — and will not use this information for any purpose other than that described in the CDA.

To submit a CDA, you must provide the following documents and information:
–   Principal investigator name and contact information
–   CU IRB #
–   Abbreviated title
–   Type of funding: external or internal
–   Sponsor name and contact information
–   Clinical Research Organization (CRO) name and contact information (if applicable)
–   Electronic copies of CDA and any CDA-related correspondence from sponsor

Read CUMC's standard operation procedures for executing CDAs

 
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