Indiana University

Clinical Trials Contracting

Getting Started

Link: Basic Steps Diagram

Clinical Trials Contracting (CTC) reviews and negotiates contracts for all industry sponsored clinical trials. In general, the Contract Officer will review contract language to protect the University and the investigator's rights for publication, intellectual property, indemnification and other such issues. The following are the documents negotiated by CTC. The PI is requested to use the Kuali Coeus (KC) Proposal Development Document to forward new CTA's including budgets and amendments to CTC.

Confidential Disclosure Agreement (CDA)

A Confidential Disclosure Agreement (CDA) is a legal contract that defines the terms and criteria used to assure that a study sponsor and Indiana University will maintain 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. Learn More >

Clinical Trial Agreement (CTA) & Amendments

The Clinical Trial Agreement is an agreement between the sponsor and Indiana University to define the scope of work required by the clinical trial protocol. Learn More >

An amendment to a clinical trial agreement is a contract modification. It may introduce or cancel specifications of terms of the existing, underlying contract, while leaving intact the CTAs overall purpose and effect. Learn More >

Master Agreements

The purpose of a Master Agreement is to improve efficiency of execution of clinical trial agreements. By shortening contract negotiation time for clinical trial agreements, investigators will be able to open the study and begin recruitment of research participants to achieve enrollment projections quicker. Learn More >

Material Transfer Agreement

A Material Transfer Agreement (MTA) is an agreement that allows one party to perform research using the materials of another party. This agreement governs common issues such as allowable uses, transfer of rights, intellectual property rights, confidentiality, and liability. Learn More >

Kuali Coeus (KC)

Indiana University requires a hierarchy approvals have to be obtained before Clinical Trials Contracting is permitted to begin to review and negotiate your contract and budget. Learn More >

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