What is a Clinical Trial Agreement?

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When specific commercial products, like medications or cosmetics, need to be tested on people, a clinical trial might be necessary. A Clinical Trial Agreement is a legally binding agreement between the company that makes the product (known as the "sponsor") and an appropriate institution (such as a research university). It addresses specific legal and policy issues related to human subject research, including allocation of risk, and the protection of rights.

Use the Clinical Trial Agreement document if:

You're a company operator who wants to commission a clinical trial of a product.
You work at an institution that conducts clinical trials.
You've developed a product and needs to conduct a trial before selling your idea or product.

A Clinical Trial Agreement specifies what product (for example, the study drug or device) the sponsor will provide the institution, as well as any financial support, and/or proprietary information. Additionally, Clinical Trial Agreements specify what the institution will provide in the way of data, as well as resulting publication, and input into further intellectual property development. It is crucial that in setting up a clinical trial that all parties comply with existing laws. If you have any questions, it is a good idea to consult an attorney who specializes in clinical trials.

Other names for this document: Clinical Trial Agreement Form

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