A clinical trial agreement definition outlines the governing terms and obligations that apply to all parties when a clinical trial is conducted. The agreement must be fully executed prior to the study being activated.

Types of Clinical Trial Agreements

Clinical Trial Agreement

The agreement (CTA) is also known as a clinical study agreement or a clinical research agreement. It is a contract between an academic institution and another party regarding a clinical trial or study.

A CTA outlines, in its entirety, the details of what the clinical trial will cover and puts into writing the formal understandings of each party for the conduct of the study. It also contains the legal and financial terms related to the clinical study.

Clinical Trial Agreement With an Industry Sponsor

This type of agreement can be initiated by either a sponsor or investigator. A sponsor initiated clinical trial agreement is required when the drug or device to be studied has funding provided.

Investigator Initiated Clinical Trial

An investigator initiated clinical trial agreement is required when an industry sponsor supplies the device or drug to be studied and/or the funding necessary for the trial.

Clinical Trial Agreement With an Academic Institution

This agreement is either a subcontract or a sub-award that has a lead site recruiting one or more sub-sites where the clinical trial will be conducted.

Sponsored Projects

A sponsored project involves negotiating, reviewing, and executing legal agreements from outside funding sources. Coordination among all parties, which includes the investigator and the external funding source, is essential to ensuring a successful contract with mutually acceptable terms.

Negotiating Clinical Trial Agreements

Pharmaceutical companies usually fund clinical trial projects to study drugs and devices and take on the important role of assuring the safety of the product. The company also obtains approval from the Food and Drug Administration (FDA) and brings the drug or device to market.

Academic institutions have policies and regulations specifying what can and cannot be accepted in a clinical trial contract. Policies focus on the protection of the participating individuals as research subjects and minimize the liability associated with human research.

For-profit private sponsors are motivated differently than an academic institution. This can lead to differences in ideals and principles, which results in longer contract negotiations before arriving at an agreement that is mutually acceptable.

During the contract negotiations for a clinical trial, academic institutions focus on securing acceptable clauses regarding high-risk issues such as:

  • Research subject injury.
  • Ownership of clinical study results.
  • Confidentiality.
  • Patent rights.
  • Publication rights.

There are additional common issues when creating a clinical trial agreement. These include:

  • Agreement parties.
  • Financial arrangements.
  • Intellectual property.
  • Insurance.
  • Governing law.
  • Termination.
  • Use of name.

Clinical Trial Contracts: Language and Limitations

Trials conducted under the regulations of the FDA require a contract between the trial site and the clinical study sponsor or organization.

The contract does not need to be written in legalese. To ensure that all parties have a clear understanding of the definitions of legal terms, the contract should be written in plain language. The tasks, deliverables, and responsibilities of the trial site should be clearly written and detailed so that there is no confusion about what is required to conduct the study.

Both the sponsor and the trial site have primary goals related to conducting a clinical trial.

Sponsor Goals

  • Collect data that is complete and accurate in support of attaining marketing approval.
  • Protect confidential information and intellectual property.
  • Be in compliance with the current applicable laws and regulations.

Trial Site Goals

  • Be compensated for their work.
  • Indemnification.
  • Receive authorization to publish the results of the study.
  • Receive pay for any subject-related injury during the study.
  • Secure protection for the trial site.

It is important that all parties understand the language used in the contract. When reviewing the agreement, things to look for include capitalized terms, words that are limiting, and words that are not understood. The contract should contain a definitions section.

Limiting language in the contract can lead to problems and should be replaced with words that have specific expectations and details. Words to look for include:

  • Any.
  • All.
  • Without limitations.
  • Immediately.
  • Best efforts.
  • Sole discretion.

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