Industries
Features
Apps
Plans and Pricing
Developers
CONTACT SALES START FREE TRIAL
Free Template

Clinical Trial Agreement

2 signers
1 Institution
2 Sponsor
Use this template
USE THIS FREE TEMPLATE

Prepare for Clinical Trials with Ease Using Our Agreement Template

Also known as a clinical study agreement (CSA), a clinical trial agreement (CTA) is an agreement that indicates rules and obligations to be followed during a clinical study. It is a legally binding agreement in nature.
USE THIS TEMPLATE - FREE
clinical trial agreement template

Identifying Clinical Trial Agreements

A CTA is easily identified as a trial agreement that outlines the scope of work between two parties (such as a university) while also formalizing facts and things that must be known regarding the study to be done. It would have both financial and legal terms and conditions to be agreed upon and set by the sponsor alongside compliance.

What is outlined in the CTA?

  • Protocol (this may take the form of legislative and regulatory requirements, conditions of ethics approval, and applicable standard operating procedures)
  • Investigational product
  • Conduct of the study
  • Confidentiality
  • Handling software and equipment if necessary
  • Payments between parties
  • Privacy details
  • Publication rights
  • Liability and insurance
  • Disputes
  • Study results as well as intellectual property
  • Study sponsor
  • The investigator
  • The subjects
  • Data

The clinical trial agreement outlines the legal and financial terms, responsibilities, as well as obligations to be respected by parties involved in the agreement.

Clinical trials are usually conducted in laboratories, but they can also be done in a hospital environment. These trials are done in a manner that is patient-oriented, as studies include human disease mechanisms as well as emerging technologies or treatments that would eliminate these diseases.

What are the types of Clinical Trial Agreements or Clinical Study Agreements?

CTAs are split into two types:

  • CTA in collaboration with an industry sponsor – This type of clinical research agreement may be initiated by an investigator or a sponsor.
  • CTA in collaboration with an academic institution or a university – This is normally used for a subaward or a subcontract in the event that a different site arrives to provide assistance with a trial.
USE THIS TEMPLATE - FREE

The need for clinical trial agreements

It is a requirement when dealing with financial terms related to the partnerships, both academic and non-academic. It outlines key details such as the number of subjects participating, compensation, the duration of the trial, and the ownership of the data to be obtained.

Parties in a clinical trial agreement

An industry sponsor as well as participants are those we work with when completing a Clinical Trial Agreement. In the agreement, expectations from the trial sponsor are outlined such as the fact that they would provide the device or drug that will be studied, their financial support, and much more. A research institution is also involved in a CTA, as it will be outlined that they would perform testing, provide results and interpret the data afterwards.

Identifying a clinical trial agreement

If the document legally binds parties, outlines aspects such as risk, the allocation of funding, agreements to be followed or the contract terms, various responsibilities, and the protection of intellectual property as well as the reputation of each party, it is a clinical trial agreement or CTA.

Accelerated clinical trial agreements

Make sure to sign and date the form when you have completed it, as required by the IRS. By doing so, you are confirming that the information reported on Form 5329 is accurate to the best of your knowledge.

FAQs Regarding Clinical Trial Agreement

Also known as a clinical study agreement (CSA), a clinical trial agreement (CTA) is an agreement that indicates rules and obligations to be followed during a study. It is an agreement that is legally binding in nature.
A sponsor as well as participants are those we work with when completing a CTA. A research institution or a university is also involved in a CTA, as they would perform testing, provide results and interpret the data afterwards.
A clinical trial agreement is also a contract as it is a signed document between engaged parties.
It is a requirement when dealing with partnerships, both academic and non-academic. It outlines key details such as the number of subjects participating, the responsibilities, the protocol, the compensation, the duration of the trial, and the ownership of the data or intellectual property to be obtained.

" Undoubtedly one of the best eSignature application available in the market right now. Would love to recommend Fill. "

Liam Washington
Capterra

Ready to get started
with this template?

Click the button below to add this template to your account. If you do not have an account, you can sign up for a free trial to start using this template.
USE THIS TEMPLATE - FREE
Arrow-up