What is Clinical Trial Agreement Drafting?
A clinical trial agreement is a legal contract that outlines rules for conducting a medical research study. It must explain all the important terms that apply, such as parties’ roles, payment plans, and more.
This type of agreement is usually signed between a study sponsor, such as a company, and a research institution or hospital.
Read the rest of this article to explore what key terms to include in a clinical trial agreement, how to draft it, and how a lawyer can help you draft it for legal validity and clarity.
What Core Components are in a Clinical Trial Agreement?
A clinical trial agreement usually contains key terms, such as the following:
- Budget. This outlines the payment amounts and timelines to follow so the hospital or medical facility gets paid for the tests. It should also discuss any costs that will be covered by parties.
- Project description. This section should outline the study, such as its purpose and objectives.
- Duties. This specifies the scope of work the researchers must fulfill and what the sponsor is expected to provide.
- Safety. The agreement should clarify which party must cover costs if something goes wrong, such as if a patient is injured.
- Ownership. It’s important for the parties to know who owns the test results. If the study findings will be published, there should be information about how and where they will appear.
- Responsibilities. Parties should know what their obligations are, such as complying with all regulatory requirements.
- Confidentiality. Proprietary information that’s shared between parties during the trial must be protected. The agreement should specify security measures.
- Termination. This agreement must clarify what conditions can trigger contract termination, such as breaches.
What are Tips for Drafting a Clinical Trial Agreement?
Now that you’ve included key terms in your clinical trial agreement, there is some additional information to detail. This includes the following.
Include a Purpose
For clarity, and to protect parties should there be future audits, the agreement requires a clear purpose section. Explain exactly what the trial will do, with details regarding its activities.
Outline IP Rights
Avoid vague language when detailing who owns the IP, such as inventions created or used during the trial. This will prevent disputes.
Explain Compensation
The agreement should detail how parties will be compensated if there is any harm or damage inflicted during the trial. This should be aligned with insurance coverage to reduce potential liabilities.
Provide Detailed Payment Terms
Your agreement should include detailed information about all budgets and payments, such as start-up fees, milestone payments, and patient-related expenses. Mention what payments will be made for deliverables and if milestones trigger payments.
Specify Confidential Information
To protect information during the trial, the agreement requires provisions to protect study data and other materials that aren’t shared with the public. This should also mention any exceptions, such as if information disclosure is required by law.
Discuss Reporting Obligations
Your clinical trial agreement should outline all duties for reporting any adverse events and safety information, ensuring everything is in accordance with applicable regulations. Reporting issues must be done within specific timelines.
Include an Amendments Clause
There could be changes made to the clinical trial, such as an increased work scope, which is why it’s important to include a clause in the agreement for how amendments can be made. This will help to make any changes a smooth process that prevents project delays.
How Does a Lawyer Help You with Clinical Trial Agreement Drafting?
Drafting a clinical trial agreement isn’t something to take lightly, even if it seems straightforward. A lawyer is advisable to hire so that you can feel confident that all its terms are clear and legally sound.
They can help you with various aspects of the contract drafting process, such as:
- Understanding the clinical trial’s goals. A lawyer will review the study protocol and requirements so that the agreement accurately reflects them.
- Explaining parties’ obligations. A lawyer ensures the agreement specifies all duties and roles to prevent misunderstandings.
- Writing clear and specific payment provisions. A lawyer will include details covering all aspects of the agreement’s financial terms, such as payment milestones, budgets, and other financial duties if the trial is terminated.
- Including confidentiality clauses. To protect all sensitive information and research, a lawyer will clarify confidentiality and data protection measures. They will also specify what confidential information can be used or disclosed.
- Reviewing a clinical trial agreement you already have. Your agreement might need to be updated in future. A lawyer can help you with this. They can also review a clinical trial agreement that you’ve already drafted so that you can feel confident it’s specific and avoids red flags such as missing information.
Where to Find a Lawyer to Draft a Clinical Trial Agreement
If you need to find a lawyer to draft your clinical trial agreement, use an online legal platform instead of having to cold-call traditional law firms.
ContractsCounsel is one of the largest online legal marketplaces that gives you access to a network of vetted lawyers with contract drafting and review experience. From the comfort of your home, you can quickly connect with and hire a lawyer to draft your agreement for you.
To request that a lawyer on the ContractsCounsel platform drafts your clinical trial agreement, here are the easy steps to follow:
- Go to the ContractsCounsel marketplace, where you can post your project for free. Try to mention a few details about the project to match with the best lawyers, such as what the study trial is about or what research will be conducted.
- Receive lawyer bids. You’ll receive multiple bids from lawyers directly on the platform who can assist you, instead of having to find a lawyer from scratch.
- Once you receive the lawyer bids, review the lawyers’ profiles to select the most suitable one. There’s lots of info on the platform, such as the lawyers’ credentials, client ratings, years of experience, and field of expertise.
- After reviewing the information, connect with a lawyer and hire them to draft your clinical trial agreement for a flat fee.
