Clinical trial agreement template

Clinical trials are complex projects with lots of different stakeholders. That said, having a robust Clinical Trial Agreement in place underpins the relationship between the participants and those running the trial and makes life a little easier for both parties.

Read all about how to make this happen in this guide to clinical trial agreements, or simply use our use our free clinical trial agreement template to get started.

What is a Clinical Trial Agreement (CTA)?

A Clinical Trial Agreement (CTA) is a legal document that clearly outlines the relationship between two parties involved in a clinical trial. In the UK, a clinical trial refers to a study that compares the effects of one treatment with another - this could involve patients, healthy people or both.

The first party is the sponsor, they provide the study drug, device, financial support or proprietary information.

The institution makes up the second party, who provide data, results, publication rights or input into further intellectual property - they may also have rights to further research and development.

What is the purpose of a Clinical Trial Agreement?

Clinical Trial Agreements set out how the clinical trial will be conducted, as well as the roles and responsibilities of each party.

They provide a framework for conducting the trial in line with ethical guidelines and legal requirements, such as patient safety and data privacy.

CTAs are vital for businesses as they ensure the safe and regulated conduct of clinical trials. They are among the most common contracts in the pharmaceutical and biotech industries.

When should you use a Clinical Trial Agreement template?

It's all well and good understanding what a Clinical Trial Agreement is and why it's important, but when should you actually use one?

Let's run through a few of the most common use cases:

1. Conducting a new clinical trial

‍When you conduct a new clinical trial, you'll need a CTA with each participating institution. It's essential, as the agreement outlines each party's responsibilities, financial arrangements, handling of intellectual property and other key aspects of the trial.

2. Collaborating with a research institution

‍You need to collaborate with a research institution for a clinical trial, as a CTA defines:

• the roles and responsibilities of each party;
• the handling of data and results; and
• the financial arrangements.

3. Working with a Contract Research Organization (CRO)

‍When you engage a CRO to manage a clinical trial, a CTA defines the scope of their work, how they handle data, results and any financial arrangements.

4. Engaging a Principal Investigator

‍When you hire a Principal Investigator to lead a clinical trial, the CTA will define their investigator's responsibilities, and again how they handle data, results and any financial arrangements.

5. Collaborating with other sponsors

The CTA also defines the roles and responsibilities of each sponsor‍ collaborating on a clinical trial, and (you guessed it) how they handle data, results and any finances.

Who is responsible for managing Clinical Trial Agreements?

A sponsor is usually in charge of managing clinical trial agreements.

However, the investigator and the institution also play a crucial role in reviewing and approving the agreement.

Not to mention the legal teams, research administrators and ethics committees that may also be involved in the process.

What should a Clinical Trial Agreement template cover?

If you are in the business of clinical trials, creating a solid template to base your agreement on is indispensable. The below outlines exactly what this should cover if you were to create your own trial agreement template.

1. Parties involved

‍This section identifies the parties involved in the clinical trial. It includes the full legal names, addresses, and contact information of the sponsor alongside the investigator and the institution where the trial will be conducted. It may also include the names of any sub-contractors or third parties involved in the trial.

2. Scope of the trial

‍This section provides a detailed description of the clinical trial, including the:

• objectives;
• number of participants;
• duration of the trial; and
• the specific procedures to be followed.

It also outlines the responsibilities of each party. For example, it will detail the sponsor's duty to provide funding and the investigator's duty to conduct the trial in accordance with the agreed-upon protocol.

3. Budget and payment terms

This part of the agreement specifies the total budget for the trial, how the funds will be allocated, and the schedule for payments. It should also cover any additional expenses, such as costs for additional tests or procedures and how these will be handled.

4. Data ownership and publication rights

This section addresses the ownership of the data collected during the trial, including patient records, test results, and any intellectual property generated during the trial.

It also outlines the rights of each party to publish the results of the trial, including any restrictions or requirements for co-authorship.

5. Confidentiality clause

This clause ensures that all parties will maintain the confidentiality of sensitive information obtained during the trial. This may include patient data, proprietary information about the trial protocol and any trade secrets or proprietary information of the sponsor.

6. Insurance and indemnity

‍This section provides details about the insurance coverage for the trial, including the types of risks covered and the limits of liability. It also includes an indemnity clause, which protects the parties from legal liability for certain actions or events that occur during the trial.

7. Termination conditions

‍This part outlines the circumstances under which the contract can be terminated, by either party. This may include failure to meet the trial objectives, non-compliance with the trial protocol, or failure to make the agreed-upon payments.

8. Dispute resolution

This clause outlines the procedures for resolving any disputes that arise during the trial. This may include negotiation, mediation or arbitration procedures.

9. Regulatory compliance

‍This section ensures that the trial will be conducted in compliance with all applicable laws and regulations, including ethical guidelines for clinical trials, data protection laws and regulations for the use of human subjects in research.

10. Patient consent

‍The agreement should also address the process for obtaining informed consent from the trial participants, including the information to be provided to the participants and the documentation of their consent.

11. Monitoring and auditing

‍This section outlines the procedures for monitoring the conduct of the trial and auditing the trial data. This includes the sponsor's right to monitor the trial site, review the trial records, and verify the accuracy of the data.

12. Amendments

This section provides a mechanism for making changes to the agreement or the trial protocol after the agreement has been signed - this typically requires the written consent of all parties.

By including all these elements in a clinical trial agreement, you ensure all parties have a clear understanding of their roles and responsibilities, and that the trial will be conducted in a manner that protects the rights and welfare of the participants.

Traditional workflow for managing Clinical Trial Agreements

1. Drafting the agreement

‍The first step in the process is drafting the clinical trial agreement. Typically, this is done by the sponsor's legal team or contract manager.

They will use a clinical trial agreement template as a starting point and customize it to fit the specifics of the trial. This includes details about the trial protocol, the roles and responsibilities of the parties, the budget and payment terms and any other specific terms and conditions.

The drafting process requires a deep understanding of the trial, the regulatory environment, and contract law.

2. Internal review

‍Once the draft agreement is ready, it undergoes an internal review. This involves various stakeholders, including the project management team, the finance team and the legal team.

Each team reviews the agreement from their perspective. For example:

• The project management team checks the feasibility of the trial protocol.
• The finance team verifies the budget and payment terms.
• The legal team ensures that the agreement is legally sound and protects the interests of the sponsor.

3. Approval

‍After the internal review, the agreement is submitted for approval. This process varies depending on the organization's structure and policies.

It may require approval from senior management, a contracts approval committee, or a legal department. The approval process ensures that the agreement is in line with the organization's strategic objectives and risk tolerance.

4. Contract negotiation

Once the agreement is approved internally, it is sent to the investigator and the institution. Following this, there may be some negotiation, as the investigator and the institution may have their own requirements and concerns.

The negotiation process can be time-consuming and repetitive without the right tools and skills in place.

5. Finalization and signature

‍After all parties have agreed on the terms, the agreement is finalized and signed. This could happen in person with a 'wet signature' or it may be done electronically, with an 'eSignature'. The signed agreement becomes a legally binding contract that governs the conduct of the clinical trial.

6. Contract management

‍After the agreement is signed, it needs to be managed throughout the life of the trial.

This involves monitoring compliance with the terms of the agreement, managing any amendments, resolving any contractual disputes and ensuring that the trial is conducted in accordance with the agreement.

Contract management is a critical part of the process and requires strong project management skills and attention to detail.

7. Closeout

‍Once the trial is complete, the agreement needs to be formally closed out.

This means verifying that all contractual obligations have been fulfilled, that all payments have been made and that all data and materials have been properly transferred or disposed of.

The closeout process ensures that there are no loose ends and that the relationship between the parties is properly concluded.

The traditional workflow for managing clinical trial agreements is a complex and time-consuming process. It also lacks accessibility, requiring a high level of expertise and coordination among various teams that may not be possible in a short period of time.

That said, it is an essential element of a clinical trial, ensuring that the trial is conducted in a legally sound and ethical manner.

How can a Clinical Trial Agreement template help?

Fortunately, a clinical trial agreement template can streamline this process.

It acts as a standardized document that can be customized for each trial, saving time and reducing the risk of errors.

The template ensures that all essential elements are included and that the agreement complies with regulatory requirements.

Automating Clinical Trial Agreements

Clinical trial agreements can be automated using contract management software. This can help to generate contracts quickly while ensuring consistency and reducing repetitive admin work.

Features such as automated contract templates, seamless integrations, bulk actions, real-time negotiation, and legally binding eSignatures can make the management of clinical trial agreements more efficient and effective.

Bur what are these features and how they can be used to automate clinical trial agreements?

1. Automated contract templates

With a robust clinical trial agreement template in place and a CMS like Juro, you can initiate contracts within seconds.

The templates are automatically populated using a straightforward Q&A workflow, or by importing contract data from other tools via one of our integrations.

This allows you to generate watertight clinical trial agreements quickly and with minimal manual work.

2. Real-time contract negotiation

With contract management software, you can negotiate terms directly from your browser.

All stakeholders can collaborate on the same document in real-time, making the negotiation process streamlined and efficient.

3. Electronic signing

The platform includes native eSignature capabilities, making the contract signing process quicker and more convenient.

Parties can add legally binding signatures to the clinical trial agreement from anywhere in seconds.

4. Secure contract storage

After your clinical trial agreements are signed, the software provides a secure, data-rich contract repository for storage.

You can access valuable information from your agreements whenever you need, which is beneficial for tracking obligations, understanding client relationships, and making strategic decisions.

5. Instant visibility into contracts

The search functionality in the software isn't limited to just document titles.

With Juro's Optical Character Recognition (OCR) functionality, you can search the contents of your clinical trial agreements to find specific clauses, terms, or parties in a matter of seconds. This is a massive time-saver when handling numerous clinical trial agreements.

Find out more

With Juro, you can automate up to 75% of contract admin and agree contracts up to 10x faster.

For more information, check out this guide to CLM software for healthcare organisations or simply hit the button below to book a personalized demo.