Clinical trial agreement template
Use this free clinical trial agreement template to agree terms between sponsors and institutions in 2023.
Use this free clinical trial agreement template to agree terms between sponsors and institutions in 2023.
Are you preparing to conduct a clinical trial? This comprehensive guide will help you understand the importance of a well-structured clinical trial agreement.
You can also use our free clinical trial agreement template to get started.
A Clinical Trial Agreement (CTA) is a legal document that outlines the relationship between two parties involved in a clinical trial.
The first party is the sponsor. They may provide the study drug, device, financial support, or proprietary information.
The second party is the institution. They may provide data, results, publication rights, or input into further intellectual property. They may also have rights to further research and development.
Clinical Trial Agreements are used to agree on the conduct of the clinical trial and 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, enabling the safe and regulated conduct of clinical trials. They are among the most common contracts in the pharmaceutical and biotech industries.
Understanding what a Clinical Trial Agreement is and why it's important is a great start. But when should you actually use one? Well, let's run through a few of the most common use cases:
When you conduct a new clinical trial, you'll need a CTA with each participating institution. This agreement outlines each party's responsibilities, financial arrangements, handling of intellectual property, and other key aspects of the trial.
When you collaborate with a research institution for a clinical trial, a CTA defines the roles and responsibilities of each party, the handling of data and results, and the financial arrangements.
When you engage a CRO to manage a clinical trial, a CTA defines the scope of the CRO's work, the handling of data and results, and the financial arrangements.
When you engage a Principal Investigator to lead a clinical trial, a CTA defines the investigator's responsibilities, the handling of data and results, and the financial arrangements.
When collaborating with other sponsors on a clinical trial, a CTA defines the roles and responsibilities of each sponsor, the handling of data and results, and the financial arrangements.
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The responsibility of managing clinical trial agreements typically falls on the sponsor's shoulders.
However, the investigator and the institution also play a crucial role in reviewing and approving the agreement.
Legal teams, research administrators, and ethics committees may also be involved in the process.
This section identifies the parties involved in the clinical trial. It includes the full legal names, addresses, and contact information of the sponsor, 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.
This section provides a detailed description of the clinical trial, including its objectives, the number of participants, the duration of the trial, and the specific procedures to be followed.
It also outlines the responsibilities of each party, such as the sponsor's duty to provide funding and the investigator's duty to conduct the trial in accordance with the agreed-upon protocol.
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.
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.
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.
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.
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.
This clause outlines the procedures for resolving any disputes that arise during the trial. This may include negotiation, mediation, or arbitration procedures.
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.
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.
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.
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 these elements in a clinical trial agreement, you can ensure that 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.
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The first step in the process is drafting the clinical trial agreement. This is typically 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.
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, and the legal team ensures that the agreement is legally sound and protects the interests of the sponsor.
After the internal review, the agreement is submitted for approval. The approval 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.
Once the agreement is approved internally, it is sent to the investigator and the institution. This stage often involves 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.
After all parties have agreed on the terms, the agreement is finalized and signed. This may happen in person, or it may be done electronically. The signed agreement becomes a legally binding contract that governs the conduct of the clinical trial.
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.
Once the trial is completed, the agreement needs to be formally closed out.
This involves verifying that all 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 requires a high level of expertise and coordination among various teams. However, it is a critical part of conducting a clinical trial and ensures that the trial is conducted in a legally sound and ethical manner.
Fortunately, a clinical trial agreement template can streamline the process we just described.
This is because 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.
Clinical trial agreements can be automated using contract management software. This can help to generate contracts quickly, ensure consistency, and reduce 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.
Let's explore these features and how they can be used to automate clinical trial agreements in more detail.
With a robust clinical trial agreement template in place, 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 means that watertight clinical trial agreements can be generated quickly, with minimal manual work required.
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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.
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.
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.
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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.
If creating and managing clinical trial agreements are causing headaches for your organization, Juro's contract management software can help.
With Juro, you can automate up to 75% of contract admin and agree contracts up to ten times faster. To find out more, hit the button below to book a personalized demo. Or, check out this guide to CLM software for healthcare organisations.
Juro is the #1-rated contract platform globally for speed of implementation.
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