Abpi Model Clinical Trial Agreement

The ABPI Model Clinical Trial Agreement: A Comprehensive Guide for Researchers and Sponsors

In the world of clinical research, agreements are a crucial component of any study. These documents outline the terms and conditions for the collaboration between the sponsor and the investigator or institution conducting the trial. The ABPI Model Clinical Trial Agreement (CTA) is a widely accepted document that provides a standard framework for creating such agreements.

What is the ABPI Model CTA?

The ABPI Model CTA is a template agreement for clinical trials created by the Association of the British Pharmaceutical Industry (ABPI). It is designed to be a flexible and comprehensive document that can be adapted to suit the needs of different clinical trials. The template covers a range of topics, including:

– Confidentiality and intellectual property rights

– Safety reporting and monitoring

– Data management and ownership

– Payment and reimbursement

– Termination and indemnification

Why Use the ABPI Model CTA?

The use of a standard template like the ABPI Model CTA can save time and resources for both sponsors and investigators. The template has been reviewed and approved by multiple parties, including the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health and Social Care (DHSC). Using the ABPI Model CTA can help ensure that both parties understand the terms and conditions of the trial and can avoid disputes that may arise from unclear or incomplete agreements.

How to Use the ABPI Model CTA

The ABPI Model CTA includes several schedules that outline the specific details of the trial, such as the study design and protocol, the trial site(s), and the roles and responsibilities of the parties involved. It is important to carefully review and customize these schedules to ensure that they accurately reflect the needs and expectations of the trial.

In addition to the schedules, there are several key clauses in the template that require particular attention. For example, the confidentiality clause should clearly define what information is considered confidential and how it will be protected. The indemnification clause should clearly outline the responsibilities and liabilities of each party in the event of any harm or injury arising from the trial.


The ABPI Model CTA is a useful tool for researchers and sponsors conducting clinical trials in the UK. By providing a standardized template that covers a range of topics, the ABPI Model CTA can help ensure that both parties are on the same page and can avoid disputes or misunderstandings that may arise from unclear agreements. It is important to customize the template to fit the specific requirements of the trial and to pay close attention to the key clauses. With careful planning and execution, the ABPI Model CTA can help ensure a smooth and successful clinical trial.