Clinical Trial Agreement Example

If one of the parties to the Contract decides to take legal action, this Agreement will specify the jurisdiction in which the matter will be dealt with. In general, the purpose of a clinical trial is to collect data on the safety and efficacy of a particular medical device. In this article, I will present nine key elements of a Clinical Trials Agreement (CTA). You will learn the purpose of these components and how they can protect you in case of conflict or disagreement. In addition, in some cases, payments are triggered when certain milestones are reached. For example, once the site is enabled for registration, a startup payment is triggered for the site. On the other hand, proponents and CROs are required to inform the IRB/EC directly of any non-compliance that could affect the safety and well-being of subjects. Just like your auto or health insurance, locations, CROs, and sponsors typically have clinical trial insurance to protect themselves or the parties involved in a clinical trial. The purpose of this section is to document the agreement between the site and the sponsor on how long the study data will be retained after the study has been completed (usually at least two years). It is not surprising to us that clinical research is a regulated industry. If a signed CTA is agreed, sponsors have the right to collect data prior to contract termination, and sites receive compensation for testing activities performed by research staff.

This model agreement for clinical trials was developed as part of a collaboration between vereniging Samenwerkende Topklinische opleidingsZiekenhuizen (STZ), Nefarma, Stichting Het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis (NKI/AvL) and ACRON to facilitate the conduct of clinical trials in the Netherlands. The termination and publication clauses are consistent with the CCMO`s Directive on Clinical Trial Agreements. But what if the clinical location provides incomplete or incorrect data to the sponsor? Or is he reluctant to allow a CRO to monitor data on-site? Websites want to get paid for their search services. In the case of a multi-year clinical trial, sponsors and CROs want to manage their budget and spending forecasts for current and future years. This clinical trial will be conducted at multiple sites under existing NIAID-sponsored contracts and grants. NIAID will act as the sponsor of the Investigational New Drug (IND) application. NIAID contractors, fellows, research networks, clinical research sites or their investigators are not parties to this Agreement. The website may recognize that there is more work involved in a study than expected. Or the proponents decide to revise the protocol, which in turn affects the milestone payment plan in the CTA. A CTA should include the sponsor`s perspective on the publication and presentation of clinical trial data. In addition, this section contains other agreements, such as.B. Sponsor`s right to periodically review the Site or review data, and the Site`s responsibility to cooperate with Sponsor or a regulatory body such as the FDA.

Use this article as a guide when reviewing or writing your next agreement for a clinical trial. However, you should always seek advice from a qualified lawyer on all CTA conditions. The payment terms and schedule also state what the search site is NOT paid for. For example, in a post-approval clinical trial, the sponsor may not want to make the medical device available for free. Kunal Sampat, Senior Director, Clinical Research, Abbott, explains the essential elements of a clinical trial agreement when a third party, e.B. a person in the clinical trial that negatively affects CTA between the sponsor and the site, the sponsor compensates for the loss and assumes full responsibility. Data from a clinical trial are the property of the study sponsor, unless otherwise specified in the agreement. Kunal is the founder of the Clinical Trials Podcast, a podcast and blogging platform for clinical research professionals. Its goal is to interview leading experts in clinical trial management to help you accelerate your career and become a more effective leader. He enjoys connecting like-minded people, introducing new ideas and immersing himself in a continuous learning environment. Finally, this section of the agreement must clearly indicate where the website must send invoices (name and contact details of the person) as well as the terms of payment (example: payment is made within 45 days).

Or a clinical website published data from study participants without giving the sponsor the opportunity to review the results. Sponsors undertake to communicate the results of the study for ethical reasons. Researchers at clinical sites, on the other hand, are enthusiastic about publishing research data. In the United States, the Sunshine Act provides for increased control over payments to health organizations and health professionals. The project description contains the necessary details of the type of agreement. This section of the agreement is often overlooked by sponsors, CROs, and locations. The purpose of this section is to explicitly state the description of the research project. You would like to document the overall purpose of the agreement in this section. Whether you`re new to clinical research agreements or a contractual ninja, at some point there`s at least one agreement you can think of that could have been phrased differently. As a sponsor and venue, you want to prepare for the termination of the contract.

Sponsors, CROs and sites have a serious responsibility to comply with the study protocol, state laws and regulations. The sponsor is a partner of the IMI COMBACTE consortium (COMbatting BACTerial resistance in Europe) and has concluded the IMI COMBACTE grant agreement with IMI JU (the joint IMI company between the EU and EFPIA). This Clinical Trial Agreement (the “Agreement”) will be effective with __. .