A Data Protection Impact Assessment is a process or operation(s) conducted by the controller to identify possible high risks arising from data processing and to minimize them as early as possible. The principal purpose of a DPIA is to ensure the protection of the rights and freedoms accordingly to the GDPR of the natural person whose personal data will be processed. It is a process that must be undertaken before the actual data processing starts.
The National Agency for the Safety of Medicines and Health Products (ANSM) of France published on October 24th, 2022, a writing guide for clinical trials requests. The purpose of this set of recommendations is to bring clarity about the intricate process of fulfilling a request and the necessary procedure to start a clinical trial in France, as well about the medical devices that will be used in a clinical trial.
On October 10, 2022 the European Data Protection Board (EDPB) issued the updated Guidelines 9/2022 on personal data breach notification under GDPR.
Any expense reimbursement to the clinical trial participants (patients or healthy volunteers) have always been a topic for a never-ending discussion between the clinical trial market stockholders. Such payments imply ethical, technical, logistical, and surely financial aspects that are not always clear and vary from country to country, or even from site to site.
Global clinical research services provider CTA Focus has expanded its physical footprint by opening an additional office in North Carolina, USA. The move will provide clients operating in North America with seamless access to the organization's world-class clinical trial agreement and negotiation services. It comes just nine years after the company's inception.
With this Article we are going to share our experience around negotiating any invoiceable costs in the study budgets for clinical sites. We will focus on procedural costs and site specific fees and mention our most common challenges, providing examples from day to day interactions.
Spain, as a Member State of the European Union (EU) applied, starting with January 31, 2022, the new Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance (the “Regulation”). This Regulation is now the legal benchmark for the EU concerning clinical trials on medicinal products for human use.
Starting with January 31, 2022, a new European clinical trials regulation with medicinal product is in place, applicable throughout the European Union (EU).
Building of any site budget is a complex task that can conventionally be divided into three parts: 1. Visits/procedures costs, 2. Conditional procedures and 3. Site fees - the last two are usually called invoiceables. Nowadays, there are several widely used systems that can generate site budgets quite quickly, yet they cannot substitute a ‘human’ professional since budget creation requires not only a good knowledge and understanding of the protocol, but also adjustments at site level.
A rescue study is as such a challenge. According to some sources almost 50% of clinical trial programs end up with rescue status due to various reasons: these can be imperfections in the study design, failed enrolment expectations, regulatory approval delays, poor study management etc.