The GDPR (General Data Protection Regulation) has been with us for three years now. Yet, the industry continues to struggle through the multiple legal interpretations of how the GDPR requirements apply to the clinical research. Ethics committees, data protection officers of the clinical sites and of study funding sponsors, as well as the other stakeholders, defend their approaches. This altogether expands the gap in how a CRO and therefore, a Sponsor should process personal data to state with confidence, “We are GDPR compliant”. To enable mutual agreement on the rules of applying the GDPR requirements to clinical research and help CROs demonstrate compliance with the GDPR, the EUCROF task force developed and is proud to introduce the first clinical trial Code of Conduct. The Code is aimed at explaining the application of the GDPR to the services delivered by the CROs. If you are a data protection officer, you work in a regulatory or legal department, if you are a healthcare professional wishing to boost your awareness about protection of personal data in the trial-related domain and get some insightful tips, you are welcomed to join us on this webinar! 25 May 2021, on the day of the 3rd anniversary of the GDPR, we will guide you through the first clinical trial Code of Conduct. You will have the opportunity to ask questions about the Code and our reasons to trust in its value, as well as receive practical advice on adherence.
n the light of a global pandemic, clinical research in early-stage development reached a new degree of interest as the world relies on scientists to find solutions for unmet medical needs. Under the pressure of this scenario all parties involved in clinical research have to re-organise the working floor and find to ensure the utmost safety of trial participants while in parallel improve the productivity and speed. In drug development the most sensitive part is the switch from non-clinical to clinical conduct, namely the First-in-Human/First-in-Patient (FIH/FIP) Phase I clinical trials. To ensure utmost safety a trial specific risk analysis and risk-minimizing measures are required for trial design and protocol as well as for the translation into practical conduct for executing infrastructures in specialized Phase I research clinics. The basic principles of safety arrangements in clinical trials are regulated by international guidelines and local laws and requirements. For the EU countries the Clinical Trials Regulation 536/2014 based on ICH GCP E6 is implemented as binding law for the conduct of clinical trials. Since this law does not distinguish between the different phases of drug development starting with FIH/FIP Phase I up to confirmatory Phase III trials, the EMA took action in 2017 to update the guideline for FIH/FIP clinical trials which states that “the early clinical development of human medicinal products has an intrinsic element of uncertainty in relation to both the possible benefits and risks of a novel drug candidate”. This webinar will help to understand more about the risks and benefits of early-stage clinical trials conducted in specialized Phase I research clinics. It will highlight the points to be considered for planning and conduct of Phase I trials.
How will the world for clinical research evolve in the near future? What are the main changes in the new era, the new opportunities and what kind of challenges might we have to overcome? Listen to the experts in the different fields, i.e., the EU Commission, the European Medicines Agency (EMA), ethic committees‘ representatives, industry, academia, and patient representatives and learn about what we are to expect in the years to come.
As of December 2021, only 8 months from now, all scientific research with medicinal products in the EU need to be submitted via the Clinical Trial Information System, the CTIS. To make sure all future users of the CTIS system, both sponsors and member states, are familiar with the settings and way-of-working in the system, the EMA has setup a training program - consisting of both free e-learning material and a Master Trainer Programme instructing the company’s trainers to support implementation and use of the system. In this webinar, Marieke Meulemans shows what training material has been created, where to find it and supports your preparation in the use of the CTIS with useful tips and considerations. Attending this webinar makes you aware of the steps to take in the next 8 months to get ready.
This webinar on electronic informed consent (eConsent) addresses the practical considerations when implementing eConsent. It introduces the EUCROF Implementation Practical Guide to eConsent which addresses key themes and hot topics, and provides a view on the modernization of the clinical trials informed consenting process, including the current perception shift of eConsent adoption in light of the COVID-19 pandemic.
Software is used widely in clinical trials: from managing worldwide trials to finding and scheduling patients, gathering trial data, and analyzing trial results. How is the quality of the computerized systems ensured? And how do we know the data generated by these systems is reliable and robust? Validation of software ensures that clinical data generated by these systems is done in a structured way and ensures integrity, reliability, and robustness of the generated data.In this 1-hour webinar, you will learn why computerized systems must go through a validation process when used in clinical trials, as well as the consequences of failing to validate your systems. We will explain the requirements for validation, who is responsible and when it is necessary. Through the speaker’s experience, you will learn the why, what, and how of validation with regards to regulatory requirements. This webinar also provides you with a walk through the process of system validation and its key deliverables. And finally, you will be shown the way to either manage the validation process of your own system or make the right considerations when selecting software for your clinical trials.