Event Categories: EUCROF

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.

The presentation covers epidemiology, infectivity and incubation period, mode of transmission, clinical presentation, prevention, socio-ecological impact, frequently asked questions, and clinical trials with COVID-19 together with the risk management.

The patient centric benefits of electronic informed consenting (eConsent) technologies have been well documented, from the provision of better educational mechanisms of informing patients and overall improved comprehension of the study.