integrated training

By Ethical 31 Jan, 2024

Did you know that endpoint adjudication audits often detect compliance failures related to users training?

Deploying a validated software platform on the cloud for use by sponsors and other parties participating in clinical trials includes a mandatory step of training for all future users as a guarantee that the system will be used as expected. Did you know that most endpoint adjudication audits detect compliance failures related to the users’ training? At Ethical, we understand the importance of training, but we also believe that there is no need to overcomplicate this essential, yet critical, step. For our team, the integrated video training was the obvious way to go and we now have it available on eAdjudication® for all profiles.

The rationale and challenge of training users of validated systems for clinical research

Validation is a complex, formal procedure aiming to ensure that a system or a procedure involved in drug development such as endpoint adjudication works as expected in all foreseeable circumstances. This is the guarantee that no errors can occur because of incorrect use of the system or because the system behaved in a way that was not intended.

As part of the complex validation procedure, all end users must take and record training and understanding of the system’s features before they are allowed to use it. In other words, even if the system is intuitive and user-friendly, it is essential to offer adequate training and to track this training so that the study team is fully ready when time for audit arrives.

Organizing and documenting the training of large numbers of users, especially when there are many sites involved and different time zones, is often a painful step for the study team. Online training is clearly a solution if it allows to provide the guarantee that users are able to correctly perform the required tasks for their role from their first access, with a compliant proof of training completion.

Why integrated video training helps simplify the training process

Integrating the training into the system makes it possible to track the training steps for all users, and automatically issue training certificates when trainings are completed. This allows to easily provide training evidence upon request for audit and compliance reasons. Neither the study team nor the user need to perform any additional task for that time-critical step.
Video-based learning has clear benefits. A video recording can be paused and restarted at will, meaning that users can view it at their own pace. Furthermore, in the world of clinical trials, study teams, investigators, site staff and clinical committee experts don’t want to spend a large amount of time in computer systems training when they know that, by watching a focused video of only a few minutes, they can quickly grasp essential information. It is particularly important that medical experts, who often work on several studies with different sponsors, be supported to identify the key features and differentiate between studies quickly and easily.

On-line or remote training is not new. On-line training is being increasingly used by students, workers and individuals all over the world to acquire knowledge and develop skills. The World Economic Forum reported in January 2022 that “the global growth in online learning continues an upward trend that predates the pandemic but has since gained momentum”.

Users want to use an intuitive and user-friendly platform

As seen above, the availability of an integrated video training can be an interesting criterion for choosing a software for online clinical adjudication. Nevertheless, clinical leaders must remember that what users want, first and foremost, is an intuitive and user-friendly system. Such a system is pleasant to use, saves time and helps avoid mistakes.

As we like to say it at Ethical, there is a lot "under the hood" of a "simple", easy to use software platform. Intuitiveness and user-friendliness are all but simple to build in a software that offers all the necessary functionalities and innovations for even the most complex business requirements. But this is it: our eAdjudication® software is so easy to use that a short, integrated video training is perfectly appropriate. There is clearly no need to overcomplicate the training.

Ethical’s user-friendly endpoint adjudication platform with integrated video training is your winning choice

In conclusion, integrated training with video presentations allows quick and efficient training, can be easily adjusted for different studies and even different roles, saves time and money and can be used in a flexible manner regardless of role, timing or geographic location. Ethical’s intuitive and user-friendly eAdjudication® platform with integrated video training is your winning choice.

eAdjudication® offers such flexibility that the software configuration and support provision are tailored to exactly match your need.

Manage Adjudication Data with Compliance, Simplify Endpoint Adjudication with a Platform



Download Ethical eAdjudication for Endpoint Adjudication Dossier

Solution Description


Request a Demo of the eAdjudication® Software Solution

We are EU-GDPR compliant: Your Data will never be used improperly

Event Adjudication Charter Guide

Event Adjudication
Charter Guidebook
Free Download

Previous Next

Data management in clinical trials: could AI help do a better job?

In this article, we will discuss how AI is used today and how it might be used in the near future to boost the data management capacity, and we will look at the advantages and the risks.

clinical data management AIREAD MORE

Embracing the potential of Artificial Intelligence in clinical development with eAdjudication® (2/2)

In this second blogpost on the topic AI in clinical endpoint adjudication, we are looking at how Ethical’s customers are already taking advantage of AI technologies to improve performance and decrease burden [...]

clinical endpoint AI 2READ MORE

AI Redaction Technology to support Clinical Endpoint Adjudication

 AI can help automate this tedious task and preserve patient confidentiality as well as company compliance. [...]

AI redaction technologyREAD MORE