Promoting best practice procedures for effective inspections of clinical trials
The training need
The European Medicines Agency (EMA) of the European Union (EU) evaluates, supervises and monitors the safety of medicines in the EU. The EMA needed a modern and flexible online training solution to promote best practice for Good Clinical Practice inspectors, in order to meet a wider audience for its educational materials. The target audience was approximately 1,000 staff members of the EMA and workers in 45 other similar medicines agencies within the EU. The e-learning needed to be suitable for international medical and non-medical staff.
Our bespoke learning solution
Walkgrove created a bespoke one-hour e-learning solution that gave learners the knowledge to carry out inspections of clinical trials in a consistently high-quality manner. It explains the medical product development process and the role of authorisation within this, ensuring that learners understand and engage with the importance of inspections to safeguard the rights and wellbeing of patients and ensure the credibility of trial results. As well as signposting to key legislation information points, the course explains best practice inspection scheduling, tools and processes.
The training is professional but friendly, using a photographic character-based approach to introduce practical and methodological information. Simple, clear and creative learner interactions are used to present important information in easy-to-digest content blocks and regular knowledge checks help to validate learner understanding. The design was tailored with an international audience in mind, using diverse photographic representation and Plain English principles throughout to ensure that language is professional, but never a barrier to learning.