July 11, 2011 -- Infonetica, pioneers of Good Clinical Practice online training, have responded to the joint challenge of creating a practical and standardised GCP course. As well as being a comprehensive guide to GCP principles, the GCP Practical Implementation online course takes users into the workplace so they can see how to apply what they have learned in real-life situations.
The need for training to advance from theory to practice was highlighted at this year’s European Federation of Good Clinical Practice Annual Conference, held in Budapest, Hungary in February. The same objective was behind Infonetica’s decision to develop the new course, released this month.
“The 25,000-plus people we have already trained provided us with useful feedback on course needs,” said Gaynor Bray, Infonetica’s Director of Commercial Services. “One of the key advantages of our existing GCP online course is its wide applicability to all those involved in trials, from investigators to support staff, research nurses, R&D personnel and ethics committee members, thus satisfying the desire for standardised training. We discussed the need for a practical course with experts in the clinical trial sector and they felt that real-life dilemmas could be an invaluable tool in our unique training format. There are in the region of 80,000 medical trials actively recruiting worldwide whose personnel are under very real pressure to perform, so it makes perfect sense for us to focus our courses on application in the workplace.”
Author Nick Deaney - a chartered scientist in clinical research - has placed case scenarios strategically throughout the new course, taken from real-life examples encountered during his 30 years in the industry. As trainees progress through the course, they are presented with situations that apply and reinforce the principles they have learnt. These problems require careful analysis and response, preparing students for effective application in the workplace. The course is designed to give them the confidence that they are performing at the expected level, can deal with issues that may arise and are prepared for internal and external audits. Having worked up to Research Director level in a major pharma group, Nick has experienced numerous US FDA and UK mhra inspections, so is well versed in compliance issues.
Two versions of the GCP Practical Implementation course are available - one for the UK and one for the international market. The courses are available online (price £75 +VAT) at www.onlinegcp.com to individuals and organisations around the world who are dedicated to designing, conducting and monitoring trials.
As with Infonetica’s other online courses, students can learn at their own pace and fit the training in with their individual working and home lives, studying when it suits them. Successful trainees receive a certificate accredited by the Royal College of Physicians’ Faculty of Pharmaceutical Medicine (London, UK), and 9 CPD points as well as the option of being added to a publicly accessible database of GCP-certified personnel who have passed the course. Users receive free access to the course content and resources for six months after account activation. Presented in a clear, attractive format illustrated with photographs and diagrams, the interactive course includes links to the ICH-GCP E6 document to allow quick cross reference to the regulations themselves. Multiple-choice questions throughout the course provide an excellent opportunity for exam preparation.
Organisations working in clinical research point to the benefits of Infonetica’s online courses allowing them to achieve the same standard of GCP knowledge across their whole team without the need for staff to be away from the office for long periods or all at the same time. Training managers appreciate the user-friendly administrator panel, which allows them to monitor both individual and group progress, identify any specific issues and highlight successes. It also allows managers to quickly and easily extract any information needed for inspection.
