May 2005
EDC - Supporting Global Use Through a Coordinated Training Strategy
Presented by Paul MacDonald, Quintiles
ABSTRACT
This presentation looks at how the role of training can help overcome both technical and cultural issues on a global basis. Firstly, the presenter will outline some key challenges that can impact the success of EDC training, such as:
1 Timing of training for new and replacement staff and who should conduct it - training off-site and on-site by trainers, CRAs or SMEs
2 Dealing with change to roles and responsibilities – facilitating change management through training
3 Classroom training versus e-learning – costs and benefits
4 Qualifying trainers across regions to meet the training demand – central global co-ordination of trainer qualification.
Based on experience to date, the presenter will describe how a successful training policy has been developed to meet the growing need of various roles and functions.
The presentation will also capture thoughts on how e-learning and technology can be used to facilitate timely training as EDC based trials expand in number.
Having being closely involved with data management training for some time, I was intrigued to hear what Paul had to say of his extensive experience with EDC training. Paul's incredibly insightful presentation on the challenges for EDC training left me feeling sure that the cosy world of data management training had certainly become a jungle where, in true Ray Mear's style, preparation and knowledge are key to survival.
Preparation and knowledge? Surely all trainers are prepared to talk about their area of expertise? Well, yes but the EDC training jungle is full of diversity. In order to achieve its goals, the EDC training team must consider the wealth of diverse challenges it faces.
Challenges can be considered in terms of people e.g cultures, location, skills and in terms of practical factors e.g trainer resource, logistics, timing and technical infrastructure. A radically different training plan is required if you are to be successful and survive.
Paul convinced me that EDC training is as much about influencing and organising as it is about training. Experience has taught me that 'training' is just one part of an effective learning strategy and Paul demonstrated that this approach lends itself to EDC. Adopting a learning strategy made up of different learning blocks is essential for EDC as a 'fit for all' approach would not survive the demands of such a diverse audience.
The EDC training audience is dominated by large groups of CRAs and site staff having very different characteristics from the usual data management training audience. For example, they are likely to be geographically diverse, have a range of languages and cultures, are generally EDC naive with variable IT skills. Paul compared a CRA arriving at their first EDC training to a startled rabbit in the headlights of a fast car on a dark night – a situation to be avoided at all costs! To be successful, Paul recommended a flexible approach incorporating different learning methods. This would start from pre-study activities familiarising staff with the EDC world, setting expectations, promoting benefits and planning for opportunities for face to face training, for example at monitors meetings.
Traditional hands on training methods are essential for system training and should use the actual study design rather than a test protocol. Post training support and mentoring are also an essential component.
Once you have effectively trained your CRAs and convinced them that EDC will work miracles for them, they can then serve as your local trainers, ready to work their magic on site staff.
Janice Charters
GSK