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International Clinical Trials

Education, Education, Education

When a clinical study is assessed, the first things that the auditor will search for are certificates; more specifically, certificates of education and training. For an auditor, these certificates show that the people involved in the trial – the investigator, the site staff or any team member on the sponsor’s side – are properly trained on study-related procedures, ICH-GCP, and the regulatory and legal guidelines.

WHY TRAINING?

Working with knowledgeable clinical trial personnel can raise the level of quality achieved in a clinical study, in turn improving the level of the data accrued. There are no clear international rules or legislation stating which party can provide training certificates and what those certificates should test. Indeed, these certificates can be generated by anyone at any time. But, as you might expect, experienced and dedicated trainers and professional training organisations are best placed to deliver high quality standards and give a better return on investment – you wouldn’t ask your butcher to repair your roof!

Did you know that the budgets for training in Belgian companies, for instance, are seldom greater than two per cent of the total salary amount? Too often, the perception is that training is an optional overhead. Scientific research and practical examples, however, illustrate that training and development is an investment which often pays off in a relatively short timeframe (1).

To highlight this point, a Louis Harris and Associates poll reported that among employees with “poor” training opportunities, 41 per cent planned to leave the company within a year. On the other hand, of those who considered their company’s training opportunities to be “excellent”, only 12 per cent planned to leave within the same time period. Clinical research is a sector which should strive to achieve a low turnover of personnel – each employee that leaves takes their knowledge with them, and bringing in a new recruit at the same level is time consuming.

INITIAL TRAINING

An education programme should start with ‘initial training’. To make sure that the training is pitched at the right level and will deliver the intended outcome, the process of developing the content of the training is key. Not only should the content be set out clearly, but the format of the course should be established at the start.

Once the training programme has been designed, you can start with working out what techniques you will use. Trainees typically are only capable of learning a maximum of three to four ideas in a span of 20 to 30 minutes. Knowing this, slice your training into bite-size pieces that are easy to digest. Moreover, the average attention span of a trainee is up to 60 to 75 minutes at a time; therefore, regular breaks should be scheduled into the course in order to allow the participants to keep focus throughout the session. If there is a lot of important information to convey, make sure the goals of the course are specified; course attendees should be able to easily recognise the value of the training.

TRAINING TECHNIQUES

Every participant in a training session wants to feel that they are learning something ‘new’. Recognise this by utilising the knowledge of everybody present. Use examples related to the work environment and experiences of each individual trainee.

On average, only 20 per cent of the information presented by a trainer is retained in the long-term by the attendees. To improve this percentage, it is useful to employ a mix of teaching methods during the session; for instance, increasing participation by asking the attendees to read or speak. In this way, a level of knowledge retention of up to 90 per cent can be attained. Peter Senge, the author of The Fifth Discipline: The Art and Practice of the Learning Organization, and one of today’s teaching and learning gurus, says that learning is natural – everybody is born with this capacity (2).

THE NEED FOR A CONTINUOUS TRAINING PROGRAMME

It is probably fair to assume that ‘initial’ training is not enough in and of itself to permanently change the way an attendee performs their tasks. A continuous training programme is therefore advisable to maintain and develop knowledge – and to steer clear of old habits and dated ways of thinking. Of course, this depends on the topic and the company policy on re-training, but many companies organise re-training methods on the work floor, which means that the line manager has an active role to play. They should ensure that they follow-up with their staff members on their training needs and decide whether a refresher course would be beneficial.

To ensure that qualified staff maintain a certain level of performance, the coaching duties of the line manager cannot be over-emphasised. The line manager is best placed to evaluate the quality of the work and give feedback on the implementation of the course content.

Continued training has its price, but the money here is well spent. The real question is not how much the training will cost, but how much it will cost when there is no training. For example, issuing a paper query in a Phase 3 trial may cost €40. Spending dozens of hours of staff time to prepare for an audit is also costly. Therefore, being capable of preventing these costs by having well trained employees is already a profitable investment for most organisations.

Training is, of course, not only a way of generating certificates. The fundamental objective of each training programme should be to deliver knowledge to employees, to have some uniformity in the way tasks are performed, and to provide an opportunity to share the new knowledge accumulated.

eLEARNING

Face-to-face training has proven to be a highly efficient way to teach. However, eLearning platforms are a quick and flexible alternative that allows participants to manage their own learning programme and follow sessions at times that are convenient for them.

When trainees meet the other participants in person, the training session can receive a swell of ideas and new practices can emerge. One key disadvantage of using an eLearning programme exclusively is the loss of a group dynamic.

Ideally, training sessions should be highly interactive, blending together different kinds of methodology. “Tell me and I forget. Teach me and I remember. Involve me and I learn”, said Benjamin Franklin. Training is not only about being given information verbally; good training that gives a return on investment is training where the participants are also being involved – they have to assimilate the information and then find a way to be able to reproduce it.

MEASURING THE QUALITY OF TRAINING

So, what test should you use to measure the quality of training and its implementation in the workplace? Again, it is important to emphasise the role that line managers have to play in this area. As part of their HR routine, they should review their colleagues’ performance. For example, during the appraisal meeting, the line manager and the employee should identify areas open for improvement, and establish whether additional training could be beneficial.

For fully trained employees who know the regulations and the SOPs, you can measure the quality of work by implementing control mechanisms. This can be conducted unofficially by peers, or using audits or official inspections. In particular, the reports generated by auditors or inspectors give a careful overview of key issues that should be addressed. These mistakes can then be corrected through training.

If you want to check the quality of your employees in an unofficial capacity, but in the style of an official review, you can organise a mock inspection. During a mock inspection, the quality of the work is checked by an accredited inspector in close collaboration with your management teams. The team should not be informed that it is a mock inspection; all the employees’ reactions to unknown inspectors can be seen (and employees react as if it were a real audit or inspection taking place).  Conclusions can then be drawn on how your employees can be trained in order to be better prepared for official audit or inspection.

CONCLUSION

Solid clinical studies require good quality data. To achieve this quality, you need to have employees that produce work of a high standard – a goal that can be achieved when staff receive proper training from the start as well as ongoing follow-up sessions. As Harvard University President Derek Bok said, “If you think education is expensive, try ignorance.”

References

  1. Laurijssen J and De Meyer J, Kluwer Learning Indicator 2010
  2. Senge PM, The fifth discipline: the art and practice of the learning organization, Doubleday/Currency, 1990

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Gerald Van Roey, MPhEd, is the Training Manager at the European Centre for Clinical Research Training, Brussels. He has more than 10 years’ experience in clinical research in a wide variety of companies. He specialises in the regulatory aspects of ICH-GCP, European legislation and in giving on-the-job trainings for clinical professionals. Since 2009 he has tutored more than 1,000 participants on these topics. He is also the author of Best Practice for Clinical Monitoring. Email: gerald.van.roey@eccrt.com
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