Clinical Research Training

All people involved in clinical research must be fully competent to carry out their specific roles. This is essential for the protection of patients and integrity of data.  Having competent staff also benefits organizations in being able to work efficiently and effectively and gives individuals satisfaction and the confidence to do their jobs properly.  In order for competence to be achieved, people have to be properly trained.  It is undeniable that clinical research training costs money and time and takes people away from their frontline jobs.  One of the most cost-effective ways of identifying training needs and then meeting them is to use a targeted approach to training.

What does a targeted approach involve?

The concept behind a targeted approach to clinical research training is that it is concentrated on high risk areas and therefore has the maximum impact for each learning intervention.  Areas of high risk include anything that is:

  • Novel – such as new legislation, or individuals who are new to a job role
  • Complex
  • Known to be high-risk from previous experience
  • Evident from trend analysis of incidents of non-compliance
  • A significant impact on patient safety and data integrity

Risks can be identified in clusters such as those pertaining to patient safety, data integrity, regulatory compliance and may also include operational metrics such as time and cost.

Identification of the possible root causes of these risks enables analysis of what part training can play in mitigating or preventing these threats occurring.

Some applications of targeted Clinical Research training

One of the biggest wastes of time and money is the repetitive and redundant GCP training of investigator sites each time a new study starts.  Many sponsors have fallen into the trap of a box ticking mentality to GCP training which is frustrating for the investigator site staff and diverts the sponsor’s valuable resources towards unproductive effort.  This time could be better spent on targeting clinical research training on those high risk areas which could compromise patient safety, and regulatory and protocol compliance.

Using a brand new investigator site with no previous clinical trial experience is a potential risk for a sponsor (and for the investigator site. However a risk assessment in the form of pre-training competence check of the site staff on what they already know about GCP would allow the training to be targeted on those areas and individuals where knowledge was weak, so filling the competence gaps.

For study-specific training for sponsor and investigator site staff alike, the learning should be focused on those parts of the protocol which have the biggest impact on subject safety and data integrity. Any complex sections of the protocol (e.g. investigational product dose adjustment) or CRF should also be the subject of risk-targeted training. In terms of the CRF, analyzing trends in data errors can highlight the ‘high risk’ pages and data fields and training can be focused on those specific areas.

The introduction of new regulations often poses a threat of potential regulatory non-compliance. A targeted approach to regulatory training concentrates on those areas of the legislation where the threat of non-compliance is greatest. The same principles apply to SOP training when new procedures are implemented and efforts should be focused on those parts of the process which are complex or significantly different from previous practice.

Benefits of targeted clinical research training

Using a targeted approach enables the training to be designed in a logical and constructive way.  It also enables the learners to see the relevance of the training in preventing risks occurring, improving their performance and increasing their confidence. The overriding concept should be to acquire the maximum benefit for the minimum learning intervention so the targeted training is time and cost effective.

Applying this concept allows the effects of training to be more readily measured from an organization’s perspective i.e. did the risk manifest itself? What was the effect on incidents of non-compliance? Were the numbers of data errors reduced and in which particular areas? What were the savings in terms of cost and time?

Finally, the most important benefit of targeted clinical research training is the impact on patient safety and its use as a tool in the protection of the rights & wellbeing of clinical trial subjects.  Focusing on this key aspect helps put the training in context and gives it an underlying theme, making it relevant for the trainers, learners and of course for the benefit of clinical trial subjects and patients.

Please do get in touch if you have any targeted Clinical Research training requirements, please email Jane at:

By Martin Robinson, Co-founder, EVP and Head of Global Regulatory and Industry Relationships

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