Spring 2006
Site Implementation of EDC – Don’t Get Burnt
Presented by Karen Roy, Chiltern International Limited
The old adage that prevention is better than cure was what popped into my mind as I listened to Karen Roy’s energetic and timely presentation on Site Implementation of Electronic Data Capture (EDC). As a data manager at GlaxoSmithKline I have been involved in our company’s ‘great leap forward’ to EDC; in 2005 over 80% of new studies started used an EDC strategy. So I was really interested to see if Karen’s talk covered the issues and experiences we had, and continue to have, when adopting and implementing our EDC strategy.
Karen initially focused on the impact of using EDC in a clinical trial and the implications for the people using this new revolutionary tool at the site. If you are going to implement EDC at a site then you will have to ensure that the site understands the benefits that EDC will bring to them and that they will be left with a positive perception of EDC. So in essence you need to sell the tool to the site.
This ‘selling’ is essential as you will have to overcome resistance to change to not only a new tool but also, and more importantly, to changes in working practices and process. So to help people to do this Karen listed some of the pros and cons of EDC at sites and then tackled how organisations should manage these potential issues to prevent them becoming problems.
Points to help sell EDC are based around effort saving at the site. Two aspects that contribute to this are the query management process and storage/archiving. By employing EDC the site no longer has to manage and store paper CRFs and paper or faxed query forms, thus saving in space and organisational effort in managing these. Also archiving can be reduced to a CD ROM rather than boxes of paper and is carried out by the trial sponsor resulting in less work for the site. Karen also mentioned that investigator payments can be based on milestones in EDC and thus can be automated to ensure the investigator is paid in a timely manner.
As mentioned above Karen stressed that there are aspects of implementing EDC that can cause sites major problems but by anticipating these we can prevent them. Experience has shown that investment in time and effort at the site can underpin the previously mentioned benefits of EDC to provide a system that is easy to use and to evolve processes that can make the sites more effective. Net result happy site and buy-in to EDC based clinical trials.
“Training should be ‘topped up’ so that staff are reminded of good practice or changesto tool functionality”
Karen highlighted the following aspects as key to a successful EDC site and supplied details and examples of what to address and how to tackle problems.
Site assessment needs to be thorough to determine what IT set up the site has and to include a review of the security environment, i.e. who has access to and regularly uses site PCs. Connections to the web need to be assessed as nothing irritates as much as a ‘slow’ system. Often the solutions are to provide laptops or help with installation of better networks.
Once this has been done technical support is important to be able to resolve issues once up and running. Multi-lingual helpdesks are a boon as is 24/7 support, especially in multi-centred international studies.
Training was the thing Karen got most animated about and rightly so. This really can be where the sponsor makes a difference and here Karen explained the Sunburn analogy. If training is given it should be timely. So in sunburn terms its best to apply lotion before going into the sun, not a week before! Again training should be ‘topped up’ so that staff are reminded of good practice or changes to tool functionality. Again in sunburn terms, not just one application!
Training at site can also be used to sell the tool’s benefits and this should be reinforced as part of the training objectives. It also helps to establish a link to the site and to understand their level of EDC experience to pitch the training accordingly. Key to site training is hitting those people who will actually use the tool; it’s not just the principle investigator. Karen then expanded on the challenges to training which covered the use of local trainers who can train in their own language or around English based slides. Examples of this approach would be the use of CRAs to provide this training, once they have been trained on the tool and, importantly, how to train others. Remote training or e-training can be useful but would need to be followed up upon as what may be obvious to us may not be to the site. Investigator meetings and the use of a ‘professional’ trainer can be another tactic to employ, even if expensive, as in the bigger picture these costs will be lost against the overall trial cost and could have a big impact on the success of the trial. Again you need to tailor your training to suit your trial and sites, but it is important to invest in training as a sponsor.
Karen then reminded us of challenges to training such as getting to all at once, making it memorable and having a strategy to deal with changes to site staff or to the protocol or EDC tool. It’s not enough to train a site then walk away. One of the biggest challenges is to implement process change at the site. You can’t just carry on as you did with paper; it won’t work. The site has to be clear about their roles and the sponsor’s expectation of them. What is their role in the query process, what will the CRAs do or the sponsor’s data managers? This must be clear up front and be reinforced throughout the study life cycle, especially at key milestones such as interim release or database lock. Use of a helpdesk will allow you to monitor common issues and resolve them; often these are simple such as password problems or clarity on roles. There needs to be a support mechanism for both the tool and the processes and in sites languages.
In summary Karen emphasised the selling of EDC to sites, reinforced by a significant and focussed training effort. She also reiterated the ongoing support required both technically and process related that is accessible to the sites i.e. in their language. Process clarity and role clarity will facilitate the trial and this must be clear to site and sponsor. Also proactivity must be key for the sponsor to follow up with sites to demonstrate a commitment to them as this will help with their commitment to your trial.
Karen’s talk was a good model for budding presenters, her obvious enthusiasm for her subject shone through and facilitated engagement with the audience, especially useful for a session in the morning after the night before. Karen’s key points were clear and highlighted with good examples and her use of the sunburn metaphor and clever graphics was a great way of enforcing the take home message in a memorable fashion. Prevention is better than cure.
Mark Fry
GlaxoSmithKline