Although tablets and smartphones are widely used nowadays, not everybody is yet familiar with these devices. An adapted training will guarantee the best outcome when using eCOA solutions. But who needs to be trained and how?
Train your study team
Every protocol is different and to ensure maximum benefit of eCOA and a successful trial, a well-adapted eCOA solution is needed.
- The study team will need to take appropriate decisions regarding the study protocol based on possible workflows for the eCOA solution. For example, the Investigator might be requested to provide additional information to trigger different questionnaires, or it might be important not to skip questions for a specific questionnaire.
- Visual documentation can help the team to better understand the workflow, and full testing of the solution before implementation is imperative.
Train your CRA
Whenever a site has a question, the first reflex is to contact the sponsor CRA.
- Although a multi-lingual helpdesk should be available for sites 24/7, the capacity of CRAs to help sites can determine the completeness of eCOA data. As a minimum, CRAs should be informed of the solution, but hands-on training is even better.
- Even the most intuitive solutions require familiarity. With a good eCOA solution this could be done simply in a 15 minute, hands-on session.
Train your site
In most clinical trials the study site has to handle different portals and solutions from different vendors. Moreover, not all site personnel may be able to attend the Investigator Meetings to complete hands-on training.
- Therefore, clear documentation must be available at all times. This could be a video or a written document. Alternatively, personnel could be trained directly using a device in a specific training session.
- An experienced eCOA vendor will be able to anticipate frequently asked questions and site expectations, and will be able to provide advice on the most appropriate study training.
Train your patient
To assure quality and reproducibility of data in ePROs, patients should have the opportunity to familiarize themselves with the device and the different types of question.
- Depending on the study design a training session on a representative sample of questions or on whole questionnaires could be offered.
- For studies with long delays between visits, refresher training sessions should be possible.
In the same way that the setup of your eCOA solution and the workflow need to be adapted to your trial, so does the training on its use. Although there are some standard practices that should be followed, adapting the training to your particular needs can be a determinant factor of the success of your eCOA solution.
Björn Felber, Kayentis Project Manager – September 8, 2016
