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eCOA training: How to maximize data collection and completeness?

Although tablets and smartphones are widely used nowadays, not everybody is yet familiar with these devices, maybe even more in a clinical trial environment. An adapted training will guarantee the best outcome when using eCOA solutions. Who needs to be trained and how?

TRAIN YOUR STUDY TEAM

Every protocol is different. To ensure maximum benefit of eCOA services and a successful clinical trial, a well-adapted eCOA solution with dedicated training support 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 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 and should have seen it, but hands-on training is even better. Investigator’s meetings are instances that provide opportunity for hands on training and interaction with eCOA provider project teams, as necessary.

• Even the most intuitive solutions require familiarity. With a user-friendly eCOA solution a 15-20-minute hands-on session should be sufficient for comprehensive training.

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.
It is important to remember that despite the development of digital solutions in clinical trials in the last years, not all site’s staff is equal as it comes to technology.

• Clear documentation must always be available. This could be a video or a written document. Additionally, 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

As the end user of most eCOAs, patients should have the opportunity to familiarize and engage themselves with the device and the different types of question.
This will increase patient’s comfort in using the eCOA solution, which is key not only to minimize the patient’s burden and improve the patients clinical trial experience, but also to assure quality and reproducibility of data.

• Depending on the study design, and according to the patient population, a training session on a representative sample of questions or on whole questionnaires could be offered.

• Dedicated training for the use of the device in an autonomous at-home setting will be critical for successful eDiary completion, as applicable.

• 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 and to the patient population can be a determinant factor of the success of your eCOA solution.

Björn Felber, Kayentis Portfolio Manager

See “ePRO and eDiary: What about using a single device?”

Last update : 3 July 2020