People Power

Ensuring data excellence in a clinical trial is vital to its success. Many trials face a variety of obstacles such as challenges related to the selected electronic data capture (EDC) system, ambiguity in the electronic case report forms (eCRFs), the volume of queries, and a lack of communication between trial team members.

While much focus has been put on improving the EDC systems, there should also be a focus on the end users, who are essentially responsible for the data quality. Providing site staff with appropriate training, support and flexibility throughout the trial can be the difference between high quality data and trials that get left behind.

At AXON, we believe that timely and well-planned education programs can play a significant role in improving data quality, and the earlier trial sites can be assessed and engaged, the better. Through this process of assessment, training and continuous support, site staff can stay engaged and on track with overall trial goals. These include:

1.      Understanding the current reality through an assessment of site readiness and technology

2.      Establishing data quality metrics and specific goals for each site

3.      Optimizing the EDC system to be study-specific and user-friendly

4.      Tailoring the online and in-person training curriculum to meet study and site staff needs

5.      Providing ongoing and comprehensive communication and support throughout the trial

These initiatives can provide the additional structure and focus that can help sites achieve their goals. Making the site staff a top priority, and not just seeing them as a means to an end, can improve data quality and help to achieve data excellence.

To view the entire article this post is based on, ‘People Power’ published in the Autumn issue of International Clinical Trials, click here:

http://edition.pagesuite-professional.co.uk//launch.aspx?eid=1a03a232-f656-48c3-836f-75698b057048

Caroline Chin