Empowering sites to perform at the highest level

Posted on Nov 18, 2009

At the Fourth Annual Site Solutions Summit in October, 150 site stakeholders and two dozen sponsors and CROs achieved consensus on six site best practices. Organizers of the event said if investigators can adhere to the following standards it will help raise the performance bar for sites everywhere:

• Sites should require all staff to have Good Clinical Practice training, documented within 60 days of the start of employment
• Sites should have an ongoing compliance program in place
• Sites should respond to study monitoring reports in Corrective and Preventive Action (CAPA) format
• Sites should request a post-study “report card” from their sponsor as an aid for enhancing future performance
• Sites should require monthly payment terms for study sponsors (as opposed to quarterly)
• Sites should support education of the general public about clinical research

These best practices will surely improve overall performance of investigator sites if they are followed. But, there are a few additional steps that can be taken by sponsors and CROs to empower sites to perform at the highest level:

• Provide fast, intuitive data collection tools: Sites should not be burdened with tedious paperwork and time-consuming processes when collecting data. By streamlining data collection through advanced EDC technologies like the digital pen, site personnel are freed up to focus on more meaningful aspects of the trial and think more critically when seeing patients and reviewing data trends.
• Provide a real-time report card: Sites should have continuous access to their performance metrics, as well as information on how they measure up to other sites throughout the study. This can be accomplished through a web portal, where sites can view reports on enrollment goals, screen failures, study closeout metrics, and more, and share information with other sites on what works and what doesn’t. A report card at the end of the study is a step in the right direction, but empowering sites to improve their performance on the current study is much more valuable than doing it better next time.
• Simplify query management: Sites should be able to quickly and accurately resolve queries through an integrated online system. The system should automatically resolve queries whenever possible, to limit the back and forth between the site and the sponsor or CRO. The system should also flag and sort queries to present them to sites in a way that is easy for them to prioritize and respond to.