As a daughter and healthcare advocate, Lizzie Wittig understands the value of cancer research. A clinical trial, she says, gave her six additional years with her mother, who was diagnosed with stage III (a) HER2+ breast cancer in 2003.
I strongly believe that simplicity is key to successful implementation of Risk-Based Monitoring for any organization. I have unfortunately seen too many organizations unintentionally over-engineer processes at their first attempts, particularly in areas such as the pre-study risk assessment and risk identification. The start-up period of a study is a very busy time for cross-functional study teams, so organizations implementing Risk-Based Monitoring need to make sure they don’t create a resource- and time-heavy process which will increase burden and may actually contribute to increased risk.