The regulatory push to the paperless clinical trial has occurred despite a pharmaceutical industry that has been risk-averse in adopting modern-day technology tools that could support clinical trials.
Risk-based approaches to monitoring (RBM) in clinical research1, 2, characterized by more cerebral operations with focus on critical processes and data components, are growing in popularity.
The economic impact of using a paperless trial master file (TMF or eTMF) in a 80-center study in ulcerative colitis.
This article proposes a practical risk-based monitoring approach based on published statistical evidence addressing the impact of database changes subsequent to Source Document Verification (SDV).
The benefits of eSource data: collecting data digitally without having to record the data on a piece of paper first.