Terri Hinkley, the interim executive director of ACRP, recently shared her thoughts with us on the current changes facing clinical research professionals.
I will be on a great panel on risk-based monitoring and eSource methodologies at DIA June 16, and I want to highlight a few points from my presentation.
In a risk-based monitoring (RBM) update released in January, TransCelerate defined source data verification (SDV) as “the process by which data within the case report form (CRF) or other data collection systems are compared to the original source of information (and vice versa).”
We’ve previously blogged about, and presented in various forums, a compelling industry benchmark that reveals the very small impact that site monitoring and source document verification (SDV)—along with other sponsor data reviews—has on the electronic case report form (eCRF) data provided by investigative sites during clinical trials.
Risk-Based Monitoring was all the buzz at the Society for Clinical Data Management (SCDM) 2013 conference in Chicago. The last day of the event kicked off with ~120 attendees at the 8:15am session, "The New Data Manager: Merging of Traditional Roles with Implementation of Risk-Based Monitoring," chaired by Candace Friend Shelton, director of clinical data sciences at Celerion. Dr. William Bill Gluck, VP at DATATRAK International and Stephen Young, senior product director at Medidata both spoke at this well-attended session, with Steve's presentation focusing on the implications of risk-based monitoring on data management.