Classroom, full day
Part 1: At about the half-way point we come together to team build, clarify questions, discuss each modules key concepts and application. Essential documentation requirements before, during and after a study are reviewed per ICH E6 Section 8. Work in groups on case studies that involve compliance issues related to challenges in the areas covered so: 1) Site evaluation and Initiation, 2) Essential Documents, 3) Proactive Protocol Compliance, 4) Informed Consent, and 5) Safety Reporting, using real industry case scenarios to practice identifying and facilitation effective issues management for assigned research sites.
Part 2: Adequate and accurate source documentation is critical to ensuring subject safety, data integrity and regulatory compliance. This module reviews the critical role of the Monitor in verifying data accuracy and integrity. Good documentation practices are expanded upon from, including strategies for identifying all supporting data sources, and strategies for supporting sites to appropriately correct data discrepancies and proactively avoid discrepancies. The module also stresses the importance of reviewing eCRF and any other available data prior to the actual visit, with the goal of identifying potential issues and promoting a more effective and efficient on-site visit. The emphasis is on the role of the Monitor in recognizing the relevance of the source data, as well as key questions to ask throughout the process (i.e., is it an adverse event? Is there a trend with data? Does it indicate compliance with the protocol? Was it obtained by a qualified individual?).