Amanda MacGregor<\/strong><\/p>\n\n\n\n Product Manager, Strategic Solutions<\/em><\/p>\n\n\n\n Data Integrity (complete, consistent, and accurate data) must be maintained throughout a clinical trial. Current guidance aims to not only assure data integrity, but to take a more proactive approach, documenting how data will be monitored throughout the clinical trial. Ensuring your trial has a data monitoring plan in place will provide a mechanism to meet regulatory guidance and maintain data integrity.<\/p>\n\n\n\n The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) revised guidance requires documented evidence on how the sponsor performed surveillance of the study. The Data Integrity guidance put out by the MHRA, FDA, and theEMA aimed to not only assure data integrity but to enhance and take a more proactive approach. When developing a rigorous data monitoring plan, a solution must be incorporated to perform the necessary data reviews. This could involve manual data exporting and verification across multiple eclinical solutions if an integrated solution is not in place.<\/p>\n\n\n\n Periodic reviews of this data will ensure data integrity is maintained. The IXRS\u00ae is a critical control point, as in many instances, it is the first point of entry of data. As such, this data is ultimately pushed to other systems (EDC, eCOA, CTMS). Our system, the IXRS, is often used to investigate any potential discrepancies between systems or ongoing reconciliation activities during the trial.<\/p>\n\n\n\n <\/strong>Reports and integrations play a crucial role in a data monitoring plan. While data is generally accessible through reports, it must be organized effectively for the periodic reviews and monitoring being performed. Otherwise, additional effort is needed to analyze the data, which is essential for identifying initial entries and any subsequent changes which are part of an audit trail. This analysis helps in spotting trends or potential concerns. Additionally, capturing historical data updates\u2014such as who made changes and when\u2014 is vital for comprehensive monitoring.<\/p>\n\n\n\n OVERSIGHT\u2122, Almac\u2019s data monitoring tool, is a suite of analytic reports which automatically organizes the IRT data and transaction history for ease of data integrity reviews, audit trail reviews and data monitoring.<\/p>\n\n\n\n Almac\u2019s OVERSIGHT\u2122 solution will help identify anomalies such as sites making high risk data edits, too many data adjustments, or unexpected system transactions. OVERSIGHT\u2122 enables our users the ability to filter and organize data on-demand, directly within the IXRS\u00ae. Having access to a summarized view of how many events occurred in the study, at which location, and what data change was performed, allows for easily identifying trends and potential irregularities.<\/p>\n\n\n\n Proactive and ongoing data review is expected by regulators. Identifying anomalies, such as high-risk data edits, too many data adjustments, or unexpected system transactions, empowers sponsors to maintain control of the data integrity of their trial. With Increased regulatory guidance and recommendations in this area, incorporating sufficient tools to support monitoring and inspection requests is essential.<\/p>\n\n\n\n It is important to enable our Sponsors to make informed, risk-based decisions on the usage of the IXRS\u00ae. Providing real time, on-demand visibility into the data is key. OVERSIGHT\u2122 will aid clients to identify data inconsistencies, protocol deviations, and data integrity issues through audit trail reviews. <\/p>\n\n\n\n There have been increases in inspection support requests, which may include agency audits. Recent examples include a focus on IRT data such as:<\/p>\n\n\n\nWhat should be considered in a data monitoring plan?<\/h2>\n\n\n\n
What tools are available to support data monitoring?<\/h2>\n\n\n\n
How will data monitoring benefit my trial?<\/h2>\n\n\n\n
How else can a data monitoring plan be used?<\/h2>\n\n\n\n