February 5, 2019
High-quality clinical data is imperative for clinical research and studies. Effective clinical data management minimizes clinical errors and helps ensure that the regulatory questions receive rapid responses, thus accelerating the speed of the drug development process. It is important to safeguard clinical data to protect patient privacy. Some of the challenges of clinical laboratories include securely managing massive amounts of data, providing accurate clinical test results, minimizing turnaround times, and improving health outcomes at minimal cost. Additionally, there are several regulations that clinical laboratories need to follow, such as FDA’s 21 CFR Part 11, HIPAA, CLIA, GCP, EU GDPR etc. Laboratory informatics systems, such as a Clinical LIMS, Privacy Impact Assessment (PIA), privacy engineering, operations assessment, can help address clinical data management and regulatory challenges. The webinar focuses on the importance of data privacy, discusses clinical data management challenges, and emphasizes the tools and tactics to mitigate such challenges.
- Data management challenges for clinical laboratories
- Regulations and guidelines to follow
- Tools and tactics for data privacy and security
WHO SHOULD WATCH
Recommended attendees include laboratory directors, managers and quality managers of clinical research laboratories and biobanks.
Senior Advisor for Division Resources
National Cancer Institute
Marianne Henderson Senior Advisor on biobanking to the National Cancer Institute’s (NCI) Center for Global Health and the Senior Advisor for Division Resources, Division of Cancer Epidemiology and Genetics (DCEG). She trained in Zoology and Marine Ecology at the University of Maryland, College Park. She has post-graduate training in molecular biology and genetics. In her role in DCEG, she is responsible and involved in program operations and contract management, fiscal and scientific reporting; strategic planning; and laboratory/biorepository infrastructure planning for large-scale molecular epidemiology studies. She is a founding member of the NCI Biospecimen Coordinating Committee established by the NCI Biorepositories and Biospecimen Research Branch (BBRB) and participated in the development and revision of the first and second editions of NCI’s Best Practices for Biospecimen Resources. Since 1999, she has been a member of the International Society for Biological and Environmental Repositories (ISBER) and served as ISBER President 2011-2012. Marianne is currently the Chair of the ISBER Organizing Advisory Committee. She also served as a member for BBMRI-LPC Scientific and Ethics Advisory Board; member of the NIH Precision Medicine Initiative – Cohort Program Biobank working group. She is a current member of the US Interagency Working Group on Scientific Collections; Marble Arch, a biobanking think tank; and Chair of the Education and Training subcommittee and and the Steering committee member of the International Agency on Cancer’s LMIC Biobank and Cohort Network (BCNet) and the Chair of the BCNet Education & Training subcommittee; she is actively involved in large-scale human biospecimen management process improvements in processing, handling, technology transfer, sustainability and repository automation.