While we face unprecedented challenges of interest and mandates for data and result sharing, there is a unique opportunity to improve our knowledge and understanding of the field to help us to address these challenges.

This 3 part webinar series discusses these challenges at all stages of the data lifecycle, from study inception to data archive/disposal, and demonstrate strategies to manage and document data integrity based on the ALCOA+ attributes and FAIR principles.

WEBINAR 1 - Effective strategies to manage data integrity risks webinar was held on 7 September 2022

Clinicians, consumers, journal editors and regulators alike expect reliable and accurate trial data, which requires meaningful and effective strategies to manage data integrity risks. In the presentation, Tracey Meares and Kylie Rogers briefly describe the ALCOA+ attributes of data quality, common methods of managing data integrity risks across paper and electronic records and how to document these strategies in data management and data monitoring plans.

PRESENTERS:
Tracey Meares is the Trial Manager for the BEAT-CF platform trial in the Health & Clinical Analytics team, at the University of Sydney, Australia. She has over 20 years of experience as a trial manager in both industry (CRO, big pharma and small biotech) and academic clinical trials. Tracey spent the first 6 years of her career in clinical trials in Data Management, before moving into the Operational side of trials. Tracey specializes in the implementation and management of Bayesian adaptive clinical trials.

Kylie Rogers is the Data Management Lead in Adaptive Health Intelligence team, which is co-located between Telethon Kids Institute (TKI) and the University of Sydney, Australia. She has over 12 years of Clinical Data Management experience in both industry and academic clinical trials. Kylie specializes in database setup, data standards and automated data quality and consistency checks in complex clinical trials.