PHASTAR presents webinar on Medrio

On Tuesday 24th July 2018, PHASTAR presented a webinar on the topic 'Efficiencies when delivering a quality database'. The presenters were Sheelagh Aird, Head of Clinical Data Operations and Gillian Childs, Principal Data Coordinator. The webinar, hosted by X-talks and Medrio, demonstrated the importance of controlling the quality of a database right from study set-up.

The webinar introduced the use of the Data Quality Plan and the concept of identifying risk items and processes, defining quality, how quality is assessed and how it can be achieved. The presenters discussed how to select key personnel for ensuring quality and the processes to action and report on findings identified at data quality review timepoints.

The presenters described how the Data Management team at PHASTAR use Medrio tools and functionality to efficiently monitor data quality within the database. At study level, the analysis of data by comparing various expected limits against observed limits allows a visual understanding of where the potential errors occur and draws focus to particular site(s) for investigation.  At site level, outlying subject data can be scrutinised for errors, making quality control more time efficient. Observation of data trends can be identified, giving an overview of which data points may not follow the trends and can be targeted for further investigation. Focus is given to data which have the highest risk where errors would have the greatest impact on the integrity and safety of the trial.

An interactive audience poll on the frequency of use of the audit trail to monitor data quality revealed a diversity of approach from ‘Never’ to ‘Daily’.  PHASTAR’s use of the audit trail was summarised as daily during subject data review and frequently during data quality monitoring. The presenters highlighted the importance of reviewing the audit trail and its use as a tool to ensure accuracy of data and site data entry issues.

The webinar discussed how to feed findings back to site following data quality reviews, which are performed at defined periods in accordance with the Data Quality Plan. Positive feedback as well as areas to concentrate on improvement were highlighted, especially encouraging sites to enter data as early as possible and maintain good data flow. The webinar showed various ways to measure site performance within Medrio and discussed how sites can use tools such as the Dashboard, missing data and query ageing reports to review their own efficiencies.

The early identification of issues is vital to ensure that meaningful data is collected, allowing time for sites to improve processes and for errors to be addressed. By adopting these processes, PHASTAR is able to successfully reduce timelines between last subject last visit to database lock whilst ensuring high data quality.

The webinar was very well received with a range of questions during Q&A session including how to set expectations in early phase rare disease studies and the use of Medrio in Phase III studies. There was excellent feedback from attendees including post-webinar requests for additional information and PHASTAR’s Data Management team will be following up with further presentations and white papers.