All studies on human subjects should have an assured level of quality to protect the rights of the participants and to ensure data are reliable. It is the aim of the Consortia, with the help of REDe, to assure that quality standardised data is collected through all studies. Following on from the meeting in Havana, Cuba, in August 2017 where REDe Co-ordinator, Nina Jamieson launched the ‘REDe scheme for assuring data quality and introduced reciprocal monitoring’, a live training webinar was conducted on ‘Data quality management using the ZIKAlliance 'Pregnant Women Cohort Study' as a working example’ by Professor Trudie Lang.
It was a very interactive session, as study co-ordinators and principal investigators from ZIKAlliance sites in Brazil, Colombia, Mexico and Venezuela attended this webinar. The purpose of the webinar was to address the question of how to build in research study monitoring, and quality assurance in to the clinical study and why it is important to do so. The webinar was based on the ZIKAlliance pregnancy cohort studies in pregnant women.
The concept of conducting a study walk through at the research site was introduced as a great way to explain the whole study to everyone involved. The importance of involving all staff was empathised so that everyone can work through what happens to a participant at each stage; what the tasks of a particular member of staff would be, and how these tasks are conducted. This task-specific approach means that staff learn the study procedures by ‘doing’, rather than reading the study manual. This method is easy to do, costs little and helps flag any problems, which may not have been previously been identified, e.g. a problem could be anything from the logistics of getting a participant from the examination room to another part of the hospital to take consent, to a missing check box on the case report form etc.
The importance of Quality Management Plans and a practical approach to writing one was also discussed.
To download the presentation, click here
To download the Quality Management Toolkit, click here