Country Clinical Quality Manager, MSD, Auckland, NZ
Renee is a Country Clinical Quality Manager employed by MSD working across Australia and New Zealand. She has been in the clinical trials industry for the past 19 years. During this time she has worked with several CROs and Sponsors in a variety of roles including: Research Nurse, Clinical Research Associate, Clinical Operations Manager and more recently in quality management roles.
Embedding Data Quality at Trial Sites
Data quality at trial sites is a hot topic considering the current industry focus on source record management and electronic data in clinical trials. Sites face many challenges related to data quality in the current clinical trial landscape. In fact, the burden of managing source documents and maintaining data integrity can feel like lifting a heavy weight at times.
Review of recent publications from overseas regulatory authorities speak to an increasing trend in observations related to electronic source and protocol compliance. These are critical elements to consider for data integrity.
The recent editions in ICH-GCP E6 (R2) include updated guidance for handling source data, including paper and electronic records. In addition, the importance of being able to confirm validation of computerised systems is a new crucial element embedded in GCP. These updates have resulted in an increased focus in assessing implementation of these aspects at sites by sponsors, CROs, auditors and inspectors i.e. in order to establish if site processes are in accordance to E6 (R2).
So, what are key implications for sites managing paper and electronic records? How can sites maintain data integrity?
This presentation will explore the concept of data integrity, discuss challenges of source data management and provide some practical tips for embedding data quality at trial sites. Aiming to lift the burden of the weight and win the data trophy!