Isobel is currently the NZ Country Manager for PPD, a global CRO.
A qualified Pharmacist, she joined the NZ Clinical Research industry after
developing a successful career in hospital pharmacy and has worked in New
Zealand, Australia and the United Kingdom in a variety of Clinical Research
Risk Based Monitoring: Evolution and Change Management
Risk-Based Monitoring is here to stay!
Traditionally, clinical monitoring of study data involved 100% SDV
– cross-checking each data point against the original data source. This method
is undoubtedly time-consuming and expensive - and doesn’t guarantee data
Technology changes have allowed methods of Risk-Based Monitoring
to develop as an alternative to 100% SDV. Endorsed and encouraged by Regulatory
Agencies and the recent revision to ICH GCP E6, the industry believes that
Risk-Based Monitoring can lead to both improved data quality and patient safety
within clinical trials, with targeted on-site data review in place alongside
focused centralised monitoring activities.
This presentation will review current aspects of Risk-Based
Monitoring for both CRAs and sites.