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 roles.

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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 quality. 

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.