Why the value of on-site monitoring cannot be challenged by remote/ centralized monitoring

This is not to say we should do as we always did. This is also not to promote unnecessarily frequent monitoring visits or a 100% source data verification (SDV). However, in times were risk-based quality management including centralized monitoring are in the regulatory focus, I feel we forget to reflect the undeniable value that on-site monitoring can give to a clinical study [...]

Risk-based quality management – the new magic phrase in clinical research

The for mid-2017 expected final version of the ICH-GCP guideline addendum takes the subject risk management to the next level: the extent and implementation of a risk-based quality management for a clinical trial no longer remains within the judgement of the sponsor but actually becomes a legal obligation.

By |2019-07-24T18:01:07+02:00November 7th, 2016|Categories: Regulatory, Study Management|Tags: , , |