The recent draft guidance on Risk Based Monitoring (RBM) suggests that sponsors consider this when determining the timing, types, frequency and extent of monitoring activities. ‘The research coordinator serves an important role in ensuring the quality of the investigation at the investigative site…. the research coordinator often recruits subjects, collects and evaluates study data, and [...]
This is a no-brainer! You can ensure early in the enrolment phase that procedures are being done correctly. If not, a CAPA can be implemented sooner. The recently issued FDA draft guidance on Risk Based Monitoring (RBM) extols the benefit of an early monitoring visit or other early monitoring activities when determining the timing, types, [...]
Location where subjects will be seen: a factor to consider in monitoring activities The recently issued draft guidance recommends that the location where subjects will be seen (and how the data will be collected) relative to where sponsor oversight activities will be conducted, should be a factor you consider when determining the timing, types, frequency [...]
The recently issued draft guidance on A Risk Based Approach to Monitoring of Clinical Investigations recommends that turnover at the clinical investigator site or among monitoring staff be one factor you consider when determining the timing, types, frequency and extent of monitoring activities. Turnover at the site Historically a change in personnel at the investigative [...]
