Tag Archives: Source Documentation

In Part One of this blog series, the definition of good source documentation and its importance was outlined. In Part Two, we look at the nature and causes of poor documentation, along with how these can be addressed. Failure to … Continue reading →

Interestingly, inadequate and/or inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites, while in Europe, source documentation issues ranked 5th among the top 10 findings from European Medicines Agency (EMA) inspections of … Continue reading →