The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. To understand the importance of good source documentation we should first review the purpose of source documentation. WHAT IS THE PURPOSE OF SOURCE DOCUMENTATION? There were two underlying potential issues here: For the trial subjects there were no other hand-written progress notes which the site would normally use for routine patients. This method was adopted only for clinical trial subjects. In normal practice the site did not use MS word to generate medical records. The site was actually using MS word to document the data collected during the study. I would like to share an experience at a recent investigator site audit.ĭuring the audit opening meeting we were informed that all the source data is on paper and no electronic documentation is used. Not surprisingly, clinical trial monitors and auditors also report documentation issues as a frequent area of GCP concern. Similarly, source documentation issues ranked 5th among the top 10 findings from European Medicines Agency (EMA) inspections of investigator sites in 2009 and in some instances the findings were classified ‘critical’. Inadequate/inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites.
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