![]() ![]() Documentation should be such that it is able to provide audit trail to permit investigation if and when required. It should enable an independent observer to reconfirm the data. 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’. ![]() Click here to learn more about Covered California’s privacy practices.Inadequate/inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites. Find in-person assistance near you.Ĭovered California is dedicated to safeguarding the privacy and security of your personal information. Trained Certified Enrollment Counselors, Certified Insurance Agents and county eligibility workers can help you. If you mail paper copies of your documents, please include the Document Cover Page. If you fax copies of your documents, please include the Document Cover Page.
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