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Perspect Clin Res. 2011 Apr;2(2):59-63. doi: 10.4103/2229-3485.80368.

Good documentation practice in clinical research.

Author information

1
Department of Clinical Trials and Safety, Global Quality and Regulatory Compliance, Bristol Myers Squibb, Mumbai, India.

Abstract

One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement.

KEYWORDS:

ALCOA; documentation; source; training

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