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QUALITY
Year : 2011  |  Volume : 2  |  Issue : 2  |  Page : 59-63

Good documentation practice in clinical research


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

Correspondence Address:
Chitra Bargaje
Bristol-Myers Squibb Co., 1st floor, Shivsagar Estate, AB Road, Worli, Mumbai-400018
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.80368

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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.


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