Good documentation practice in clinical research.

作者: Chitra Bargaje

DOI: 10.4103/2229-3485.80368

关键词:

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

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