Open AccessGood documentation practice in clinical research
Author(s) -
Chitra Bargaje
Publication year - 2011
Publication title -
perspectives in clinical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 8
eISSN - 2229-5488
pISSN - 2229-3485
DOI - 10.4103/2229-3485.80368
Subject(s) - documentation , audit , foundation (evidence) , good practice , clinical practice , key (lock) , medicine , computer science , business , engineering ethics , accounting , engineering , family medicine , political science , law , computer security , programming language
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.