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Assessment and classification of protocol deviations
Ravindra Bhaskar Ghooi1, Neelambari Bhosale1, Reena Wadhwani1
1Jehangir Clinical Development Centre, Jehangir Hospital, Pune, Maharashtra, India.
Introduction:
Deviations from the approved trial protocol are common during clinical trials. They have been conventionally classified as deviations or violations, depending on their impact on the trial.
Methods:
A new method has been proposed by which deviations are classified in five grades from 1 to 5. A deviation of Grade 1 has no impact on the subjects' well-being or on the quality of data. At the maximum, a deviation Grade 5 leads to the death of the subject. This method of classification was applied to deviations noted in the center over the last 3 years.
Results:
It was observed that most deviations were of Grades 1 and 2, with fewer falling in Grades 3 and 4. There were no deviations that led to the death of the subject (Grade 5).
Discussion:
This method of classification would help trial managers decide on the action to be taken on the occurrence of deviations, which would be based on their impact.
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