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ORIGINAL ARTICLE
Year : 2016  |  Volume : 7  |  Issue : 3  |  Page : 132-136

Assessment and classification of protocol deviations


Jehangir Clinical Development Centre, Jehangir Hospital, Pune, Maharashtra, India

Correspondence Address:
Ravindra Bhaskar Ghooi
Ethics Committee-Jehangir Clinical Development Centre, Jehangir Hospital, Sassoon Road, Pune - 400 001, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.184817

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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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