Assessment and classification of protocol deviations

• Main Authors: Ravindra Bhaskar Ghooi, Neelambari Bhosale, Reena Wadhwani, Pathik Divate, Uma Divate
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2016-01-01
• Series: Perspectives in Clinical Research
• Subjects: Data quality; deviations; noncompliance; subject protection
• Online Access: http://www.picronline.org/article.asp?issn=2229-3485;year=2016;volume=7;issue=3;spage=132;epage=136;aulast=Ghooi

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.