Assessment and classification of protocol deviations

Ravindra Bhaskar Ghooi, Neelambari Bhosale, Reena Wadhwani, Pathik Divate, Uma Divate, Ravindra Bhaskar Ghooi, Neelambari Bhosale, Reena Wadhwani, Pathik Divate, Uma Divate

Abstract

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.

Keywords: Data quality; deviations; noncompliance; subject protection.

Figures

Figure 1
Figure 1
Publications concerning protocols on the Medline
Figure 2
Figure 2
Relation between incidence and impact of deviations
Figure 3
Figure 3
Grade-wise occurrence of protocol deviations

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Source: PubMed

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