| Autor: |
Ghooi, Ravindra Bhaskar, Bhosale, Neelambari, Wadhwani, Reena, Divate, Pathik, Divate, Uma |
| Předmět: |
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| Zdroj: |
Perspectives in Clinical Research; Jul-Sep2016, Vol. 7 Issue 3, p132-136, 5p |
| Abstrakt: |
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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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