title: Assessment and classification of protocol deviations.
abstract: BACKGROUND
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Jehangir Clinical Development Centre, Jehangir Hospital, Pune, Maharashtra, India.
authors.forename: Ravindra Bhaskar
authors.initials: RB
authors.lastname: Ghooi
authors.affiliation: Jehangir Clinical Development Centre, Jehangir Hospital, Pune, Maharashtra, India.
authors.forename: Neelambari
authors.initials: N
authors.lastname: Bhosale
authors.affiliation: Jehangir Clinical Development Centre, Jehangir Hospital, Pune, Maharashtra, India.
authors.forename: Reena
authors.initials: R
authors.lastname: Wadhwani
authors.affiliation: Jehangir Clinical Development Centre, Jehangir Hospital, Pune, Maharashtra, India.
authors.forename: Pathik
authors.initials: P
authors.lastname: Divate
authors.affiliation: Jehangir Clinical Development Centre, Jehangir Hospital, Pune, Maharashtra, India.
authors.forename: Uma
authors.initials: U
authors.lastname: Divate
keywords: Data quality; deviations; noncompliance; subject protection