Assessment and classification of protocol deviations
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...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer Medknow Publications
2016-01-01
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| Series: | Perspectives in Clinical Research |
| Subjects: | |
| Online Access: | http://www.picronline.org/article.asp?issn=2229-3485;year=2016;volume=7;issue=3;spage=132;epage=136;aulast=Ghooi |