Farahnaz Sadoughi; Masoud Salehi; Leila Amirhajlou
Volume 10, Issue 1 , May 2014, , Pages 16-25
Abstract
Introduction: Good data management practices are essential to any clinical trial, yet this area is one ofwhich can be neglected during the planning stages of a trial. This study focused on the management of thedata during each stage of the life for a trial from planning to archive in compliance with ...
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Introduction: Good data management practices are essential to any clinical trial, yet this area is one ofwhich can be neglected during the planning stages of a trial. This study focused on the management of thedata during each stage of the life for a trial from planning to archive in compliance with good clinical datamanagement practice (GCDMP) standard in clinical trials conducted by the clinical research centers.Methods: This cross-sectional study about data management of clinical trials in clinical research centerswas conducted in 2010. A checklist containing 239 questions for total objectives was developed using thestandards described in the GCDMP. Based on the Ministry of Health evaluation scores, clinical researchcenters were divided into three categories of strong, average, and weak. We reviewed documents,facilities, records and any other resources of 15 clinical trials for each category. Collected data wereanalyzed by Mann-Whitney U and analysis of variance (ANOVA) tests using SPSS software.Results: Results showed that there was a statistically significant difference between strong, average, andweak groups. In terms of data quality and reporting, no statistically significant difference was indicateedbetween strong and average clinical trials groups.Conclusion: Clinical trial data management in Iran did not meet GCDMP requirements. Therefore,development of national specific and practical standard with technical detail, establishing a data qualitymonitoring committee, clinical research assistant training for GCDMP requirements are necessary forachieving data quality and international expectations.
