Comparison of Status of Pharmaceutical Clinical Trial Data Management in Compliance with Good Clinical Data Management Practice Standard in Clinical Research Centers of Tehran University of Medical Sciences, Iran*

Document Type : Original Article

Authors
Farahnaz Sadoughi 1
Masoud Salehi 2
Leila Amirhajlou 3
1 Associate Professor, Health Information Management, School of Management and Medical Information, Tehran University of Medical Sciences, Tehran, Iran
2 Assistant Professor, Biostatistics, School of Management and Medical Information, Tehran University of Medical Sciences, Tehran, Iran
3 Medical Records, School of Management and Medical Information, Tehran University of Medical Sciences, Tehran, Iran (Corresponding Author) Email: l.amirhajlou@gmail.com
Abstract
Introduction: Good data management practices are essential to any clinical trial, yet this area is one of
which can be neglected during the planning stages of a trial. This study focused on the management of the
data during each stage of the life for a trial from planning to archive in compliance with good clinical data
management 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 centers
was conducted in 2010. A checklist containing 239 questions for total objectives was developed using the
standards described in the GCDMP. Based on the Ministry of Health evaluation scores, clinical research
centers 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 were
analyzed 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, and
weak groups. In terms of data quality and reporting, no statistically significant difference was indicateed
between 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 quality
monitoring committee, clinical research assistant training for GCDMP requirements are necessary for
achieving data quality and international expectations.

Keywords

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Health Information Management
Volume 10, Issue 1
Spring 2014
Pages 16-25