Document Type : Original Article
Authors
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
2. Chow SC, Liu JP. Design and Analysis of Clinical Trials: Concepts and Methodologies. 2nd ed. New Jersey, NJ:
John Wiley & Sons; 2008.
3. Yousefi-Nooraie R, Yazdani K, Etemadi A. Registration of clinical trials: how developing countries could
prepare for the upcoming storm. Arch Iran Med 2008; 11(4): 361-3.
4. Mahendra P. Clinical trial and data management. International Journal of Pharmaceutical Sciences 2011; 7(2): 46.
5. Ministry of health and medical education.food and drug organization.Drug deputy.Office for narcotics and Drug
supervision and Evaluation. Good Clinical Trial Mnual [Online]. 2004; Available from: URL:
http://fdo.behdasht.gov.ir/uploads/114_1403_rahnamaye%20karazmayee%20matloob.pdf/
6. Society for clinical data management. Good Clinical Data Management practice guidance document [Online].
2007; Available from: URL: http://www.scdm.org/sitecore/content/be-bruga/scdm/Publications/gcdmp.aspx/
7. Kuchinke W, Ohmann C, Yang Q, Salas N, Lauritsen J, Gueyffier F, et al. Heterogeneity prevails: the state of
clinical trial data management in Europe - results of a survey of ECRIN centres. Trials 2010; 11: 79.
8. Ohmann C, Kuchinke W, Canham S, Lauritsen J, Salas N, Schade-Brittinger C, et al. Standard requirements for
GCP-compliant data management in multinational clinical trials. Trials 2011; 12: 85.
9. Babre D. Medical coding in clinical trials. Perspect Clin Res 2010; 1(1): 29-32.
10.Richesson RL, Andrews JE, Krischer JP. Use of SNOMED CT to represent clinical research data: a semantic
characterization of data items on case report forms in vasculitis research. J Am Med Inform Assoc 2006; 13(5):
536-46.
11. Toneatti C, Saidi Y, Meiffredy V, Tangre P, Harel M, Eliette V, et al. Experience using MedDRA for global
events coding in HIV clinical trials. Contemp Clin Trials 2006; 27(1): 13-22.
12.Bohaychuk W, Ball G. Conducting GCP- Compliant Clinical Research: A Practical Guide. New Jersey, NJ: John
Wiley & Sons; 1999.
13.Rico-Villademoros F, Hernando T, Sanz JL, Lopez-Alonso A, Salamanca O, Camps C, et al. The role of the
clinical research coordinator--data manager--in oncology clinical trials. BMC Med Res Methodol 2004; 4: 6.
14. Pollock BH. Quality assurance for interventions in clinical trials. Multicenter data monitoring, data management,
and analysis. Cancer 1994; 74(9 Suppl): 2647-52.
15.Kuchinke W, Aerts J, Semler SC, Ohmann C. CDISC standard-based electronic archiving of clinical trials.
Methods Inf Med 2009; 48(5): 408-13.
16. Thiessard F, Roux E, Miremont-Salame G, Fourrier-Reglat A, Haramburu F, Tubert-Bitter P, et al. Trends in
spontaneous adverse drug reaction reports to the French pharmacovigilance system (1986-2001). Drug Saf 2005;
28(8): 731-40.
17.Confidentiality, Data Security, and Cancer Research: Perspectives from the National Cancer Institute [Online].
1999 [cited 1999 Mar 23]; Available from: URL: http://www3.cancer.gov/confidentiality.html.
)