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

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SADOUGHI FARAHNAZ; SALEHI MASOUD; AMIRHAJLOU LEILA

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Journal: Journal of Health Information Management Year:2013 | Volume:10 | Issue:1 (29) Page(s): 1-10

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Title

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

Author(s)

SADOUGHI FARAHNAZ | SALEHI MASOUD | AMIRHAJLOU LEILA | Issue Writer Certificate

Keywords

INFORMATION MANAGEMENTQ3

CLINICAL TRIALSQ3

STANDARDSQ2

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.

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APA: Copy

SADOUGHI, FARAHNAZ, SALEHI, MASOUD, & AMIRHAJLOU, LEILA. (2013). 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. HEALTH INFORMATION MANAGEMENT, 10(1 (29)), 1-10. SID. https://sid.ir/paper/121994/en

Vancouver: Copy

SADOUGHI FARAHNAZ, SALEHI MASOUD, AMIRHAJLOU LEILA. 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. HEALTH INFORMATION MANAGEMENT[Internet]. 2013;10(1 (29)):1-10. Available from: https://sid.ir/paper/121994/en

IEEE: Copy

FARAHNAZ SADOUGHI, MASOUD SALEHI, and LEILA AMIRHAJLOU, “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,” HEALTH INFORMATION MANAGEMENT, vol. 10, no. 1 (29), pp. 1–10, 2013, [Online]. Available: https://sid.ir/paper/121994/en

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