The Contribution of Quality Control in the Management of Clinical Trial Data: A case of Makerere University-Johns Hopkins University Health Care Ltd

Abstract

The purpose of this study was to assess the contribution of QC in the management of clinical trial data at Makerere University Johns Hopkins University (MUJHU) Health Care Limited. The study was guided by the following specific objectives: - To examine the effect of compliance with clinical trial requirements on the management of clinical trial data in MUJHU Health Care Limited; To analyze the effect of an operational quality management plan on the management of clinical trial data in MUJHU Health Care Limited; and To establish the effect of quality control measures on the management of clinical trial data in MUJHU Health Care Limited. This study used a cross sectional case study design and employed both qualitative and quantitative data collection approaches to address the different aspects of the research problem. Both purposive and random samplings were used to select the respondents. The study employed both the quantitative (semi-structured questionnaire) and qualitative (key informant interviews) data collection methods. Data were analyzed using statistical methods such as frequencies and percentages including Spearman correlation and coefficient of determination and were presented in tabular form. Findings revealed that compliance with clinical trial requirements had a significant but weak effect on the management of clinical trial data. Operational quality management plan had a significant very strong effect on the management of clinical trial data. Quality control measures had a significant but moderate effect on the management of clinical trial data. It is recommended that compliance with clinical trial requirements, operational quality management plan and quality control measures should be improved for the better management of clinical trial data in MUJHU Health Care Limited.