Postgraduate course in Clinical Data Management – MSc Project work.pdfVIP

Postgraduate course in Clinical Data Management – MSc Project work Dear clinical trial colleague, I am a student pursuing a postgraduate qualification in Clinical Data Management at Kingston University. I will be evaluating processes which have been implemented through the life-cycle of the clinical data aimed at ensuring the data collected is integral, reliable and fit for submission in clinical trials. I will be comparing quality control (QC) procedures in a number of African medical research institutions with similar institutions in Europe, the United States of America and others to identify any differences in expectation or standards. If there are differences, then a gap analysis will be performed and improvements suggested with reference to Good Clinical Data Management Practice (GCDMP) produced by the Society of Clinical Data Management. The topic for my industrial research is:- “An assessment of Clinical Data Management (CDM) procedures in some African research institutions to explore possible improvements in processes to better ensure data quality and auditability in clinical trials conducted in Africa” It is hoped that your responses to the questionnaire below will be used to evaluate the data quality challenges faced in clinical trials. You may consult other sections of your department or organization where applicable so as to have a representative response of activities in your institution. The results of this project will be made available in early next year (2010). Please select the option that is applicable to your institution/organisation/industry on the right side of the question from the combo box provided. Thanks in advance for your help and support with this research. If you would like to be involved with this industry research, please return completed questionnaire via one of the following methods: Email: sdonkor@mrc.gm; or simon_donkor@ Fax: +220 4495919 Tel: +220 7030604 Post: Simon Donkor