md-medicaldata

Authors

 

Nataša Nikolić, Marko Simović, Tanja Dimitrijević, Marko Niketić
Centre for humanistic and medical studies, Belgrade, Serbia

 

• The paper was received on 10.11.2015./ Accepted on 15.11.2015.

 

Abstract

 

Both USA Food and Drug Administration (FDA) and European Medical Agency (EMA) had encouraged risk-based management (RBM) approach as the part of successful trial. The industry and regulatory bodies are going towards using risk-based management in clinical trials with a goal to decrease costs and improve study management. Many are already questioning the rationale of 100% SDV (Source Data Verification) suggesting that focus should be changed. This new IT (Informational Technology) technology will bring changes in everyday work of Clinical Research Associate (CRA). CRA is the main line of communication between Sponsor and the investigator/site with diversity of job tasks to perform. Will RBM decrease the need of CRA on and off-site? Or is industry at the beginning of understanding that CRA role will become more complex and important for the success of the trial. CRA with all previously desired skills will need to adapt and be trained (as well as the others in this business) to the whole new set of skills (deeper IT knowledge, risk and data management, patient safety, disease history and treatment etc.). This paper intends to explore how big the changes that CRA job will undergo are.

 

 

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PDF Nikolić N. et al. • MD-Medical Data 2015;7(4): 287-290