Clinical study report
Drug Development & Registration magazine published an article written by specialists from Data MATRIX and OCT ‘Clinical Study Report: Overview of Regulatory Documents and Organizational & Practical Aspects of Report Preparation’.
The article covers special aspects related to study report preparation, provides a list of regulatory documents and industry recommendations such as CONSORT 2010 Statement and CORE Reference.
The article also provides a detailed description of all stages of clinical report preparation, data cleaning, data review meeting, statistical analysis plan finalization, database lock and data transfer. The authors emphasize the importance of using adequate methods and approaches to represent and describe clinical study results.
The article is available to magazine subscribers only:
E.A. Radkova, I.N. Petrova, K.A. Leus, I.A. Dobromyslov Clinical Study Report: Overview of Regulatory Documents and Organizational & Practical Aspects of Report Preparation // Drug Development & Registration. 2017. V. 4 (21). P. 262-270.