Clinical study report

Overview of regulatory guidelines,organizational and practical aspects of report development.

Drug Development & Registration magazine published an article about clinical study report authoring written by specialists at OCT and Data MATRIX.

The article covers particular aspects of clinical study report writing, required extent of knowledge and skills of those involved in the process, as well as regulatory requirements and industry recommendations.

In particular, the authors focus on the importance of the latest changes to European legislation, which require from pharmaceutical companies a submission of clinical trial reports in two formats: one full version for scientific review by EMA and another version edited for open access publication.

The article also covers principles described in CORE Reference, a detailed algorithm of data management and analysis for a clinical trial report, as well as quality assurance procedures applied to the final document.

You can find the article in issue No. 4 (21).

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.