Clinical study report

Overview of regulatory documents and organizational & practical aspects of report development.

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

The article covers particular aspects of clinical study report preparation, 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 to submit clinical reports in two formats: one version for scientific review by EMA and another version redacted as appropriate for open access publication.

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