Data Management in Clinical Trials

The purpose of this SOP is to provide the minimum standards required to ensure all Clinical Trial data, from the point of collection from source documents up to the point of archiving, excluding the requirements for statistical analysis, are managed, collected and verified in the appropriate manner. This SOP is to ensure the data are recorded correctly in order that Clinical Trials conducted within the partner institutions comply with UK and European Law. These laws comprise; Statutory Instrument 2004/1031 – the Medicines for Human Use (Clinical Trials) Regulations 2004 which transposed the European Union Directive 2001/20/EC for Clinical Trials into UK law effective from the 1st May 2004. The original UK regulations were amended in August 2006 to incorporate the EU Good Clinical Practice Directive (2005/28/EC) as Statutory Instrument 2006/1928 and as amended at any time.

Efficient data collection and management is an essential component of a Clinical Trial. Only data that is relevant for the purpose of the Clinical Trial should be recorded.

SOP: Data Management in Clinical Trials (376Kb)

Related Templates

DMP Template (1200Kb)