Quality Assurance

The Data Centre has developed a number of operating procedures, in accordance with
international standards regarding good clinical practice, that ensure consistency in activities
carried out within the structure.
The Data Centre has developed a number of standard operating procedures (SOPs), in accordance with international Good Clinical Practice (GCP) guidelines, that guarantee consistency in activities carried out within the organisation. To this end it has formed a unit with the remit of setting up, developing and continuously improving quality assurance.

These procedures have been validated and in 2002 the Data Centre was awarded the UNI EN ISO 9001:2000 Certificate for the "Design, conduction and management of clinical trials".


The GIMEMA Data Centre reference documentation is made up of 14 SOPs, many Operational Instructions and Quality Assurance Documents.


The Quality Assurance Manual is the GIMEMA Data Centre's main reference document. In it you will find a description of the quality assurance policy, the organisation of the Data Centre and the responsibilities and processes undertaken by the Data Centre within the scope of its own activities. The objective of this manual is to illustrate the elements on which the whole quality assurance system has been developed, thanks to which it is possible to guarantee a high standard of services undertaken.

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