Clinical trials in the European Community must be conducted in compliance with the ICH Good Clinical Practice guideline. For investigator-initiated trials the Coordinating Investigator’s responsibilities are those of both sponsor and investigator. The Coordinating Investigator is responsible for the implementation and maintenance of a quality system with written Standard Operating Procedures to ensure that the trial is prepared, conducted, analysed and reported in compliance with the protocol, GCP and other relevant regulatory requirements. Profess has developed a set of procedures which fulfils these requirements. The entire clinical trial process from design to publication is described in a set of 11 SOPs. These ready to use SOPs have been linked to instructions, forms, checklists and templates. Profess will maintain the Quality System.

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