Paragraph 3 Organisation and personnel

Purpose: to determine whether the test facility has sufficient qualified personnel, staff resources and support services for the variety and number of studies undertaken, whether the organisational structure is appropriate, and whether management has established a policy regarding training and staff health surveillance appropriate to the studies undertaken in the facility.

The management should be asked to produce certain documents, for example—

• —floor plans,

• —facility management and scientific organisation charts,

• —CVs of personnel involved in any types of studies selected for the study audit,

• —lists of on-going and completed studies with information on the type of study, initiation/completion dates, test system, method of application of test item and name of study director,

• —staff health surveillance policies,

• —staff job descriptions and staff training programmes and records,

• —an index to the facility’s standard operating procedures,

• —specific standard operating procedures related to the studies or procedures being inspected or audited,

• —lists of the study directors associated with the study(ies) being audited.

The inspector should check, in particular—

• —the identity and qualifications of the study directors, the head of the quality assurance unit and other personnel,

• —the existence of standard operating procedures for all relevant areas of testing.