Paragraph 3 Organisation and personnel

Purpose: To determine whether: the laboratory has sufficient qualified personnel, staff resources and support services for the variety and number of studies undertaken; the organisational structure is appropriate; and 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 key personnel involved in the type(s) of studies selected for the study audit,

• list(s) of on-going and completed studies with information on the type of study, initiation/completion dates, test system, route of administration and name of study director,

• staff training and health surveillance policies, where such policies have been established,

• staff training records where available,

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

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

• list(s) of the study directors associated with the study(ies) being audited.

The inspector should check, in particular—

• lists of on-going and completed studies to ascertain the level of work being undertaken by the laboratory,

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

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