Division 2 At a minimum it should:

ensure that a statement exists which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by these principles of good laboratory practice;

ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study;

ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual;

ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions;

ensure that appropriate and technically valid standard operating procedures are established and followed, and approve all original and revised standard operating procedures;

ensure that there is a quality assurance programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with these principles of good laboratory practice;

ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the study director before the study is initiated. Replacement of a study director should be done according to established procedures, and should be documented;

ensure, in the event of a multisite study, that, if needed, a principal investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a principal investigator should be done according to established procedures, and should be documented;

ensure documented approval of the study plan by the study director;

ensure that the study director has made the approval study plan available to the quality assurance personnel;

ensure the maintenance of a historical file of all standard operating procedures;

ensure that an individual is identified as responsible for the management of the archive(s);

ensure the maintenance of a master schedule;

ensure that test facility supplies meet requirements appropriate to their use in a study;

ensure for a multisite study that clear lines of communication exist between the study director, principal investigator(s), the quality assurance programme(s) and study personnel;

ensure that test and reference items are appropriately characterised;

establish procedures to ensure that computerised systems are suitable for their intended purpose, and are validated, operated and maintained in accordance with these principles of good laboratory practice.