The investigator should:

• have qualifications and competence in accordance with local laws and regulations as evidenced by an up-to-date curriculum vitae and other credentials (decisions relating to, and provision of, medical or dental care must always be the responsibility of a clinically competent person legally allowed to practice medicine or dentistry);

• have good knowledge and experience of the field of medicine/dentistry defined by the protocol;

• be experienced in clinical trial research methods or receive scientific support from an experienced colleague;

• be aware of available relevant data and literature and all information provided by the sponsor;

• have access to human and other resources to assume full responsibility for the proper conduct of the trial;

• be aware of and comply with national regulatory, legal and ethical requirements.