Does your study protocol demand changing treatment/care/services from accepted standards for any of the patients/service users involved?
Note: Clinical Audit and Service Evaluation or Service Improvement / Development examine how standard care is delivered or measure improvements in standard care, and by definition all decisions around what treatment regime, care or services to follow and administer are made jointly by the care professional and patient/service user. If this is not the case and treatment regime, care or service is determined by following a set protocol then you should select YES.
