Investigational plans, or protocols, are developed with what authors believe are clear inclusion and exclusion criteria that must be confirmed prior to the initiation of any investigational treatment or test. There are certain inclusion criteria that are common including an age range, willingness to provide consent and adhere to the study schedule, and particular condition or diagnosis. Common exclusion criteria include a past medical diagnosis, excluded treatments or medications, or family history of a certain disease. According to 21 CRF 812.110 (b), it is the investigator’s responsibility to conduct the trial according to the investigational plan and therefore, adequately review medical history, interview the subject, and obtain labs or imaging to confirm that all inclusion and no exclusion criteria are met.
Topics: Inclusion Criteria, Exclusion Criteria, 21 CRF 812.110 (b)