ICH E3 Structure and Content of
Clinical Study Reports (cont.)
9. Investigational
plan
9.1 Overall study design and plan description
9.2 Discussion of study design, including the choice of control groups
9.3 Selection of study population
9.3.1 Inclusion Criteria
9.3.2 Exclusion Criteria
9.3.3 Removal of Patients from Therapy or Assessment
9.4 Treatments
9.4.1 Treatments Administered
9.4.2 Identity of Investigational Product(s)
9.4.3 Method of Assigning Patients to Treatment Groups
9.4.4 Selection of Doses in the Study
9.4 Treatments (cont.)
9.4.5 Selection and Timing of Dose for each Patient
9.4.6 Blinding
9.4.7 Prior and Concomitant Therapy
9.4.8 Treatment Compliance
9.5 Efficacy and safety variables
9.5.1 Efficacy and Safety Measurements Assessed and Flow Chart
9.5.2 Appropriateness of Measurements
9.5.3 Primary Efficacy Variable(s)
9.5.4 Drug Concentration Measurements
9.6 Data quality assurance
9.7 Statistical methods planned in the protocol & determination of sample size
9.8 Changes in the conduct of the study or planned analyses