3.1 Protocol Development
Key information outlined in protocol
- Introduction and rationale
- Study objectives and endpoints
- Study design; inclusion/exclusion criteria; drug dosage and administration
- Measurements and evaluation
- Data analysis methods
- Consent; Unblinding; Indemnity
- Adverse events and serious adverse events
- Trial organisation
- Protocol summary
- Case study reports (data collection forms)
- Patient information leaflets & consent forms
ICH
guideline E6: Section 6. Clinical Trial Protocol and Protocol amendment(s)
