3.1.1 When planning trials, the sponsor should ensure that sufficient safety and efficacy data (e.g., from nonclinical studies and/or clinical trials and/or real-world sources) are available to support human exposure by the route, at the dosages, for the duration and in the trial population to be studied.
3.1.2 Sponsors should incorporate quality into the design of the clinical trial by identifying factors that are critical to the quality of the trial and by managing risks to those factors.
3.1.3 Sponsors should consider inputs from a wide variety of interested parties, for example, healthcare professionals and patients, to support the development plan and clinical trial protocols as described in ICH E8(R1) and when developing the informed consent materials and any other participant-facing information.
3.1.4 The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures and data collection. Protocols, data acquisition tools and other operational documents should be fit for purpose, clear, concise and consistent. The sponsor should not place unnecessary burden on participants and investigators.