Guidance 4 will address methodologies, standards, and technologies that may be used for the collection, capture, storage, and analysis of clinical outcome assessment (COA) data. The guidance will also address methods to better incorporate COAs into endpoints that are considered significantly robust for regulatory decision-making. This includes methods to define meaningful change in a COA-based endpoint and interpretation of results. The guidance will include information on the format and content required for regulatory submissions incorporating patient experience, in particular COA data.