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.

Target audience

Patients, Pharmaceutical companies or industry , Researchers (investigators and academic researchers), Other

Types

Guidance

Formats

Online e-learning

Levels

Beginner

Language

English

Accessibility

Not applicable

Certification

No

Patients involved

No

Length of training (in hrs)

1

Version date/number

03 Jan 2020

PFMD last access

28 Nov 2020

Organizations