T/SHPPA 029-2024 Active

Scope: This document applies to the management of all parties involved in the collection of human experience, including sponsors, researchers, medical institutions, etc. Main technical content: This document stipulates the requirements for collecting human experience data in an evidence system combining traditional Chinese medicine theory, human experience, and clinical trials for the registration and evaluation of traditional Chinese medicine. It clarifies the responsibilities of sponsors, researchers, medical institutions, ethics committees, and other relevant parties. It stipulates aspects such as the collection and organization plan for human experience data, the collection path, collection requirements and implementation methods, analysis and research report writing requirements, ethical requirements, quality assurance, communication and exchange with regulatory authorities, and a list of documents, and provides corresponding collection record templates.