The National Health Commission (NHC), National Administration of Traditional Chinese Medicine, and National Disease Control and Prevention Administration have issued a notification regarding the management measures for investigator-initiated trials (ITT) in medical and health institutions, effective from October 1.
ITTs within these institutions are defined as activities with individuals or groups as subjects, conducted not for the purpose of registering drugs, medical devices (including in vitro diagnostic reagents), or other products. The aim is to study the etiology, diagnosis, treatment, rehabilitation, prognosis, prevention, control, and health maintenance of diseases. Provincial health administrative departments are instructed to enhance the monitoring, evaluation, and analysis of ITTs and to enforce supervision and management.
Medical and health institutions are tasked with the implementation of ITTs, which are categorized into observational studies and intervention studies. Observational studies should not impose research interventions on subjects, who must not be exposed to additional health risks or incur extra economic burdens beyond routine medical needs. Unless specified, these studies are subject to ethical review. Intervention research must adhere to medical theories and ethical standards, be grounded in preliminary research, and have scientific, standardized research and risk plans that have passed ethical and scientific reviews. Such research is typically led by Class III medical and health institutions at the city level (with districts) or above, with potential participation from other institutions.
Investigators have the option to apply for the suspension or termination of ITTs, with requirements to report to the clinical research management department and provide reasons. Medical and health institutions are directed to reinforce the management of clinical research archives, ensuring accurate records and proper storage. The retention period for archives should not be less than 10 years from the completion date of the research, with electronic archiving being permissible provided that safety is ensured.- Flcube.com
