T/CGCPU 015-2020 The requirements for building a clinical trial subject risk early warning system

Scope

Scope: This standard specifies the construction requirements and content for implementing subject protection using a risk early warning system for clinical trial subjects. This standard applies to ethics committees using risk early warning systems for clinical trial subjects, and it stipulates the content and process of building such systems. Ethics committees of various medical institutions may refer to and implement it accordingly. If there are inconsistencies between the content of this standard and government or government-related authorities, or if new regulations are issued by higher-level authorities, the provisions of the higher-level authorities shall prevail. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions 3.1 Clinical trial 3.2 Ethics committee 3.3 Clinical trial management department (GCP Office) 3.4 Investigator 3.5 Subjects 3.6 Standard operating procedure 3.7 Serious adverse event 3.8 Protocol deviation 3.9 Subjects risk warning system 3.10 Risk warning event 4. Composition and responsibilities 5. Software and hardware requirements 5.1 Software requirements 5.2 Hardware requirements 6. Data sources and activation conditions 6.1 Data sources 6.2 Activation conditions 7. Use of the subject risk warning system 7.1 Notification of early warning events 7.2 Handling of early warning events 7.3 Closing of early warning events

Development Information

Related Standards