T/ZCHSP 001-2023 Immune checkpoint inhibitor adverse event/event monitoring management standard

Scope

Main technical content: This standard mainly stipulates the specific requirements of the following main technical parameters, as detailed below: (1) Basic requirements ① Organizational structure: Requires the establishment of a monitoring and management team for adverse reactions/incidents of immune checkpoint inhibitors in the unit, a monitoring system, and a training and assessment mechanism. ② Personnel qualifications: Specifies the qualification requirements for prescription issuance, medical order review, drug dispensing, medication preparation, order execution, adverse reaction/incident judgment, adverse reaction/incident monitoring, adverse reaction/incident treatment/handling, and supervisory personnel responsible for adverse reaction/incident supervision and management. (2) Monitoring content The monitoring content mainly clarifies pre-use assessment, in-use management, post-use monitoring, monitoring result evaluation and processing, and monitoring records, establishing a standard reference for clinical monitoring work. (3) Supervision and management requirements Medical institutions shall establish supervision mechanisms and strengthen management.

Development Information

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