T/ZCHSP 001-2023
Adverse reaction/event monitoring management practices of immune checkpoint inhibitors (English Version)

Standard No.
T/ZCHSP 001-2023
Language
Chinese, Available in English version
Release Date
2023
Published By
Group Standards of the People's Republic of China
Latest
T/ZCHSP 001-2023
Scope
This standard mainly stipulates the specific requirements for the following main technical parameters. The details are as follows: (1) Basic requirements ① Organizational construction: It is required to establish the unit’s immune checkpoint inhibitor adverse reaction/event monitoring and management team, monitoring system, training and assessment mechanism, etc. ②Personnel qualifications: Standardizes the qualifications of personnel involved in prescription issuance, medical order review, drug dispensing, drug dispensing, execution of medical orders, adverse reaction/event judgment, adverse reaction/event monitoring, adverse reaction/event treatment/handling, adverse reaction/event supervision and management Require. (2) Monitoring content The monitoring content mainly clarifies pre-use assessment, use process management, post-medication monitoring, monitoring result evaluation and processing, and monitoring records, so as to establish a standard reference for the development of actual clinical monitoring work. (3) Supervision and management requires medical institutions to establish a supervision mechanism and strengthen management.

T/ZCHSP 001-2023 history

  • 2023 T/ZCHSP 001-2023 Adverse reaction/event monitoring management practices of immune checkpoint inhibitors



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