T/SHQAP 016-2024 Active Group standards

T/SHQAP 016-2024 Drug Clinical Trial Management System Dataset Specification

Publish Date: 2024-07-25 Implement Date: 2024-08-24 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/SHQAP 016-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Traditional Chinese medicine preparations

ICS Name: Drugs

Publish Date: 2024-07-25

Implement Date: 2024-08-24

Pages: 18 pages

Scope

Main technical content: This document specifies the data classification and content of the drug clinical trial management system data set, which includes a basic information data subset and an application information data subset. The basic information data subset defines the basic information of the institution, the trial specialty, and the data items and requirements that the ethics committee should include. The application information data subset defines the data items and requirements that the clinical trial project management and the institution's annual report should include.