DB32/T 4652-2024
Guidelines for the development of multi-center drug clinical trial management systems based on blockchain technology (English Version)

Standard No.
DB32/T 4652-2024
Language
Chinese, Available in English version
Release Date
2024
Published By
Jiangsu Provincial Standard of the People's Republic of China
Latest
DB32/T 4652-2024
 
Scope
This document provides a guide for the development of a multi-center drug clinical trial management system. This document is applicable to the development of a multi-center drug clinical trial management system. It can also be used as a reference for the development of a single-center clinical trial management system and a multi-center medical device clinical trial management system.

DB32/T 4652-2024 Referenced Document

  • GB/T 37964-2019 Information security technology—Guide for de-identifying personal information
  • GB/T 39725-2020 Information security technology—Guide for health data security
  • GB/T 42570-2023 Information security technology—Security framework for blockchain technology
  • GB/T 42571-2023 Information security technology—Security specification for blockchain information service

DB32/T 4652-2024 history

  • 2024 DB32/T 4652-2024 Guidelines for the development of multi-center drug clinical trial management systems based on blockchain technology
Guidelines for the development of multi-center drug clinical trial management systems based on blockchain technology

Topics on standards and specifications

Clinical Trials Clinical Trial Guidelines Drug Clinical Trials drug test experimental drug experimental drug System Development Clinical + Trial Clinical Trials clinical trial quality Drug Clinical Trials multicenter clinical trial

Standard and Specification

Pharma-Guidelines-Nanodrug003 Technical Guiding Principles for Non-clinical Safety Research of Nanomedicines (Trial Implementation CLSI I/LA34-A-2011 Design and Validation of Immunoassays for Assessment of Human Allergenicity of New Biotherapeutic Drugs; Approved Guideline SN-CEN ISO/TS 22756:2020 Health Informatics — Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes (ISO/TS 22756:2020 CEN ISO/TS 22756:2020 Health Informatics - Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes (ISO/TS 22756:2020 IEEE 3224-2023 IEEE Standard for Blockchain-Based Green Power Identification Applications Pharma-Guidelines-Nanodrug001 Technical guidelines for nanomedicine quality control research (Trial BICSI 002-2014 Data Center Design and Implementation Best Practices EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015 CLSI POCT09-A-2010（R2017 Selection Criteria for Point-of-Care Testing Devices CLSI POCT09-A V.30 N.8-2010 1875 Selection Criteria for Point-of-Care Testing Devices


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