Drug clinical trials and GCP

Introduction

This book is based on the latest relevant laws and regulations of my country and the GCP of developed countries or international organizations, mainly the WHO and ICH GCP guidelines. Foreign materials, combined with the experience and experience of participating in and organizing domestic and foreign GCP training.

This book is mainly for doctors, nurses, pharmacists and file managers in medical units engaged in drug clinical trials, as well as personnel in pharmaceutical companies engaged in new drug registration or GCP inspectors as an introductory reading. It can also be used at all levels It can be used as a reference book for all kinds of GCP training courses for personnel engaged in GCP supervision and inspection by the drug regulatory authority.

Book Catalog

Part Ⅰ Introduction to Drugs’ Prompt Trial

1 Procedures for Drug Research and Development

Discovery of the first compound

Animal experiment

Phase I clinical trial

Phase II clinical trial

Benefit-risk ratio

Phase III clinical trial

Applying for drug registration or marketing authorization

Phase clinical trials

Adverse reactions and revocation of permits

2 Significance of the trial for social entertainment

Evaluate the application value of new drugs for temporary entertainment

Determine the best use method of new drugs

Provide new drug registration information

For enterprise new drugs Research and market development decision-making provide basis

Provide basis for doctors and patients to use new drugs correctly

Health economics evaluation

3 Basic elements of temporary entertainment trials

Basic principles of drug clinical trials

Research risks and protection of subjects

Approved by the competent authority

Clinical trial protocol

Case report form

Experimental purpose

Control

Experimental design

Random

Get Balanced treatment group

Blind trial

Sample size

Placebo

Double-blind and double-simulation technology

Multicenter clinical trial

Baseline and endpoint

Dosing schedule

Dose-response relationship

Compliance

5 Implementation procedures of clinical trials

Guidelines for the quality management of clinical trials of drugs in the second edition

6 GCP overview

7 GCP implementation in China

8 GCP protection for subjects

9 GCP requirements for the responsibilities of relevant personnel

10 Clinical Management of trial documents and data

11 GCP's assurance of clinical trial quality

12 Factors and countermeasures affecting the success of clinical trials

Part III Appendix< /p>

Appendix Ⅰ "Regulations for the Management of Drug Coordination Trials"

Appendix II ICH GCP Guidelines on Requirements for Necessary Documents for Drug Coordination Trials

Appendix III Helsinki Declaration ( Revised edition in 2000)

Appendix IV "Administrative Measures for Drug Registration (Trial)" Provisions on Drug Clinical Research

Chinese version of professional terminology

References< /p>