WHO_GCP指导原则.doc

WHO GCP 指导原则 World Health Organization WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products*.INTRODUCTION Glossary 1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL 1.1 Justification for the trial 1.2 Ethical principles 1.3 Supporting data for the investigational product 1.4 Investigator and site(s) of investigation 1.5 Regulatory requirements 2. THE PROTOCOL 3. PROTECTION OF TRIAL SUBJECTS 3.1 Declaration of Helsinki 3.2 Ethics committee 3.3 Informed consent 3.4 Confidentiality 4. RESPONSIBILITIES OF THE INVESTIGATOR 4.1 Medical care of trial subjects 4.2 Qualifications 4.3 Selection of trial subjects 4.4 Compliance with the protocol 4.5 Information for subjects and informed consent 4.6 The investigational product 4.7 The trial site 4.8 Notification of the trial or submission to the drug regulatory authority 4.9 Review by an ethics committee 4.10 Serious adverse events or reactions 4.11 Financing 4.12 Monitoring, auditing and inspection 4.13 Record-keeping and handling of data 4.14 Handling of and accountability for pharmaceutical products for trial 4.15 Termination of trial 4.16 Final report 4.17 Trials in which the investigator is the sponsor 5. RESPONSIBILITIES OF THE SPONSOR 5.1 Selection of the Investigator(s) 5.2 Delegation of responsibilities 5.3 Compliance with the protocol and procedures 5.4 Product information 5.5 Safety information 5.6 Investigational product 5.7 Trial management and handling of data 5.8 Standard operating procedures 5.9 Compensation for subjects and investigators 5.10 Monitoring 5.11 Quality assurance 5.12 Study reports 5.13 Handling of adverse events.5.14 Termination of trial 6. RESPONSIBILITIES OF THE MONITOR 6.1 Qualifications 6.2 Assessment of the trial site 6.3 Staff education and compliance 6.4 Data management 6.5 Case-report forms 6.6 Investigational product 6.7 Communication 6.8 Notification of the trial or submission to the regulatory authority