WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report
(1995; 36 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentINTRODUCTION
View the documentGLOSSARY
Close this folder1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL
View the document1.1 Justification for the trial
View the document1.2 Ethical principles
View the document1.3 Supporting data for the investigational product
View the document1.4 Investigator and site(s) of investigation
View the document1.5 Regulatory requirements
View the document2. THE PROTOCOL
Open this folder and view contents3. PROTECTION OF TRIAL SUBJECTS
Open this folder and view contents4. RESPONSIBILITIES OF THE INVESTIGATOR
Open this folder and view contents5. RESPONSIBILITIES OF THE SPONSOR
Open this folder and view contents6. RESPONSIBILITIES OF THE MONITOR
Open this folder and view contents7. MONITORING OF SAFETY
Open this folder and view contents8. RECORD KEEPING AND HANDLING OF DATA
Open this folder and view contents9. STATISTICS AND CALCULATIONS
Open this folder and view contents10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
Open this folder and view contents11. ROLE OF THE DRUG REGULATORY AUTHORITY
View the document12. QUALITY ASSURANCE FOR THE CONDUCT OF A CLINICAL TRIAL
View the document13. CONSIDERATIONS FOR MULTICENTRE TRIALS
View the documentREFERENCES
View the documentAPPENDIX 1: World Medical Association’s Declaration of Helsinki1
View the documentAPPENDIX 2: Model list of items to be contained in a clinical trial protocol
 

1.2 Ethical principles

All research involving human subjects should be conducted in accordance with the ethical principles contained in the current version of the Declaration of Helsinki (see Appendix 1). Three basic ethical principles should be respected, namely justice, respect for persons, and beneficence (maximizing benefits and minimizing harms and wrongs) and non-maleficence (doing no harm) as defined by the current revision of the International Ethical Guidelines for Biomedical Research Involving Human Subjects1 or the laws and regulations of the country in which the research is conducted, whichever represents the greater protection for subjects. All individuals involved in the conduct of any clinical trial must be fully informed of and comply with these principles. (See chapters 3 and 4).

1 These guidelines are updated regularly by the Council for International Organizations of Medical Sciences (CIOMS); the most recent update was published in 1993 (2)

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