Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series, No. 850, 1995, Annex 3) (WHO, 1995, 36 p.)

Guidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series, No. 850, 1995, Annex 3) (WHO, 1995, 36 p.)

		(introductory text...)
		INTRODUCTION
		GLOSSARY
		1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL
		2. THE PROTOCOL
		3. PROTECTION OF TRIAL SUBJECTS
		4. RESPONSIBILITIES OF THE INVESTIGATOR
		5. RESPONSIBILITIES OF THE SPONSOR
		6. RESPONSIBILITIES OF THE MONITOR
		7. MONITORING OF SAFETY
		8. RECORD KEEPING AND HANDLING OF DATA
		9. STATISTICS AND CALCULATIONS
		10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
		11. ROLE OF THE DRUG REGULATORY AUTHORITY
		12. QUALITY ASSURANCE FOR THE CONDUCT OF A CLINICAL TRIAL
		13. CONSIDERATIONS FOR MULTICENTRE TRIALS
		REFERENCES
		APPENDIX 1: World Medical Association’s Declaration of Helsinki1
		APPENDIX 2: Model list of items to be contained in a clinical trial protocol