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: 10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS: 10.2 Investigational labelling and packaging

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]

Índice de contenido

	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 Site of the trial, facilities and staff
		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/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 drug regulatory authority
		6.9 Reports
	7. MONITORING OF SAFETY
		7.1 Handling and recording adverse events
		7.2 Reporting adverse events
	8. RECORD KEEPING AND HANDLING OF DATA
		8.1 Responsibilities of the investigator
		8.2 Responsibilities of the sponsor and the monitor
		8.3 Archiving of data
	9. STATISTICS AND CALCULATIONS
		9.1 Experimental design
		9.2 Randomization and blinding
		9.3 Statistical analysis
	10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
		10.1 Supply and storage
		10.2 Investigational labelling and packaging
		10.3 Responsibilities of the investigator
		10.4 Responsibilities of the sponsor and monitor¹
	11. ROLE OF THE DRUG REGULATORY AUTHORITY
		11.1 General responsibilities
		11.2 On-site inspections
	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

10.2 Investigational labelling and packaging

The sponsor is responsible for the proper packaging and investigational labelling of the pharmaceutical products used. Study products should be labelled in compliance with the protocol and any applicable national regulations. The investigational label should state that the product is for clinical research purposes only. Investigational label information should be accurate and in a language that is understandable to the subject.

In blinded trials, the package should be labelled in a way that does not reveal the identity of the product. A coding system should be used to allow for the proper identification of the blinded products given to individual subjects (in case of emergency). In addition, all study products, including comparator products, should be indistinguishable by appearance, taste, smell, weight and other physical characteristics.