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: 11. ROLE OF THE DRUG REGULATORY AUTHORITY: 11.1 General responsibilities

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]

Table of Contents

	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

11.1 General responsibilities

The national drug regulatory authority should ensure that the protocols for clinical trials are submitted in advance for review and are in accordance with existing national regulations. On the basis of its review of clinical trial protocols and/or reports, the regulatory authority may propose revisions or request additional data on a clinical trial or terminate a trial.

The drug regulatory authority should evaluate the adequacy of supervision of the trial by reviewing the monitor’s reports to the sponsor (see Section 6.9). In addition, the authority should be able to conduct on-site inspections of the reliability and quality of reported results.

National regulations should specify the procedures for reporting and handling cases of misconduct discovered in connection with clinical trials.