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: 5. RESPONSIBILITIES OF THE SPONSOR: 5.3 Compliance with the protocol and procedures

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

5.3 Compliance with the protocol and procedures

The sponsor is responsible for assuring the investigator’s agreement to undertake the clinical trial as described in the protocol, and according to Good Clinical Practice, and to accept procedures for data recording (particularly in the case-report form or CRF), monitoring, audits, and inspections. The sponsor and the investigator must sign the protocol or an alternative document confirming this agreement.

Both the sponsor and the investigator should agree to any amendment to the protocol before it is implemented and this should be documented in writing.

Amendments which may affect the safety of the subjects or the conduct of the trial should be submitted in writing to the ethics committee (see Section 3.2) through the investigator or, if applicable, directly by the sponsor. The sponsor should provide justification for the amendments. If required, the amendments should be submitted to the drug regulatory authority. The amendments should not be implemented until all required approvals have been obtained, unless the delay caused by this process is likely to expose the subjects to an immediate hazard or danger.