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: APPENDIX 2: Model list of items to be contained in a clinical trial protocol

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

APPENDIX 2: Model list of items to be contained in a clinical trial protocol

The trial protocol should, where relevant, be required to cover the following points:

1. Title and justification for the trial.

2. Statement of rationale, objectives and purpose of trial.

3. Brief description of the site(s) where the trial is to be conducted

4. Name and address of the sponsor.

5. Name, address and qualifications of each investigator.

6. Description of the type of trial (randomized, blinded, open), trial design (parallel groups, cross-over technique), blinding technique (double-blind, single-blind), and method of and procedure(s) for randomization.

7. Description of trial subjects (criteria for inclusion and exclusion of potential subjects), process of recruitment, types, method(s) and timing of allocation of subjects into investigational groups.

8. Number of trial subjects needed to achieve the trial objective, based on statistical considerations.

9. Description of and justification for the route of administration, dosage, dosage interval and treatment period for the investigational and comparator products, if used. Dose-response relationships should be considered.

10. Any other treatment that may be given or permitted concomitantly.

11. Clinical and laboratory tests, pharmacokinetic analysis, etc., that are to be carried out.

12. Description of how responses are recorded (description and evaluation of methods and frequency of measurement), follow-up procedures and measures to determine the extent of compliance with the treatment among trial subjects.

13. Discontinuation criteria for trial subjects and instructions on terminating the whole study or a part of the study.

14. Methods for recording and reporting adverse events or reactions, and provisions for dealing with complications.

15. Procedures for the maintenance of subject identification code lists, treatment records, lists for the randomization of subjects and/or case-report forms (CRFs). Records should permit identification of individual patients or participants as well as auditing and reconstruction of data.

16. Information about how the trial code is established, where it will be kept and when, how and by whom it can be broken in the event of an emergency.

17. Measures to be implemented to ensure the safe handling and storage of investigational and comparator products, if used, and to promote and determine the extent of compliance with the prescribed treatment and other instructions.

18. Description of methodology to be used to evaluate the results, (including statistical methods) and to report on patients or participants withdrawn from the trial.

19. Time schedule for completion of the trial.

20. Information to be presented to the trial subjects, including how they will be informed about the trial, and how and when their consent will be obtained.

21. Instructions for staff involved in the trial, including how they are to be informed about the way the trial is to be conducted and about the procedures for drug usage and administration.

22. Ethical considerations and measures relating to the trial.

23. Medical care to be provided after the trial, modalities of post-trial treatment.

24. When the protocol serves as a contract, statements regarding financing, insurance, liability, delegation or distribution of responsibilities, and publication policy.

25. List of literature referred to in the protocol.