Expand Document  |  Expand Chapter  |  Full TOC  |  Printable HTML version
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] View the PDF document
Table of Contents
View the documentINTRODUCTION
View the documentGLOSSARY
Open this folder and view contents1. PROVISIONS AND PREREQUISITES FOR A CLINICAL TRIAL
View the document2. THE PROTOCOL
Open this folder and view contents3. PROTECTION OF TRIAL SUBJECTS
Open this folder and view contents4. RESPONSIBILITIES OF THE INVESTIGATOR
Open this folder and view contents5. RESPONSIBILITIES OF THE SPONSOR
Open this folder and view contents6. RESPONSIBILITIES OF THE MONITOR
Open this folder and view contents7. MONITORING OF SAFETY
Open this folder and view contents8. RECORD KEEPING AND HANDLING OF DATA
Open this folder and view contents9. STATISTICS AND CALCULATIONS
Open this folder and view contents10. HANDLING OF AND ACCOUNTABILITY FOR PHARMACEUTICAL PRODUCTS
Open this folder and view contents11. ROLE OF THE DRUG REGULATORY AUTHORITY
View the document12. QUALITY ASSURANCE FOR THE CONDUCT OF A CLINICAL TRIAL
View the document13. CONSIDERATIONS FOR MULTICENTRE TRIALS
View the documentREFERENCES
View the documentAPPENDIX 1: World Medical Association’s Declaration of Helsinki1
View the documentAPPENDIX 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.

to previous section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: November 5, 2014