- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
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.