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CLINICAL TRIALS ACT
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Schedule 2
2023 Laws not yet authenticated through a Commencement Order
Revised Laws of Saint Lucia (2023)
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Schedule 2
(Section 12(7)(b) and (h))
CONDITIONS AND PRINCIPLES OF GOOD CLINICAL PRACTICE AND FOR THE PROTECTION OF CLINICAL TRIAL SUBJECTS
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Schedule 2
1. Short title and commencement
2. Interpretation
3. Act binds the Crown
4. Application and non-application
5. Application of other laws
6. Ethics Committee
7. National Competent Authority
8. Electronic database system on clinical trials
9. Annual report
10. Restriction on clinical trial
11. Application for opinion of Ethics Committee
12. Opinion of Ethics Committee
13. Application for authorization
14. Consideration of application for authorization
15. Grant or refusal of application for authorization
16. Withdrawal of application
17. Notice of substantial modification
18. Withdrawal, revocation and suspension
19. Conditions and principles of good clinical practice
20. Urgent safety measures
21. Notification of serious adverse events
22. Notification of suspected unexpected serious adverse reactions
23. Annual list of suspected serious adverse reactions and safety report
24. Infringement notice
25. Sale or supply of investigational medicinal product or investigational medical device
26. False or misleading information
27. Limitation on prosecution
28. Prosecution of offences
29. Payment of compensation
30. Establishment of Appeals Board
31. Constitution and procedure
32. Further appeal
33. General penalty
34. Amendment of Schedules
35. Regulations
Schedule 1
Schedule 2
Schedule 3
ACT
PRELIMINARY
1. Short title and commencement
2. Interpretation
3. Act binds the Crown
4. Application and non-application
5. Application of other laws
PART 1 ADMINISTRATION
6. Ethics Committee
7. National Competent Authority
8. Electronic database system on clinical trials
9. Annual report
PART 2 CLINICAL TRIALS
10. Restriction on clinical trial
11. Application for opinion of Ethics Committee
12. Opinion of Ethics Committee
13. Application for authorization
14. Consideration of application for authorization
15. Grant or refusal of application for authorization
16. Withdrawal of application
17. Notice of substantial modification
18. Withdrawal, revocation and suspension
19. Conditions and principles of good clinical practice
20. Urgent safety measures
21. Notification of serious adverse events
22. Notification of suspected unexpected serious adverse reactions
23. Annual list of suspected serious adverse reactions and safety report
PART 3 ENFORCEMENT
24. Infringement notice
25. Sale or supply of investigational medicinal product or investigational medical device
26. False or misleading information
27. Limitation on prosecution
28. Prosecution of offences
29. Payment of compensation
PART 4 APPEALS
30. Establishment of Appeals Board
31. Constitution and procedure
32. Further appeal
PART 5 MISCELLANEOUS
33. General penalty
34. Amendment of Schedules
35. Regulations
Schedule 1
PART 1 APPLICATION AND INTERPRETATION
PART 2 CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
PART 3 CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY
PART 4 CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A MINOR
PART 5 CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT
Schedule 3
SUBSIDIARY LEGISLATION