Good Clinical Practice And (S.L. 458.47)

Contents

1. Art. 1 Title and scope. S.L. 458.43 S.L. 458.42
2. Art. 2 Application of provisions.
3. Art. 3 Good clinical practice for the design, conduct, recording and reporting of clinical trials.
4. Art. 4 Ethics Committees.
5. Art. 5 Sponsors.
6. Art. 6 Investigator’s brochure.
7. Art. 7 Manufacturing or import authorisation.
8. Art. 8 Requirements to obtain authorisation.
9. Art. 9 Issuing of authorisation.
10. Art. 10 Compliance with andapplicabilityof authorisation.
11. Art. 11 Holder to comply with requirements.
12. Art. 12 Change in authorisation.
13. Art. 13 Suspension etc., of authorisation.
14. Art. 14 The trial master file and archiving.
15. Art. 15 Retention of documents.
16. Art. 16 Transfer of data ownership.
17. Art. 17 Archives.
18. Art. 18 Inspectors.
19. Art. 19 Inspectors to have proper qualifications.
20. Art. 20 Inspection procedures.
21. Art. 21 Duties of the Authority.