Division 1 — General

4 Sponsors

5 Principal investigator, etc.

6 Investigator’s brochure

Division 2 — Regulatory submissions for clinical trials of therapeutic products

7 Requirement for authorisation for or notification of clinical trial

8 Application for authorisation for clinical trial

9 Notification of clinical trial

10 Amendments and substantial amendments to clinical trial, etc.

11 Notification of serious breaches and urgent safety measures

12 Notification of status of clinical trial

Division 3 — General duties

Subdivision 1 Good clinical practice and conduct of clinical trials

13 Conduct of clinical trials: good clinical practice

14 Conduct of clinical trials: in accordance with authorisations and notifications

15 Place of clinical trial

Subdivision 2 Duties relating to consents and provision of information

16 Consent of subjects, etc., in clinical trials

17 Consent of subjects, etc., in clinical trials in emergency situations

18 General requirements as to consent

19 Duty to give full explanation and information

20 Coercion

Subdivision 3 Duties relating to safety and interests of subjects

21 Urgent safety measures

22 Suspension or termination of clinical trial

Subdivision 4 Duties relating to information obtained and reports

23 Record of clinical trials

Division 4 — Vigilance

24 Notifications of serious adverse events

25 Notifications of unexpected serious adverse drug reactions

Division 5 — Labelling

26 Investigational therapeutic product and auxiliary therapeutic product labelling