4 Sponsors

5 Principal investigator, etc.

6 Investigator’s brochure

7 Requirement for clinical trial certificates

8 Application for clinical trial certificates

9 Conditions of clinical trial certificates

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

13 Conduct of clinical trials: good clinical practice

14 Conduct of clinical trials: in accordance with clinical trial certificates

15 Place of clinical trial

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

21 Urgent safety measures

22 Suspension or termination of clinical trial

23 Record of clinical trials

24 Notifications of serious adverse events

25 Notifications of unexpected serious adverse drug reactions

26 Investigational medicinal product and auxiliary medicinal product labelling