4 Sponsors

5 Principal investigator, etc.

6 Investigator’s brochure

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

13 Conduct of clinical trials: good clinical practice

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

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

23A Traceability of applicable CTGT products used in clinical trials

24 Notifications of serious adverse events

25 Notifications of unexpected serious adverse drug reactions

26 Investigational product and auxiliary product labelling