Medicines (Clinical Trials) Regulations
Table of Contents
1 Citation
2 Definitions
3 Clinical trial
4 Exclusions
5 Application for certificate for clinical trial
6 Period of validity of clinical trial certificate
7 Principal investigator to supervise clinical trial
8 Clinical trial confined to place specified
9 Discontinuance of clinical trial
10 Change of principal investigator
11 Consent required to use person as subject in clinical trial
12 Clinical trials in emergency situations
13 Coercion
14 Duty to give full explanation and information
15 Subjects to be treated by certificate holders
16 Licensing authority may require information and report
17 Notification of serious adverse events
18 Test materials’ particulars, identification and storage
19 Record of clinical trials
20 Financial interest in clinical trial
21 Duty to comply with guidelines and instructions of licensing authority
22 Penalty
Legislative History