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
11A Clinical trials in emergency situations
12 Coercion
13 Duty to give full explanation and information
14 Subjects to be treated by certificate holders
15 Licensing authority may require information and report
16 Notification of serious adverse events
17 Test materials’ particulars, identification and storage
18 Record of clinical trials
19 Financial interest in clinical trial
19A Duty to comply with guidelines and instructions of licensing authority
20 Penalty
Legislative History