Control of Clinical Trials Flashcards
Under which acts are clinical trials and clinical research materials under?
HPA and Medicines Act
What are covered under both acts?
Clinical trials and clinical research material
Does clinical research materials need product registration/license?
No
Does dealers of clinical research materials need any dealers license?
No need for any license (manufacture, import or supply). But before they engage in any transaction, they have to inform HSA.
Manufacturers must inform HSA before supply. Importers must inform HSA before importing.
They also have to keep a record of their clinical research materials
Requirements before conducting clinical trials
- Authorisation by HSA, which then issue Clinical Trial Certificate. If authorisation not necessary, HSA has to be notified about the trial
- Ethical review and approval by an institutional review board
- Conducted under the supervision of specified “principal investigator”
Definition of INFORMED consent
Participants have the right to know the following details :
- nature and purpose of trial
- treatments and procedures involved
- potential risks and expected benefits
- expected duration of the trial
Their participation are voluntary and they can withdraw at any time (w/o having to pay for any penalty)
Definition of informed CONSENT
- must get consent in accordance with a specified procedure eg writing
- must get consent from subject in person &/ his legal representative (under certain circumstances)
- EXEMPTED during emergency trials
What happens if there is any ADR?
Principal Investigator to inform ADR to Sponsor immediately
Sponsor have to report Unexpected Serious ADR (USADR) to HSA within specified period
Labelling of clinical trials
For unblinded clinical trials, in accordance to those specified in Second Schedule
For blinded clinical trials, decoding key must be readily available in case of emergency
