Clinical Trials
Clinical Trials tests the PPB authorisation pathway and the ongoing safety and ethical oversight of research involving human participants.
Authorisation and oversight
A sponsor or investigator submits a clinical trial application to PPB with the protocol, investigator’s brochure, ethics review committee (ERC) approval, GCP evidence, site and investigator details, investigational product dossier, import permit application and participant protection arrangements. PPB reviews scientific quality, safety, ethics and site suitability before authorising the trial. Amendments, annual progress reports, serious adverse event (SAE) reports and protocol deviations are submitted as required. Investigational products need authorised importation and accountable storage. Informed consent must be voluntary, documented and appropriate for vulnerable participants. PPB may inspect trial sites and suspend or terminate a trial for non-compliance.
Worked example
A participant is hospitalised with a suspected SAE. The site does not wait for the annual report. It provides immediate medical care, documents the event, assesses causality and reports to the sponsor, ERC and PPB within the applicable expedited timeline. Follow-up information is submitted when available. The reasoning is that SAE reporting is time-critical: regulators and ethics committees need early signal information to protect current and future participants.
Traps that cost marks
- Assuming ERC approval alone authorises the trial.
- Importing investigational product without PPB authorisation.
- Missing SAE reporting timelines.
- Obtaining consent without proper documentation or witnesses where required.
- Failing to report protocol amendments or deviations.
- Poor accountability records for investigational products.