The safety reporting responsibilities of stakeholders involved in clinical trials with investigational medicinal products (IMPs) or investigational medical devices (IMDs), are described in NHMRC: Safety monitoring and reporting in clinical trials involving therapeutic goods. The responsibilities of Sponsor-Investigators and site Principal Investigators (PIs) are summarised in two flow charts:
The site PI has a responsibility to report events that occur in participants at their site to both the Sponsor-Investigator and to their local Research Governance Office (RGO).
The Sponsor-Investigator has a responsibility to report certain safety events to all site PIs, the approving Human Research Ethics Committee (HREC) and the Therapeutic Goods Administration (TGA).
Details about the types of safety events, who must report and to whom, and the timeframe for the report, are summarised according to IMPs and IMDs:
The protocol can define certain serious adverse events (SAEs) that do not require immediate reporting to the Sponsor-Investigator. In this case, the trial specific Risk Assessment and Management Plan should provide justification. All SAEs must still be recorded in the participant’s notes and the case report form.
The protocol should describe the safety reporting requirements for the trial and be in accordance with the Sponsor organisation’s written procedure for safety reporting.
Sponsor-Investigators can provide Investigators with a template safety reporting form to facilitate the provision of useful information about SAEs, SUSARs and USMs. This information will help the Sponsor-Investigator fulfil their requirements for onward reporting of safety events to the HREC, site PIs and TGA (if applicable).
The site PI should report safety events to the local RGO using the locally approved process. For example, RGOs in Victoria may require completing the safety report form accessed within ERM and submission through the ERM portal.
The Sponsor-Investigator is responsible for reporting individual safety events and an annual safety report to the approving HREC using forms developed by the relevant state department of health. The process for submitting forms may be via a portal, e.g. ERM in Victoria, or by submitting the form via email.
See the Vic Health website for monitoring and reporting on an approved research project.
The procedure for reporting safety events to the TGA depends on the type of therapeutic good (unapproved or registered drug/device) and if the safety event is a SUSAR, USADE or SSI.
Details on how to report safety events from unapproved medicines/devices are provided in the TGA Australian Clinical Trial Handbook.
Safety reporting requirements, including the procedure to report, for registered medicines and devices, are described in the TGA Pharmacovigilance responsibilities of medicine sponsors.
See the MCRI: SOP Monitoring Visit Activities for Clinical Trials of Investigational Products for an example.
