Ensuring Safety

Ensuring the safety of your trial participants is the most important task when conducting a clinical trial.

Sponsor-Investigators, site Principal Investigators (PIs) and their research staff, institutions and ethics committees all have a responsibility to monitor, assess and report safety events that occur in investigator-initiated trials (IITs).  

Institutions should have standard operating procedures and supporting guidelines and templates to help everyone monitor and report safety events for IITs.  

See the MCRI: SOP Monitoring Visit Activities for Clinical Trials of Investigational Products for an example.

Responsibilities and decision-making

The process for reporting safety events can be confusing. To make it easier to understand here are two process maps that show the responsibilities and decision-making process for both the Sponsor-Investigator and site PIs when monitoring, assessing, reporting and documenting safety events:

• MCRI: Sponsor-Investigator IIT Responsibilities: Safety Monitoring, Assessment, Documentation and Reporting
• MCRI: Site Principal Investigator IIT Responsibilities: Safety Assessment, Documentation and Reporting

Regulatory guidelines

• NHMRC: Safety monitoring and reporting in clinical trials involving therapeutic goods
• TGA: Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
• TGA: Australian clinical trial handbook: Guidance on conducting clinical trials in Australia using 'unapproved' therapeutic goods
• TGA: Pharmacovigilance responsibilities of medicine sponsors
• TGA: Australian regulatory guidelines for medical devices (ARGMD)