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March 2019 - Changes to the Safety Monitoring and Reporting Procedures

The Eye and Ear previously had the following procedures

RS1.3 HREC Procedure Protocol Deviation or Violation Reporting

RS1.4 HREC Procedure Monitoring and Safety

RS1.6 HREC Procedure Safety Reporting

These Procedures have been combined into a single procedure RS1.4 Safety Monitoring and Reporting for research projects v3 dated 27 March 2019

The NHMRC released the following guideline documents which the Eye and Ear have adopted and incorporated into Procedure RS1.4:

  • Safety monitoring and reporting in clinical trials involving therapeutic goods (NHMRC; November 2016)
  • Risk-based management and monitoring of Clinical Trials involving Therapeutic Goods (NHMRC; 2018)
  • Reporting of Serious Breaches of Good Clinical Practice (GDP) or the Protocol for Trials Involving Therapeutic Goods (NHMRC; 2018)
  • Data Safety Monitoring Boards (DSMBs) (NHMRC; 2018)

The key changes are:

  1. Removing the requirement to submit individual reports of adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), unanticipated serious adverse device effects (USADEs) and six monthly line listings to HRECs.
  2. Removing the requirement to submit individual reports of AEs, SAEs, SUSARs/USADEs and six monthly line listings to investigators to align with EU Regulation.
  3. Removing the requirement to submit individual reports of AEs, SAEs, external SUSARs/USADEs and six monthly line listings to institutions.
  4. Including the requirement for sponsors to provide HRECs with an annual safety report. 
  5. Clarifying requirements and terminology for the reporting of significant safety issues.

The aim of the changes is to 

  1. Ensure the safety, health and well-being of research participants / patients
  2. Adopt NHMRC guidelines
  3. Align Procedures with other Australian sites
  4. Facilitate research

The Research Office welcomes your feedback and suggestions for further improvement.

Last updated 27 March 2019