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Safety Monitoring and Reporting (from 1 April 2019)

The Eye and Ear has adopted the following guidelines from 1 April 2019

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

All guidelines are available from the NHMRC website.

The Eye and Ear Safety Monitoring and Reporting Procedures have changed and new monitoring and reporting procedures will apply from 1 April 2019.  Refer to Safety Monitoring and Reporting Changes website for a detailed description of the changes.

Risk Assessment

The Eye and Ear requires that all research projects are monitored according to a risk-based approach.

Risk assessment can be conducted using any model.  Suggestions include:

Monitoring and Safety Reporting

Refer to the sections below regarding monitoring and safety reporting requirements

Last updated 27 March 2019