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Safety Monitoring and Reporting (from 23 October 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 Monitoring and Safety Reporting of Research Projects Procedures (including a summary table) have been reviewed and updated and apply from 23 October 2019. 

 

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:

• Table 1 of NHMRC Guidelines 'Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods'
• European Clinical Research Infrastructure Network
• Northern Sydney Local Health District Assessment for clinical trials

Monitoring and Safety Reporting

Refer to the sections below regarding monitoring and safety reporting requirements:

Last updated 23 October 2019

• Non-clinical research

  This section relates to research which does not involve patients or procedures: Analysis of data only Observational research

• Clinical Research

  This section relates to clinical research only. If the research project is a Clinical Trial then refer to the Clinical Trial section. Procedures

• Clinical Trials

  This section specifically relates to Monitoring and Safety Reporting for Clinical Trials

• Frequently Asked Questions

  Why does the Eye and Ear request information from the Sponsor? The Eye and Ear may from time to time request additional information from the Sponsor to facilitate compliance with the NHMRC Guidelines Extract from Safety monitoring and reporting in...