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How to start a trial in Australia? * Adverse Reaction Reporting

ADRs and ADEs

Well established national procedures are in place for the reporting of adverse drug reactions (ADRs) and adverse device events (ADEs) related to pharmaceuticals and medical devices respectively, whether registered or unregistered.

Suspected ADRs must be reported in specified formats within specific time frames to the Drug Safety and Evaluation Branch of the TGA. Serious reactions must be reported immediately and reporting of less serious events must comply with less urgent timeframes.

Serious ADEs must also be reported immediately, unless the HREC accepted protocol specifically lists an exemption from immediate reporting of specific ADEs. ADE reporting needs to be directed to the Medical Officer, Office for Devices, Blood and Tissues in the TGA

More detailed information regarding ADR and ADE classifications, reporting and other reporting requirements can be found in Access to Unapproved Therapeutic Goods – Clinical Trials in Australia – October 2004.

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