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Seeking volunteers: Good Clinical Practice Inspection Program

25 January 2021

The Therapeutic Goods Administration (TGA) completed a pilot program of voluntary Good Clinical Practice (GCP) inspections of clinical trial investigator sites involving medicinal products in June 2020. The pilot program of inspections demonstrated a capacity for the TGA to adopt internationally aligned inspection procedures.

A report on the pilot program was provided to Minister Hunt who endorsed implementation of an ongoing GCP clinical trials inspection program. Updates to the Therapeutic Goods Regulations 1990 and the registration of the Therapeutic Goods (Clinical Trial Inspections) Specification (No.2) 2020 establish the legislative powers to support an ongoing GCP inspection program.

As planning for an ongoing program is underway we now seek volunteers to assist us as we further refine our inspection processes and approach. Investigator sites involved in clinical trials of SARS-CoV-2 vaccine candidates are particularly encouraged to consider volunteering.

Volunteering

Organisations conducting regulated clinical trials and interested in volunteering are invited to contact GMP@health.gov.au.

GCP inspections conducted under the pilot program are of clinical trial investigator sites involving medicinal products. These inspections are conducted free of charge over three days and may be performed remotely.

Resources

Contacts

For any GCP Inspection Program enquiries please email GMP@health.gov.au.