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Onsite Monitoring

The Mater Research Governance Office performs onsite monitoring of research studies conducted at Mater. Monitoring of research studies is performed to ensure studies are conducted in accordance with the principles of Good Clinical Practice and adhere to the currently approved research protocol and institutional requirements. This is a crucial component of ensuring Mater satisfies its responsibilities under the National Statement and the Code, promoting the conduct of high-quality research and the delivery of exceptional, evidence-based healthcare. Onsite monitoring also identifies areas of improvement to increase the integrity of research conducted at Mater. 

The Research Governance Monitoring Officer will determine the level of monitoring for an individual study based on the nature of the research, level of risk, complexity of the study and regulatory requirements that underpin the research. Monitoring visits involve reviewing site files including ethical, governance and contractual documentation, consent forms, data collected and the processes in place for conducting the research. 

We have many resources and site file templates that you may find useful. Please contact us if you would like any of these emailed to you:

Procedures and Fact Sheets:

  • Monitoring Clinical Research Studies Procedure (also available in the Mater Policy and Procedures Library (MPPL)
  • Mater Sponsored, TGA-registered studies  
  • Delegation Log Fact Sheet

Site File Log Templates:

  • Master Site File Index
  • Participant Informed Consent Log
  • Participant Enrolment Log
  • Participant Identification Log
  • Subject Concomitant Medication Log
  • Training Log
  • Delegation Log
  • Drug Accountability Log
  • Investigational Product Log
  • Investigational Product Temperature Log
  • Adverse Event Log
  • Voucher/Expense Log
  • Monitoring Visit Log

For more information about onsite monitoring, please contact:

Mater Research Governance Monitoring Officer

Telephone: 07 3163 4338

Send an email

Level 2, Aubigny Place
Raymond Terrace
South Brisbane QLD 4101

 

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