Research & Ethics Unit

 Auditing and monitoring
Home > Research governance > Auditing and monitoring

Monitoring process

The Ethics Committee is required to monitor all approved research in accordance with the National Statement on Ethics Conduct in Human Research (2007).

Monitoring adverse events

Researchers must monitor their research in accordance with guidelines contained in the National Statement on Ethical Conduct in Human Research (2007). They must report adverse events where necessary, to the appropriate authorities including the Office of Ethics and Research Governance.

Audits of research projects

Self audit

A Self Audit Tool has been designed to help research personnel reflect on their research conduct and comply with guidelines for responsible research conduct.

The Ethics Committee requires that all relevant members of the study team complete the Self Audit annually, list the names of those who have completed the Self Audit in the annual Progress Report and retain completed Self Audits in your study files.

Audit by the Ethics Committee

As part of the Committee's research governance obligations, the Research Governance Officer regularly conducts short audits of a range of research projects. This involves meeting with researchers to:
  • Examine relevant documentation including signed consent forms, completed Case Report Forms, data spreadsheets, medical records, correspondence and approval certificates
  • Check on arrangment to protect privacy and confidentiality of participant data
  • Check source data

This process usually takes around two hours. The Research Governance Officer will contact researchers a fortnight before the audit to set up a mutually convenient time.

Occasionally, the Ethics Committee may recommend that a full audit of the project is undertaken. This involves the Research Governance Officer examining all of the study files, observing randomisation procedures etc. This may take two or three days and can be spread over several sessions if necessary.

Within a week of completion of the audit, researchers will receive by email, an audit report including a summary of the main findings and a list of items that require action in order to comply with guidelines for good clinical practice. Researchers are expected to take appropriate action and notify the Ethics Secretariat within a month of receiving the report. If this is deemed satisfactory by the Committee, the audit will be considered closed. If the Committee is not satisfied, the researcher may need to discuss the issues with nominated members who can assist with resolving specific issues.

If researchers do not notify the Ethics Secretariat of the action taken within a month of receiving the audit report, the Ethics Committee can recommend that approval for the project be withdrawn.

Common problem areas

Issues that surface most often during audit of research projects include compliance with privacy and confidentiality requirements, participant recruitment numbers and timelines, notification of research participation in the participant's medical records and registration of clinical trials with the WHO trials registry.

Complaints

Researchers must direct all complaints regarding the conduct of the audit to:

Manager, Ethics & Research Governance
Research & Ethics Unit
The Alfred Hospital
55 Commercial Road
Melbourne  VIC  3004

or email research@alfred.org.au

[ ^ ]


This page was last modified on 17/02/12

The Alfred 2000 - 2012
E-mail: research@alfred.org.au