Audit of Research Projects

The Office for Research considers that training and auditing are both educational activities aimed at improving and streamlining procedures.

Auditing of research projects at Melbourne Health may be initiated the HREC or by the Office for Research but in practice, all of the auditing will be coordinated by the Office for Research. Auditing of research projects is an important means by which Melbourne Health can ensure that research conducted under its auspices is conducted in accordance with GCP and approved ethical standards. Audits may examine specific research projects and documentation or the research groups /teams that undertake them.

HREC Audits: Projects may be selected for auditing for a variety of reasons: Audit of consent documentation and/or practices. HREC - may request a review of the project as part of the  conditions of approval or due to the classification of risk; Random selection as part of ongoing improvement processes; A complaint has been received; Discrepancies in Annual Progress Report compared with the approved project protocol.

Office for Research Audits: The Office for Research will randomly audit research projects for compliance with GCP and ethical guidelines from 1 August 2011. Research projects, including both investigator-initiated and externally-sponsored clinical trials, will be selected at random for audit by staff from the Office for Research.  Three types of audits will be implemented: Site Visit by Office for Research staff - The Principal Researcher and study coordinator for a given project will be contacted, by email and telephone, and provided six weeks notice that a project will be audited and a mutually convenient time for the audit confirmed. It is anticipated that the project audits will take up to 6 hours. Office for Research auditors will review study documents against the clinical trial audit form (see below under auditing documents). Desk-Top, Self-Audit - This type of audit will be completed by the Principal Researcher or nominee and forwarded to the Office for Research upon request. Themed audits: Will review one aspect across a number of studies. Themed audits may be conducted as desk-top audits or site visits depending on the theme of the audits.

To assist researchers in preparing for audits, the Office for Research has provided a suite of audit tools, which are listed below. It is recommended that researchers audit their own research teams initially using the Research Team: New Team Checklist, GCP Audit and Office for Research Audit Checklist – Research Project templates. Research teams should also set up a schedule to work through the applicable audit documents listed below to ensure their research complies with approved ethical standards and Melbourne Health Guidelines.  Auditing Documents:

Clinical Trial Audit Form Research Team: New Team Checklist Research Team: New Researcher Checklist Research Team: Researcher Self-Accreditation Checklist Research Team: Investigator Self-Accreditation Checklist for Clinical Trials VMIA Requirements for Drug & Device Trials Under CTN Scheme Checklist for Induction, Training and Accreditation –Department/Team Checklist for Induction, Training and Accreditation - Researcher Office for Research Audit Checklist – Research Project

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