Auditing of research projects is an important means by which RMH ensures that research conducted under its auspices is conducted in accordance with good clinical practice and approved ethical guidelines.
Auditing is also an educational activity aimed at improving and streamlining procedures.
Research project audits
Projects may be selected for HREC auditing for a variety of reasons:
- It is part of the conditions of approval or due to the classification of risk
- A complaint has been received
- Discrepancies in Annual Progress Report compared with the approved project protocol
All HREC approved projects are eligible for audit. Three types of audits are conducted by the Office for Research:
- On-site audit - Office for Research staff will review study documents using the Clinical Trial Audit Form It is expected that Principal Researchers attend the audit. The Principal Researcher will be notified prior to the audit to identify a mutually convenient time for the audit.
- Desktop audit - these are conducted by researchers. The Principal Researcher is notified when a desktop audit is required to be submitted to the Office for Research. The audit is completed by the Principal Researcher or nominee then forwarded to the Office for Research upon request.
- Themed audits - the Office for Research will review one aspect across a number of studies. Researchers will be notified if they are required to provide information for this type of audit.
Researchers are encouraged to audit their own research teams and projects.
It is recommended that researchers set up a self audit schedule to work through the applicable audit documents. This will ensure that the research complies with good clinical practice, approved ethical standards and the organisation's guidelines.