Auditing research projects
A Self Audit Tool has been designed to help research personnel reflect on their research conduct and comply with guidelines for responsible research conduct.
Relevant members of the study team should complete the Self Audit annually, list the names of those who have completed the Self Audit in the annual Progress Report (if using the Alfred template) and retain completed Self Audits as part of the study files.
Audit by the Research Governance Officers
Research Governance Officers regularly conduct short audits of a range of research projects including low risk review 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 the arrangements 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 and to provide researchers with a list of prospective questions.
Occasionally, a full audit of the project is undertaken. This involves the Research Governance Officer examining all of the study files, observing randomisation procedures etc in detail. This may take two or three days and can be spread over several sessions if necessary. Researchers will be informed if a full audit is to take place.
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 respond to the Office of Ethics & Research Governance within a month of receiving the report. If this is deemed satisfactory the audit will be considered closed. If this is not satisfactory the researcher may need to discuss the issues with the Research Governance Officer, the Director of Research and/or nominated members of the Ethics Committee, who can assist with resolving specific issues.
If researchers do not notify the Office of Ethics & Research Governance of the action taken within a month of receiving the audit report, ethics approval for the project may be withdrawn or the research be suspended.
Common problem areas
Issues frequently identified during audits of research projects include: compliance with privacy and confidentiality requirements; poor and slow recruitment; inadequate notification of research participation in the participant's medical records; inconsistencies with consent form completion and changes to research methodology and recruitment without seeking ethics approval.
Researchers must direct all complaints regarding the conduct of the audit to the Manager, Office of Ethics & Research Governance Alfred Health, by email: firstname.lastname@example.org or email@example.com