Clinical Trials and Research Facilitation
MACH Audit Tools
A commercially sponsored trial will generally be monitored by a Sponsor appointed Clinical Research Associate (CRA) whose job it is to work with the Investigator and site staff to ensure the study complies with all guidelines. Most sponsor companies and Contract Research Organisations (CRO’s) will have their own internal audit departments which could audit any site where a clinical trial is being conducted. Additionally, if the study is a pivotal study for the development programme of the investigational product, the study may also be audited by overseas regulatory agencies like the FDA (USA) or the EMA (Europe).
Investigator Initiated research often does not have the capacity (financial or resource) for regular monitoring, and is not likely to be audited by a regulatory agency. If the hospital is listed as the study sponsor then there is an obligation under ICH GCP to monitor a study especially focusing on safety matters.
The purpose of auditing within a hospital is arguably to reduce risks to the institution and to protect patient safety, rights and privacy. It would therefore seem appropriate to focus the majority of audit activities on Investigator Initiated Trials or for trials with a ‘for cause’ being a complaint by a participant, study staff member or by an external sponsor.
MACH have developed a set of checklists to assist with auditing clinical research to comply with the Australian research guidelines and the internationally recognised research standard of ICH GCP.
The three checklists can be accessed by the links below and guidelines for their use are as follows:
This tool can be sent to Researchers for them to complete and return. The aim is to highlight the key criteria of good research practice and for them to confirm compliance with the guidelines. Depending on the answers provided you may wish to audit the study in more detail.
This checklist itemises the essential documents required for research conduct and can be used for a specific audit of the Investigators site file. A thorough review of a site file could take between 1-2 hours depending on the stage of the study and how long it has been ongoing.
This tool is to be used when you are conducting a process review of a study. By reviewing the items listed you will be able to identify the following;
whether the PI has study oversight,
whether all study personnel are trained and updated on study matters
Appropriate delegation of duties
Participant safety and privacy are being preserved
Integrity of study data.