Monitoring helps make sure that:

• you're carrying out your approved research according to the research proposal or protocol
• the research is keeping to time and budget
• you're conducting your project ethically.

Who's responsible

Monitoring is a shared responsibility between:

• researchers
• the institutions where they perform their work or are employed
• the Human Research Ethics Committees (HREC) assigned to your project
• any sponsors
• any expert committees who help any of the above groups.

We need to make sure that any research work done in our facilities meets relevant legislation, codes of conduct, standards and guidelines.

Our Research Office team can monitor any approved research undertaken at Sunshine Coast Hospital and Health Service. This is beside any external monitoring or auditing from clinical trial sponsors.

Monitors are also able to help you make sure that your research uses best practice processes and procedures.

A monitoring activity may review and support you with the following:

• conducting your research the way it has been approved in your protocol
• using the right documents
• getting the informed consent process right
• the right use and sharing of patient data
• your HREC and Research Governance reporting and correspondence
• how you're training and delegating to your research personnel
• how you're verifying data and source data availability
• how you store and account for your investigational product
• your data collection forms and methods, storage, and security issues
• how you're implementing approved project amendments
• keeping up to date the credentialing and CVs of researchers
• any other reviews of documents or processes specific to a project protocol
• any other support we can give you to make your research processes easier to manage.