Study Management

In accordance with Good Clinical Practice (GCP) and International Conference on harmonisation (ICH) guidelines, the following section has been created to help you through the processes and procedures of managing your study.

Research study management refers to the ongoing oversight of your research project that enables you to ensure the rights, safety, dignity and wellbeing of research participants are safeguarded at all times, while also preserving the scientific integrity of the research.

The processes and systems will vary depending on the nature of the research but may include the following:

• The research team
• Research documentation and file management
• Amendments
• Progress and safety reporting
• Reporting recruitment data
• Audit and monitoring of project
• Data management and validation
• Suspension and termination of research projects