Running Your Study

Research study management refers to the ongoing oversight of your research project that enables you to continue to ensure that the rights, safety, dignity and wellbeing of research participants is 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

The following pages have been created to help you through the processes and procedures of running your study according to Good Clinical Practice (GCP) and International Conference on harmonisation (ICH) guidelines.