Systems and processes - University of the Sunshine Coast, Queensland, Australia

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Systems and processes

To maintain accountability and oversight over our clinical trial operations we employ a comprehensive set of processes and systems to ensure we adhere to high standard of best practice.

All processes are guided by a set of Standard Operating Procedures
  • monitoring of Electronic Medical Records (EMR)
  • ethics and governance
  • contracts and fees
  • insurance and indemnity
  • Investigational Product (IP) management and dispensing
  • invoicing and payment terms
  • consent process
  • training (protocol specific, Good Clinical Practice (GCP))
  • maintaining clinical trial equipment
  • documents and record management including archiving
  • biological sample collection, handling and shipping
  • safe transport of biological samples - International Air Transport Association (IATA) Dangerous Goods Regulations (DGR)
  • safety reporting
  • data entry and query resolution

Systems available at site:

  • MediClinic (EMR)
  • Realtime Clinical Trial Management System (CTMS)
  • Documents and record management (Trial Master File, Investigator Site Files)
Please see below for a list of our current SOPs:
  • CTCSOP001 SOP Management
  • CTCSOP004 Study Organisation and Planning
  • CTCSOP005 Documentation of Investigational Site Qualifications
  • CTCSOP007 Pre-Study Planning Investigational Products
  • CTCSOP008 Investigator Meeting
  • CTCSOP009 Site Initiation Visit
  • CTCSOP010 Subject Recruitment
  • CTCSOP012 Investigational Product Management
  • CTCSOP013 Investigator Site File and Essential Documents
  • CTCSOP014 Obtaining Written Informed Consent
  • CTCSOP015 Monitoring Visit
  • CTCSOP016 Review of Protocol Amendments
  • CTCSOP017 Storage and Monitoring of IP
  • CTCSOP018 IP Destruction
  • CTCSOP019 Ethics Applications
  • CTCSOP020 USC CTC Governance and Site Approval of Clinical Trials
  • CTCSOP025 Equipment Control and Asset Management
  • CTCSOP027 Subject Complaints
  • CTCSOP030 Adverse Event and Serious Adverse Event Reporting