Ethics and governance - University of the Sunshine Coast, Queensland, Australia

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Ethics and governance

Clinical Trials approval pathway

Step 1: Site identification
Step 2: Confidentiality agreement
  • USC encourages institutional confidentiality agreements to cover specific and prospective collaborations
  • confidentiality agreements are signed by the USC Clinical Trials Director
  • an attempt is made to complete and return confidentiality agreements within 1-2 business days
Step 3: Feasibility assessment
  • a feasibility assessment should be completed in combination with the therapeutic area leader/Principal Investigator
  • detailed potential cohort analysis and patient funnel can be provided
  • perform on site or virtual site visit
  • institutional fees and study charges will be provided based on final protocol
  • recruitment strategies and plan discussed
  • feasibility assessment sent via email to the USC Clinical Trials Director
  • an attempt is made to complete and return the feasibility assessment within 2-5 business days
Step 4: Site selection
  • Sponsor to formally notify the USC Clinical Trials which of its sites will participate in clinical trial.
Step 5: Ethics approval
  • USC accepts ethics approval from any National Health and Medical Research Council (NHRMC) certified committee under the National Mutual Acceptance scheme
  • USC Clinical Trials Centre can act as lead site to coordinate initial submission or as a participating site in accepting ethics approval from a NHRMC certified committee
  • preparation for ethics submission can take 1-2 weeks
  • USC monitors all ethics and governance process metrics
  • typical ethics approval timeline is about 20-30 business days
Step 6: Governance approval
  • governance and ethics submissions can be prepared in parallel
  • a standardised contract is used in accordance with Medicines Australia
  • budget and contracts can be reviewed within three business days
  • full institutional governance approval is estimated to take two weeks to obtain
Step 7: Site initiation
  • sponsor conducts training of investigative site
  • Clinical Trial Notification received
  • investigational product received at site
  • patient recruitment plan completed
  • pre-screening activities commence pending ethics and governance approval
  • delegation of responsibilities documented
  • communication and monitoring plan detailed
  • formal notification from sponsor indicating USC Clinical Trials can commence recruitment of participants to the clinical trial