Site Principal Investigator responsibilities
This page has information on the responsibilities of a site Principal Investigator (PI) for Northern Territory (NT) Health.
Processes and guidelines have recently been developed to support the changes to the institutional governance procedures for conducting research within NT Health, to bring the NT in line with national best practice in research governance.
The role of the NT Health Research Governance Office is to ensure research is conducted according to established ethical principals, guidelines for the responsible research conduct, relevant legislation, regulations and NT Health policies.
NT Health authorises the PI to assume ultimate responsibility for the scientific, technical and administrative aspects of the research project, even when certain tasks have been delegated to other members of the research team.
Checklist of responsibilities of site PIs:
1. For all research team members
- Maintain documented evidence that they have adequate qualifications and experience to perform delegated tasks and have received appropriate and adequate training in research-related procedures.
- Maintain documented evidence of accredited Good Clinical Practice certification every three years that meets the minimum criteria set out by the TransCelerate Biopharma Inc.
- Maintain an up-to-date delegation log of appropriately qualified persons to whom the investigator has delegated significant research-related duties.
- Notify the RGO of any changes in study personnel - site PI, Associate Investigators, study coordinator / study contact person, all non-NT Health staff and students accessing identifiable data or NT Health facilities.
2. For Non-NT Health research team members accessing patient identifiable data
In addition to point 1:
- complete and endorse External agency access to clinical systems form (ACIS) form
- an initial national Police check (valid within six months)
- working with children’s clearance (WWCC) if the research involves accessing data of children under 18 years of age
- evidence of indemnity.
3. For Non-NT Health research team members accessing NT Health sites
In addition to points 1 and 2:
- ensure all research members comply with NT Health policy and procedures
- maintain documented evidence of appropriate qualifications and professional registration boards
- satisfy immunisation requirements as per NT Health policy
- evidence of indemnity.
For more a detailed description of site investigator general responsibilities, go to the Good Clinical Practice Network website.
Last updated: 15 September 2020
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