Responsibilities of NT Health Site Principal Investigators and Endorsers
Responsibilities of endorsers
The role of the site endorser(s) is to assess whether the research is appropriate to be conducted at the relevant site by evaluating the research according to criteria to be considered for granting Site Specific Approval. On-the-ground assessment and endorsement is done by on-site Unit heads, Co-Directors and/or General Managers (collectively called endorsers).
The role of Unit Heads is to assess:
- There are suitable and adequate facilities and resources for the research project to be conducted at this site.
- The research is relevant to the NT Health site and aligns with the strategic goals.
- The Organisational benefit of participating in the research is consistent with the resource contribution.
- The research translation strategy is demonstrated and will provide evidence based information for improving patient outcomes, clinical care or service delivery.
- All external researchers/students involved in the research project have the skills, training and experience necessary to undertake their role.
- All NT Health researchers/students involved in the research project have the skills, training and experience necessary to undertake their role.
- There is no conflict of interest for the researcher’s or that the declared conflict of interest is acceptable.
- There is evidence of compliance with indemnity requirements.
- Requirements for access to organisational data are clear and comply with legislative and NT Health policy requirements.
- Data management, privacy and confidentiality requirements are described, and comply with legislative requirements.
The role of Co-directors and/or general managers is to assess:
- There is a clear organisational benefit of participation in the research.
- The research is consistent with the strategic objectives of the organisation.
- The research project and resource implications are within the allocated budget of the service.
- The Site Principal Investigator (Site PI) is responsible for obtaining approval from the relevant endorsers as outlined in the SSA Form. Endorsements can be in the form of email or letter and once obtained should be forwarded to the NT Health RGO.
- If an endorser is concerned about the research they are encouraged to discuss concerns with the site PI and the NT Health RGO. If approval is withheld, the rationale for doing so, or requests for additional information and/or guidance is provided by the endorser.
Responsibilities of Site Principal Investigators (PIs)
All research projects conducted within NT Health must designate an individual qualified by training and experience to serve as the NT Health Site Principal Investigator (PI).
The PI must have sufficient authority, relevant scientific knowledge, and the requisite training to personally carry out or supervise all aspects of the project at NT Health. 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.
All research team members responsibilities
- 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 training in the principles of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) every three years.
- Maintain an up-to-date delegation log of appropriately qualified persons to whom the investigator has delegated significant research-related duties.
- Notify the NT Health RGO of any changes in site PI, addition / removal of Associate Investigators, study coordinator / project contact person and all Non-NT Health staff and students accessing identifiable data or NT Health facilities, and any changes to the police clearance and working with children’s clearance (WWCC) status of any member of the research team.
Additional responsibilities for non-NT Health research team members accessing patient identifiable data
In addition to the above responsibilities:
- complete and endorse External agency access to clinical systems form
- an initial national Police check (valid within six months)
- WWCC if the research involves accessing data of children under 18 years of age
- evidence of indemnity.
Additional responsibilities for non-NT Health research team members accessing NT Health sites
In addition to both the above responsibilities:
- 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.
Last updated: 08 July 2022
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