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RGS
 

Roles in RGS

Other references
Training Manual ​for All Users

 

​​​​​​​​​​Below is a reference to all the roles used within RGS which allow different levels of security to users.  These include the different roles that can be selected when requesting access, the roles that identify people within a project and the different administrative roles within the RGS:

Access Roles

RGS User

This role is automatically given to all users that have been granted access to RGS. This role allows you basic access to the system, with a limited summary view of projects.

Research User​

This role should be selected if you are intending to be a member of a research project team (Project Member) involved in an application processed through the RGS.  Your specific role within each project may differ.   You can be a Coordinating Principal Investigator (CPI)​, CPI Delegate, Principal Investigator (PI), PI Delegate, Associate Investigator (AI), Research Group Member (RGM), Sponsor​ role which gives you different levels of access/security within the project.

Hospital Administrator (HA)

This role is allocated to a person, who is appointed to, or acting in, a position within the organisation that has to decide whether to provide resources or services to support a research project; or authorise the commencement of a project at a site. This may involve one or more of the following: 

  • Provision of information, including quotes, for departmental resources and/or services to enable the development of a budget for a project.
  • Provision of either an authorisation or decline decision to provide departmental resources and/or services for a project on the governance application and budget.
  • Review and decide whether to provide authorisation to conduct a project within a department or at a site.

This person can be a Data Custodian, Data Steward, Head of Research Department (HoD), Head of Supporting Department (HoSD), Business Manager (BM), Divisional Director (DD), Regional Director (RD​) or Chief Executive (CE).

Committee Member (CM)

This role is allocated to a person that has been appointed to a position on a WA Health Human Research Ethics Committee (HREC) or their affiliated subcommittees.

Research Governance Officer (RGO)

This role applies to a person that has been appointed to an administrative position within a WA Health Research Governance (RG) Office. The role has the following responsibilities:

  • Approves or declines a request for new project workspace creation.
  • Reviews forms and supporting documents related to governance applications and administers site authorisation documentation. Provides recommendation for site authorisation to the CE or Delegate.
  • Reviews and manages the monitoring of authorised research projects.
  • Produces reports on behalf of the organisation.

Ethics Executive Officer (EEO)

This role applies to a person that has been appointed to an administrative position within a WA Health Ethics Office. The role has the following responsibilities:

  • Provides administrative support and advice on the HREC, its subcommittees and the sponsoring institution's processes for ethical review of research projects conducted under the HREC's approval.
  • Assigns projects to a meeting agenda.
  • Creates and updates the minutes of the meeting.
  • Drafts correspondence and produces reports on behalf of the committee(s).
  • Performs the administrative requirements of the committee(s) as agreed and directed by the Chair.

Project Roles within RGS

Coordinating Principal Investigator (CPI)

Within the RGS, there is only one CPI per project and must be the person communicating with the WA Health HREC. The CPI may also be known as the Chief Investigator/Researcher, Lead Investigator/Researcher. The role has the following responsibilities:

  • Overall responsibility for the conduct, monitoring and reporting related to the research project for all sites under the HREC's approval.
  • Submits a request to create a project workspace through 'Create Project' form, which designates them the role of CPI.
  • Nominates the sites where the project will be conducted.
  • Invites Project Members to the project, including their delegate. The CPI must invite the PIs. Ensure external sponsors are only given the Sponsor role.
  • Authorises in Project Details - Project Header, Ethics Information and Investigator Contact Information.
  • Completes the ethics application forms and uploads supporting documents.
  • Authorises the ethics application forms and supporting documents included in an ethics application submission.
  • Submits ethics applications for scientific and ethical review by the HREC.
  • Corresponds between the HREC Chair (and subcommittee), the Sponsor (if applicable) and PI.
  • In a single-centre research, the CPI and PI may be the same person. In RGS, all sites must be allocated a PI, including those involved in an Access Request.

CPI Delegate

In the RGS, the CPI can appoint one Project Member to be their CPI Delegate. This position can be changed to another person at any time. The CPI Delegate can fulfil most of the CPI responsibilities in the RGS. If the person holding the CPI position leaves the project the CPI Delegate automatically leaves their position and becomes a RGM of that project.  

The CPI Delegate has the same access/security rights for the research project as the CPI within RGS, with the exception of authorising the ethics application form for submission.

Principal Investigator (PI) 

Within the RGS, the CPI is responsible for nominating the PIs for a project.  A PI can be PI of more than one site and must be the person communicating with the WA Health Research Governance (RG) Office. The PI may also be known as the Site PI. The role has the following responsibilities:

  • The conduct, management and reporting related to the research project for their site(s) and reports to the CPI.
  • Invites Project Members to join the project at their site (including their delegate) and manages memberships within the site(s). Ensure external sponsors are only given the Sponsor role.
  • Authorises in Project Details - Governance Information.
  • Completes the governance application forms and uploads supporting documents.
  • Authorises the research governance application forms and supporting documents included in a governance application submission for their site(s).
  • Submits governance applications for review and authorisation by the RG Office and CE for their site(s).
  • Corresponds between the CPIAI, RGM​s, HoDHoSD, BM, DD, RD​ and RGO.
  • In a single-centre research, the CPI and PI may be the same person. If this is the case, the person must be allocated both roles. In RGS, all sites must be allocated a PI, including those involved in an Access Request.

PI Delegate

In the RGS, the PI can appoint one Project Member to be their PI Delegate. This position can be changed to another person at any time. The PI Delegate can fulfil most of the PI responsibilities in the RGS. If the person holding the PI position leaves the project the PI Delegate also leaves their position and becomes a RGM of that project. 

The PI Delegate has the same access/security rights for the research project as the PI within RGS, with the exception of authorising the research governance application form for submission.

Associate Investigator (AI)

Within the RGS, the AI is any other investigator at a site who is not the PI but is a named investigator on the research project; they have the same access/security rights as an RGM within RGS. The AI is also known as the Assistant Investigator, Sub-investigator, Co-investigator/Researcher.

Research Group Member (RGM)

This is default membership given to anyone invited to the project as a Project Member who has not been given a project specific role.  Within RGS they can provide information and edit project forms and upload supporting documents to which the​y are assigned according to their security and access rights.

Sponsor

This is the designated representative of an entity that provides funding for a research project. The sponsoring organisation may be a pharmaceutical/technology company, a Contract Research Organisation (CRO), collaborative research group, a higher education institution, a research institute, or the health or medical organisation where the research is to take place.  The Sponsor can assist with the completion of the ethics application forms and supporting documents. This security access does not allow for viewing of the site Budget Form.

Administrative Roles

​Head of Research Department (HoD)

This role applies to a person that has been appointed to, or acting as a Head of Department within an organisation where the research project will be conducted i.e. the department which is spearheading the project at a site. The role has the following responsibilities:

  • Reviews the project including the feasibility of conducting it within their department.
  • Provides authorisation for the project to be conducted within the research department, including agreeing with the resources, services, costs and funding outlined in the budget form.

Head of Supporting Department (HoSD)

This role applies to a person that has been appointed to, or acting as a Head of a Supporting Department within an organisation where the project will be conducted i.e. the department which is providing resources or services to support the project. The role has the following responsibilities:

  • Provides information and estimated costs in the budget, for their department to provide resources and/or services required for the conduct of the project.
  • Provides either an authorisation or decline decision to provide departmental resources and/or services for a project on the budget form.

Business Manager (BM)

This role applies to a person that has been appointed to, or acting as a Business Manager responsible for the department intending to conduct a research project. The role has the following responsibilities:

  • Reviews the budget to ensure that the costs that impact on the site is accurately reflected and funding for services and resources are identified and agreed to.
  • Provides authorisation on the research governance form.

Divisional Director (DD)

This role applies to a person that has been appointed to, or acting as a Divisional Director with responsibility for the Division intending to conduct a research project. The role has the following responsibilities:

  • Reviews the project to ensure that the services and resources are adequate to conduct the research project within the Division.
  • Provides authorisation on the research governance form.

Regional Director (RD)

This role applies to a person that has been appointed to, or acting as, a Regional Director, within WA Country Health Services (WACHS), with responsibility for the site(s) where the research project will be conducted. The role has the following responsibilities:

  • Reviews the project to ensure that the services and resources are adequate to conduct the research project within the Region.
  • Provides authorisation on the research governance forms.

Chief Executive (CE)

This role applies to a person that has been appointed to, or acting as, the Chief Executive of the organisation. The role has the following responsibilities:

  • Decides whether site authorisation should be given to a project, based on the HREC and research governance reviews, at a site to which they have responsibility.
  • Provides site authorisation related to monitoring forms and supporting documents.
  • Can suspend a project at a site if required.

CE Delegate

The CE can delegate their authorisation rights to a person within their organisation.  The CE Delegate has the same access/security rights as the CE within RGS. 

HREC Chair

This role applies to a person that has been appointed to the position by the CE of the sponsoring organisation of the HREC.  A committee member (CM) can act as the HREC Chair for a specific meeting and is noted in the minutes of the meeting. The role has the following responsibilities:

  • Chairs the HREC meetings.
  • Provides an ethical approval decision on a research project following the HREC review.
  • Approves minutes and correspondence compiled by the EEO.

HREC/Subcommittee Member

This role applies to a person that has been appointed to a position on an ethics committee. This person can assume the role of Chair for a meeting but can't hold dual roles for the meeting. The role has the following responsibilities:

  • Reviews forms and supporting documents related to ethics applications and monitoring.
  • Corresponds with the HREC Chair and EEO.​

RGS Administrator​

This is a business administrative role within RGS to assist users with business support. The person may hold additional administrative roles within RGS at the same time, such as EEO or RGO. The role has the following responsibilities:

  • Responsible for user management and granting access to the RGS.
  • Responsible for the upkeep and configuration of data stored and managed in RGS.
  • Manages organisation and committee structures within RGS.
  • Assists in RGS user enquiries.

​RGS Support​

 This is a technical administrative role within RGS to assist users with technical issues. The person may hold additional administrative roles within RGS at the same time, such as RGS Administrator.

 

Other references
Training Manual ​for All Users

 

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