Addition of External and Overseas Researchers and Addition of Registrars

Researchers who are external to NSW Health/non-SLHD employees seeking authorisation to be onsite and performing research in any department or service within the SLHD [RPAH Zone] [Concord Zone] to access either patients, staff or patient’ medical record information, are required to provide the following to the RGO:

If they are an Investigator we require:

1.     A cover letter from the Principal Investigator requesting the addition of the new person.

2.    Their details on the SSA Investigator Details Form, (link at bottom of page), including whether they are a post-graduate student and the component of the research they will be conducting.     

If they are a research assistant:

1.     A cover letter from the Principal Investigator endorsing their inclusion in the project by listing their name, role in the project and relevant experience.

If they are a post-graduate student (Masters or PhD candidates) of any Australian University

1.     Provide evidence of candidature (current enrolment documentation)

2.     Names of their academic and clinical supervisors

Non - Sydney Local Health District Researchers to provide:

1.    Evidence of a Criminal Record Clearance within the last two years. For people with a NSW Health Clinical Placement Card or evidence of registration on ClinConnect, no CRC is required.

      2.    A copy of photo ID (e.g. university/hospital ID card). It is the responsibility of the [CRGH] [RPAH] researcher to      organise [Concord] [RPAH] Hospital ID; staff health checks etc. for the external researcher once they have been authorised by the RGO to perform the study on site.

3.    A signed Confidentiality Agreement. This is available in the Forms and Templates section of our website

4.    A signed Ministry of Health Code of Conduct form to confirm that they have read and will abide by the NSW Health Code of Conduct.  Copies are available here: NSW Health Code of Conduct Form

5.    A brief CV (max two pages)

University of Sydney students in the Faculty of Medicine undertaking MD projects do not need to complete the above clearance checks.

Addition of Registrars/Changes to Investigators

Addition of Registrars

• The trial coordinator should email the relevant RGO:

- with the names of the registrars to be included and the relevant project(s), and

- also email when the registrar has completed their rotation.

• The registrar must be listed in the site Delegation Log

• Annual Report (inclusion of new personnel)

- a simple statement on the annual report form referring to the “rotation of medical registrars onto the project as previously notified to the RGO” would be sufficient without having to name individuals.

Change of Principal Investigator:

Please submit as an Ethics Amendment in REGIS if the HREC is within NSW, external to NSW submit a Site Amendment in REGIS:

• A formal letter signed by both the outgoing PI and the incoming PI

• Clarify whether the outgoing PI will still have a role as an associate investigator

• If the new PI was not previously on the project please also provide:

- Their details and signature on the Declaration of Researchers (see link below)

• If a clinical trial you may need to update the regulatory documentation

• If a clinical trial and the PI will be recruiting provide a current GCP certificate

• Updated Participant Information and Consent Forms as the PI is listed in these.

- The Master version will remain the same as the change is local

- The site version and date should be updated

Change or addition of an Associate Investigator

Please submit as a Site Amendment in REGIS:

• A Notification of Change in Personnel Form signed by the PI requesting the addition of or departure of an associate investigator

• Provide:

 - Their details and signature on the Declaration of Researchers Form

• If a Clinical Trial and the Associate Investigator will be recruiting provide a current GCP certificate