• NSWHP is improving the way we offer research services with a new streamlined online eResearchWithUs application portal.
• Researchers can request access to NSWHP research biospecimens, data or services via the eResearchWithUs application portal.
• In recent years, NSWHP has worked to improve governance and agreements for research and material transfer, in accordance with the Human Tissue Act and NSW Health research policies.

• Researchers who want to use NSWHP biospecimens, data or research services must apply through our eResearchWithUs portal.
• One application for each customer/site should be submitted by the responsible Coordinating Principal Investigators or their delegates. For example:
  • John Hunter Hospital is taking part in a national/global study and wants access to services/tissue from any NSWHP facility. It completes an eResearchWithUs application and request ‘statewide setup’* to include patients they have recruited who have been treated both at John Hunter Hospital/HNELHD and at other hospitals in NSW.
  • Westmead Hospital is taking part in the same study. It also has to complete an eResearchWithUs application. It may request services/tissue for patients treated at Westmead Hospital only (location in application is Western Sydney) or can also choose ‘statewide setup’ to include patients who have been treated at other hospitals.
• If sponsor request services/tissue direct from NSWHP’s Research Team, separate customer/site applications are not required, sponsor fills out eResearchWithUs application.
• Where NSWHP staff are investigators in collaborative projects, a site-specific assessment (SSA) must first be generated by adding ‘NSW Health Pathology’ as a site in REGIS. Our Research Governance Office will then approve the SSA and notify you if an eResearchWithUs application is also required.

*Statewide Setup costs more but can save time and efficiency when tissue is later located at other NSWHP locations. See our Statewide Pricing here.

• You can easily access the eResearchWithUs application portal here.
• Alternatively, you can save this page as a favourite on your computer for quick access.

• Absolutely! The eResearchWithUs application allows you to save your progress at any point and generates a unique return code you must save.
• With this code, you can resume your application later by simply clicking on the link provided in the email you receive.
• If you lose your unique code, contact the Research Office to retrieve your code.

• You cannot return to your application after you have submitted it. If you need to make any changes to your application, you can reach out to your local research coordinator and reference your ‘Record ID’ from your confirmation email.
• If you are unsure who your local research coordinator is, see below.

• Your application is automatically directed to your local research coordinator.
• Your local research coordinator will review your application and supporting documents.
• We will check with our laboratories to make sure we can deliver the services you want.
• If anything is missing or unclear, we will reach out to you to clarify your needs.
• Subsequently, you will receive a quote based on your specified requirements.

• Carefully review your quote to make sure it accurately reflects the services you requested.
• If you need to update or add to the services quoted, please contact your local research coordinator.
• Please return your accepted and signed quote with any extra documents we’ve requested.
• We enter into a research agreement with you for the project.
• Once a research agreement/Quote+ is signed by both parties you will be provided with a Research Request Form to be used to request your research services from NSWHP.
• If your project involves sample collection processing or testing, we will supply you with your pathology request form.

Yes. An application is still required to obtain a site selection quote. There is no charge for requesting a quote, and ethics approval is not required at this stage. A draft quote will be provided to support budgeting and feasibility assessments during site selection.

If a study is no longer proceeding, please notify the NSWHP Research Coordinator as soon as possible. Early notification allows any related assessments, quotes, and site processes to be closed or updated in a timely manner.

HREC ETHICS

• HREC Application if ethics has not been granted yet
• Initial Ethics Approval (includes conditions)
• Proof of Extension/Renewal

PATIENT INFORMATION CONSENT FORM (PICF) - IF TISSUE IS REQUIRED

• Main PICF
• Optional PICF (if applicable)

PROTOCOL

• Protocol (ethically approved)
• Are any local NSWHP PIs included in this study? If yes, please notify the NSWHP coordinator in your application

LAB MANUAL FORM SPONSOR

• Lab Manual for Central Lab Processing
• Lab Manual for Tissue/Biological Sample Processing

TABLE OF ANALYTES

List of Local Lab testing and processing for NSWHP

The establishment fee will be invoiced once the relevant agreement has been signed by all parties and is fully executed. At that point, the study is considered formally established, and the fee will be invoiced in accordance with the agreed arrangements.

Primary contact: Refer to the NSWHP Catalogue: https://catalogue.pathology.health.nsw.gov.au/home OR
NSWHP Customer Service at local hospitals

A Draft quote (Word doc) will be sent to you for your review to ensure we are capturing all necessary services required. Please confirm that this draft is correct. We don’t need a signature at this stage.

NSWHP Research Coordinators will then seek necessary approvals from the laboratories and operations. Once received, we will send the quote to you in PDF format for signature.

Your organisations delegation manual will typically state who is authorised to sign off on research agreements. For LHD, the local Research Governance Office (RGO) should be able to advise.

Approval timeframes can vary depending on the services involved and the approvals required.

NSWHP requires the laboratory to approve they have capacity to take on the research work and studies involving tissue services require both local Clinical Director approval and operational approval before they can proceed. For all other services, including collection, processing, and testing, approval is required from the relevant Laboratory Manager as well as operational approval. Delays can occur when multiple reviews are needed or when additional information is required to support the approval process.

A completed NSWHP Research Request form, the Fully Executed Material Transfer Agreement (MTA) and signed patient consent are required to action a tissue request.

Please send this paperwork to your local Anatomical Pathology Laboratory as outlined in the NSWHP Research Request form.

Please send all paperwork the NSWHP Research Coordinator. The coordinator will confirm a current MTA is in place, seek the necessary lab approvals and set up billing for the site before updating the request form to include these details.

Please send all paperwork to the relevant NSWHP Research Coordinators and the Research Coordinator will check whether there is an MTA in place.

Please see the NSWHP Test Catalogue, quick links: Clinical Trial and Research Information

If you cannot find what you require, please reach out to the relevant lab contact in the Test Catalogue or email your local Research Coordinator.

The protocol is ethically approved and outlines the overall study design, objectives, methodology, participant requirements, and study procedures. It provides the high-level framework for how the research will be conducted.

A laboratory manual (sometimes called a lab manual or laboratory handbook) contains the detailed instructions required for laboratory staff to process study samples correctly. This may include sample collection requirements, processing procedures, storage conditions, shipping instructions, testing requirements, and timelines. This is particularly important for studies involving central laboratory blood samples and tissue specimens, where specific handling requirements must be followed.

Any Central Lab blood processing will need to be dropped off within appropriate Central Specimen Reception (CSR) hours (from 8:30am) as follows:

• For same day, courier pick up, samples to be dropped off by 11am on the day
• For next day courier pick up, samples to be dropped off by 3pm (2pm in some hospitals) a day prior

These may vary slightly from Hospital to Hospital.

Any samples arriving outside the standard hours listed will be subject to Out of Hours and additional staff time charges. Please give 24 hours’ notice of any Central Lab processing to our CSR Lab.

The best way to ensure the kit is at hand for the central lab processing is to provide it to the patient and ensure the patient takes it along when they present to have their blood collected. You could also take it along if you are accompanying the patient to collections.

Please ensure all kits are pre-labelled to avoid any interruptions with processing and ensure the tubes are all in date.

This is only required for Central Lab processing of blood samples. A calendar invite is required at least 24hours prior to the sample arriving in the laboratory.

If all paperwork has been submitted, you can expect a draft quote with 1-2 weeks. Once a draft is returned and ready to proceed, subject to approvals, this can be finalised within 3-4 weeks.

These may vary from region to region and best to contact your assigned Research Coordinator.

A Participant Information and Consent Form (PICF) is an ethically approved document that provides potential study participants with information about the research, including its purpose, procedures, risks, benefits, and privacy arrangements.

NSWHP needs to review this document if the study requires surplus diagnostic samples (i.e. archival FFPE tumour tissue) to know the patient has been informed about the samples going overseas.

The full protocol is required to enable a comprehensive assessment of the study and its impact on NSWHP services. While a protocol snippet may describe a specific laboratory procedure, it often does not provide sufficient context about the overall study design, participant requirements, visit schedules, sample collection timepoints, testing requirements, data collection, or sponsor expectations.

Reviewing the full protocol helps ensure that all pathology-related activities are identified, costed accurately, and assessed for operational feasibility. Submitting the ethically approved protocol reduces the need for follow-up queries and supports an accurate feasibility and approval review.

Before a Research Request Form can be released, several internal NSWHP has to set up the study for ordering and billing (to do this we require a fully executed research agreement).

Any proposed changes to study-related NSWHP services, must be submitted for review and approval before they can be implemented.

A revised Quote 2 may be required to reflect the additional work and associated costs. The requested changes will undergo the relevant approval processes and set up for ordering/billing.

Responsibility for courier bookings, sample pick-up arrangements, and sample shipment rests with the study team, not NSWHP. The study team is responsible for coordinating logistics and ensuring that samples are packaged, labelled, and transported in accordance with the study protocol, laboratory manual, and any applicable regulatory or sponsor requirements.

NSWHP will perform the agreed laboratory services; however, the study team remains responsible for organising and funding any courier or shipment requirements unless alternative arrangements have been specifically agreed to in writing.

• Our Research team is here to assist you. Feel free to get in touch via email at [email protected] or reach out to your local research coordinator.
• Visit our website for more information and to find your local Research Coordinator https://pathology.health.nsw.gov.au/research/research-services.