Terms and conditions

On this page you will find important information about engaging Pathology Queensland for your clinical trial or research project.

Please contact us as early as possible in your project planning phase to ensure that we can provide you with the service that you need.

On this page:

Application and setup

To engage our services please complete our clinical trials or research application form.

In your application, please ensure that you clearly outline Pathology Queensland’s involvement in the project—including any cost and resource implications. We may not perform activities that are not agreed to in advance.

Please indicate which services you require from us, such as:

  • tests in the protocol
  • sub-studies required, if any
  • clinic or hospital staff required to undertake any of the services described in the protocol that relate to pathology testing
  • any pathology testing or sample processing outside of standard business hours.

Once the application is received it will be reviewed. We may contact you to clarify your requirements. We will then assign your project a unique Pathology Queensland reference number (CT #). This number should be included in all future project correspondence with us.

Projects that require access to patient information, such as data and diagnostic material, may need additional approvals and documentation.

To accept our terms of service we will supply you with a written quote. This quote must be signed by the applicant and returned to us as acceptance of our services.  We may require proof of financial approval before services can begin.

We will supply you with pre-printed request forms. These forms must be used for any testing or activity including storage and processing. These forms will include:

  • computer codes that link the activity specifically to the trial or project
  • specific collection and/or processing instructions
  • specific storage location (if required) to ensure specimens are traceable
  • Pathology Queensland reference number (CT #).

Clinical trial or research project requests that are received on forms without the Pathology Queensland reference number may not be processed. Tests that are handwritten on these forms will not be accepted unless they are approved by the laboratory beforehand.

Please keep local laboratory staff informed about the project or trial to enhance our service delivery to you.

Available tests

For a list of available tests, refer to the Pathology Queensland test list. For tests that are not on the test list, please contact us for pricing.

Patient records

Results and records for research activities identified by a hospital UR number will be included in patient records. Please advise if you require any de-identification or additional confidentiality of patient data.

Multi-site research

If your project or trial is to be conducted at multiple Queensland Health sites, you will need to advise us which sites will be involved. A clinical trial or research application form should be submitted for each site unless the project is managed centrally. The application must clearly advise which services are required at each site. Project documentation such as clinical protocols, laboratory manuals or ethics approval only need to be submitted once.

Pre- and post-analytical services

Sample collection (such as venepuncture) will not be included in test costs unless indicated. Pre- and post-analytical services will be included in test costs where testing is by a standard Pathology Queensland methodology. Other situations will be costed on a case-by-case basis.

Referred testing

Tests that are not performed or referred by Pathology Queensland must be contracted by the researcher.

Pre-analytical services may be available in order to prepare specimens for external testing. These should be budgeted for in addition to the test costs levied by other providers.

Accessing Pathology Queensland laboratories

Access to the laboratory, or use of our equipment, may only be granted through prior arrangement and with approval from the laboratory manager.

If you would like to visit a laboratory, contact the Client Services manager who will seek approval from the relevant laboratory manager on your behalf. We require at least one week’s notice to organise laboratory visits.

Those wishing to access a laboratory to use equipment or facilities will be required to undergo an induction process. Please provide a list of approved research assistants or other personnel who require access to the laboratory, or to whom specimens may be released to.

If you would like to perform an audit, please make the request in writing.

Find a Pathology Queensland laboratory.

Releasing patient tissue or other samples

Patient consent is required to access materials for research that were originally collected for patient diagnosis. When patient consent cannot be obtained approval to access materials can be sought from the Director General of Queensland Health.

Read more about accessing confidential information at Queensland Health.

Prior to considering a request to access patient tissue we may ask for evidence of ethics approval.

When requested to release a tissue sample, we may do so on the possibility of retaining some tissue for future diagnostic requirements.

Where required, we will provide cut tissue sections. Requests for diagnostic tissue blocks will be reviewed by the appropriate anatomical pathology director on a case-by-case basis.

Archived tissue recall and pathologist review will incur additional costs. You will be advised of these costs before the work is undertaken.

Communication

Prior to starting the project, communication will primarily be with Pathology Queensland Client Services’ staff. After the project is setup, communication will predominantly be with staff at the laboratory performing the services.

The client is responsible for communicating all protocol amendments and organising scheduling with the laboratory so that the project can be accommodated.

To enable us to effectively communicate any issues directly related to a specimen or testing, please provide an appropriate contact on the request forms. A clinic, mobile or pager number is desirable.

Priority

Our priority for pathology activities is governed by our commitment to patient safety; therefore, blood collections for clinical trial patients will not be given priority over other patients.

Monitoring and inspections

Please discuss your monitoring and inspection requirements with the laboratory. For example, include standard logs, forms and documents that need to be maintained relating to sample processing and storage, monitoring visits or audits.

Public Health Act approvals

Researchers can apply for the release of confidential information from Pathology Queensland for the purposes of research under the provision of Section 280 of the Public Health Act 2005.

You will need to complete a Public Health Act (PHA) application form and send it to Pathology Queensland’s data custodian for authorisation prior to submitting the application to the Director-General for approval.

Once the Director-General has approved the request, present the approved PHA application form and ethics approval to the Client Services team so that the material, or data, can be released.

Read more about accessing confidential information at Queensland Health.

Accessing data

To request access to data, including test results, from our laboratory systems, please contact our Client Services' team for a data request form.

Accreditation and certificates

Upon request, we can supply you with copies of our accreditation certificates and relevant CVs for laboratory staff.

Our NATA accreditation details are available on the NATA website. Go to the 'Search' field, insert 'Pathology Queensland' in section 1. In section 2 select 'Facility name or location' then click on 'Search'. Current details for all Pathology Queensland sites are available.

Information management

All documentation related to a clinical trial will be logged in our digital data storage database.

Reference ranges

Our Client Services' team would be happy to provide details of reference intervals for commonly requested tests.

Need more information?

Contact our Client Services’ team:

Last updated 01 January 2018