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Clinical Trial Toolkit

Supporting clinical trials at site

Dr Kara Vine-Perrow in IHMRI laboratories. Photo credit Paul Jones

clinicaltrialsNSW provide operational support for your clinical trial with centralised, standardised resources that support high quality trial conduct.

Our Clinical Trial Toolkit has the essential tools you need to establish your clinical trial in New South Wales.

It is a voluntary suite of documents available to anyone working in clinical trials.

National Teletrials Compendium

The National Teletrials Compendium, a significance deliverable from the Clinical Trials Project Reference Group, has now been released.

The National Teletrials Compendium supports a national approach to teletrials and consists of:

The Teletrials Compendium is consistent with the National Statement on Ethical Conduct in Human Research 2007 (Updated 2018), and also aligns with the Clinical Trials Governance Framework which has been designed to support the delivery and integration of high-quality clinical trials service provision into routine hospital care for improved patient outcomes. These National Principles for Teletrials are also consistent with recommendations from the Clinical Oncology Society of Australia’s (COSA) Australasian Teletrial Model – A National Guide to Implementation, September 2016.

The National Principles for Teletrials and the standard operating procedures have been developed to assist organisations engaged in conducting trials in Australia to, wherever possible, standardise their procedures for key operations related to clinical trials and specifically teletrials. They have been endorsed by all states and territories, together with the Therapeutic Goods Administration (TGA) and the National Health and Medical Research (NHMRC) through the CTPRG.

Compliance with the Teletrials Compendium provides public assurance that the rights, safety and well-being of trial participants are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data generated from the clinical trials are credible.

Requests and inquiries concerning reproduction and other rights to use are to be sent to the Communication Branch, Commonwealth Department of Health, GPO Box 9848, Canberra ACT 2601, or via e-mail to copyright@health.gov.au.

Standard Operating Procedures templates

The zip files contains the following templates in PDF or Word format:

  • clinical trial training and qualification
  • hosting an audit or regulatory inspection
  • sub-contracting of external vendors
  • trial feasibility and start-up
  • delegation of duties by the principal investigator
  • informed consent
  • managing and reporting safety events
  • reporting non-compliance and suspected breaches of GCP or the protocol
  • investigational medicinal product management and emergency unblinding
  • source data and case report form completion
  • handling and transporting biological specimens
  • investigator site file and essential documents
  • close-out at a trial site
  • clinical trial archiving
  • work instruction site templates (customisable Word document for use by sites to document site-specific activities/procedures).
  • Standard Operating Procedures templates volume 1

    ZIP - 1 MB

  • Standard Operating Procedures templates volume 2

    ZIP - 1 MB

  • Standard Operating Procedures templates volume 3

    ZIP - 1 MB

  • Standard Operating Procedures templates volume 4

    ZIP - 367 KB

Contact us on how to use the SOPs
How will these SOPs be implemented?
All users are encouraged to provide feedback and suggestions for improvement, as well as any suggestions for additional SOPs during the current six month review period.

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GCP, safety and compliance guidance

Protocol

The Protocol is the document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organisation of a clinical research project.

Investigator’s brochure

The investigator’s brochure is a compilation of the clinical and non-clinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects:

Finance, contracts and intellectual property

Patient information

Provides information about a clinical trial to prospective participants and a mechanism for obtaining their written consent to participate.

Updated 1 month ago