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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 assistance for your clinical trial with centralised, standardised resources that support high quality trial conduct for anyone working in clinical trials.

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

We are currently reviewing the collection of documents and resources in the Toolkit. Updates will be made accordingly to ensure currency, quality and documents remain of high standard.

Please contact the clinicaltrialsNSW team if you require assistance with locating a document.

Good Clinical Practice (GCP), safety and compliance guidance

The following documents make up the guiding principles on which research is to conducted in the Australian clinical trials environment.

For further information on Australian guidelines related to clinical trials, please visit the Commonwealth Department of Health and Aged Care’s Australian Clinical Trials website

National Teletrials Compendium

The National Teletrials Compendium, is a significant deliverable from the Clinical Trials Project Reference Group (CTPRG). 

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

The compendium was 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. The documents 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 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 clinical trials are credible. 

The documents are consistent with the National Statement on Ethical Conduct in Human Research 2007 (Updated 2018), and also aligns with the National 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. The 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. 

Requests and inquiries concerning reproduction and other rights to use the documents, 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. 

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

This section is currently under review.  

For further guidance on Standard Operating Procedures (SOPs) please see the National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia. These documents were published in 2021 and aim to help organisations standardise their clinical trial related procedures. The SOP templates have been agreed by all states and territories.      

The list below provides a guide to common SOPs considered best practice for sites to maintain:      

  • 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  

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: 

Trial registration

In August 2005 the World Health Organization (WHO) launched its International Clinical Trial Registry Platform (ICTRP). The ICTRP’s main objectives are to ensure that all clinical trials are registered and can be easily found, as well as setting standards for good registry practice. The Australian and New Zealand Clinical Trials Registry (ANZCTR) is part of this worldwide initiative. 

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. 

  • National participant information and consent form (PICF) 
  • Patient ID card – An identity card is given to participants in clinical trials. This card is approved by the studies ethics committee and contains information about the participant and study that is particularly useful in an emergency. For example, it may contain the study title, name and contact details of the Principal Investigator (PI), important study safety considerations and an emergency contact number in case the PI is not immediately contactable.     
  • Lay summaries of clinical study results: an overview. Pharmaceutical Medicine (2019) 33:261–268 

Updated 4 months ago