ITCC resources have been developed to assist you in effectively running your clinical trial and to ensure compliance with Good Clinical Practice and other regulations.
Resources
Standard Operating Procedures
Standard Operating Procedures (SOPs) underpin the quality clinical research coordinated by the ITCC. We have developed a suite of SOPs to provide process and rigour to the conduct of the entire research program. The SOPs are reviewed every two years and new SOPs are developed as required.
Go to the Standard Operating Procedures page.
Guidance documents and templates
We have also developed guidance documents and templates that align with the Standard Operating Procedures (SOPs) to be used when conducting ITCC-coordinated clinical trials.
Manuals
The Coordinating Principal Investigator Manual is for clinicians and researchers who have an idea for a new palliative care or cancer symptom clinical study and who wish to progress this idea into a clinical trial.
coordinating principal investigator manual (pdf, 445 kb)
The Principal Investigator Manual is for organisations that are recruiting patients to clinical trials coordinated by the ITCC.
principal investigator manual (pdf, 244 kb)
The e-Consent manual is for sites and investigators of ITCC coordinated clinical trials involved in obtaining participant consent using electronic means.
e-consent manual (PDF, 541 kb)
New study proposals
PaCCSC and CST studies
All new study applications must be submitted on the PaCCSC or CST New Study Proposal template, available on the templates page. The PaCCSC template is for studies in the palliative population, and the CST template is for studies in the cancer-only population. Submit your study proposal to paccsc@uts.edu.au or cst@uts.edu.au.
In line with the purpose and aims of PaCCSC and CST, new study support will be considered for:
- randomised controlled trials (RCTs)
- small pilot studies for proof of concept (feasibility, safety, efficacy)
- sub-studies embedded within a current study, which adds value to the suite of currently running RCTs
Support offered to new studies is outlined in the PaCCSC and CST new study proposals standard operating procedures. New studies that do not fit within the listed criteria cannot be considered for support from PaCCSC or CST.
Other studies
Please contact the National Manager, Linda Brown, to discuss how to submit your proposal.
Presentations
The presentations below are available for our researchers and partners to use to introduce your colleagues or broader network to the ITCC as well as PaCCSC and CST.
About PaCCSC (PPT, 8,058 KB)
About CST (ppt, 8,292 kb)
PaCCSC membership (ppt, 8,564 kb)
CST membership (ppt, 3,223 kb)
Consent
Discussion of consent with a potential clinical trial participant is a critical element of clinical trial research. The Palliative Care Research Cooperative (PCRC) has developed a training video to demonstrate the process of consent.
Informed Consent Process and Discussion [opens external site]
Teletrials
Teletrials are an important innovation in clinical trials that may improve access to trials for people living in remote and rural communities. We are seeking opportunities to make our clinical trials more inclusive and welcome new study ideas from our members, including ideas for teletrials. The below resources may be useful in planning and learning more about teletrials.
https://www.health.gov.au/resources/collections/the-national-teletrials-compendium [opens external site]
https://vcccalliance.org.au/our-work/research-and-translation/clinical-trial-innovations/teletrials/ [opens external site]
https://www.health.qld.gov.au/hiiro/html/teletrials [opens external site]
Information for clinical trial participants
The brochures below answer frequently asked questions about participation in clinical trials. You are welcome to print copies for potential clinical trial participants who are interested in a PaCCSC or CST clinical trial.
PaCCSC FAQs (pdf, 124kb)
CST FAQs (pdf, 128kb)
Information for researchers and collaborators
Please print and share the below flyers with anyone who looking for support to develop a study idea.
about impacct (pdf, 197kb)
about itcc (pdf, 163kb)
about cst (PDF, 125kb)
about paccsc (pdf, 93kb)
