COSA Clinical Professional Day Workshops

Since 2009 the CTRPG Executive Committee has provided members with valuable opportunities to enhance professional development by organising Clinical Professional Day Workshops.  Invited speakers provide clinical and regulatory updates and ideas on how to improve the efficiency of clinical trial processes, particularly for investigator led studies.  Information about pending CPD Workshops can be found on the Annual Scientific Meeting area of the COSA website prior to the ASM each year. People involved in clinical trials research are encouraged to register early to attend a workshop.

Australian National Cooperative Cancer Trials Groups

Cooperative, or collaborative cancer trials groups often have useful toolkits and other information on their websites. All of these groups are COSA Affiliated Organisations. More information about them can be found here.

The Value of Site Operating Procedures (SOPs)

SOPs provide detailed written instructions to achieve uniformity of the performance of a specific function (ICH GCP Sec. 1.55).

SOPs form a single source of reference, so procedures are performed efficiently, effectively and uniformly, and:

  • ensure uniformity of standards → increased efficiency and performance
  • ensure complex procedures are performed correctly
  • a good reference document – aid in interpreting GCP
  • provide a basis for discussion on improvements required
  • assist in planning (daily and project)
  • if well written, they allow for flexibility when it is appropriate
  • are required by GCP regulations

Please refer to the short, informative slide presentation (pdf) for background on why we have SOPs.  Slide set included with kind permission from Ms Sally Dean, Clinical Trial Coordinator, Newcastle Private Hospital and presented at an ANZGOG Study Coordinator Workshop.

NHMRC Clinical Trials Toolkit contains useful information and resources for conducting a clinical trial in Australia.

SOP templates

PRAXIS Australia (Promoting Ethics and Education in Research) is a hub, providing a central place that facilitates and fosters the exchange of ideas and sharing of knowledge, through education, training and other interactive forums.