Independent Quality Assurance Program

Specific Aims

• Review existing QA programs and resources
• Identify QA needs of CCTGs in relation to GCP and training in GCP
• Completion of two training courses; review pilot data by QA committee 
• Roll out training courses for online learning of CCTG staff and members from COSA website 

Achievements

• The CCTG undertook a needs assessment to address requirements in this area in June 2006
• A Quality Assurance Workshop which had broad consumer representation was held on the 25 August 2006. 
• The purpose of this workshop was to agree on definitions in QA terminology and identify a collaborative way to address the specific aims.  The workshop identified the need for the development of a standardised education program and the development of basic QA standards, specifically SOPs.  
• A training course in Clinical Trials Operational Procedures has been developed by an Education and Training Working Party and the Quality Assurance Subcommittee.  This training program has been piloted at the ANZBCTG meeting in July 2007 and at the COSA ASM in Nov 2007 and at the Australian Health & Research Data Managers Association (AHRDMA) meeting in March 2008.  A report on the pilot ICH GCP Workshop is available for viewing. 
• A review of national and international clinical trials education programs is in the midst of being completed.