Australia

Welcome to the new Australia and New Zealand (ANZ) ACRP Chapter.

The Australian presence of ACRP began with exams in Sept 2003 and the first courses began in April 2005. The creation of the ANZ Chapter began at our exciting inaugural conference in Melbourne in August 2007. The Australian Chapter has expanded to incorporate New Zealand and has thereby grown to offer subchapters in the major cities of Australia and in New Zealand. This corresponds with course delivery in those cities as well.
Nucleus Network Ltd partners with Clinical Network Services Ltd and Beltas Ltd to deliver courses and the certification program in this region.

Nucleus Network Limited is a centre for excellence in clinical research. It is a focal point for some of the brightest academic, medical and commercial minds in Australia, and is the gateway to Australia's thriving medical, research and biotech communities.

A unique co-operative of Australian and international clinical research organisations, Nucleus Network Limited offers Phase I and IV capabilities and support, which includes provision of clinical research training to the industry. As a leader in the clinical research industry, Nucleus Network aims to enhance GCP compliance and recognition of competence through ACRP programs.

Nucleus Network Education

Nucleus Network Education is now the education arm of Nucleus Network Limited. Dedicated to increasing the awareness of Good Clinical Practice for clinical research professionals, Nucleus Network established exclusive arrangement with the Association of Clinical and Research Professionals (ACRP), to deliver the GCP courses and certification in Australia. These programs are now endorsed by Royal College of Nursing, Australia (RCNA).

In 2007, for the first time, Nucleus Network, together with its partner Clinical Network Services, will introduce Good Clinical Practice for Pharmaceutical Physicians and Investigators in a one-day introductory training course designed to boost knowledge and understanding of good clinical practice (GCP) and locally applicable regulations and guidelines such as the TGA Regulations, NHMRC National Statement, FDA Code of Federal Regulations (CFR), the European Directives, and the International Conference on Harmonisation (ICH). The GCP for Research Professionals will be extended nationally to 5 states including Victoria, Queensland, New South Wales, South Australia, and Western Australia.

Clinical Network Services (CNS) Pty Ltd is a Brisbane based contract research organisation (CRO) providing clinical management support to the healthcare community during the early phase clinical development of their products. CNS is Queensland's leading educator of research professionals (Association of Clinical Research Professionals - ACRP) and provider of quality consultation to all parts of the industry.

BELTAS is a Clinical Research Organisation (CRO) and Clinical Trials Technology company headquartered in New Zealand, with operations in New Zealand, Australia and Europe. BELTAS manages Phase I - IV clinical trials for pharmaceutical, biotechnology and medical device companies, and conducts clinical studies in New Zealand and Australia on behalf of international Clinical Research Organisations. Clinical study practices and standards in New Zealand and Australia are similar to those in Europe and North America.

Certification Exam

The ACRP Certification Exams will be offered on September 6th. All applications need to be received by July 14th. After July 14th, a late fee will be added. Applications can be found below and additional information on the certification exam can be found here,

Certification is the formal recognition of clinical research professionals who have met professional eligibility requirements and demonstrated at least a minimal level of job-related knowledge and skills. ACRP's certification is granted in recognition of documented and verified work experience and successful performance on a multiple-choice exam. ACRP offers three certification exams, one for Clinical Research Associates/CRAs (Monitor), one for Clinical Research Coordinators/CRCs (Site) and one for Certified Physician Investigators/CPIs. The exams are based on the industry's largest validated job analysis to ensure the exams reflect the frequency and importance of what CRAs, CRCs, and CPIs do in the clinical research process. Please see the calendar for course dates.

Certification exams - offered in March and September every year - test your expertise on topics and regulations specifically related to your ability to make decisions in specific practical scenarios. All exams for this region are processed through Nucleus Network using the “Australian” specific forms. These exams are based on ICH content only. The ACRP ICH Certification exams focus on internationally recognized ICH standards (this exam is typically for candidates outside of North America and Europe).

Application Forms: CRA, CRC, CPI, About Australian/ICH Certification (PDF).

To be eligible to take the ACRP exams, each candidate must fulfill one of the following two combinations of education and working experience as a research professional. For the purpose of meeting the working experience requirement, a minimum of 35-40 hours per week qualifies as full-time employment and a minimum of 20 hours per week qualifies as part-time employment, completed prior to the exam date.

GCP Courses

The 2-day GCP course is held around Australia and in New Zealand through out the year. Please consult the website for dates and course details

For comprehensive details and on-line registration for any of our courses:

• in the ANZ region, go to Nucleus Network website.
• in the QLD region, go to Clinical Network Services website.
• in the NZ region, go to Beltas Ltd.

CRA, CRC Certification Exam Review Course

If you plan to take ACRP's CRA certification exam, the certification exam review course will help you maximize your results. Offered prior to the exams, the exam reviews help you assess your level of preparation and become familiar with important regulatory information resources.  These courses are conducted subject to numbers. In the event of a course not being conducted, Review Packages and study group support are available to assist in preparation.

What’s New?

The ANZ ACRP chapter provides opportunity for reduced Insurance Premiums for ACRP certified and trained Clinical Research teams and Consultants in Australia.

In recognition of the level of training and education achieved by ACRP members, Strathearn Insurance Brokers have arranged Clinical Trials Insurance and Professional Indemnity insurance, at preferred rates, for Clinical Research organisations that employ ACRP accredited and trained professionals.

Strathearn Insurance Brokers provides preferred rates for Research Organisations who employ ACRP accredited practitioners.

ACRP ANZ Chapter Annual Conference —August 7-9, 2008

In 2008, Clinical Network Services will represent Nucleus Network, as the ANZ Chapter of ACRP, working in collaboration with Centres for Clinical Research Excellence (CCRE) and Melbourne University’s School of Enterprise to co-ordinate the 2nd CCRE- ACRP Annual Conference.

August 2008 will present the second of such conferences where ~ 500 professionals working in clinical research related fields and clinical research organisations around Australia will be brought together. The conference targets current ACRP members, investigators, Sponsors, Government and professionals from hospital clinical sites, Sponsor sites and CROs around Australia, New Zealand and Asia Pacific. For highlights of the 2007 conference see www.crx08.com.

We welcome all ACRP members around the world to come to this event.

For more information and to register, please see the conference web site, www.crx08.com.

If you have additional questions, please contact:

• Robyn Lichter on r.lichter@nucleusnetwork.com.au (+613) 9207 1909 (Australia) or
• Maria Chiam m.chiam@clinicaltrialsconsulting.com.au +1 (415) 544 0958 (USA)

Contact Information