www.rxt.com.au

Good Clinical Practice for Research Professionals Don’t miss the nationally recognised GCP Course.

CLASSROOM COURSE  

Do you work in Clinical Research? Are you looking for a course to increase your knowledge and understand of what GCP means for your clinical practice? The key to working appropriately in clinical trials is an understanding of the overall picture and why GCP is important to all parties: sponsors, sites, trial volunteers, ethics and regulators. In addition the course covers the international perspective including the FDA code of federal regulations and the EU Directive, and how these impact on your studies.

Who should attend? Clinical researchers working in any area who wish to review and apply their knowledge gained in formal GCP training

Course Includes: Why the RXT course

The program will cover • Details and updates of ICH GCP for Australia • Trial design, documents and processes • Australian and international regulations and ethics • Sponsor/regulatory audits and inspections • Course book, CD, certificate, all meals & refreshments

• It is a nationally recognised course (formerly Nucleus Network Education)

• Based on the global gold standard • Tailored for Australian regulatory environment • Accredited and ACRP certified trainers • Quality materials and resources • Conforms with CME/CPD points

Program details DAY 1 Registration 1. Welcome 2. Introduction to Clinical Research 3. Ethics 4. Informed Consent 5. Sponsor Responsibilities 6. Investigator Responsibilities 7. Recruitment

DAY 2 8. Research Records & Documents 9. Adverse Experience Reporting 10. Audits & Inspections 11. Fraud & Misconduct 12. International Studies Course Assessments

Course Details Time 2 days, 8.30 am – 5.30 pm.

Date & Venue See our website for details of a course convenient for you. Cost RRP $1100. Early bird $990. Up to 10% discount for groups of 4+ from the same department.

Travel Map & parking instructions will be sent to you before the course Payment Policy Payment of course fees must be made prior to the commencement of the course. Payment can be made

by credit card or by account by prior arrangement only for group bookings. This account should be made payable to Research Excellence Training.

Cancellation

1. Participants who cancel their enrolment more than 14 days prior to the scheduled commencement of the course will be refunded all fees less an administration charge of $99 2. Participants who cancel their enrolment less than 14 days prior to the scheduled commencement of the course will forfeit their full fee. However, a substitute attendee may take their place.

For more information contact   Courses  supported  by      

Robyn Lichter

 

0418 548 486

education@rxt.com.au

   

2014