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www.rxt.com.au [email protected] Good Clinical Practice for Research Professionals Investigators & Refresher ~ Composite CLASSROOM COURSE Do you work in Clinical Research? The design of this course allows for parrticipation of the reserch team where investigators and support team with varying experience can attend and all be onthe same page. The first day covers introductory and comprehensive knowledge topics. The second day covers topics of major concern for the investigator and areas where there have been regualtory change and focus – becoming a GCP refresher. All content covers the Australian and internation perspectives of research. 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 Nationally recognised course (formerly Nucleus Network) Based on the global gold standard Tailored for Australian regulatory environment Leading experts and ACRP certified trainers Quality materials and resources Conforms with CME/CPD points Program details GCP DAY 1 – Full course 1. Welcome 2. Introduction to Clinical Research 3. Ethics & Governance 4. Investigator Responsibilities 5. Recruitment 6. Sponsor Responsibilities 7. Fraud & Misconduct 8. International Studies GCP DAY 2 –also for Investigator or GCP Refresher 9. Informed Consent 8. Research Records 9. Research Documents 10. Adverse Experience Reporting 11. Audits & Inspections Course Assessments Course information covers Devices and Investigator Initiated Trials Course Details Time Choose 1 Day or 2 days, 8.30 am – 5.30 pm. Date & Venue See our website for details of a course convenient for you. Cost (GST excl) RRP $1050 (2 days) or $850 (1 day). Early bird $945 and $795 respectively Up to 10% discount for groups of 4+ from the same department. Early bird and group not to be used together (non-VIC courses excepted) 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 2015

RXT Brochure - GCP - GCPI Composite Course 2015 Febrxt.com.au/uploads/1/2/3/...gcp_-_gcpi...2015_feb.pdf · Title: RXT Brochure - GCP - GCPI Composite Course 2015 Feb Author: Robyn

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Page 1: RXT Brochure - GCP - GCPI Composite Course 2015 Febrxt.com.au/uploads/1/2/3/...gcp_-_gcpi...2015_feb.pdf · Title: RXT Brochure - GCP - GCPI Composite Course 2015 Feb Author: Robyn

               

www.rxt.com.au           [email protected]

Good Clinical Practice for Research Professionals Investigators & Refresher ~ Composite

CLASSROOM COURSE  

Do you work in Clinical Research? The design of this course allows for parrticipation of the reserch team where investigators and support team with varying experience can attend and all be onthe same page. The first day covers introductory and comprehensive knowledge topics. The second day covers topics of major concern for the investigator and areas where there have been regualtory change and focus – becoming a GCP refresher. All content covers the Australian and internation perspectives of research.

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

• Nationally recognised course (formerly Nucleus Network) • Based on the global gold standard • Tailored for Australian regulatory environment • Leading experts and ACRP certified trainers • Quality materials and resources • Conforms with CME/CPD points

Program details GCP DAY 1 – Full course 1. Welcome 2. Introduction to Clinical Research 3. Ethics & Governance 4. Investigator Responsibilities 5. Recruitment 6. Sponsor Responsibilities 7. Fraud & Misconduct 8. International Studies

GCP DAY 2 –also for Investigator or GCP Refresher 9. Informed Consent 8. Research Records 9. Research Documents 10. Adverse Experience Reporting 11. Audits & Inspections Course Assessments

Course information covers Devices and Investigator Init iated Trials

Course Details Time Choose 1 Day or 2 days, 8.30 am – 5.30 pm.

Date & Venue See our website for details of a course convenient for you.

Cost (GST excl) RRP $1050 (2 days) or $850 (1 day). Early bird $945 and $795 respectively Up to 10% discount for groups of 4+ from the same department. Early bird and group not to be used together (non-VIC courses excepted)

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

2015