GCP purpose

• Adherence to GCP serves as a best-practice standard for all clinical trials to protect the rights, safety and well-being of participants and provides assurance that the clinical trial data are credible. 
• As GCP is an international standard, it facilitates mutual acceptance of data from clinical trials by regulatory authorities.
• The ICH Good Clinical Practice E6 (R2) Guideline ('GCP Guideline') details and delineates the respective responsibilities of those involved in the conduct of clinical trials. 
• It also specifies requirements, including those related to participant consent, protocol and associated amendments, the investigational product, essential documentation, safety reporting and quality management. 
• GCP provides best-practice processes, many of which can be applied to all types of research, not just clinical trials. 

Requirement for GCP training in Metro South Health

• The GCP Guideline is an international ethical and scientific quality standard for designing, conducting, recording and reporting of clinical trials that involve human participants. 
• Metro South Health Research Council has endorsed a mandate for members of research teams involved in clinical trials (Metro South Health as sponsor and high risk interventional stidues) to undertake accredited GCP training.
• Clinical trials are not just pharmaceutical trials but any research investigations involving human participants to test new treatments, interventions or tests.
• These types of studies would ordinarily require full ethical review by a NHMRC Certified Human Research Ethics Committee (HREC).

New clinical trials

• From 1 February 2020, all principal investigators and research personnel submitting a new clinical trial for research governance authorisation within Metro South Health must provide evidence of accredited GCP certification undertaken within the previous 3 years.
• Evidence of GCP certification will form a requirement for Site-Specific Assessment (SSA) authorisation. The responsibility for ensuring that all members of the research team undertake GCP training prior to the commencement of the study, rests with the principal investigator at the site.  

Existing clinical trials

• From 1 June 2020, all researchers conducting clinical trials authorised prior to 1 February 2020 must provide evidence of GCP certification.

Evidence of GCP training

• Researchers intending for Metro South Health to act as sponsor for clinical trials and high risk interventional studies (ie research utilising unapproved therapeutic goods) must complete a facilitator led/face-to-face GCP course following completion of the online GCP course.
• The GCP course completed must be TransCelerate Biopharma Inc. accredited.
• Registration for these sessions will be facilitated by the Metro South Research office.
• When completing externally provided online courses, it is important to register online and complete the course in its entirety.
• It is also recommended that researchers access the GCP in Australia guidelines and tools to provide further guidance and assistance.
• If a GCP course completed is recognised by TransCelerate Biopharma Inc. the certificate can be provided as evidence.

GCP course options

GCP Training - Online 

• Metro South Health employees are able to complete GCP Training - Online via LEAPOnline.
• Our perferred provider is the The Global Health Network.

GCP Training - Facilitator Led/Face-to-Face

• Throughout the year, Metro South Research coordinates facilitator led GCP courses with an external GCP trainer at a competitive price. 
• Dates for these courses are linked below. 

Other GCP Training Options

• Online GCP courses are offered by various external providers.

• Facilitator led/face-to-face GCP course options are also regularly offered by other bodies including ARCS and Datapharm Australia (these are external to Metro South Health).

Metro South Health GCP Training - Facilitator Led/Face-to-Face

Target audience

• This course is targeted at Metro South Health research teams – ie all staff assigned a role within the trial delegation log, including (but not limited to); the study principal investigator, associate investigators, research nurses, coordinators, research assistants and data managers

Course objectives

• Using interactive discussion and case studies, this TransCelerate-accredited GCP course will provide participants with:
  • an awareness of GCP principles
  • an understanding of the roles & responsibilities of all parties under GCP
  • an ability to apply GCP requirements to their daily research practice
  • a knowledge of source documents, essential documents and adverse reporting for clinical trials
  • preventative and corrective action applying to clinical trials

• It will not teach participants how to:
  • prepare and submit ethics or governance applications
  • write a protocol
  • set up or run an investigator-initiated clinical trial

Cost

• $250 for Metro South Health employees (please see note below)
• $275 (inclusive of GST) for self-funded participants

Please note:

• Priority is given to Metro South Health employees 

• Metro South Health's Study, Education and Research Trust Account (SERTA) is subsidsing course fees for Metro South Health employees – therefore there will be no cost to Metro South Health departments/work areas at this time

• Registration of external staff will be considered subject to availability of places and a waiting list for each course will be established

Time & Materials

• 8:30am – 1:00pm
• Zoom – video link and webcam (required)
• DropBox – receipt of course materials
• Relevant links and course information will be provided prior to the session

Registration

• 1. Register via LEAPOnline​

• 2. Complete either registration form linked below:​​
• Metro South Health Cost-centre Funded GCP Course Registration Form (DOCX, 268.68 KB)
• Externally Funded GCP Course Registration Form (DOCX, 268.97 KB)
   
• 3. Email completed form to MSH-Research@health.qld.gov.au   

2020 course dates

• 15 October 2020
   

Getting started with research series

Biostatistics service

Metro South Research Biostatistics Service offers a range of one-on-one services to Metro South Health clinicians and researchers on a range of topics including:

• longitudinal data analysis
• survival analysis
• analysing categorical outcome variables
• tests for multiple measurement variables
• statistical inference - tests for categorical and continuous variables
• descriptive statistics and presentation of data
• sample size and power calculations
• designing studies and surveys

A resident biostatistician is available for consultations every weekday with waiting times ranging from a few days to a fortnight depending on current demand, and can provide advice on:

• experimental design
• data mining
• data presentation
• statistical analysis
• data integration

The provider for this service is the Queensland Facility for Advanced Bioinformatics (QFAB), University of Queensland. Bookings and enquiries can be made directly on QFAB’s website and the biostatistician can be contacted via email biostats@qfab.org.

In addition, the service holds a biostatistics seminar series at least once a year. See Metro South research events for more information.

This service is funded by the Metro South Health Study, Education and Research Trust Account (SERTA).

When sharing data with the biostatistics service please share only encrypted data (especially when working remotely). Please see Queensland Health Passwords and encryptions for more information.

PowerTrials training

• Please view PTF2 - MSH PowerTrials WBT eLearning Module (PDF, 412.7 KB) and use the username and password provided
• PowerTrials Quick Reference Guides are also available through Metro South Digital

Library research support and training

Metro South Health Libraries supports medical, allied health and nursing staff who are undertaking work related research activities. The Princess Alexandra Hospital Library offers Literature Searching and Endnote training.

• Princess Alexandra Hospital Library
• Logan Hospital Library (internal link)
• QEII Jubilee Hospital Library (internal link)
• Redland Hospital Library (internal link)

Ethics and governance - Ethics Review Manager (ERM) Applications platform

ERM Training - Researcher

• Quick guides
• Videos
• Training schedule

Clinical trials - education

• NHMRC Clinical Trials eLearning Modules
• Australian Clinical Trials - Clinical Trials Toolkit