Research credentialing, education and training

All individuals undertaking research at Epworth, including investigators, honorary research appointees and students are required to complete research credentialing as outlined in SOP - RG - 04 - FORM - 01 Research Credentialing Form See: Resources for researchers - SOP - Related SOP forms and templates to ensure that they are adequately qualified and insured to conduct research at Epworth safely and in accordance with all necessary guidelines and legislation.

Credentialing requirements are role dependent and described in SOP - RG - 04 - FORM - 01 Research Credentialing Form See: Resources for researchers - SOP - Related SOP forms and templates

Research credentialing does not authorise:

• Clinical practice at Epworth by an individual; or
• Research governance for a study.

To apply for Epworth research credentialing:

1. Complete a Researcher Credentialing Form by either using the Online Credentialing Form or SOP - RG - 04 - FORM - 01 Research Credentialing Form
   See: Resources for researchers - SOP - Related SOP forms and templates
2. Submit this form to the Office for Research along with other required documentation including but not limited to; a current Good Clinical Practice (GCP) training certificate, CV and evidence of clinical registration (as required)
3. The Office for Research will review the application and ask for further information if required
4. The Office for Research will provide written confirmation of researcher credentialing authorisation upon receipt of a satisfactory submission.

Epworth’s requirements for research credentialing:

• Research credentialing is completed in accordance with Epworth’s procedure SOP - RG - 04 Researcher Credentialing
  See: Resources for researchers - SOP - Related SOP forms and templates
• Research credentialing is valid for 3 years, with the following exceptions:
  • For honorary research appointees – 12 months or the term of the appointment (if less than 12 months)
• It is the applicant’s responsibility to apply for research credentialing and to ensure all documentation (i.e. GCP training, professional indemnity) remains valid during this period.
• The PI must ensure evidence of researcher credentialing for all researchers on a project are maintained on file and available for review upon request.

The Office for Research must be notified where there is a change in appointment/affiliation or if the researcher no longer intends to conduct research at Epworth.

All individuals undertaking research at Epworth must have the necessary expertise and experience necessary to conduct their role on the research study in a safe, ethical, and high-quality manner.

• All Epworth employees, Visiting Medical Officers and honorary research appointees should complete and maintain up to date Mandatory Epworth training.
  Complete mandatory training via the intranet eLearning and Courses page.
• All research staff involved in research at Epworth should complete role and research specific training as described in:
  • SOP - QA - 01 Documentation of Qualifications and Training Records 
    See: Resources for researchers - SOP - Quality and;
  • Appropriately document the training, including via SOP - QA - 01 - TEMPLATE - 01 Epworth Researchers Training Plan 
    See: Resources for researchers - SOP - Related SOP forms and templates

GCP is an internationally accepted standard for designing, conducting, recording, and reporting clinical trials involving human participants. It's an ethical and scientific quality standard that ensures the safety and rights of participants are protected, and that the trial data is reliable and credible.

Epworth applies the principles of GCP to all research conducted under its auspices.

Epworth’s requirements for GCP training

• Anyone conducting research at Epworth must hold and maintain a current, valid GCP training certificate before commencement of delegated study activities in a research project. This includes Principal and Associate Investigators, Research Nurses, Research Coordinators and Research Managers.
• The GCP training course undertaken must meet the minimum criteria set out by the TransCelerate Biopharma Inc. Mutual Recognition Program and appear on the website.
• Australian based GCP training is strongly preferred.
• A valid GCP training certificate must be provided to the Office for Research for each Epworth team member before they start on a research study at Epworth.
• TransCelerate GCP certification is accepted for a maximum of three (3) years unless a shorter timeframe is specified on the certificate.

Free GCP training:

The self-paced courses listed below are examples of courses that are mutually recognised and listed by TransCelerate as meeting the minimum requirements of ICH E6 (R2) GCP.

Australian Clinical Trials Education Centre (A-CTEC)

The aim of the A-CTEC GCP course is for you to become GCP-certified with the expected time for completion being 2.5 hours.

1. Access your A-CTEC account, or
   For first time users, create an account to sign up to A-CTEC
   Need support? Access helpful instructions.
2. Once logged in, navigate to “online courses” under the Comprehensive Course Packages you will see ‘Good Clinical Practice = Good Research Practice’.

The Global Health Network
The Global Health Network GCP course has been updated to incorporate additional information from the latest International Conference on Harmonisation E6 (R2) Guidelines for GCP and re-named ‘ICH Good Clinical Practice E6 (R2)’ to reflect this update. Please take the revised version of this course for the latest updates and to gain the required certification. Start the Global Health Network GCP course.

The EKS is based at Epworth Richmond and provides online access to comprehensive collections and services. They provide expert assistance in searching, finding and using evidence for your practice and research. EKS provides expert assistance to support you to provide great patient care, education and research.

Talk to EKS about all manners of support including:

• Staying current
• Scholarly skills
• Systematic reviews
• Database advice and access
• Help guides
• The research process
• Publishing
• Information management
• Project management
• and much more

Site Visits: EKS staff regularly travel to all sites across the group for in-services, consultations, and tutorials.

Book an on-demand training/support session that fits your schedule:

• P: 9426 6134
• E: [email protected]

Find out more at Epworth Knowledge Service (EKS)

REDCap (Research Electronic Data Capture) is a secure web application for building and managing online surveys and databases.

For Epworth projects, the data must be stored on Epworth REDCap instance, not at another organisation.

Epworth data may only be stored on REDCap at another organisation where this has received Epworth research governance authorisation.

Guides

• REDCap software has built-in prompts and instructional text for the most current information.
• Refer to https://projectredcap.org/resources/videos/ for informational REDCap videos that can help you get started and gain a better understanding of the REDCap application and its functionality.
• Google REDCap guides – examples such as those below provide general information and how to’s.
  Note - REDCap must be used in the Epworth context including compliance with Australian laws and Epworth policy such as, but not exclusive to, data management and privacy requirements:
  • University of Nebraska – a comprehensive guide to REDCap
  • University of Chicago – general guidance on the use of REDCap

Courses

Epworth currently do not run any internal training courses, please see the following external courses available:

• University of Melbourne

There are a number of free resources that can support researcher team members understand research and clinical trial practices.

A-CTEC clinical research training for all your research team members

A-CTEC offers a suite of free self-paced training packages and short courses that will equip researchers with foundational knowledge of research and trial related practices and requirements about running clinical trials in Australia.

The training is useful for both new and established research team members and investigators.

The self-paced Comprehensive Course Packages are mutually recognised and listed by TransCelerate as meeting the minimum requirements of ICH E6 (R2) GCP.

1. Access your A-CTEC account, or
   For first time users, create an account to sign up to A-CTEC
   Need support? Access helpful instructions.
2. Once logged in, navigate to “online courses” under the Comprehensive Course Packages and select from packages including:
   • Trials Essentials for Research Support Team (ICH E6 R2 GCP included) – this is 6 courses with an evaluation and completion certificate
   • Trials Essentials for Investigators (ICH E6 R2 GCP included) – this is 5 courses with an evaluation and completion certificate
   • Research Integrity

Australian Clinical Trials.gov

Visit https://www.australianclinicaltrials.gov.au/researchers for self-paced training and guidance on:

• Developing and conducting a clinical trial as a principal or co-investigator and becoming affiliated with a clinical trials network.
• Developing and running a clinical trial in Australia.
• Applying for ethics approval.
• From how to get started to registering a clinical trial.
• Understanding what laws, regulations and governance apply to Australian clinical trials.

Epworth launched the Academy to empower our dedicated nurses and midwives, enabling them to achieve excellence in their respective fields, ensuring Epworth can continue to deliver exceptional patient experience and outcomes.

Innovative learning pathways in clinical, leadership, education and research & innovation are provided at the Brookes Academy include:

• Clinical
• Leadership
• Education
• Research and Innovation

Find out more at the Brookes Academy website.

Research integrity is a way of thinking and behaving that ensures that research undertaken is trustworthy.

Research integrity education

Epworth is committed to supporting a research culture that encourages responsible research practices based on the principles of research integrity.

Responsible research practices guide researchers in the conduct of their work as well as in their engagement with the practical, ethical and intellectual challenges inherent in research.

The primary responsibility for ensuring the integrity of research lies with individual researchers and institutions.

Key guidelines include:

• The Australian Code for the Responsible Conduct of Research (the Code)
  The Australian and international community expects research to be conducted responsibly, ethically and with integrity. The Code articulates the broad principles that characterise an honest, ethical and conscientious research culture. It establishes a framework for responsible research conduct that provides a foundation for high-quality research, credibility and community trust in the research endeavour. It outlines the expectations for the conduct of research in Australia or research conducted under the auspices of Australian institutions.
• The National Statement on Ethical Conduct in Human Research (2023) (National Statement)
  Consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992. Research merit and integrity, respect for human beings, justice, and beneficence are core principles of the National Statement.

Read the guidelines for self-paced learning on responsible and ethical conduct of research.

Resources and training

• A-CTEC Research Integrity training
  Research Integrity – self-paced short session (approx. 30 min)
  I. Access your A-CTEC account, or
  For first time users, create an account to sign up to A-CTEC
  Need support? Access helpful instructions.
  II. Once logged in, navigate to “Research Integrity” under the Comprehensive Course Packages.
  
  
• Macquarie University Human Research Ethics course
  The Human Research Ethics Training for Social Sciences and Humanities course is self-paced and suitable for undergraduate students, or anyone interested in human research ethics and integrity.

Publishing research data offers numerous benefits including enhanced transparency and reproducibility, compliance with funding and publication requirements, and increased visibility and credit for researchers. It also promotes collaboration, reduces duplication of effort and can lead to greater impact and citations.

Ethical issues around publication of research data involve ensuring data integrity, respecting participant privacy, and upholding the standards of scientific rigour and credit for all stakeholders.

NHMRC ‘Publication and dissemination of research’

Epworth adopts the principles established in the NHMRC’s Publication and dissemination of research - A guide supporting the Australian Code for the Responsible Conduct of Research.
Read the guideline for self-paced learning on publication and dissemination of research.

The Committee on Publication Ethics (COPE)

COPE provides leadership in thinking on publication ethics and practical resources to educate and support members and offers a professional voice in current debates.

Visit the COPE website to access information and self-paced learning via case studies on a wide range of topics, including:

• Allegations of misconduct
• Authorship and contributorship
• Complaints and appeals
• Conflicts of interest
• Data and reproducibility
• Ethical oversight
• Intellectual property
• Journal management
• Peer review processes
• Post-publication discussions