Research Trials – Information for Clinical Trials Groups

All research and clinical trials groups will need to ensure they adhere to the new National Clinical Trials Governance Framework.

Clinical trial groups will be assessed on the first two NSQHS Standards

• Clinical Governance, Standard 1 – which aims to ensure that there are systems in place within health service organisations to maintain and improve the reliability, safety and quality of health care. This standard focuses on ensuring:
  • Clinical trial services are integrated into clinical and corporate governance systems for improved safety and quality of clinical trial service provision.
  • Managers and the clinical trial workforce have the right qualifications, skills and supervision to provide safe, high-quality clinical trial services to patients.
  • The environment in which clinical trials are conducted is safe and promotes high-quality clinical trial service provision.
• Partnering with Consumers, Standard 2 – which aims to ensure that consumers are partners in the design, delivery and evaluation of healthcare systems and services, and that patients are given the opportunity to be partners in their own care. This standard focuses on:
  • Supporting patients, consumers and carers to actively participate in the organisational design and governance of clinical trial services.
  • Ensuring information on clinical trials is provided to trial participants, patients, carers and their families, and consumers, including information about their healthcare rights.

All healthcare organisations who run clinical trials are required to be assessed once in a three-year cycle. Short notice assessment will take place and means that a notice period of 24 to 48 hours is given before the visit.Assessors will gather evidence from a variety of sources including:

• Interviews with members of the workforce, consumers and their nominated representatives, health care providers, allied health workers, volunteers and contractors.
• Observation of workforce practices and interactions with consumers across all operational and clinical areas.
• Review of documents and records to confirm that safety and quality systems are described in policies and procedures, to assess compliance and review reported outcomes.

A sample of research studies will be chosen by the accreditors for further review. Each area will need to provide the following summary for all active studies as part of the GEMS submission:

• Department or specialisation
• Clinical trial name
• Clinical trial phase (I, II, III, IV)
• Sponsor (commercial, university, hospital) and sponsor name
• Principal investigator (name and position)
• Number of staff allocated to the trial
• Number of participants in the trial
• Number of Aboriginal and Torres Strait Islander participants in the trial

1. Review the National Clinical Trials Governance Framework
2. Download the Excel template 'Accreditation for Clinical Trial Groups', which provides a list of the evidence requirements.
   1. Column A is the number linked to the accreditation item
   2. Column B is the actions within the NSQHS standards against which WCHN will be assessed
   3. Column C provides reflective questions which the accreditors are looking to answer by reviewing the evidence provided
   4. Column D suggests what strategies will assist WCHN in identifying evidence to fulfil the action items.
   5. Column E notes if this is completed by the Research Secretariat and at an Organisational Level or if evidence should be identified at the study level.
   6. Column F suggests what examples may be relevant to each Clinical Research Group to provide as evidence
      • Not all evidence examples will be relevant to your area, and some may be areas which you are working to improve as the purpose is to ensure the ongoing process of each trial is in line with best practice.
      • The website also provides additional examples and fact sheets, including a link to the SA Health South Australian clinical trials portal.
3. Review the Clinical Trials Documentation for Accreditation checklist and complete this by noting what evidence your clinical trials group have to show the requirements (review the Excel spreadsheet for examples of evidence), or what actions need to be completed.
4. Using the two documents, create an action plan which identifies which areas you need to improve and the steps you are taking to create the evidence, who is responsible and when the action is estimated to be completed.
5. Create a follow-up plan to review documentation monthly or quarterly.

Fact Sheets

• WCHN Staff Research Recruitment Advertising – Fact sheet
• Interpreters for Clinical Trials – Fact sheet
• NCTGF Roles and Functions for the Clinical Trial Workforce
• NCTGF Roles and Functions for Site Principal Investigators
• NCTGF Process for Accreditation to the National Clinical Trials Governance Framework

Templates and examples

• National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia
• Consumer Involvement and Engagement Toolkit
• Risk in Research – University of Adelaide

SA Health South Australian clinical trials portal

We are excited to advise that the SA clinical trials portal was recently made public and provides information on conducting clinical trials in South Australia, including information for researchers, sponsors and participants. The portal outlines key initiatives, how consumers can be involved, and also additional information on the Teletrials Program.

The portal contains a number of resources and external links for researchers including:

• Information for researchers regarding standard operating procedures and requirements for clinical trials conducted in SA
• Clinical trial agreements
• Research ethics
• Research governance
• Research GEMS
• Training resources including links to the free training for all South Australians through the Victorian Clinical Trials Education Centre.

Australian Clinical Trials Education Centre: A-CTEC

The A-CTEC training platform is an Australia-wide education centre with resources available for all researchers and those involved in conducting clinical trials across South Australia. They offer information on:

• Online courses
• Educational sesources
• GCP scenarios
• Live webinars
• Competency frameworks
• Community networks
• V-CTEC Annual Conference
• Career opportunities

The training platform includes a variety of interactive, practical, multi-modal, evidence-based training courses as well as networking opportunities, workshops and webinars. The training caters to a wide variety of levels of experience and competencies and includes free GCP training. To register, visit the A-CTEC website.

NHMRC eLearning modules

The NHMRC have developed learning modules on the Australian clinical trials environment, to assist with understanding how clinical trials take place in Australia; understanding and promoting responsible research practices; ensuring quality research outcome; and ensuring participant safety is maintained at all times. Topics include:

• Clinical trial design
• Participant and staff numbers and resources
• Legal requirements
• Ethical issues relating to clinical trials
• Research governance

Additional information, including the eLearning modules trailer, is available via the Australian Clinical Trials website.

• Karen Rogers: Manager, Research & Business Services – Karen.Rogers@sa.gov.au
• Prof Helen Marshall AM: Clinical Research Director – Helen.Marshall@sa.gov.au
• Dr Tamara Zutlevics: Patient Ethicist and Chair, WCHN HREC – Tamara.Zutlevics@sa.gov.au
• Kylie Harper: Research Governance Officer – Kylie.Harper@sa.gov.au
• Rose Mansfield: Research & Business Services Coordinator – RoseMary.Mansfield@sa.gov.au
• Di Smith-McCue: Director, Consumer & Community Engagement (assistance especially with Standard 2 Partnering with Consumers) – Dianna.Smith-McCue2@sa.gov.au
• Michelle Clarke: VIRTU Senior Medical Scientist (assistance especially with clinical trial group preparation) – Michelle.Clarke@adelaide.edu.au

When will accreditation happen?

All healthcare organisations who run clinical trials are required to be assessed once in a three-year cycle. Short notice assessment will take place and means that a notice period of 24 to 48 hours is given before the visit.

Can identifiable data be stored on a device outside of SA Health?

• Consented data can be stored on servers outside of WCHN provided that it has received both HREC and Governance approval through WCHN (some methods of storage may not be approved i.e. overseas servers etc.).

• Usually, a Data Transfer or other agreement that sets out how the data will be managed, will be put in place as part of the Governance process.

• If the data is being stored on an App or other method not currently used by SA Health, it needs to be reviewed by SA Health ICT security. To facilitate efficient review and approval of the study, it is recommended that researchers submit the platform to Corporate Services for review, either before or concurrently with submissions to the HREC and Research Governance Officer. The contact person for this is Jeanette Tininczky (jeanette.tininczky@sa.gov.au).

What questions will be asked by the assessors?

Please refer to the Accreditation for Clinical Trial Groups excel file. Other examples of some of the types of questions that assessors may ask include:

• What training is required for your role?
• How do you know what clinical information about trial participants needs to be recorded in EMR?
• What quality improvement projects have been undertaken in your area recently?
• If an incident or emergency was to occur, what would you do? How would your report this?
• What incidents have occurred previously and did you make any changes as a result?
• What clinical/non-clinical risks are you aware of in your area?
• How do you involve trial participants & their families in trial planning, delivery and evaluation?
• What is the process if a trial participant wants to make a complaint?
• How are trial participants encouraged to provide feedback?
• Can you provide an example of where participant feedback was acted on?
• How do you ensure trial participant information remains confidential?

Please note that this is not an exhaustive list.

Where should evidence be stored? How will this be given to the assessors?

Evidence should be stored in a location accessible by several staff members in your group (in case of leave due to the short notice of assessments) and then available to Research Secretariat staff if needed/requested. This means that you will be able to continue updating and collating, and then we will be in contact with you if your information needs to be given to the assessors.

If a study has been ongoing for quite a length of time, do the current rules apply?

If the trial is current and still running, it will need to comply with the current standards.

If a staff member is onsite the majority of the time, are there mandated training requirements they need to complete?

Yes, if they are working on site they will need to complete Fire Training for WCHN through Digital Media. They will also need to maintain WWCC checks and immunisation requirements relevant to the area.