Clinical Trials Support Unit
COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors is now available on NHMRC’s website at: www.nhmrc.gov.au/research-policy/COVID-19-impacts
This guidance reflects the shared views of all state and territory Departments of Health, the Clinical Trials Project Reference Group (CTPRG), NHMRC and the Therapeutic Goods Administration (TGA). This is also reflective in our contingency plan.
South Western Sydney Local Health District (SWSLHD) is taking every precaution for the safety and health of our clinical trial participants and staff. Due to the evolving situation with COVID-19 we are continually assessing how to approach each individual clinical trial using the below criteria:
1. Business as usual: protocol requirements remain unchanged and participants will have all assessments within the clinic/ hospital as planned
2. Participants will be seen in an alternative location: there may be a need to see participants in a different hospital or one of the SWSLHD community centres. You will be informed of this prior to this occurring and of any impact on the protocol requirements will be communicated. Onsite monitoring will cease and ongoing discussions with Sponsors regarding remote monitoring with take place.
3. Remote visits: In the event participants cannot attend their scheduled visits, a telephone or tele-health visit may be conducted. You will be informed of this prior to this occurring. The SWSLHD clinical trials team will discuss with you the supply of investigation product and logistic of administering the protocol requirements.
4. Withdrawal from the clinical trial and investigational product: there may be circumstances where it is in the best interest of the participant to withdraw from the clinical trial and your SWSLHD clinical trials team will notify you of this.
Thank you to everyone for working to identify the risks for each clinical trial and making decisions on continuing or stopping recruitment. It is important that we can support the continuance of our clinical trials in accordance with good clinical practice while we safeguard the health and well-being of participants and our teams.
• Medical Oncology
The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. We carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.
Medicines Australia Clinical Trial Research Agreement and Indemnity templates
An Australian Government website with information about clinical trials in Australia. The website includes information for clinical trial sites, sponsors and consumers.
This service is provided by the IFPMA, on behalf of its Member Companies and Associations. The portal has been designed as a single entry allowing you to search for comprehensive information on on-going clinical trials (registry) or results of completed trials (database) conducted by the innovative pharmaceutical industry.
Standard Operating Procedures (SOPs) are uniformly written procedures, with detailed instructions to record routine operations, processes and practices followed within an organisation . In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional and ICH-GCP guidelines.
Case Report Forms, Source Documents, Record Keeping and Archiving
The Clinical Trials Support Unit (CTSU) offers onsite internationally accredited GCP programs. These programs are tailored to all staff involved in clinical research and their supporting departments such as Pathology, Nursing and Pharmacy.
The course content promotes a depth of understanding about conducting research involving humans within south western Sydney and the Australian environment, through interactive scenarios and discussion.
All Researchers are ethically responsible to conduct clinical research of the highest quality. This includes the collection of high quality, credible data that contributes to the answering of specific scientific questions, while protecting the rights, safety and well-being of clinical trial participants. These principles have their origin in the World Medical Association’s Declaration of Helsinki.
GCP standards exist to provide a benchmark of clinical research quality that can be relied upon throughout the world.
As endorsed by SWSLHD Chief Executive, in collaboration with the Research Director and Research and Ethics Manager, GCP training is a mandatory requirement for all staff involved in clinical trials in South Western Sydney. The Course can be offered to all SWSLHD, Ingham Institute, Western Sydney University and University of NSW staff and students.
How to Register
6b) Orientation program for new clinical trial staff