Start-Up Seminar: Resources to Support the Early Phases of Research
Sydney Health Partners is hosting the first of a series of webinars to support you in the early stages of health services and clinical research.
Research success begins with good planning and preparation. But knowing where to begin and what processes to put in place can be confusing and overwhelming.
On April 7, 12 - 12:45pm, Sydney Health Partners hosted the first of a series of webinars to introduce a range of free resources and tools on our website to help attendees understand the processes involved in ethics and governance, planning a clinical trial and your participant recruitment strategies, and engaging meaningfully with consumers and the community.
This webinar had a particular emphasis on early career researchers and clinicians who are starting to think about clinical and health services research, as well as those who work in clinical trials, including trial coordinators and research nurses.
Browse our available resources, or read on for a summary of the Q&A portion of the event.
Questions about Consumer and Community involvement
There is a project to develop a register for interested consumers and researchers who want to partner in research. Interested people can contact us in advance (firstname.lastname@example.org or email@example.com) and we will keep you updated (see our emails below). Otherwise, to receive regular updates about Sydney Health Partners, you can sign up for our mailing list.
The time needed to develop your research idea, engage partners including consumers, obtain ethics and governance approvals, and, if necessary, seek funding will vary.
For example, some research projects are quite simple in design, are considered ‘low risk’ in terms of ethics and governance approvals and can be conducted with already-available resources. Other projects are larger scale, carry greater potential risks for participants or the study site, and need to be supported with external funding. The former could be set up in a matter of months, the latter could take a year or two or even longer.
The time involved in establishing your research team, including consumer members, will also vary. If you have established relationships with researchers and consumers, then engaging them in a new project might happen relatively quickly. If you need to build new relationships, this will take time as you find people who are interested in your project and want to contribute. Forming research collaborations is an investment over the longer term – not only for the current project, but also future projects. This is true for researcher partners and consumer partners.
Being a participant in a research project often can spark that person’s interest in being more involved in research. Depending on the nature of the study, it can also foster trust in the researcher and the research process. If the first project is finished, you can reach out to a former participant about being involved in a new project as a potential partner. This does not require approval by an Ethics Committee.
Questions About Clinical Trials
The vendor contracted by NSW Health is Advarra (formerly BioOptronics). The CTMS is a central system enabling study build, automated notifications, invoicing capability, reporting, forecasting and participant management. The CTMS includes other functions such as:
- eReg: Central online document storage allowing quick and easy access to authorised staff and external monitors, notifies staff when new versions available and tracks training compliance, enables electronic authorisation.
- eConsent: Mobile electronic consenting system that supports participant engagement, enhances comprehension of consent, and optimizes quality of the consenting process.
- eSource: Audit compliant electronic source data system that enables staff to easily capture data in real-time, reducing capture time, minimizing data entry duplication, facilitating remote monitoring visits, and optimizing study data management
We understand that these requirements vary across individual organisations. However, the regulatory guidelines for clinical trials state GCP training is required and should be renewed every 3 years. The new National Clinical Trials Accreditation Framework, which applies to health organisations (but not universities), requires this credentialing so it is likely to become a more common standard. SHP is supporting 24 people across our partnership to become GCP trainers (in April 2022), so access to the course should also be easier.
Unfortunately, SHP does not have this kind of resourcing. However, some of our partners, and larger clinical trial units are testing these kinds of ‘shared’ positions. It may be helpful to check with your local research support office.
The processes for involving consumers in health care and health research activities are managed at an organisational level. It is best to check with your organisation about the specific local requirements.
There are many published papers about the barriers and facilitators to participant recruitment, including for clinical trials. Sydney Health Partners will develop a summary as a future project. Thanks for the suggestion! We have also recently completed a Pilot Recruitment Project around the barriers to clinical trials, and will be adding a summary from that project on our website.