COVID-19 guidance for clinical trials and research projects
The safety and wellbeing of trial participants, other patients, visitors, researchers and other clinical and support staff is paramount.
https://thermh-prod.thirststudios.io/research/office-for-research/research-governance/covid-19-guidance-for-clinical-trials-research-projectsThe Office for Research oversees all aspects of research at the Royal Melbourne Hospital (RMH), with the major component of work arising from the operation of the HREC and the governance of research projects undertaken at or by the RMH.
https://thermh-prod.thirststudios.io/research/office-for-research/research-feesResearch involving ionising radiation
Researchers proposing to expose research participants to ionising radiation should provide information that allows consent to be properly considered by research participants.
https://thermh-prod.thirststudios.io/research/office-for-research/ethics/research-involving-ionising-radiationConsent process for research involving people without decision-making capacity
The Medical Treatment Planning and Decisions Act 2016 (Vic) provides a framework for making decisions about medical treatment when people do not have the capacity to make their own decisions.
https://thermh-prod.thirststudios.io/research/office-for-research/ethics/consent-process-for-research-involving-people-without-decision-making-capacityThe RMH's research integrity advisers are a key resource for advice and support with regard to research integrity and misconduct, as well as our processes and procedures relating to research integrity.
https://thermh-prod.thirststudios.io/research/about-research/conducting-research-at-the-rmh/research-integrity/research-integrity-advisorsREDCap for data collection in research
Research data and metadata must be collected, stored, retained, used and disposed of in a way that protects the rights, safety, and wellbeing of the research participants and wider community. REDCap can help meet these data requirements.
https://thermh-prod.thirststudios.io/research/about-research/conducting-research-at-the-rmh/redcap-for-data-collection-in-researchResearch integrity is a way of thinking and behaving that ensures that research undertaken is trustworthy.
https://thermh-prod.thirststudios.io/research/about-research/conducting-research-at-the-rmh/research-integrityResearch integrity is a way of thinking and behaving that ensure that research undertaken is trustworthy.
https://thermh-prod.thirststudios.io/research/resources-to-support-clinical-research-at-the-rmh/online-research-integrity-education-and-resourcesREDCap (Research Electronic Data Capture) is a secure web application for building and managing online surveys and databases
https://thermh-prod.thirststudios.io/research/resources-to-support-clinical-research-at-the-rmh/redcap-supportInternal audit of research is an important means by which the Royal Melbourne Hospital ensures research auspices is conducted in accordance with good clinical practice (GCP) and approved ethical guidelines
https://thermh-prod.thirststudios.io/research/office-for-research/post-approval-project-management/auditing-research-projectsSerious Breach is a breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree the safety or rights of a research participant or the reliability and robustness of the data generated in the research project.
https://thermh-prod.thirststudios.io/research/office-for-research/post-approval-project-management/serious-breachesSafety and adverse event reports
Maintaining and reporting of adverse events and safety information in research will ensure that RMH complies with the NHMRC's National Statement.
https://thermh-prod.thirststudios.io/research/office-for-research/post-approval-project-management/safety-and-adverse-event-reportsThe Royal Melbourne Hospital is required to monitor all approved research until the completion of the project.
https://thermh-prod.thirststudios.io/research/office-for-research/post-approval-project-management/post-approval-monitoringReporting to the Research Office is a condition of ongoing ethics approval.
https://thermh-prod.thirststudios.io/research/office-for-research/post-approval-project-management/progress-and-final-reportsIs my project quality assurance?
Sometimes it's difficult to determine whether a project is quality assurance or research. Below are a series of questions to help determine whether your project fits the criteria for QA review.
https://thermh-prod.thirststudios.io/research/office-for-research/ethics/quality-assurance/is-my-project-quality-assuranceFrom time to time, amendments to research projects are required often due to protocol changes, updated investigator brochures, personnel changes on the study, site additions, and more. Researchers and sponsors must notify the HREC of such changes.
https://thermh-prod.thirststudios.io/research/office-for-research/post-approval-project-management/amendmentsStudy to understand risk of Alzheimer’s disease in middle-aged adults Research study
An Australian-first online study of psychological, lifestyle and genetic factors that increase risk of Alzheimer’s disease.
https://thermh-prod.thirststudios.io/research/clinical-trials-research-studies/study-to-understand-risk-of-alzheimers-disease-in-middle-aged-adultsThe Department of Anaesthesia and Pain Management has a proud history of conducting quality research.
https://thermh-prod.thirststudios.io/services/anaesthesia-pain-management/anaesthesia-researchCombination treatment for locally advanced or metastatic ER-positive breast cancer Research study
A phase II, multicentre, randomised study to compare the efficacy of venetoclax plus fulvestrant as a combination treatment for locally advanced or metastatic ER-positive breast cancer.
https://thermh-prod.thirststudios.io/research/clinical-trials-research-studies/combination-treatment-for-locally-advanced-or-metastatic-er-positive-breast-cancerSailuotong for vascular dementia or Alzheimer’s disease with cerebrovascular disease Research study
A clinical study that is testing a new herbal medicine formula treatment for vascular dementia or Alzheimer’s disease with cerebrovascular disease.
https://thermh-prod.thirststudios.io/research/clinical-trials-research-studies/sailuotong-for-vascular-dementia-or-alzheimers-disease-with-cerebrovascular-disease