Clinical Research Governance

The Melbourne Children’s brings together four organisations; The Royal Children’s Hospital Melbourne (custodians of clinical care), the Murdoch Children’s Research Institute (custodians of research), the University of Melbourne, Department of Paediatrics (custodians of education) and The Royal Children’s Hospital Foundation at a single, purpose-built and multi-award winning campus in the city of Melbourne. This mutually beneficial relationship results in the delivery of high-quality clinical services underpinned by research and education. 

Collectively, these independent entities contribute to a paediatric health sciences precinct which is greater than the sum of the parts. The presence of each benefits the other, ensuring the primary focus of each entity is achieved. The delivery of innovative, high quality paediatric care is unsustainable without the input of research and education. World class research into paediatric diseases and education of medical students/other health care professionals in paediatric health is not possible without access to a paediatric clinical environment. Hence the interdependence of the four partners. 

Purpose 

The purpose of this Clinical Research Governance and Support Handbook is to provide an overview of the current governance arrangements for clinical research undertaken at MCRI and RCH. It provides descriptions of the roles involved in the different governance, approval, or regulatory functions across the two organisations and, in doing so, informs the research workforce in understanding the relevant roles and governing bodies that support the clinical research they are doing.  

This document is supported by policies and standard operating procedures (SOPs)/procedures.  

Scope 

The governance arrangements described in this handbook are limited to clinical research. For this document, clinical research is defined as: 

• Research involving the study of people (participants), or their data/samples, to understand human health and disease.  

• Research undertaken by RCH and MCRI staff and students on campus with RCH patients, research participants, and consumer partners.  

Clinical research therefore includes clinical trials and other participant facing research happening on campus. 

Additional governance sign-off and/or requirements not articulated in this handbook may be necessary for research occurring outside the campus including community, external health services, education providers, and overseas clinical research.  

NOTE: This handbook does not cover governance arrangements for animal or basic science research (as defined by the NHMRC). 

There are several binding instruments between institutional partners of Melbourne Children’s and external groups that impact research governance, including but not limited to: 

• Melbourne Children’s Relationship Agreement (Melbourne Children’s Campus Partners) 

• MoU for Centralised Ethical Review (RCH & DHHS, on behalf of the State of Victoria) 

• MoU for the Melbourne Children’s Trials Centre (RCH & MCRI) 

• Shared Funding Agreement for Research Ethics & Governance (Melbourne Children’s Campus Partners) 

Research has the potential to create life-changing advances in treatments, prevention, and better health outcomes for all. Through research we can prioritise the care that matters most, in the areas of prevention and early detection, better care, and health services and systems research.  

This Handbook is one of the documents (along with the relevant agreements, policies, and procedures) that supports compliance with applicable laws, regulations, standards, codes, and guidelines including, but not limited to: the National Statement on Ethical Conduct in Human Research (National Statement), the Australian Code for the Responsible Conduct of Research (The Code), the National Clinical Trial Governance Framework (NCTGF), and the ICH Guideline for Good Clinical Practice (ICH-GCP). Research ethics and governance compliance includes the ethical and scientific review of research, contractual and financial management of research, and research authorisation by the relevant authority. 

It is the responsibility of all Melbourne Children’s researchers undertaking or assisting with clinical research to be aware of and apply the principles and processes outlined within this Handbook. This includes all related policies and procedures, guidelines, standards, general and specific legal obligations (statutory or otherwise), including updates, that occur from time to time. 

Support Offices for Clinical Research  

Ensuring good governance of research and compliance with all relevant laws, codes, guidelines, and regulatory areas is everyone’s responsibility. 

The Melbourne Children’s has a number of departments set up to support clinical research and clinical trials. These Support Offices have a unique role to play in clinical research/clinical trial governance. They are administered by different entities across the Melbourne Children’s Campus, but work collaboratively to help Principal Investigators and Clinical Leads deliver the best possible care. 

The table below provides a high-level summary of the key role of these groups. A full description of the function of each of the Support Offices is described below. 

Detailed Role and Function of Support Offices 

RCH Research Operations  

The RCH Research Operations department sits under the Division of Medical Services and reports to the Executive Director Medical Service and Chief Medical Officer. The Melbourne Children’s ReseaRCH Unit (MCRU) and Research Ethics & Governance (REG) Office are divisions within Research Operations.  

Research Operations is responsible for leading the development of the RCH Research Strategy, setting direction, leading change, and representing RCH internally, state-wide, nationally, and internationally. 

It is responsible for the overview and management of elements of research governance relating to compliance with legislation, directives from regulatory bodies, guidelines, and codes of practice. 

Website: Research Ethics and Governance 

Melbourne Children’s ReseaRCH Unit (MCRU) 

Melbourne Children’s ReseaRCH Unit (MCRU), is a specialty outpatient day ward in which all high acuity clinical trials are conducted at RCH. The MCRU team is responsible for ensuring adherence to all policies relevant to the work occurring within MCRU, and provides professional oversight and support to trial teams who conduct trials within MCRU. 

Research Ethics & Governance Office 

The Research Ethics & Governance (REG) Office manages and supports the operations of the HREC and its subcommittees, in accordance with the applicable laws, regulations, standards, codes, and guidelines including the National Statement, Code, and GCP, as well as the relevant RCH policies and procedures. 

The Research Ethics Managers, supported by the Research Ethics & Governance Officers, are the initial contact for the HREC and its subcommittees. They provide high level advice and timely responses to ethics and governance enquiries from researchers, clinicians, students, and health service practitioners in a paediatric and child health setting.  

The REG Office reviews all applications for Human Research Governance Authorisation (SSA – Site Specific Assessments), and coordinates authorisation by the Director of Research Operations, as a delegate of the RCH Chief Executive and MCRI COO, of research studies to commence at the RCH and MCRI. This includes supporting researchers in obtaining supporting department sign off. They coordinate and oversee the processing of site-specific approvals, with the integration of ethical approvals from external organisations under the National Mutual Acceptance (NMA) scheme.  

The REG Office also provides advice in areas concerning compliance with ethical guidelines and requirements, the monitoring of adverse events, and amendments to Protocols. They evaluate Progress Reports and Final Reports for research approved by the Human Research Ethics Committee (HREC), ensuring adherence to established protocols and approvals. As well as monitoring of adverse events, they implement periodic monitoring and audit initiatives to verify compliance with all applicable laws, regulations, standards, codes, guidelines (including the National Statement, the Code, and GCP), and institutional research policies. Monitoring and auditing frequency and methods are tailored based on the level of risk to participants, promoting ongoing researcher education in ethical research practices. 

The REG Office facilitates review of all Research Contracts (in consultation with RCH and MCRI Legal Services) in relation to new research, amendments, confidentiality deeds, research collaborations, and funding agreements (with MCRI Grants). The RCH Director Research Operations, who leads the REG Office, has Level 5 delegation to review and approve research contracts in accordance with the RCH delegation of authority. 

Website: Research Ethics and Governance 

Melbourne Children’s Trials Centre (MCTC)  

The MCTC is a collaboration between The Royal Children’s Hospital (RCH), Murdoch Children's Research Institute (MCRI), The Royal Children’s Hospital Foundation and the University of Melbourne, Department of Paediatrics. 

MCTC is built on the principles of quality, efficiency, and innovation, facilitating clinical trials ranging from trialing novel therapeutic agents through to large public health prevention trials. MCTC invests in innovative trial designs and use of new technologies. MCTC enables researchers to bring new and novel therapies to children, and generates knowledge to improve healthcare for all children.  

MCTC provides mentoring and support for externally sponsored trials run by clinical trial teams embedded within RCH and MCRI departments (Trial Nodes). This includes feasibility, budget and contract negotiations and ethics submissions.  These activities are facilitated by the MCTC Business & Operations Manager and the Clinical Trial Nurse Lead.    

MCTC also conducts commercially sponsored trials for a number of RCH Departments where the trial activity is insufficient to warrant the development of a specific Trial Node.   These activities are conducted by a small team of experienced Research Nurse Coordinators who are responsible for the study visits, data entry, close-out, and archiving activities for each trial.  

The centre also supports the development and implementation of high quality MCRI Investigator Initiated (IIT)- trials through involvement in the MCRI Sponsorship Committee, and mentoring, and advice to all members of the trial team at all stages of the trial from planning, through conduct, to sharing results. An experienced team of Clinical Trial Managers supports a small portfolio of MCRI-sponsored IITs run both locally and overseas.   This team can be expanded as required and as funding permits.  The centre is also responsible for managing communications/notifications to the Therapeutic Goods Administration, and registrations with trial registry provider ClinicalTrials.gov..   

MCTC also has a key role supporting implementation of actions to comply with the National Clinical Trials Governance Framework, thereby supporting accreditation of RCH for both clinical service and clinical trial service provision.  This work is supported by a dedicated NCTGF Implementation Lead, who works across both organisations to ensure harmonisation of systems and processes with the clinical service.  

MCTC’s collaborations with the Clinical Research Development Office (CRDO), Clinical Epidemiology and Biostatistics Unit (CEBU), and leading health economists at the University of Melbourne support these initiatives.  

Website: https://www.mcri.edu.au/research/core-facilities-services/melbourne-children-trials-centre  

Clinical Research Development Office (CRDO) 

CRDO is funded by the Murdoch Children's Research Institute. It works in close collaboration with the Melbourne Children’s Trial Centre,  Clinical Epidemiology and Biostatistics Unit (CEBU), RCH Research Ethics and Governance (REG) Office, MCRI Legal, MCRI Privacy, and MCRI Data Office.  

CRDO provides education, training, and support to clinical research staff at Melbourne Children’s campus. This includes a suite of regular workshops, educational fora, and the development and maintenance of a large portfolio of Standard Operating Procedures designed to assist research teams to build quality by design into their projects as well as meet their responsibilities to various stakeholders including research participants, the HREC, the RCH Research Ethics & Governance team, trial Sponsors, and the Therapeutic Goods Administration. CRDO also provides mentoring to researchers at all stages of their project, from planning through conduct, analysis, and dissemination of results. 

The CRDO Lead/Quality and Regulatory Manager is responsible for the development and implementation of the strategy for CRDO that supports the delivery of high-quality clinical research. This position is supported by the CRDO Training and Development Coordinator and the MCTC Sponsorship and Regulatory Binder Coordinator.  

The Qualitative Research Lead sits within CRDO and is responsible for improving MCRI’s capacity to provide high quality qualitative and mixed methods research by building capacity through training and professional development, developing resources, and maintaining the Qualitative Research Community of Practice. 

Website: Clinical Research Development Office 

MCRI Research Support and Operations 

Headed up by the Chief Operating Office of the MCRI, Research Support and Operations (RSO) manages the ongoing corporate operations of the MCRI. The department includes the following teams: Operations, Finance, Information Technology, Environmental Health and Safety, Legal, Cyber Governance, Scientific Services, and Risk and Compliance. RSO is also responsible for the ongoing operations of MCRI and MCRI research.  

In the context of clinical research, RSO is responsible for providing infrastructure and resources. They also authorise contractual and indemnity arrangements, privacy and cyber governance obligations, and delegation of authority for senior level management and governance authorisations.

The below outlines the key teams within MCRI Research Support and Operation who have a substantial role in providing support for governance of clinical research (as defined in this handbook). 

MCRI Risk Management 

The risk management team identifies, assesses, and mitigates risks related to operations, research, and finances. They are responsible for the development and implementation of risk policies and frameworks to support decision making and ensure regulatory compliance. Overall, they work to protect the institute’s assets, support reliable research outcomes, and maintain safety and compliance. 

MCRI Legal 

MCRI Legal provides advice and guidance on a wide range of legal matters including insurance, intellectual property, privacy, confidentiality, conflicts, material transfer, biobanking, and marketing initiatives. 

The Legal team manages a wide range of agreements and contracts, including Materials Transfer Agreements, Confidentiality Agreements, Contractor/Services/Consultancy Agreements, Collaboration (Research) Agreements, Licence Agreements, Non-NHMRC Funding Agreements, Placement and Student Agreements, Amendment and Variation Agreements, Memorandums of Understanding, and Letter Agreements. They also manage MCRIs Insurance portfolio including work related travel insurance, international clinical trial cover, insuring equipment, cover for risks associated with medical treatment, professional advice and public liability, certificate of currency requests, managing claims, and providing advice on insurance coverage across partnerships and collaborations. 

All MCRI agreements must be signed off by the Legal team. These agreements establish enforceable obligations and provide valuable rights so as to limit MCRI’s legal and financial exposure. 

MCRI Privacy Team 

The Privacy team supports privacy training, self-education, and advice on how to incorporate privacy-by-design into the research projects lifecycle. In collaboration with legal, ethics & data, and IT teams, they provide advice related to privacy matters including consent, privacy risks, and data access requests. The team also staffs the role of Data Protection Officer and Privacy Officer for MCRI ensuring the provision of: privacy advice on the development of new initiatives that have a potential privacy impact, the general application of privacy law to research activities, safeguarding the privacy of participants and support, and Privacy Impact Assessments. The team are also responsible for managing data breaches and privacy complaints. 

MCRI Office of Research  

The MCRI Office of Research houses research-specific areas such as Data Management & Governance, Research Grants, Research Performance, and Research Governance and Integrity. The Office of Research, headed up by the MCRI Deputy Director, is responsible for the oversight of research data, grants, research integrity processes (including compliance with the Australian Code for the Responsible Conduct of Research), analysis of research performance, student onboarding and support, researcher development, and prizes and awards.  

MCRI Office of the Director: 

The MCRI Office of the Director, led by the Director of MCRI, manages the institutes research strategy, major projects, government relations, research impact, and engagement. The office is responsible for setting the strategic directions for campus research, facilitating government and consumer engagement, and research impact.  

MCRI Data Office 

MCRI's Data Office is led by Chief Data Officer. The team's purpose is to optimise the data ecosystem by supporting data governance across the research lifecycle. It is responsible for developing policies, application and tools, and data management planning, to support good data governance across the MCRI. The data team also manages the CAB: Data stream which reviews and approves certain data transfers. 

Partnering with consumers at Melbourne Children’s Campus 

• RCH Partnerships and Consumer Engagement Team: Support and empower RCH staff and consumers to work in collaboration with each other to develop and deliver programs and initiatives that support better health outcomes for children and young people. Manage the RCH’s external consumer advisory groups and internal networks. 

• MCRI Research Impact and Consumer Involvement Team: Support capacity, capability and culture for consumer and community involvement in research at MCRI and across the Melbourne Children’s Campus, with a focus on research governance, the provision of training and coaching, Communities of Practice, and centering the voices of children

• A Campus approach to consumer engagement: These RCH and MCRI teams have made a commitment to partner on partnering with consumers and community members. Together they work to enable streamlined partnership opportunities, providing support for staff and consumers, and sharing resources and learnings for the Campus.

Governance Committees 

This section introduces the various governance committees across the campus and includes their scope, role, and responsibilities.  

Clinical Trials Governance Committee 

The RCH is committed to delivering clinical trials for its patients with its campus partners.  

The purpose of the Committee is to ensure appropriate governance and risk management in clinical trials involving RCH patients, and to monitor compliance with relevant clinical research standards and guidelines including the Therapeutic Goods Administration (TGA)’s Australian Clinical Trial Handbook, The National Clinical Trials Governance Framework (NCTGF), ICH Guideline for Good Clinical Practice (ICH-GCP), the National Statement on Ethical Conduct in Human Research (National Statement), organisational policies and procedures, and international regulatory agencies where applicable.  

The committee will provide clinical governance, risk and compliance oversight, and strategic and advisory functions to the relevant Executive committees, clinical researchers, clinical research support staff, and other stakeholders as needed.  

Chair: Co-chair RCH Executive Director Medical Services and Clinical Governance and MCTC Medical Director 

Frequency: Quarterly 

Reports to: RCH Executive Clinical Quality and Safety Committee 

Campus Council 

Campus Council was established by the May 2008 Deed of Undertaking between The Royal Children's Hospital, The Royal Children's Hospital Foundation, Murdoch Children's Research Institute, and the University of Melbourne. Campus Council provides strategic leadership and advocacy for paediatrics and child health generally. It enhances the collaboration and co-operation of the campus partners to achieve a world renowned paediatric academic health centre. Campus Council assists each campus partner in their pursuit of excellence, whether it be in prevention, clinical service delivery, fundraising and philanthropy, child health research, or the training of clinicians, researchers, and educators. 

Chair: MCRI Director 

Frequency: Quarterly 

Campus Research Committee 

The Campus Research Committee is an advisory committee of the Campus Council.  

The Campus Research Committee strengthens and maximizes research opportunities on Campus for discovery, knowledge creation, and translation into quality care for children and young people. 

Their functions include: Maximise child and adolescent health research on campus; Identify high-level strategic priorities for campus-wide research for consideration by Campus Council; Advise Campus Council on appropriate performance measures for research on campus; Encourage effective communication between researchers and clinicians; Provide Campus Council with feedback on campus research issues; Oversee and advise on ongoing conduct of joint strategic initiatives. 

Chair: MCRI Director 

Frequency: Quarterly 

Reports to: Campus Council 

Human Research Ethics Committee and Drug Trials Subcommittee 

The purpose of the Human Research Ethics Committee (HREC) and the Drug Trials Subcommittee (DTS) review the ethical and scientific validity of proposed research projects; including RCH and MCRI research conducted in other states and overseas. The role of the HREC and supporting team is to ensure clinical research happening on campus meets the National Statement on Ethical Conduct in Human Research. 

The HREC acts in a consultative and advisory capacity with researchers to ensure that all clinical, research, and management practices are conducted in an ethical and scientifically robust manner, and to promote and foster ethical and good clinical/health research practices that are of benefit to the community.  

The HREC Chair provides leadership to the HREC and DTS and ensures that the HREC is functioning in accordance with all applicable regulations and standards. The position promotes compliance with Commonwealth and State regulations, sponsor and institutional policies and procedures regarding the safety and welfare of human participants involved in research studies, and provides advice on human research ethics matters as they arise.  

Chair: Human Research and Ethics Committee– appointed by the RCH Board. Chair of DTS is the Lead Clinical Trials Pharmacist

Frequency: 11 meetings a year  

Reports to: RCH Board 

Terms of Reference – Human Research and Ethics Committee 

RCH Research Innovation & Improvement Committee (and Research Leads) 

The purpose of the Research Innovation and Improvement Committee (Research Lead) role is to foster and support engagement with clinical research, both within their RCH department and with their associated MCRI Group(s). The primary focus of the Department Research Lead is to support members of their clinical department to engage in, and foster, clinical research to provide the best possible evidence-informed care for patients.  

Chair: Co-chairs: Research Lead (rotate 2 yearly), appointment by ED Medical Services and Director Research Operations 

Frequency: Monthly or as required.

Reports to: Clinical Quality and Safety Committee 

Terms of Reference: Research Innovation and Improvement Committee 

MCRI Sponsorship Committee 

The Sponsorship Committee’s responsibilities apply to all clinical trials where MCRI is proposed as the Sponsor.  MCRI will only sponsor trials where the lead Investigator, herein known as the Sponsor-Investigator, is either a paid employee of MCRI or RCH.  RCH employees must either be an employee of MCRI or hold an MCRI honorary position. The Sponsorship Committee does not have any oversight of trials sponsored by an external organisation,  e.g. pharmaceutical company or collaborative group, public/private hospital, medical research institute or university).  

The Sponsorship Committee reviews applications asking MCRI to sponsor clinical trials, to ensure that institutional risks are identified and acceptable, and appropriate reduction/mitigation strategies are in place or planned.  

The Committee provides approval (initial and ongoing) for MCRI to sponsors a trial once satisfied that risk-proportionate processes have been implemented that manage the safety of trial participants and the reliability of the trial data throughout the trial life cycle. The Committee fulfills MCRI’s sponsor responsibilities for trial oversight for the trials they approve for MCRI Sponsorship. 

Chair: Medical Director MCTC  

Frequency: Monthly (or as required) 

Reports to: Campus Clinical Trials Governance Committee 

Institutional Biosafety Committee 

All research conducted with Genetically Modified Organisms (GMOs) and genetic manipulation must carried out in accordance with the legislation outlined in the Gene Technology Act 2000, Gene Technology Regulations 2001, and subsequent amendments. 

In accordance with this legislation, the MCRI Institutional Biosafety Committee (IBC) has been established to oversee that work of this nature conducted within the Melbourne Children’s campus conforms to these legal requirements.  

Research involving GMOs must be approved by the MCRI IBC before work commences. The IBC reviews and approves all applications before work commences, including performing human clinical trials involving GMOs on the Melbourne Children’s campus. The RCH uses the MCRI IBC. 

Chair: Shireen Lamade 

Frequency: Monthly (or as required) 

MCRI  Data Transfer - Change Advisory Body 

MCRI has implemented the Data Transfer - Change Advisory Body (DT-CAB) to ensure that appropriate governance and information security measures are considered when dealing with MCRI data. This includes clinical research data, and is supported by robust data governance frameworks, data management policies, and training across the whole data lifecycle.  

DT- CAB provides oversight and final approval of data transfer proposals in order to optimise the efficiency and effectiveness of the transfer, while minimising risk, and ensuring visibility. They do this by bringing together Privacy, Legal, Cybersecurity, IT, Data Office and researchers at committee meetings. The committee actively reviews the nature of the data (classification, type, volume, format, cybersecurity), the method of transfer (data flows, tools, and systems), nature and access of involved entities (people or organisations), and location of data (start and end). 

Any transfer of data into or from MCRI is within scope for the DT-CAB. Transfer that involves only publicly available data or are wholly within MCRI/VCGS are outside scope.  

Chair: MCRI Research Data Manager 

Frequency: Weekly (as required) 

Terms of reference: CAB Data Transfer Stream 

Operational Requirements for Clinical Research Governance 

The operational requirements come under the following headings. A detailed description of the roles & responsibilities under each heading is included below.  

Collaborations and Contracts 

Collaborative research between institutions can take various forms, include research partners in industry, government, and not-for-profit sectors, and research team members from multiple countries. 

Collaborative research can pose a range of challenges, including the need to accommodate specific research methodologies, different research practices in different research institutions, variations in regulatory and legal systems, institutional funding arrangements, organisational structures, and differing research cultures. These challenges should not be seen as a barrier to collaborative research, but as elements to be managed through normal risk management processes. 

Agreements must cover (but is not limited to) sharing of research funds, intellectual property, data privacy, confidentiality and copyright issues, sharing, commercial returns, insurance, responsibility for ethics and safety clearances, and reporting to appropriate agencies. It should address the protocols to be followed by the partners when disseminating the research outcomes, and the management of primary research materials, and research data. 

Campus research is supported by Australian public funding, so the Collaborative research guide that accompanies the Australian Code for the Responsible Conduct of Research is also to be followed.  

Grants and Funding 

Organisations involved in research projects and clinical trials are required to undertake Good Stewardship of Public Resources used to conduct research, and ensure that research funds are managed in accordance with relevant funding arrangements, legislation, and RCH/MCRI policies and procedures. 

Research grant funding is awarded to researchers working on individual research projects, for the purpose of advancing research in their field of expertise with that project. 

The MCRI Grants team within the Office of Research is the registered administrative contact for external peer‐reviewed granting agencies and MCRI internal competitive funding schemes. 

All competitive research funding applications at the RCH and MCRI must be prepared in consultation with the Grants Office.  

Research Approvals 

All RCH and MCRI clinical research must have the appropriate approvals in place prior to the commencement of the research. The RCH and MCRI has various approval processes in place to ensure they support research that is ethical and safe. The approvals required depends on the type of research being conducted. These include: 

• If the research involves patients and/or their families, or other community participants, tissues, cells, or data from the RCH, the application to conduct research must be approved by the RCH HREC or another NMA participating reviewing HREC. 

• All clinical research must also seek governance authorisation from the RCH Research Ethics and Governance (REG) office. Further information can be found at the REG website. 

• The Human Research Ethics Application (HREA) provides the mechanism for ethics approval of human research, to ensure it is conducted ethically and in accordance with the National Statement. 

• The Site Specific Assessment (SSA) provides the mechanism for governance authorisation of clinical research to commence at RCH and MCRI. It ensures RCH and MCRI has the appropriate resources to support and facilitate the research, and that the contractual, risk, and financial management of the research has been authorised. SSA is the local institutional due diligence process by which the suitability of a clinical research study to take place in the context of the specific facility is assessed. 

• Sponsorship committee approval provides MCRI institutional approval of MCRI-led investigator initiated clinical trials to ensure risks associated with trial sponsorship are appropriately managed.  

Risk & Regulatory Compliance:

Clinical Research / Trials undertaken at Melbourne Children’s should sit within the Institute’s risk appetite and require the appropriate levels of risk assessment / mitigation and regulatory compliance. This includes (but not limited to): 

• Risks associated with clinical research on patients, participants, staff, the community, the environment, and the MCRI and/or RCH. 

• MCRI/RCH has the appropriate oversight, indemnity, facilities, and resources to support and facilitate the research. 

• All clinical research / trials comply with relevant RCH/MCRI policies, procedures, and standards, as well as all other applicable laws, regulations, standards, codes, and guidelines. 

• Clinical research activity is appropriately insured and the relevant risks are appropriately managed by the study team, with support from the MCRI Risk Management team. 

Monitoring: 

Monitoring is the act of overseeing the progress of a research study/clinical trial and checking it is conducted, recorded and reported in accordance with the protocol, relevant Standard Operating Procedures (SOPs), and applicable regulatory requirements and local policies/procedures. 

The purpose of monitoring is to:  

• Protect the rights and wellbeing of the research participants. 

• Ensure the data are accurate, complete and verifiable 

• Ensure recruiting sites conduct the study according to the approved protocol and ongoing legal and regulatory requirements.  

All clinical trials conducted under a CTN/CTA must implement a risk-based monitoring program.  Monitors are appointed by the Sponsor of the trial.  For MCRI-sponsored trials, the Sponsor-Investigator is responsible for appointing a Monitor(s).  Monitors must be independent of the Sponsor-Investigator and the Central Trial Coordinating Team.  For clinical research that is not a trial, monitoring may be used as part of the study risk mitigation/monitoring strategy.  

Supporting Policy/ Procedure: MCTC046 SOP | Monitoring Visit Activities for Clinical Trials of Investigational Products 

Internal Audits 

Internal audits assess compliance with defined standards at a given moment in time. Internal auditing is distinct from ‘monitoring’, which refers to the research team’s continuing research oversight and quality control measures.  

National and international guidelines outline the role and responsibilities of both Research Institutions and Clinical Trial Sponsors for auditing human participant research projects.   

There is a requirement to audit research practices to assess compliance to the study protocol, GCP, SOPs, and all applicable legal and regulatory requirements, as a part of a quality management system.  

The purpose of  the Internal Audit Program:  

• Evaluate trial conduct and ensure researchers’ compliance with the protocol, SOPs, GCP, regulatory requirements, and MCC policy. 

• Ensure participant and staff safety. 

• Ensure participant rights, welfare and well-being are being adequately protected.  

• Assess data quality and integrity. 

• Improve research systems and data quality. 

• Prepare researchers for external audit processes. 

• Demonstrate robust research processes to external funders and industry. 

• Review  reports from independent agencies. 

Data Governance 

Good data management is the foundation of good research. When data are properly organised, preserved, and well documented, and their accuracy, validity, and integrity is controlled at all times, the result is high quality data, efficient research, outputs based on solid evidence, maximised potential for future research, and reduced waste of resources of value to researchers and the wider community. 

All clinical research / trial data must be managed in accordance with the MCRI Data Governance Framework. 

Research must adhere to the NHRMC Guidance: Management of Data and Information in Research: A guide supporting the Australian Code for the Responsible Conduct of Research, and the relevant institution of Melbourne Children’s data and records management policies and procedures (e.g., RCH, MCRI). 

Data breaches (any incident in which data is compromised, disclosed, copied, communicated, accessed, removed, destroyed, stolen, lost, or used by unauthorised individuals, whether by accident or intentional) involving MCRI/RCH data must be notified to the Research and Ethics Office and MCRI as per the Data Breach Response Plan.  

Supporting Policies MCRI Data Breach Policy  

Quality & Safety Improvement Systems 

Safety monitoring and reporting in the form of adverse events, incidents and breaches of good clinical practice is essential for patient safety and integrity of clinical research. It helps to create a culture of quality improvement by using lesson learnt to drive continuous improvement. 

The responsibility for safety monitoring and reporting requirements lies with the sponsor of a clinical trial, defined as ‘an individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study’. 

All clinical research/trials adverse events/incidents and GCP breaches are to be managed in accordance with the MCC Safety Monitoring and Reporting Procedure 

Researchers must adhere to the NHMRC safety Monitoring and reporting in clinical trials involving therapeutics goods. 

The Safety Monitoring and Reporting Adverse Events Procedure below provides a road map as to what, how and when adverse events are to be reported on campus. 

Supporting Policies Procedure: Safety Monitoring and Reporting Procedure for MCRI-Sponsored IITs of Medicine / medical Devices. 

Clinical Trial Workforce Roles and Responsibilities 

Based on the ACQSHC Fact Sheets 

RESPONSIBILITIES 

WIDER CLINICAL TRIALS WORKFORCE 

All staff involved in any aspect of developing, conducting and supporting clinical trials are considered as part of the ‘Clinical Trial Workforce’ and therefore have the following responsibilities: 

CLINICAL TRIAL TEAM MEMBERS 

The roles listed below have additional responsibilities based on their position in the Clinical Trial team. 

This document undergoes rolling reviews. For any updates or feedback please contact [email protected]