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(1) La Trobe University (the ‘University’) is committed to supporting clinical trials. (2) The Clinical Trials Policy (‘Policy’) establishes a framework to ensure that clinical trials are carried out at the highest scientific and ethical standards to ensure data quality and safety of research participants. (3) The Policy works in conjunction with the University Research Governance Policy to ensure legislative and regulatory requirements, policy mandates, principles and best practice standards for research are met. (4) The purpose of the Policy is to: (5) For the purposes of this policy, a clinical trial is defined as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments, process-of-care changes, preventive care etc.. (World Health Organization) (6) This Policy applies to clinical trials, as: (7) The University encourages and supports clinical trial-related activities. (8) The Policy is based on the Principles of Research Governance as specified in the Research Governance Policy. (9) All clinical trials must be conducted in compliance with: (10) La Trobe staff and students must inform the University Research Office about any clinical trial they are involved in on La Trobe premises or conducted at other sites (e.g., hospitals, other universities, research institutes, or sites within the community). The process is outlined on the clinical trials website. (11) Prior to the University and/or its staff and students initiating, or agreeing to participate in, clinical trial-related activities, the following must be considered: (12) La Trobe Co-ordinating/Site Investigators where appropriate, will seek advice from the Research Office as early as possible in the development process about the project. (13) Additional consultation regarding the roles and responsibilities may be required between the researchers, the Research Office, the sponsor company and/or funding body. The Research Office can help facilitate any consultation as required. (14) Where the University considers taking on the roles and obligations of Sponsor, each situation will be assessed on its individual merits in consultation with the Research Office. (15) If La Trobe is acting as the Sponsor and is collaborating with a Foreign Organisation to conduct a clinical trial in another country, an equivalent to a Clinical Trials Research Agreement must be signed prior to site activation in the Foreign Country. (16) Researchers must source all equipment and materials through safe and ethical channels. (17) Where appropriate, the Principal Investigator must ensure all contracts and warranties are in place before the use of any research equipment or materials. (18) All staff and students should be adequately trained and/or certified to use any research equipment and materials. (21) Projects should be designed in line with the NHMRC National Statement on Ethical Conduct in Human Research 2007 and for drug and device trials should also be designed in accordance with the Therapeutic Goods Administration Guideline on Good Clinical Practice. Where there is conflicting advice, the National Statement should take precedence over the TGA notes on Good Clinical Practice. (22) Project authorisation includes the relevant checkpoints and approvals from Parts G-M below. (23) The Sponsor is responsible for arranging Clinical Trials Insurance, and the site is responsible for other matters of Indemnity. The minimum amount and responsibilities are outlined on the clinical trials website. (24) Researchers must be aware of their responsibilities and obligations associated with intellectual property (IP), including ownership, copyright and patents as outlined in any legal agreements and Research Data Management Plans. Any IP should be informed by the University’s Intellectual Property Policy, which is designed to ensure commercially valuable intellectual property is protected to the benefit of relevant parties and society. (25) Research data should be managed according to the research data management plan that has been approved as part of the lead HREC ethics approval. Where possible data management should comply with the University’s Research Data Management Policy. (26) Researchers must manage all aspects of data capture, storage, retention and sharing before, during and after research is completed. (27) All research requires a written agreement between the University and each participating clinical trial site. This is required even if there is no funding provided for or required by the project. The research agreements depend on sponsor type and are outlined on the clinical trials website. (28) Where an existing approved Partnership Agreement exists, that agreement shall be used. Where there is no such agreement in place with that partner, collaborator or site, the University supports the use of the Medicines Australia approved Collaborative Research Group (CRG) Clinical Trial Research Agreement (CTRA) template or Medical Technology Association of Australia (MTAA) agreements. (29) All CTRAs/MTAAs must be discussed with the Research Office prior to execution. (30) All CTRAs and other research agreements should comply with the Research Contracts and Grants Policy. (31) These can only be signed by an authorised signing authority such as the Executive Director, Research Office. Refer to Delegations and Authorisations Policy. However, the Site Principal Investigator must sign the Principal Investigator section of the CTRA or MTAA. (32) Researchers must ensure they have adequate funding to cover costs associated with the clinical trial. (33) Multiple funding sources may be required to adequately fund the clinical trial. (34) Research must not commence without the relevant approvals or acknowledgements in place. The types of approvals and processes are outlined on the clinical trials website. (35) When La Trobe is engaged in a clinical trial and the requirements of this Policy cannot be met by a collaborating institution and/or clinical trial site, the Research Office (on behalf of the researchers) will engage with the University’s Risk Management Office to seek advice on risk and liability. (36) All staff and students on a project must declare any real or perceived conflicts of interest in compliance with the University’s Conflict of Interest Policy. (37) Any research involving the manufacture of therapeutic products used in clinical trials must be manufactured in accordance with the Good Manufacturing Practice principles and procedures to ensure that therapeutic goods are of high quality. (38) All clinical trials must have ethics approval prior to project commencement. Whether they are submitted to the La Trobe University Human Research Ethics Committee (HREC) or to an external HREC depends on the circumstances of the trial as outlined on the clinical trials website. The lead HREC is the allocated HREC which provides ethical approval for the project. The lead HREC is identified based on the following information: (39) For externally approved clinical trials (that is, approved by a non-La Trobe University HREC), researchers must provide a completed and externally approved form via the process outlined on the website. (40) Management of post-approval requirements such as modifications to an approved project, annual and final reports and safety reporting should be done in accordance with the sponsorship type and lead HREC requirements. Advice on these requirements is outlined on the clinical trials website. (41) The Co-ordinating Principal Investigator must register any clinical trial when the University is the sponsor on a primary registry in the World Health Organisation (WHO) Registry Network. The University recommends the Australian New Zealand Clinical Trials Registry. (42) Trials using experimental or off-label drugs and/or medical devices must complete a Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) form. The process is outlined on the clinical trials website. (43) Project delivery includes the relevant checkpoints and approvals from Parts O-Q below. (44) Safety of research participants, staff and students should be prioritised over all other aspects of the research. Therefore, during the conduct of a clinical trial, staff on the project must notify the Research Office (and any external HREC if they are the approver) as soon as they become aware of any of the following: (45) The Research Office will: (46) Complaints about the conduct of clinical trials by University staff, students, and/or clinical trials sponsored by the University should be made per the University’s complaints process outlined on the clinical trials website. (47) Allegations involving possible breaches of the Australian Code for the Responsible Conduct of Research (2018) are to be made and managed per the process outlined in the University’s Research Misconduct Procedure. (48) Reporting of safety events, changes to the project, annual monitoring reports, and any other reports as required from time to time should be done so in line with the Sponsor and Lead HREC requirements as outlined on the clinical trials website. (49) The Research Office should be notified when a clinical trial is closed per the processes outlined on the clinical trials website. (50) The University is responsible to: (51) The Executive Director, Research Office is responsible for the administration and implementation of this Policy or any processes associated with it. (52) The Research Office is responsible to: (53) Co-ordinating Investigators are responsible to: (54) All staff and students involved in clinical trials are responsible to: (55) Definitions in the procedure are intended for use within the University Policy and Research Governance Framework. They are not necessarily defined the same way as definitions of the same terms in external documents, even if these documents are referred to in this Policy.Research Clinical Trials Policy
Section 1 - Background and Purpose
Top of PageSection 2 - Scope
Top of Page
Section 3 - Policy Statement
Section 4 - Procedures
Part A - General Principles
Part B - Initial Assessment
Part C - Equipment and Materials
Part D - Training and Credentialing
Part E - Project Design
Part F - Project Authorisation
Part G - Insurance and Indemnity
Part H - Intellectual Property and Research Data Management
Part I - Legal and Contract Administration
Part J - Finances
Part K - Risk Management
Part L - Ethics and Governance Review
Part M - Registration and Notification
Part N - Project Delivery
Part O - Monitoring
Part P - Complaints Handling
Part Q - Reporting
Part R - Project Closure
Part S - Roles and Responsibilities
Top of PageSection 5 - Definitions