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Research Clinical Trials Policy

Section 1 - Background and Purpose

(1) The purpose of the Policy is to:

  1. Provide a framework and procedures to ensure the highest standards of clinical practice, ethics and safety in the governance of clinical trials; and
  2. Enable effective and quality clinical trial research partnerships with commercial/industry partners, the health sector, not-for-profit organisations and other organisations collaborating with La Trobe researchers.

(2) 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.

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Section 2 - Scope

(3) This Policy applies to:

  1. Staff and Students of the University who engage in the conduct of a clinical trial within their University roles and sponsored by:
    1. Commercial/Industry Partners
    2. La Trobe University
    3. By another organisation (e.g., another University, non-for-profit and other organisations collaborating with La Trobe Researchers.)
  2. Clinical trials where the University is a site of a clinical trial, regardless of whether the University is the Sponsor.
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Section 3 - Policy Statement

(4) The University is committed to supporting clinical trials and will ensure that clinical trials including data quality and safety of research participants are carried out with the highest scientific and ethical standards.

(5) The Policy is based on the Principles of Research Governance as specified in the Research Governance Policy.

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Section 4 - Procedures

Part A - General Principles

(6) All clinical trials must comply with:

  1. All relevant laws;
  2. University policies and procedures; and
  3. Any guidelines and codes required by legal agreement, contract or by a regulatory authority.

(7) The University via the Research Office must be informed by the about any clinical trial undertaken by La Trobe staff and students on La Trobe premises or conducted at other sites (e.g., hospitals, other universities or research institutes). The process is outlined on the clinical trials website.

Part B - Initial Assessment

(8) 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:

  1. Who will be the Sponsor of the Clinical Trial (in most cases this will be the institution administering the funds);
  2. Possible benefits and risks to the University,
  3. Agreement of supporting departments, collaborating organisations and the University asset managers and, if applicable, site-specific assessment conducted in accordance with the procedures associated with this Policy;
  4. Study documentation covers the following study feasibility points:
  5. The appropriate management of work health and safety responsibilities
  6. The proposed contractual and legal arrangements
  7. Insurance and indemnity responsibilities
  8. The Sponsor’s requirements
  9. Ethical and regulatory requirements
  10. Financial requirements
  11. Sourcing of any materials or equipment to be used in the trial
  12. Proposed locations of trial sites
  13. Required training for Staff and Students involved in the trial
  14. Any involvement of international trial sites and/or partners

(9) La Trobe Co-ordinating/Site Investigators will seek advice from the Research Office as early as possible in the development process about the project.

(10) 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.

(11) 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.

(12) If La Trobe is acting as the Sponsor and is collaborating with a Foreign Organisation to conduct a clinical trial, an equivalent to a Clinical Trials Research Agreement must be signed prior to site activation in the Foreign Country.

Part C - Equipment and Materials

(13) All research equipment and materials must be sourced through safe and ethical channels.

(14) Where appropriate, contracts and warranties should be in place before the use of any research equipment or materials.

(15) All staff and students should be adequately trained and/or certified to use any research equipment and materials.

Part D - Training and Credentialing

(16) The University will:

  1. Provide ongoing training and education that promotes and supports responsible research conduct for all researchers and those in other relevant roles;
  2. Provide Transcelerate accredited Good Clinical Practice Training;
  3. Ensure supervisors of research trainees have the appropriate skills, qualifications and resources.

(17) The Sponsor will:

  1. Ensure all researchers involved in the conduct of clinical trials have appropriate skills, qualifications, experience and resources; and
  2. Ensure all researcher involved in the conduct of clinical trials have a current GCP training certification.

Part E - Project Design

(18) Projects should be designed in line with the NHMRC National Statement on Ethical Conduct in Human Research 2007 and the Therapeutic Goods Administration Guideline on Good Clinical Practice.

(19) The National Statement should take precedence over the TGA notes on Good Clinical Practice.

Part F - Project Authorisation

(20) Project authorisation includes the relevant checkpoints and approvals from Parts G-M below.

Part G - Insurance

(21) 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.

Part H - Intellectual Property and Research Data Management

(22) Researchers need to be aware of their responsibilities and obligations associated with intellectual property, including ownership, copyright and patents as outlined in any legal agreements and Research Data Management Plans. The issues surrounding 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.

(23) All research data must be captured in an ethics approved data management plan as per the Research Data Management Policy.

(24) Researchers must consider and manage all aspects of data capture, storage, retention and sharing before, during and after research is completed.

Part I - Legal and Contract Administration

(25) All research at non-University sites where the University is Sponsor 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.

(26) Where an existing approved Partnership Agreement exists, that agreement shall be used. Where there is no such membership 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.

(27) All CTRA’s/MTAAs must be discussed with the Research Office prior to execution.

(28) All CTRA’s and other research agreements should comply with the Research Contracts and Grants Policy.

(29) Researchers cannot sign-off on legal agreements such as grant agreements or research contracts on behalf of the University. 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.

Part J - Finances

(30) Researchers must ensure they have adequate funding to cover costs associated with any regulatory application.

(31) Multiple funding sources may be required to adequately fund the clinical trial.

Part K - Risk Management

(32) 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.

(33) 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, on behalf of the researchers, the Research Office will engage with the University’s Risk Office to conduct an institutional risk assessment to assess the feasibility of La Trobe being engaged in the clinical trial.

(34) 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.

(35) Any research involving the manufacture of therapeutic products must adhere to the Good Manufacturing Practice principles and procedures to ensure that therapeutic goods are of high quality.

Part L - Ethics and Governance Review

(36) 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:

  1. The site where the study is conducted
  2. The number of sites (single or multisite)
  3. The Coordinating Investigator and Site Principal Investigator requirements (for multisite projects)

(37) For externally approved clinical trials (that is, approved by a non-La Trobe University HREC), researchers must provide a completed externally approval form via the process outlined on the website.

(38) 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.

Part M - Registration and Notification

(39) 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.

(40) Trials using experimental or off-label drugs and/or medical devices must complete a Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) to the TGA via the process outlined on the clinical trials website.

Part N - Project Delivery

(41) Project delivery includes the relevant checkpoints and approvals from Parts O-Q below.

Part O - Monitoring

(42) 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:

  1. Refer to any Safety Reporting and Monitoring Guidelines of the University, collaborating partners and lead HREC.
  2. If a reportable event arises where the University acts as Sponsor and/or Lead HREC and/or a reportable safety event occurs on La Trobe premises, the Research Office must be notified within the reporting timeframes outlined on the clinical trials website.
  3. Change in the information provided in the risk assessment process for that clinical trial;
  4. Breach or potential breach of any law, regulation or external guideline or code applicable to the clinical trial; or
  5. Other matters required by this Policy or pertaining to the ethical acceptability, participant safety or integrity issues in relation to the clinical trial.

(43) The Research Office will:

  1. Establish and maintain a University record of clinical trial activities notified to it; and
  2. Where required, provide the Risk Management Office and the University’s Insurance Office with any information that may impact on the acceptable risk and/or insurance requirements.
  3. When the University is acting as the Sponsor or monitoring responsibilities have been delegated to the University in a legal agreement, it may from time to time conduct monitoring.

Part P - Complaint Handling

(44) Complaints about the conduct of clinical trials by University staff, students, an visitors and/or clinical trials sponsored by the University should be made per the University’s complaints process outlined on the clinical trials website.

(45) 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.

Part Q - Reporting

(46) 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.

(47) Reporting of key project milestones as outlined in the Clinical Trials Research Agreement (CTRA) or equivalent agreement/s.

Part R - Project Closure

(48) The Research Office should be notified when a clinical trial is closed per the processes outlined on the clinical trials website.

Part S - Roles and Responsibilities

(49) The University is responsible for:

  1. Making appropriate training available to researchers on the requirements of this Policy and legislative, regulatory and other requirements applicable to clinical trials;
  2. Obtaining and maintaining appropriate insurance cover for clinical trial activities conducted by it or on its behalf; and
  3. Managing the formal membership requirements in any health partnerships the University enters.

(50) The Executive Director, Research Office is responsible for the administration and implementation of this Policy or any processes associated with it, including being the delegated authority to sign Clinical Research Trial Agreements (CTRAs) or equivalent agreements on behalf of the University.

(51) The Research Office is responsible for:

  1. Developing, negotiating, co-ordinating and supporting the documentation and contracts relating to clinical trials;
  2. Coordinating the risk assessment process;
  3. Providing or coordinating research support services for researchers involved in clinical trials; and
  4. In consultation with the Co-ordinating Investigators, determining whether, and on what terms, the University will participate in clinical trials.

(52) Co-ordinating Investigators are responsible for:

  1. Conducting the clinical trial;
  2. Ensuring compliance with the applicable protocol;
  3. Taking appropriate steps to ensure compliance with all legislative, regulatory, policy and other requirements applicable to any clinical trial, including any requirements of the reviewing Human Research Ethics Committee;
  4. Monitoring the conduct of researchers and others undertaking activities within the clinical trial, ensuring they are aware of their responsibilities;
  5. Registering the clinical trials and maintain evidence of registration consistent with this Policy and any associated procedures;
  6. Providing information to the Research Office and other groups specified in this Policy or the processes associated with this Policy where required; and
  7. Carrying out safety monitoring and reporting as required.

(53) All staff and students involved in clinical trials are responsible to:

  1. Keeping appropriate records where required;
  2. Identifying and inform the co-ordinating investigator of existing and emerging risks relating to clinical trial activities;
  3. Undertaking appropriate Good Clinical Practice training; and
  4. Undertaking activities in accordance with this procedure.
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Section 5 - Definitions

(54) For the purpose of this Policy and procedure, the definitions provided are intended for use within the University Policy and Research Governance Framework. They are not necessarily defined in the same way as definitions of the same terms in external documents, even if these documents are referred to in this Policy.

  1. Affiliate: means clinical title holders; adjunct, conjoint and honorary appointees; consultants and contractors to the University; holders of offices in University entities, members of Boards of University Foundations, members of University Committees; and any other persons appointed or engaged by the University to perform duties or functions on its behalf.
  2. Clinical trial: means 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 (this definition is from the World Health Organisation).
  3. Research Office: The University Office that supports all researchers with contracts, grants, research partnerships, ethics and research performance data. It includes the following teams:
    1. Ethics, Biosafety and Integrity (includes Research Governance)
    2. Consulting and Contracts
    3. Grants
    4. Research Performance
    5. Research Impact
  4. Co-ordinating investigator (CI): means the investigator responsible for co-ordination of all other investigators in a clinical trial conducted at multiple sites. For single site clinical trials, the terms principal investigator and co-ordinating investigator are synonymous. For clinical trials where the University is both the sponsor and a trial site, the co-ordinating investigator may be the principal investigator at the University site.
  5. Clinical Trial Notification (CTN) scheme: means the scheme operated by the Therapeutic Goods Administration (TGA) that permits therapeutic goods to be used for experimental purposes if the relevant clinical trial is notified to the TGA.
  6. Clinical Trial Exemption (CTX) scheme: means the scheme operated by the Therapeutic Goods Administration (TGA) that permits therapeutic goods to be used for experimental purposes if the relevant clinical trial is approved by the TGA.
  7. Good Clinical Practice: means the international standard for conducting clinical research. Generally referred to as GCP, it is a process incorporating established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human beings. All researchers involved in clinical trial research must be GCP trained.
  8. Good Manufacturing Practice: means a system for ensuring that investigational products are consistently produced and controlled according to quality standards. See the Australian Government Therapeutic Goods Administration Good Manufacturing Practice Overview.
  9. Investigational product: means any medicine, device or other product or intervention being investigated, tested or used as a placebo or reference in a clinical trial.
  10. National Health and Medical Research Council (NHMRC): refers to Australia's peak funding body for medical research.
  11. Policy: means this entire document.
  12. Protocol: means a document describing the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record keeping of a clinical trial. The sponsor of a clinical trial is responsible for the protocol.
  13. Research: has the definition given in the Australian Code for the Responsible Conduct of Research. The concept of research is broad and includes the creation of new knowledge and/or the use of existing knowledge in a new and creative way so as to generate new concepts, methodologies, inventions and understandings. This could include synthesis and analysis of previous research to the extent that it is new and creative.
  14. Researcher: has the meaning given in the Australian Code for the Responsible Conduct of Research (2018) that is, person (or persons) who conducts, or assists with the conduct of research.
  15. Research Governance: means broadly the framework of principles, roles and responsibilities at the University that ensure the quality, safety and integrity of research and compliance with all obligations and commitments. See the Research Governance Policy for more detail. 
  16. Serious Adverse Event: has the meaning given in the NHMRC’s Safely Monitoring and Reporting Clinical Trials Involving Therapeutic Goods 2016 (or any replacement for it). The 2016 version is ‘Any adverse event/adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect’.
  17. Site: means the physical location where a clinical trial is conducted. When a clinical trial is conducted at more than one site, using the same protocol, it is referred to as a multi-site or multi-centre trial.
  18. Site Principal Investigator: means for multi-site clinical trials the person listed as the Site Principal Investigator takes responsibility of the project only at that site.
  19. Sponsor: means the person, body, organisation or institution which takes overall responsibility for the conduct of a clinical trial, including responsibility for the protocol. The Sponsor usually initiates, organises and supports the conduct of the clinical trial, including where another party funds the clinical trial or provides the product used in the clinical trial. The Sponsor of a clinical trial conducted in Australia must be: an Australian resident or an incorporated body conducting business in Australia with a representative residing in Australia.
  20. Staff: means all employees of the University or affiliated enterprises with which the University has a formal agreement and includes casual employees, clinical staff and unpaid members of the University such as Honorary and Adjunct appointments, all of which are registered on the HR system.
  21. Student: a student enrolled at the University
  22. Therapeutic goods: has the meaning given in the Therapeutic Goods Act 1989 and includes medicines, medical devices, biologicals and goods declared to be therapeutic goods under that legislation
  23. Therapeutic Goods Administration: means the agency in the Commonwealth Department of Health, commonly referred to as the TGA, with responsibility for regulating the supply, import, export, manufacturing and advertising of therapeutic goods in Australia.