Clinical Trial Governance Elements

It is expected that all Principal/Chief Investigators of clinical trials will have Good Clinical Practice (GCP) training.

GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human participants. Compliance with this standard provides public assurance that the rights, safety and well-being of trial participants are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. In Australia we work under the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) - annotated with TGA comments which details how Australia implements the international guideline.

Please contact Clinical.Trials@utas.edu.au for further information about accessing GCP training.

A formal agreement for all research projects is a requirement of the Australian Code for the Responsible Conduct of Research.

For drug or device trials, the University of Tasmania recommends the use of the Medicines Australia Clinical Trial Research Agreements (CTRA).  These agreements are used to document the relationship between an Australian sponsor and an Australian trial site. There are four Medicines Australia CTRAs:

• Standard Agreement, used for commercially sponsored trials
• Contract Research Organisation (CRO) Agreement, used for commercially sponsored trials with a CRO acting as the local sponsor
• Collaborative/Cooperative Research Group Agreement, used for University of Tasmania sponsored trials and collaborative or cooperative trials
• Phase 4 Clinical Trial Agreement, used for phase 4 trials

For commercially sponsored trials of medical devices, the Medical Technology Association of Australia (MTAA) standard CTRA is recommended.

The terms contained in these agreements must not be altered or amended in any way. Schedule clauses may be used for unique requirements. University of Tasmania legal review will be required for any special clauses.

The University of Tasmania may also require other agreements for trial with, for example:

• The funder of the research, if they are not the sponsor (for example the NHMRC)
• A supplier of investigational product who is not a sponsor (for example a biotechnology company)
• A service provider who is not a trial site (for example a pathology service)

Parties to a contract

The 'University of Tasmania' is the contracting party for all agreements. ABN: 30 764 374 782

The Clinical Trial Governance Coordinator will work with the Principal Investigator to select the most appropriate agreement/s for each clinical trial based on the information included in the Governance Application Form (see 'applying for governance authorisation' above).

All clinical trials must have appropriate insurance cover.

For commercially sponsored clinical trials, insurance cover must be provided by the sponsor. Insurance arrangements must be included in Schedule 4 of the Clinical Trial Research Agreements.

For University of Tasmania sponsored clinical trials, the Principal Investigator is responsible for ensuring the trial meets the University’s insurance policy. The Clinical Trials Governance Coordinator will check this at the time of Governance Application.  For any questions regarding the University's insurance provisions please see the Financial Services webpage or contact Jarrod Shaw at Jarrod.Shaw@utas.edu.au.

All clinical trials must have appropriate indemnity

For commercially sponsored clinical trials the Medicines Australia Standard Form of Indemnity, or the Medical Technology Association of Australia Form of Indemnity must be provided by the sponsor. For HREC-review only clinical trials the Medicines Australia Form of Indemnity – HREC Review only must be provided by the sponsor.

A Clinical Trial Notification (CTN) is required for all clinical trials involving;

• Any product not entered on the Australian Register of Therapeutic Goods; or
• Use of a registered or listed product in a clinical trial beyond the conditions of its marketing approval.

It is the responsibility of clinical trial sponsors to submit CTNs electronically. At the University of Tasmania, the Clinical Trial Governance Coordinator is responsible for managing the University’s online account with the Therapeutic Goods Administration (TGA). A process flow (PDF 92KB) depicting how University sponsored CTNs are reviewed and authorised provides a useful overview of the process.

• For clinical trials sponsored by the University of Tasmania, complete this form (WORD 173KB) and submit it alongside your Governance Application to provide the Clinical Trial Governance Coordinator with the required information.

• For externally sponsored clinical trials requiring a CTN, the Approving Authority will be the Head of School/Centre where the trial is being conducted. Contact the Clinical Trials Governance Coordinator at clinical.trials@utas.edu.au if you are unsure who this should be. A draft of the CTN must be submitted with the Governance Application.

See the Therapeutic Goods Administration website for more information about the CTN process, or contact the Clinical Trials Governance Coordinator at clinical.trials@utas.edu.au if you are unsure whether your trial requires a CTN.

Clinical Trials are often large and complex and as such cost more to conduct that other types of clinical research. If you would like assistance completing a budget for your clinical trial contact the Clinical Trial Governance Team at clinical.trials@utas.edu.au. For all clinical trials submitted for Governance Authorisation, the Clinical Trial Governance Officer will work with the relevant Funding Officer to review the Funding Clearance Form and Costing Tool.

It is a requirement of the Australian Code for the Responsible Conduct of Research that all clinical trials are registered to promote public access to information about clinical trials. Clinical Trials must be registered prior to the first participant being recruited.

Clinical trials must be registered with an International Committee of Medical Journal Editors (ICMJE) approved database. ICMJE requires trial registration as a condition of the publication of research results generated by a clinical trial. ClinicalTrials.gov or Australian and New Zealand Clinical Trial Registry (ANZCTR) are registries where organisations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE.

Good data management is critical in clinical trials. It leads to the generation of high quality, reliable and statistically sound data that is securely stored while participant confidentiality is maintained.

It involves the following steps:

• Deciding what data will be collected and how it will be collected (for example paper-based or web-based forms)
• Developing a data storage system to securely store the collected data
• Data collection, entry and validation
• Data cleaning and reporting

Research data should be managed in concordance with the University of Tasmania’s Management of Research Data Procedure (PDF 149.7KB) and the Australian Code for the Responsible Conduct of Research. Each clinical trial should have a staff member dedicated to managing the research data. More information can be found at the University library Research Data Management page.

Data storage systems

The type of data to be collected will dictate how they will be collected and how they will be stored.  There are a number of options available for managing research data.

REDCap

REDCap is a mature, secure web application for building and managing online surveys and databases.  It is a robust system and provides many useful functions for managing research data (e.g. participant tracking, randomisation, web-based questionnaires, separation of identifying and clinical data and tracking/auditing of data changes).  Due to its ease of use and compliance with Good Clinical Practice (GCP) it is recommended that REDCap be considered for managing research data in new clinical trials.

To get started with REDCap log a request with the University of Tasmania's Service Desk asking for a REDCap account and then log onto: https://redcap.utas.edu.au.  Here you can create REDCap projects and view training material.

Microsoft Access and SQL Server databases

Microsoft Access and SQL Server databases are used to store data for the majority of research studies and clinical trials at Menzies.  They offer a robust storage system that can be used to store a wide range of data.  They require specialised skills in order to be properly configured to ensure data security and reliability.  They are typically used with one or more of the following data collection techniques:

• Paper based questionnaires, usually managed using the Teleform optical forms processing system.
• Computer Aided Telephone Interviews (CATIs)
• Manual data entry
• Importing of data collected using a measurement device (e.g. Blood Pressure monitor or accelerometer)

For access contact Tim Albion: Tim.Albion@utas.edu.au or (03) 6226 7722

Web based questionnaires using Lime Survey

Web based questionnaires are relatively simple to implement and offer an elegant method for collecting data when a participant isn’t required to attend a clinic.  They do not provide for the separation of identifying data from clinical data or the tracking of data changes. To get started with Lime Survey log a request with University of Tasmania's Service Desk requesting an account.

Microsoft Excel

Excel is suitable for only the most basic research data.  It is easy to use but has limited ability to perform data validation, link related data or provide separation of identifying data from clinical data.  Researchers may turn to it because they are used to it however it is not suitable for clinical trials data.

Data management plans

A data management plan is a document that describes how you will collect, organise, manage, store, secure, back up, preserve, and share your data. A data management plan should be created at the start of a research project so that good practices are established early.  The University has a Data Management Plan Template.

Data sharing

Researchers are encouraged to share their data and many journals are now making it mandatory.  This should be considered when developing a data management plan.  More information is available from the Australian National Data Service.

The International Committee of Medical Journal Editors, best known for their Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals, have announced new requirements for manuscripts describing clinical trials. From the 1 July 2018 these papers will require a data sharing statement outlining:

• whether individual de-identified participant data (including data dictionaries) will be shared
• what data will be shared
• whether additional, related documents will be available
• when the data will become available and for how long
• by what access criteria data will be shared.

The full requirements are listed in their paper here.

The following tools and templates are designed to support the conduct of clinical trials in compliance with Good Clinical Practice. These are templates only and can be amended to suit your clinical trial. If you have any questions about the tools or templates provided here, or wish to request the development of a new template please contact the Clinical Trial Governance Coordinator at clinical.trials@utas.edu.au or (03) 6226 1956.

• Training log (WORD 28KB)
• Delegation log (WORD 28KB)
• Participant enrolment log (WORD 28KB)
• Participant screening log (WORD 30KB)
• Participant consent log (EXCEL 35KB)
• Clinical trial initiation checklist (WORD (22KB)
• Clinical trial close-out checklist (WORD 29KB)