Projects sponsored by La Trobe

The following parties are responsible for preparing the following documentation:

From La Trobe:

1. La Trobe is responsible for ensuring appropriate Clinical Trials Insurance is in place. Clinical Trials Insurance is automatic, a copy of the certificate of currency can be obtained from humanethics@latrobe.edu.au unless the research involves one or more of the following:
   1. Research targeting pregnant and/or lactating women and/or human foetus.
   2. Research targeting babies or toddlers up to 3 years of age.
   3. Research conducted in countries other than Australia.
   4. Research requiring Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX).
   5. Research involving HIV/AIDs.
2. If the research meets one of the insurance exemption conditions outlined above, then the La Trobe Coordinating Investigator must submit the project protocol and PICF to humanethics@latrobe.edu.au to facilitate insurance discussions with our brokers to determine insurance status of the proposed trial prior to submission of an application for Committee review.

From Australian collaborating sites:

1. If the site is another Australian University - Certificate of Currency for Clinical Trials Insurance AUD30 million
2. Public and Products Liability (or equivalent) AUD10 million
3. Professional Indemnity (or equivalent) AUD10 million
4. Medical Indemnity (or equivalent) AUD5 million

The following documentation is required from International Sites that will conduct the clinical trial on behalf of La Trobe Researchers:

• A Certificate of Currency that meets the minimum insurance requirements in each country.
• Public and Products Liability (or equivalent) that meet the minimum requirements in each country.
• Professional Indemnity (or equivalent) that meet the minimum requirements in each country.
• Medical Indemnity (or equivalent) that meet the minimum requirements in each country.

Need help?

• For insurance requirements about a specific study contact humanethics@latrobe.edu.au or +61 3 9479 1443
• For general insurance requirements email insurance@latrobe.edu.au

The type of research agreement depends on:

1. The type of organisation La Trobe is contracting with (e.g., public health, private sector, non-for-profit, sole trader or international organisation);
2. The clauses requested and/or which need to be added to meet the requirements of any other applicable agreements (e.g., funding body and materials transfer agreements)
3. Please note, the Medicines Australia Clinical Trials Research Agreement (CTRA) template has a standard set of approved clauses. If you wish to use a clause which hasn’t been approved, please contact humanethics@latrobe.edu.au to discuss this, as it takes a minimum of 8 weeks for approval.

The La Trobe Coordinating Investigator is responsible for creating a budget that correctly costs the research, regardless of what has been awarded by the funding body. This true cost allows for other funding sources to be established and/or for the La Trobe Department Head and other Site/s Department Heads to decide if they will use internal funds to cover costing short-falls.

From the La Trobe Coordinating Investigator:

• Study budget, with costings confirmed by supporting departments and/or asset holders (e.g., Medical Physicist, Pharmacist, Clinician etc.)
• Please note, each site may have different cost for the same line item, depending on their own internal costings and cost recovery processes. Therefore, each site should manage their own budget.

Need Help?

• For study budget requirements pertaining to Clinical Trials Research Agreements (CTRAs) contact humanethics@latrobe.edu.au or +61 3 9479 1443
• For enquiries about a specific grant contact researchgrants@latrobe.edu.au

Each site is responsible for ensuring compliance with their own governance processes in relation to:

1. Ionising Radiation: If any study procedure involves ionizing radiation (e.g., x-rays, CT scans, DEXA scans, PET etc.. etc..) you will need to complete the Victorian Specific Module and obtain a Medical Physicist Report from the site (i.e., physical location) where the machine is. Please note if you have multiple sites, you will need multiple Medical Physicist Reports. If you are unsure of the requirements please email humanethics@latrobe.edu.au.
   1. For machines at any La Trobe Campus:
      1. Complete protocol
      2. Complete PICF
      3. Complete Victorian Specific module
      4. Send completed documents to: (please note a fee will be charged for this service) Paul Einsiedel Consultant Medical Physicist peinsiedel@hotmail.com
   2. For machines at other sites
      1. Check requirements at the site
      2. Complete protocol
      3. Complete PICF
      4. Receive a Medical Physicist Report from each site
2. IBC approval (if using genetically modified organisms)
3. AEC approval (if using animals)
4. Autonomous sanctions (restrict activities that relate to certain countries, goods and services, persons or entities. For more information please see the La Trobe Autonomous Sanctions policy)
5. Defence export control (If you intend to take research materials or plans overseas or share them with people or entities who are overseas you may need to apply to the Australian government for a Defence export control permit)
6. Research in other countries: Additional documentation for in-country ethics approval can be found at:https://rdinetwork.org.au/resources/conducting-research-in-the-region/.
7. Any other relevant OH&S or Risk Management requirements as outlined in the ethics documentation and/or site governance requirements.

Need help?

• Please contact humanethics@latrobe.edu.au or +61 3 9479 1443

The lead HREC is the HREC which has been given the jurisdiction to approve the project. To avoid unnecessary duplication of review, La Trobe University accepts all ethics approvals from NHMRC registered Australian HRECs. In the case where the lead HREC is not La Trobe University, then you will only need to apply for site governance approval from La Trobe (see below).

If you are unsure who your lead HREC should be, please contact Human Ethics.

1. Projects to be approved by La Trobe as the lead HREC

If La Trobe is the lead HREC, the process is outlined on the Human Research Ethics homepage.

2. Projects approved by lead HREC external to La Trobe University

Submit Ethics to the lead Human Research Ethics Committee (HREC), per their requirements.

Email Human Ethics a copy of:

• A copy of the approved Ethics paperwork (including HREC approval letters)
• Clinical Trial Research Agreements and any other applicable agreements
• A copy of the sponsor's Insurance and Indemnity certificate of currency
• Budget
• Evidence of GCP training from all the named investigators
• Risk Management/OH&S form

The correct pathway for your project depends on a combination of factors which are:

• Where you will recruit your participants;
• The legal premises where study procedures will be completed (e.g., hospital, schools or overseas);
• If the project is single or multi-site, and where these sites are;
• If La Trobe's HREC has the jurisdiction to approve the project (for example, La Trobe's HREC is unable to approve clinical trials conducted in a public hospital setting)

From La Trobe:

• The La Trobe Coordinating Investigator is responsible for registering the project on our preferred registry which is the  Australian New Zealand Clinical Trials Registry. This is the preferred registry because it meets the WHO and ICMJE clinical trial registry requirements.

From La Trobe Coordinating Investigator:

• Email humanethics@latrobe.edu.au your completed CTN details form, protocol, name, email and WBS cost centre (if applicable).
• Ethics, Integrity and Biosafety team will submit the CTN/CTX on your behalf and will recover the cost of the CTN/CTX via the supplied WBS cost centre and/or raising a tax invoice.

Collaborating Sites:

• The La Trobe Coordinating Investigator is to provide a copy of the TGA notification to all collaborating sites.

From the La Trobe Coordinating Investigator:

All named investigators must hold valid GCP training certificates that meet the minimum requirements for ICH GCP E6 R2 and is recognised by TransCelerate Biopharma Inc.  Please see the following options for GCP training or refresher training if required:

1. La Trobe University, through the Clinical Trials Platform is offering face to face, introduction and refresher GCP training for all La Trobe researchers, students and staff. This is a TransCelerate Biopharma Inc. recognised training course and a certificate valid for 3 years will be issued upon successful completion of the course.
2. The Australian Clinical Trials Education Centre (A-CTEC, formally V-CTEC) offers a free 'Trials Essentials for Investigators' online course that meets the minimum requirements for ICH GCP E6 R2 training and is recognised by TransCelerate Biopharma Inc.  You will need to register as a La Trobe University staff or student member to complete this self-paced comprehensive 5 module introductory course.  A certificate will be issued following satisfactory completion. More details can be found at A-CTEC: Comprehensive Course Packages (myopenlms.net)
3. NIDA Clinical Trials Network offers a free online GCP course conducted by the NIDA Clinical Trials Network (part of the National Institutes of Health in the US) that is TransCelerate Biopharma Inc. recognised. This is a 12 module self-paced course that should take 6 hours to complete.  Upon receiving at least 80% pass rate for all the exams a certificate of completion can be obtained.  Please use the link above to access the course.
4. The Global Health Network ICH Good Clinical Practice E6 (R2) * Global Health Training Centre (tghn.org) offers free online ICH GCP E6 R2 training for site investigators that is TransCelerate Biopharma Inc. recognised.  This training will take up to 1 hour to complete and you will need to register beforehand.  A pass rate of 80% in the online exam is required to successfully complete the course and request the free certificate of completion.

GCP Refresher

Once GCP training certification has expired, a refresher course will be required.  GCP Refresher courses on offer are available through:

5. La Trobe University will be offering through the Clinical Trials Platform face-to-face GCP refresher training courses for all La Trobe researchers, students and staff.  This is a TransCelerate Biopharma Inc. recognised training course and a certificate valid for 3 years will be issued upon successful completion of the course.
6. Monash Partners offer a GCP refresher course that is free for all La Trobe staff, researchers and students.

From the Site:

1. Provide current GCP certificate of training which meets the TransCelerate Biopharma Inc. R2(E6) requirements to your lead HREC, site governance officer, and if required, to the La Trobe Coordinating Investigator.

A-CTEC

The Australian Clinical Trials Education Centre (A-CTEC) hosts a suite of evidence-based, interactive clinical trials education opportunities. It is highly recommended for all La Trobe staff and students, is free of charge and includes:

• Research competency training for investigators, study coordinators and research nurses
• Courses:
  • introduction to clinical trials
  • managing clinical trials
  • running clinical trials
  • regulatory environment and requirements
  • ethics and governance
  • safety monitoring and report
  • protocol compliance and breaches
• A-CTEC Educational Resources

If you intend to modify your project you will be required to submit a modification request form. This can include, but is not limited to, changes to the following:

• Recruitment, methodology and/or funding
• Participant Information Statement and Consent Form/s (PICF)
• Advertisements
• Approval period i.e. if your ethics approval is due to expire and you require an extension.

1. Ethics approval for modifications
   • Submit to the lead Human Research Ethics Committee (HREC), per their requirements.
   • If La Trobe is the lead HREC, the process is outlined on the Human Research Ethics homepage.
2. Site Governance approval
   • Submit a copy of the approved modification request to all sites so they can seek site governance approval
3. La Trobe Governance approval process

If La Trobe isn’t the lead HREC email a full copy of the approved modification paperwork to Human Ethics.

1. Ethics approval for Annual Progress and Safety or Final Reports
   • Submit to the lead Human Research Ethics Committee (HREC), per their requirements.
   • If La Trobe is the lead HREC, a combined Annual Progress and Safety Report must be submitted for all active clinical trials each year and should include a list of any Adverse Events occurring during the reporting period (if applicable).  Please use this form to also submit your Final Report.
   • To report annually on the progress and safety of your clinical trial or lodge a final report, complete and submit Clinical Trial Annual Progress Safety Final Report [DOC 55KB]

   • Log in to PRIME Researcher portal to lodge an annual of final report:

     To find your ethics project click on “My Ethics Approvals” tile and select the Ethics Approval Number you wish to submit an annual or final report for.

     At the top of the ethics record, click the “down” blue arrow drop down menu and click “Create Annual Report” or “Create Final Report”.

     Click the 'post approval documents' tab and upload completed annual/final report form.

     At the top of the screen click on "Submit to Research Office"

2. Site Governance approval
   • Submit a copy of the approved annual progress and safety Report or Final Report to all sites so they can seek site governance approval.
3. La Trobe Governance approval process
   1. If La Trobe isn’t the lead HREC email a copy of the approved Annual Progress and Safety Report or Final report and accompanying paperwork to Human Ethics.

Clinical Trials Safety Reporting and Breaches of Good Clinical Practice Reporting

The NHMRC’s Safety monitoring and reporting in clinical trials involving therapeutic goods (2016) sets out the requirements for the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials.

The Clinical Trial Safety Reporting Flowchart and Glossary of Terms has been developed as a valuable tool to assist you in determining which report is required, to whom it should be reported and the timelines for doing so.

• To report a safety issue (e.g. serious adverse event/reaction/effect or significant safety issue), complete and submit the Safety Report - Clinical Trial v3 [DOC 70KB].    Please note: You are no longer required to individually report Adverse Events as they occur if not serious (i.e. non-serious incidents that are not related to the trial) to the HREC.  Please retain adequate records and include these Adverse Events in your Annual Safety Report to La Trobe University.
• To report a Serious or Suspected or Non-Serious Breach as a requirement of ICH E6 (R2) Good Clinical Practice or the approved clinical trial protocol, complete and submit the Breach of Good Clinical Practice Protocol Report - Clinical Trial v3 [DOC 56KB].

If La Trobe University is not the lead HREC, please ensure you submit your safety report as per the lead HREC's requirements and provide an approved copy to La Trobe University for governance purposes.

Log in to PRIME Researcher portal to lodge an Incident/Safety/Breach of GCP report:

1. To find your ethics project click on “My Ethics Approvals” tile and select the Ethics Approval Number you wish to submit a Safety Report/Incident,
2. At the top of the ethics record click the “down” arrow and click “Create UAE/Safety Report”.
3. Upload completed Report.
4. In the progress bar at the top of the page, select "Review by Research Office" and then click "Mark as Current Status" to the right.

Clinical Trial Annual Progress and Safety Report / Final Report

A combined Annual Progress and Safety Report must be submitted for all active clinical trials each year and should include a list of any Adverse Events occurring during the reporting period (if applicable).  Please use this form to also submit your Final Report.

1. To report annually on the progress and safety of your clinical trial or lodge a final report, complete and submit Clinical Trial Annual Progress Safety Final Report [DOC 55KB]

If La Trobe is not the lead HREC, please submit your Annual Progress Report and Annual Safety Report as per their requirements and provide a copy of the approved report to La Trobe via Human Ethics.

Log in to PRIME Researcher portal to lodge an annual of final report:

1. To find your ethics project click on “My Ethics Approvals” tile and select the Ethics Approval Number you wish to submit an annual or final report for.
2. At the top of the ethics record, click the “down” blue arrow drop down menu and click “Create Annual Report” or “Create Final Report”.
3. Click the 'post approval documents' tab and upload completed annual/final report form.
4. At the top of the screen click on "Submit to Research Office"

Modifications to Study Documentation

Urgent modifications required to address urgent safety issues for participants should be submitted to the Lead HREC immediately, but no later than 15 calendar days of becoming aware of the issue.

For immediate threats modifications can be implemented prior to receiving Lead HREC Approval.

Temporary Halt / Early Termination of Study

A temporary halt or early termination of the clinical trial may be necessary due to safety issues for participants. This occurrence should be reported to the Lead HREC immediately, but no later than 15 calendar days of becoming aware of halting or terminating the project.  If La Trobe University is not the lead HREC a copy of this notification should also be forwarded to Human Ethics as soon as practicable.

Who to report to (Refer to the Clinical Trial Safety Reporting Flowchart)

Site Principal Investigator

1. Site Institution's delegated officer
2. La Trobe Coordinating Investigator

La Trobe Coordinating Investigator

1. Lead HREC
2. La Trobe's delegated officer
3. TGA (if applicable)
4. Other site Principal Investigators