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 certificate of currency can be download from the Insurance webpage), unless the research involves one or more of the following:
   1. Research targeting pregnant and/or lactating women and/or human foetus
   2. Research conducted in countries other than Australia
   3. Research requiring Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX)
   4. Research involving HIV/AIDs
2. If the research meets one of the conditions outlined above, then the La Trobe Coordinating Investigator must submit the project description/protocol to humanethics@latrobe.edu.au to obtain a certificate of currency.

From collaborating sites:

1. If the site is another Australian University - Certificate of Currency for Clinical Trials Insurance AUD20 million
2. If the site is in a country other than Australia, then the site must provide a Certificate of Currency that meets the minimum insurance requirements in that country
3. Public and Products Liability (or equivalent) AUD10 million
4. Professional Indemnity (or equivalent) AUD10 million
5. 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, Clinical Trials Research Agreement (CTRA) 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 arrange 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 governance for a Deference 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 the jurisdiction to approve the project. To reduce duplication of review, La Trobe accepts all ethics approvals from NHMRC registered HRECs. In the case where the lead HREC is not La Trobe, 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

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

Email Human Ethics a copy of:

• A copy of Ethics paperwork (including approval letters)
• Clinical Trial Research Agreements and any other applicable agreements
• Insurance and Indemnity
• Budget
• Evidence of GCP training
• 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 HREC has the jurisdiction to approve the project (for example, La Trobe HREC are unable to approve projects conducted in public hospitals)

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.
• La Trobe 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:

1. GCP training to the protocol; and
2. General GCP training 
   • Researchers can undertake online GCP training and obtain a training certificate via Genesis Research Services (https://genesisresearchservices.com/product/good-clinical-practice-ich-gcp-course/). The online GCP training is a self-placed online training option with a focus on the application of the GCP principles in a global setting. It takes approximately 2-4 hours to complete. As of December 2022, Gensis Research Services are charging a fee of $10 to complete the course, retain the course material and receive a certificate of completion.  This ICH-GCP training meets the minimum criteria for ICH E6 (R2) GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc.
   • GCP training is also available through some of our Melbourne Academic Centre for Health partners including the Royal Melbourne Hospital and the Murdoch Children's Research Institute.  Fees may be applicable.
   • GCP Refresher - If a refresher course is required once GCP certification has expired, Monash Partners offer a GCP refresher course that is free of charge for La Trobe staff and students.

From the Site:

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

V-CTEC

The Victorian Clinical Trials Education Centre (V-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
• Live webinar series and workshops

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/Final Reports
   • 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 annual/final report 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 copy of the approved Annual/Final paperwork to Human Ethics.

Urgent Safety Measure (USM)

Safety issues affecting the conduct of the study must be reported to the Lead  HREC

1. Immediately,   but no later than seven calendar days after becoming aware of the event
2. Follow-up   information within eight calendar days

Suspected Unexpected Serious Adverse Reactions (SUSAR) - medicinal products

When a SUSAR meets one of the following criteria, immediate action is required to eliminate a safety hazard to participants.

• Results in death
• Is life-threatening
• Safety issue affecting participants or ethical conduct of clinical   trial

Following elimination of the safety hazard SUSARs meeting these criteria must be reported to the Lead  HREC

1. Immediately,   but no later than seven calendar days after becoming aware of the event
2. Follow-up   information within eight calendar days

When a SUSAR meets one of the following criteria

• Requires hospitalisation or prolongation of existing hospitalisation
• Results in persistent or significant disability
• Consists of a congenital anomaly or birth defect

SUSARS meeting these criteria must be reported to the Lead  HREC immediately, but no later 15 calendar days of becoming aware of the event.

Note: SUSARs resulting in death or which are life-threatening are classified as USMs.

Some USMs may also require an Amendment to Study Documentation. For immediate threats amendments can be implemented prior to receiving Lead HREC Approval.

Unexpected Serious Adverse Device Events (USADEs) - medical devices

When a USADE meets one of the following criteria, immediate action is required to eliminate a safety hazard to participants.

• Death
• Life-threatening illness or injury

Following elimination of the safety hazard USADEs meeting these criteria must be reported to the Lead  HREC

1. Immediately,   but no later than seven calendar days after becoming aware of the event
2. Follow-up   information within eight calendar days

When a USADE meets one of the following criteria,

• Permanent impairment of a body structure or a body function
• In-patient or prolonged hospitalisation
• Medical or surgical intervention to prevent life-threatening illness or   injury or permanent impairment to a body structure or a body function
• Fetal distress, death or congenital abnormality or birth defect

USADE meeting these criteria must be reported to the Lead  HREC immediately, but no later 15 calendar days of becoming aware of the event.

Note: USADEs resulting in death or which are life-threatening are classified as USMs.

Some USMs may also require an Amendment to Study Documentation. For immediate threats amendments can be implemented prior to receiving Lead HREC Approval.

Amendments to Study Documentation

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

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

Temporary Halt / Early Termination of Study

A temporary halt or early termination of study may be required due to safety issues to 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.

Annual Safety Report

An annual safety report should be submitted to the Lead HREC. This is aligned with the annual progress report.

Protocol Deviations

A protocol deviation is any non-serious and non approved change, deviation or departure from the approved protocol (including study procedures) that is under the control of the Site Principal Investigator and study personnel.

Check with the Lead HREC reporting requirements.

• If reportable, report immediately
• If not reportable, record the deviation in the site study file / documentation

Protocol Violations

A protocol violation is any serious and non-approved change, deviation or departure from the approved protocol that poses a rish to participant safety and/or has ethical impact on the study data.

Check with the Lead HREC reporting requirements.

• If reportable, report immediately
• If not reportable, record the deviation in the site study file / documentation

Who to report to

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