Commercial and Industry sponsored projects

Commercial and Industry Sponsorship: is defined as when La Trobe research staff and students are conducting research that is funded by an Australian arm of an International Pharmaceutical and/or Biotechnology Company or an Australian Clinical Research Organisation (CRO), or from an Australian Private Company.

If a Commercial and Industry Sponsor is providing funding to La Trobe to create the protocol and run the project as Sponsor, please refer to ‘Projects Sponsored by La Trobe’.

Definition of Site: Is defined as the premises where the clinical trial is being conducted.

La Trobe Principal Investigator: Is defined as the La Trobe staff member who is taking responsibility for the La Trobe component of the study.

Getting your clinical trial approved

Step 1: Study Documentation

From the sponsor

  • Ethics documentation and approval
  • Feasibility checklist
  • Investigator’s Brochure/Product Information
  • Data Safety Monitoring Board
  • Protocol
  • PICF/s
  • Case Report Forms
  • Adverse event tracker
  • Study tracker
  • Budget template
  • Delegation log
  • Enrolment log
  • Screening log

From the La Trobe Principal Investigator

  • Site logos
  • Investigator CV’s
  • Evidence of current GCP training
  • Study file

Step 2: Insurance

Sponsor Insurance

Clinical trials certificate of currency

AUD 20 million for any one occurrence and in the annual aggregate - required for all clinical trials

Clinical trials indemnity

Required where an indemnified party is providing premises only and/or lead HREC review

Drug

Form of indemnity – standard

Form of indemnity – HREC review only

Device

MTAA Form of indemnity – standard

MTAA Form of indemnity – HREC review only

Site Insurance

Public and products liability (or equivalent)

AUD 10 million - if required, must provide to sponsor

Professional indemnity

AUD 10 million - if required, must provide to sponsor

Medical indemnity

AUD 5 million - if required, must provide to sponsor

Need Help?

For insurance requirements about a specific study contact Human Ethics or +61 3 9479 1443

For general insurance requirements email the Insurance Office

From the Sponsor

  • Clinical Trials Research Agreement
  • Materials Transfer Agreement (if applicable)
  • Funding Agreement (if applicable)

** Must be an Australian Legal Entity

Drug trials (commercial/industry sponsored)

Pharmaceutical
Contract Research Organisation (CRO

Device Trials (commercial/industry sponsored)

La Trobe University contact details:

When La Trobe is being engaged to act as a site (i.e., the clinical trial will be conducted on La Trobe premises) for a Commercially Sponsored Clinical Trails, the Institution must be noted as:

La Trobe University

Bundoora, Vic, 3086

ABN: 64 804 735 113

Research Agreement sign-off

La Trobe Principal Investigator submits to Human Ethics:

  • Partially executed CTRA
  • Approved ethics documentation (if approved by another HREC)

An executed contract will be returned to the Coordinating Investigator.

Need help?

For study budget requirements pertaining to Clinical Trials Research Agreements (CTRAs) contact Human Ethics or +61 3 9479 1443

For enquiries about a specific grant contact Research Grants

For enquiries about a specific tender/contract pertaining to research funds contact Contracts and Consulting

For enquiries about funding from industry/commercial sponsors contact Office for Industry Engagement

Step 4: Budgets & Grants

The La Trobe Principal Investigator is responsible for creating a budget that correctly costs the research. The study costs should include confirmed costs from:

  • Supporting departments and/or
  • Asset managers (e.g., infrastructure on La Trobe premises such as scanning machines, microscopes, laboratory space etc…)

Need help?

For study budget requirements pertaining to Clinical Trials Research Agreements (CTRAs) contact Human Ethics or +61 3 9479 1443

For enquiries about a specific tender/contract pertaining to research funds contact Contracts and Consulting

Step 5: OH&S/Risk Management

  1. Radiation safety report (if applicable, each site where radiation will be used will need a report from their medical physicist, as all machines have different requirements for calculating doses. If you are using a machine without a medical physicist please contact Human Ethics to arrange a medical physicist report)
  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.
  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 Human Ethics or +61 3 9479 1443

Step 6: Ethics & Governance

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

  3. Projects approved by lead HREC external to La Trobe
  4. Submit Ethics to the lead Human Research Ethics Committee (HREC), per their requirements.

    Email Human Ethics a copy of:

    1. A copy of Ethics paperwork (including approval letters)
    2. Clinical Trial Research Agreements and any other applicable agreements
    3. Insurance and Indemnity
    4. Budget
    5. Evidence of GCP training
    6. 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)

Step 7: Clinical Trials Registration

From the Sponsor

Provides the La Trobe Principal Investigator with the details of the name of the clinical trials registry and registration number that the study has been registered. La Trobe does prefer projects to be registered on  Australian New Zealand Clinical Trials Registry, however, the registry is left to the discretion of the Sponsor/Coordinating Investigator.

Step 8: TGA Notification (if applicable)

From the Sponsor

The Sponsor will provide the La Trobe Principal Investigator with a copy of the CTN/CTX notification from the TGA.

Step 9: Good Clinical Practice (GCP) Training

From the Sponsor

Protocol specific GCP training

From La Trobe

  • General GCP (Transcelerate R2 (E6)) training (online &/or face to face)

*available to all La Trobe staff and students

  • To register for GCP training please email name & preferred email address to Human Ethics.

Managing post-approval requirements

Modifications

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 copy of the email a full copy of the approved modification paperwork to Human Ethics

Annual / Final Reports

  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

Safety Reporting (including annual safety reports & protocol violations)

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