Projects sponsored by another organisation (with a La Trobe collaborator)

When La Trobe research staff and students collaborate with another organisation (e.g., university, hospital or medical research institute etc..), the sponsor is the organisation who is:

  1. the administering body for funds OR
  2. providing seed funding for the research

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

Coordinating Investigator: Is defined as the person responsible for the project and is employed by the Sponsor organisation. The sponsor may have delegated all sponsor responsibilities to the Coordinating Investigator. La Trobe staff or students cannot act as the Coordinating Investigator when La Trobe is not the sponsor.

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 documents

From the Sponsor/Coordinating Investigator

  • Ethics documentation and approvals
  • 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 Ethics and/or Governance Approval
  • Site logos
  • Investigator CV’s
  • Evidence of current Good Clinical Practice (GCP) training
  • Study file

Step 2: Insurance

From La Trobe:

  1. Sponsors may request the La Trobe Principal Investigator to provide certificates of currency (a certificate of currency can be download from the Insurance webpage) for:
  • Public and Products Liability (or equivalent) AUD10 million (if conducted on La Trobe premises)
  • Professional Indemnity AUD10 million
  • Medical Indemnity AUD5 million
  • When the Sponsor is another Australian University, La Trobe is responsible for ensuring appropriate Clinical Trials Insurance is in place. Clinical Trials Insurance is automatic, unless the research contains 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

    If the research meets one of the conditions outlined above, then the La Trobe Principal Investigator must submit the project description/protocol to Human Ethics to obtain a certificate of currency.

Need help?:

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

From the Sponsor:

The Sponsor will initiate their preferred research agreements with La Trobe. The Sponsor’s Coordinating Investigator may ask for the following Research Agreements to be in place:

  • Clinical Trials Research Agreement
  • Materials Transfer Agreement (if applicable)
  • Funding Agreement (if applicable)
  • When La Trobe is listed as a collaborator on a clinical trial La Trobe must enter into a clinical trial research agreement (CTRA) with the sponsor, using either one of the following Medicines Australia templates  as described below:
    1. Contracting with a non-for-profit organisation (e.g., hospital or university)
    2. Collaborative or Cooperative Research Group (CRG) Studies, or sponsor’s template

    3. Contracting with a sole trader/clinical/medical practice
    4. Sponsor’s template

    5. Contracting with an international organisation
    6. Sponsor’s template

La Trobe University contact details:

When La Trobe is listed as a collaborator, La Trobe must be named as the CRG Institution (for collaborative agreements) or Institution (other agreements) must be noted as:

La Trobe University

Bundoora, Vic, 3086

ABN: 64 804 735 113

Need help?

The La Trobe Principal Investigator should submit the agreements to:

Step 4: Budgets & Grants

The Sponsor/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

  • Site 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.

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

Step 5: OH&S / Risk Management

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

  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?

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: Therapeutic Goods Administration (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