Guidance & Resources
The guidance and resources section is intended to provide you with information to assist you in preparing your submission and complying with the Bellberry requirements.
Pre-Approval Resources
These Resources will assist in preparing and submitting an application for HREC review
Review Pathways – Higher Risk & Lower Risk Research
Ethical review pathways, lower and higher risk review, review requirements, processes, and timelines
HREC Application Review Flowchart
Step‑by‑step overview of the HREC review process
Conflict of Interest Guidance
Guidance for identifying, disclosing, and managing actual, perceived, or potential conflicts of interest
CVs & Investigator Qualifications
Requirements for evidence of suitability to conduct a research proposal in investigator CVs
Insurance & Indemnity Guidance
Insurance and indemnity requirements for all research proposals submitted to the Bellberry HREC
Medicines Australia Clinical HREC Indemnity 1 October 2012
Medicines Australia HREC Indemnity template prefilled with Bellberry details
MTAA Device HREC Indemnity 10 April 2024
MTAA HREC Indemnity template prefilled with Bellberry details
Bellberry Non-Clinical HREC Indemnity
HREC indemnity template that can be used for non-clinical research studies
TGA CTN & CTA Schemes
Guidance for appropriate regulatory (TGA) pathway, includes Bellberry CTN contact details
Application Fees
Fees for new submissions, amendments, extension studies, and ongoing oversight
Guidance for Specific Study Designs & Products
These Resources will assist in preparing and submitting an application for a specific indication, study type or study design
Extension Study Application Guidance
Ethical considerations, requirements, and approval conditions for extension (open‑label extension/roll‑over) studies
Multi-Stage Phase 1 Application Guidance
Ethical considerations, submission requirements, and approval conditions applied by Bellberry HRECs when assessing multi‑stage Phase 1 clinical trial designs
Post Marketing/Observational Application Guidance
Guidance for determining if a study qualifies as a post‑marketing (observational) study and what ethical review requirements apply
Cannabis Product Application Guidance
Ethical review requirements, supporting evidence required, and documentation considerations for studies involving cannabis‑related products
Psychedelic Drug Application Guidance
Ethical and regulatory considerations for clinical studies involving psychedelic drugs
Getting Started in eProtocol
These Resources will assist in preparing and submitting your application in eProtocol
Extension Study Application Guidance
Ethical considerations, requirements, and approval conditions for extension (open‑label extension/roll‑over) studies
Multi-Stage Phase 1 Application Guidance
Ethical considerations, submission requirements, and approval conditions applied by Bellberry HRECs when assessing multi‑stage Phase 1 clinical trial designs
Post Marketing/Observational Application Guidance
Guidance for determining if a study qualifies as a post‑marketing (observational) study and what ethical review requirements apply
Cannabis Product Application Guidance
Ethical review requirements, supporting evidence required, and documentation considerations for studies involving cannabis‑related products
Psychedelic Drug Application Guidance
Ethical and regulatory considerations for clinical studies involving psychedelic drugs
Get answers to common queries
Whether you’re preparing your first submission or managing amendments, these answers cover the most common scenarios and link to detailed guidance when needed.
The Medicines Australia Standard form of Indemnity and HREC Review Only form of Indemnity can both be found at the Medicines Australia website along with the Clinical Trials Compensation Guidelines.
Bellberry does not require the submission of Standard Indemnities. Researchers and Sponsors can find information on Bellberry’s requirements for HREC Only Indemnities in BA G15 Insurance and indemnities
Our HREC Committee meetings are usually held on a Wednesday. A Principal Investigator can expect to receive comments detailing the committee’s deliberations two business days following the HREC meeting. Comments are provided via eProtocol.
Refer to BA G1 Submission requirements and responsibilities.
When you register for eProtocol for the first time you will be asked to enter a user ID. We recommend that for your unique user ID you use your surname followed by your first name initial, for example SmithJ.
Still have questions? We’re here to help.
Browse our FAQs page or contact us for helpful guidance and detailed information.
How to Apply
Understand the full application process from start to finish. This step-by-step guide shows you how to register, prepare documents, and submit your study for review.
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Multi-centre Trials
Learn how Bellberry provides a single ethics review for studies running across multiple sites. Our streamlined approach reduces duplication and accelerates national research start-up.
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Our Fees
Review the current schedule of fees for new applications, amendments, and multi-centre studies. Transparent pricing helps you plan and budget with confidence.
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Ready to start or need advice?
If you’d like to speak with a Bellberry team member about your study or need help preparing an application, our customer service specialists are here to assist.
