Please click on the links below to access the Bellberry Policies to be complied with for conducting research under Bellberry ethics approval.
Please note that these policies are for personal use only and not for distribution.
Standard Operating Procedures
- SOP001 How to apply
- Protocol Guidelines
- Participant Information Sheet Guidelines
- Informed Consent Guidelines
- Guidance for Investigators on Conduct of Extension Studies
- Participant Documents – Version Control
- Multi-stage Phase 1 Studies in Healthy Volunteers
TGA – Online CTN Scheme
Studies under CTN
From 1 July 2015 the Clinical Trials Notification (CTN) Scheme transitioned from a paper based form to an online format. The paper-based notification form is now no longer available as there are some differences in the required information for the online form.
As a reminder any paper based forms the TGA receive after 1st July 2015 will need to be submitted online via the TGA Business Services website.
The Human Research Ethics Committee (HREC) reviews the scientific validity of the trial design, the balance of risk versus harm of the therapeutic good, the ethical acceptability of the trial process, and approves the trial protocol. The HREC is also responsible for monitoring the conduct of the trial.
The institution or organisation at which the trial will be conducted, referred to as the ‘Approving Authority’, gives the final approval for the conduct of the trial at the site, having due regard to advice from the HREC.
It is the responsibility of the sponsor to ensure that all relevant approvals are in place before supplying the ‘unapproved’ therapeutic goods in the clinical trial.
Studies under CTX
A sponsor submits an application to the HREC seeking approval to supply ‘unapproved’ therapeutic goods in a clinical trial. We evaluate summary information about the product including relevant, but limited, scientific data (which may be preclinical and early clinical data) prior to the start of a trial.
The HREC is responsible for considering the scientific and ethical issues of the proposed trial protocol.
The sponsor must notify us of each trial conducted using the unapproved therapeutic good(s) approved in the CTX application.
Bellberry HREC Contact Officer:
The person who will receive correspondence from us for the HREC (if required) about this CTN.
Name: Trina O’Donnell
Position: Operations Manager, Bellberry Ltd
Contact Number: 08 8361 3222
Contact Email: firstname.lastname@example.org
- POLICYI001 Administration Fees
- POLICYI002 Participant Payment and Reimbursement
- POLICYI003 Conflicts of Interest
- POLICY004 Adverse Events and Safety Reports
- POLICY005 Complaints Related to the Conduct of Research Projects
- POLICY006 Complaints Related to the Review Process
- POLICYI007 Ionising Radiation
- POLICY008 Advertising
- POLICYI009 Monitoring of Approved Trials
- POLICYI009a Site Monitoring
- POLICYI010 Monitoring Progress Reports
- POLICYI011 Data Storage and Retention
- POLICYI013 Pregnancy and Sexual Health
- P0LICYI014 Compensation
- P0LICYI015 Investigator Qualifications
- POLICYI016 Low Negligible Risk Research
- POLICYI017 Multi-Centre Applications
- POLICYI018 Adult Photographic Release Form
- POLICYI019 Monitoring Protocol Violations
- POLICYI020 Monitoring-Withdrawal-Suspension of Ethical Approval
- POLICY021 Communication with Researchers
- POLICYI022 Governance of Research
- POLICYI023 Timeliness of Ethical Review
- POLICYI024 HREC Member Details
- POLICYI025 Confidentiality Privacy
- POLICYI026 Quality Assurance and Ethical Review
- POLICY027 Electronic Signature
- POLICYI028 Taking Over Ethical Oversight of Approved Research
- POLICYI029 National Approach to Single Ethical Review of Multi-Centre Research (National Approach)
Please contact the Bellberry Office if you have any queries regarding these documents.