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How to Apply

Follow the steps below to ensure a streamlined submission process for new applications.

Download/Print the eProtocol User Guide to assist you step by step to  lodge your application.

Access the HREC Flow Chart

Step 1 – Meeting timeframesexpand
Please contact Bellberry prior to submitting your documents if you have specific time frames.

Please contact Bellberry administration if you wish to attend the HREC meeting to present the study either in person or via telephone conference call.

Step 2 – Prepare application documentationexpand
Prepare your application documentation in PDF format. Please ensure files are appropriately named, using a footer, to ensure the description reflects the contents. (i.e. Protocol No., version no., date.)  It is very important to save these documents  as you would like them to appear in the approval letter.

All documents that form part of your application must be attached to the application via the eProtocol system. The following documents must also be submitted.

  • Final protocol
  • Investigators Brochure – If the investigational product is marketed and its pharmacology is widely understood by medical practitioners, an extensive IB may not be necessary.  Where permitted by regulatory authorities, a basic product information brochure, package leaflet, or labelling may be an appropriate alternative, provided that it includes current, comprehensive, and detailed information on all aspects of the investigational product that might be of importance to the investigator.  If a marketed product is being studied for a new use (i.e. a new indication), an IB specific to that new use should be prepared.  Per the Note For Guidance on Good Clinical Practice CPMP/ICH/135/95
  • Information for comparator or other drugs being used in the study, whether registered or not.  This should be in the form of an Investigators Brochure or product information approved by the TGA.
    Participant Information Sheet
  • Consent Form
  • Advertisements
  • Questionnaires, Surveys etc are to be submitted in their entirety (including validated tools)
  • Up to date Curriculum Vitae of Principal Investigator if not previously known to Bellberry. Please include research credentials and relevant publications/research experience.
  • A completed site approval form if relevant. This form is required where studies are to be carried out within a hospital or institution, or where any services e.g. Pharmacy, Radiology, Pathology external to your organisation will be used. Download [Site Approval Form]. Bellberry will forward its completed review and relevant documentation to the investigator for forwarding to the Chief executive or delegate. This will allow the hospital/institution to review its own governance matters relating to the study and provide final sign off prior to commencement.
  • Completed and Signed Indemnity Forms to the minimum amount of AUD$10million for any one occurrence
  • Indemnity cover between the sponsor and Bellberry HREC
  • Indemnity cover between the sponsor and the investigator
  • Certificate of currency from sponsor
  • A copy of Principal investigator’s medical registration and personal medical insurance cover (on an annual basis).
  • Registration of the trial in a publicly accessible register e.g. Australian Clinical Trials Register www.actr.org.au. prior to the commencement of the clinical phase of the research as per the National Statement on Ethical Conduct in Human Research (2007) Section 3.3.12.
  • Please note – Therapeutic Goods Administration forms must be sent through the standard Australian postal system.

Bellberry staff are available to assist researchers and their staff through the application and review process.  Please feel free to call us on 08 8361 3222 or email bellberry@bellberry.com.au

Multi Centre applications/Single Review

Please follow the instructions on the Application Form and in the User Guide. You are required to list all Investigators and locations.

Optional studies

If it is intended to seek permission for use of optional tissue samples (either residue from obligatory tests or fresh tissue sought) a separate Participant Information Sheet and Consent Form must be included for this secondary purpose.

Refer Sample Participant Information Sheet for further details.

Step 3 – Log on to eprotocolexpand
Log into the eProtocol system. Register for a username and password if a first time user.  If you have existing studies aproved by Bellberry and have not yet lodged a new application via eProtocol, please contact bellberry@bellberry.com.au as an eProtocol User Name has been created for you.  You will not need to register.

Click here to go to User Registration information.

Step 4 – Complete online Application Formexpand
Log on and complete the online application form. Attach all documentation and submit.

Click here for information on how to complete application.

Step 5 – Application received notificationexpand
You will receive acknowledgement by email that your application has been received. You will also be notified if your application is incomplete and has been returned.

Click here for Returned Applications information.

Step 6 – Track your applicationexpand
Log on to eProtocol at any time to track your submission by checking your home page.

Step 7 – Respond to Committee commentsexpand
Bellberry will advise the Principal Investigator of the outcome of the review given by the Committee. An investigator can expect to receive comments detailing the Committee’s deliberations 2 days following the committee meeting. Any questions raised by the committee will require satisfactory responses prior to ethics approval being granted. Once the Committee is satisfied that all requirements have been met, notification will be sent via email and the approval letter will be available in the eProtocol system.

Please respond promptly to any comments via the eProtocol system to ensure quick turnaround.

Researchers may be invited by the Committee to attend review meetings to present their study or answer questions in regard to specific issues either in person or via telephone.

If a response is not received after six months you will be issued a reminder.  If no response to the reminder is received the study will then be closed.

Click here for instructions on how to respond to HREC comments.

Please click here to go to eProtocol help for comprehensive application guidelines and the User Guide.