Applications
General Application
To ensure your application is reviewed at the next available meeting, please contact the Bellberry office as soon as possible to book your study onto the agenda.
Please contact Bellberry administration if you wish to attend the HREC meeting to present the study either in person or via a telephone conference call.
The following MUST be submitted to the Committee Chairman 2 weeks prior to the meeting unless otherwise negotiated with the Committee Secretary:
- Fourteen (14) copies (the original plus 13) of the final protocol, five (5) copies of the investigators brochure (the original plus 4), attachments and any supporting information you wish to have considered.
- Completed Application Form
- A short summary providing information about the company and/or pharmaceutical manufacturer involved in the study (if not previously known to the committee)
- A curriculum vitae of all investigators and co-investigators (if not previously known to the committee). Please include research credentials and relevant
publications/research experience. - A copy of all investigators and co-investigators medical registration and personal insurance cover (on an annual basis only)
>> FORMS A completed Site Approval Form if relevant. This form is required where studies are to be carried out within a hospital or institution. - Completed and signed Indemnity Forms (Bellberry accepts the Medicines Australia Forms of Indemnity) - certificate of currency from the Sponsor
-Indemnity cover between the sponsor and Bellberry HREC
-Indemnity cover between the sponsor and the investigators
-Personal indemnity cover for all investigators - For studies being conducted within a hospital/institutions, 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.
Ordinarily research without appropriate insurance will not be approved. Some exceptions may be made e.g. non-sponsored research.
- Registration of the trial in a publically accessible register e.g.Australian Clinical Trials Registry by visiting www.actr.org.au.
- Completed and signed Therapeutic Goods Administration (TGA) forms
Multiple Site Applications
The following is required in addition to items above:
- Sponsor indemnity for all investigators and co-investigators involved in the study.
- A generic participant information sheet and consent form. Report any specific site requirements on an attached sheet.
It must be clear who the principal investigator(s) is/are along with a nominated liaison person(s) for Bellberry communication. Administration fees associated with multi-centre studies may be negotiated depending on the number of sites and potential monitoring costs.
Amendments
The following MUST be submitted with the Application Form:
- Thirteen (13) copies of the Summary of Changes, one (1)final integrated Protocol, thirteen 13 copies of the Participant Information Sheet (with tracked changes) and one (1) final copy (without changes tracked).
Subsidiary studies (Sub-studies)
A protocol is considered a sub-study when the study objective is not reflected in the main protocol and its links to the main study is purely opportunistic.
The outcome of a sub-study has no bearing on the main study. A separate participant information sheet / consent form is required.
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