eProtocol

Guidance and resources

Guidance and 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.

The section includes several different document areas.

  • Levels of Ethical Review, Bellberry Applications and Monitoring Approved Research contain guidance and forms relating to the applications.
  • Corporate Governance contains corporate policies and terms of references.
  • Information Technology relates to how Bellberry manages data.

Levels of Ethical Review (LER)

This area contains documents that aim to give a brief overview of the review pathways available to those seeking ethical review for human research, quality assurance (QA) activities, and low and negligible risk (LNR) research. There are also self-reflection checklists for QA and LNR activities.

Bellberry Applications (BA)

Once you have determined your research pathway, you are ready to apply to Bellberry. This area includes guidance and forms that cover most facets of what is required for your application.

Monitoring Approved Research (MAR)

After you have received approval, Bellberry has ongoing monitoring requirements. This area has guidance and forms related to areas such as progress & final reports, safety, protocol violations, site monitoring.

Corporate Governance (CG)

This area contains relevant public policies relating to research, privacy, complaints and terms of references.

Information Technology (IT)

This area has guidance on the Bellberry’s management and retention of data and records and the use and acceptance of e-Signatures.

 

FAQs

a

Where can I find the HREC and Standard Indemnity templates?

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

a

When will I receive the Committee’s responses?

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

a

When I register for eProtocol what should my User ID be?

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.

Refer to BA F2.1.2 Registration