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Guidelines

These guidelines are intended to assist you in preparing your submission and complying with Bellberry requirements. Please click on the links below to access requirements for the following:

Protocol Guidelines

Participant Information Sheet

Consent

Bellberry will accept electronic signatures per the Electronic Transactions Act 1999 (Cth).

Following the June 2017 Policy Committee the below policies have been reviewed and updated.  Changes are minor.
Witness section of the Bellberry Sample Consent Form has also been updated.

  • PI003 Conflicts of Interest
  • PI009 Monitoring of Approved Trials
  • PI011 Data Storage and Retention
  • PI015 Investigator Qualifications
  • PI019 Monitoring – Protocol Violations
  • PI023 Timeliness of Ethical Review
  • PI024 HREC Member Details
  • PI026 Quality Assurance and Ethical Review
  • PI028 Taking Over Ethical Oversight of Approved Research
  • PI029 National Approach to Single Ethical Review of Multi-Centre Research (National Approach)