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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 February 2017 Policy Committee meeting there have been several updates to Policies :

  • PI004 Adverse Events & Safety Reports – Policy re-written following new NHMRC Guidelines on Safety Monitoring & Reporting.
  • PI013 Pregnancy & Sexual Health – Length of time a baby exposed to study drug is followed now requires justification and is expected to be not less than 12 months following birth.
  • Sample Participant Information Sheet – Wording in introduction changed from “new treatment/investigational product” to “potential new treatment/investigational product”.