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:
Participant Information Sheet
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”.