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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 November Policy Committee meeting, the Pregnancy and Sexual Health Policy PI013 has been updated.
In the PICF – Sample Clause for Participants and Partners of Participants section, the sentence “It is highly recommended that you inform your partner of your participation in the study and the need to avoid pregnancy.” has been relocated from the male participants only section, so the instruction now applies to both female and male participants.

Following the August Policy Committee meeting, the below policies have been reviewed and updated.
Wording of the Bellberry approval clause in the Sample Participant Information Sheet has also been updated.

  • PI005 Complaints Related to the Conduct of Research Project
  • PI006  Complaints Related to the Review Process
  • PI010  Monitoring – Progress Reports
  • PI016  Low or Negligible Risk (LNR) Review
  • PI021  Communication With Investigators/Sponsors