Bellberry has updated the site-specific clauses document (BA F1.1.12) to include examples and a pre-submission checklist.
Please note the following:
- As a minimum, the HREC requires sites to outline their changes to the Master Main PICF.
- A review of the clause documents has found that most sites only make changes to the Master Main PICF. Therefore, to improve efficiency, the HREC will no longer return the site-specific clauses template if the site has overlooked listing supplementary PICFs (e.g. pregnant partner, optional biomarker PICFs).
- As per the terms and conditions of HREC approval, the site must submit an amendment if any ethical changes to content are required.
Please see the updated form here.