Please click on the links below to access the Bellberry Policies to be complied with for conducting research under Bellberry ethics approval.
Please note that these policies are for personal use only and not for distribution.
Standard Operating Procedures & Guidance
- SOP001 How to apply
- Protocol Guidelines
- Participant Information Sheet Guidelines
- Informed Consent Guidelines
- Conduct of Identical Phase 3 Studies Guidance
- Guidance for Investigators on Conduct of Extension Studies
- On-Line CTN Scheme Guidance for Investigators
- Participant Documents – Version Control
- Multi-stage Phase 1 Studies in Healthy Volunteers
Policies
- POLICYI001 Administration Fees
- POLICYI002 Participant Payment and Reimbursement
- POLICYI003 Conflicts of Interest
- POLICY004 Adverse Events and Safety Reports
- POLICY005 Complaints Related to the Conduct of Research Projects
- POLICY006 Complaints Related to the Review Process
- POLICYI007 Ionising Radiation
- POLICY008 Advertising
- POLICYI009 Monitoring of Approved Trials
- POLICYI009a Site Monitoring
- POLICYI010 Monitoring Progress Reports
- POLICYI011 Data Storage and Retention
- POLICYI013 Pregnancy and Sexual Health
- P0LICYI014 Compensation
- P0LICYI015 Investigator Qualifications
- POLICYI016 Low Negligible Risk Research
- POLICYI017 Multi-Centre Applications
- POLICYI018 Adult Photographic Release Form
- POLICYI019 Monitoring Protocol Violations
- POLICYI020 Monitoring-Withdrawal-Suspension of Ethical Approval
- POLICY021 Communication with Researchers
- POLICYI022 Governance of Research
- POLICYI023 Timeliness of Ethical Review
- POLICYI024 HREC Member Details
- POLICYI025 Confidentiality Privacy
- POLICYI026 Quality Assurance and Ethical Review
- POLICY027 Electronic Signature
- POLICYI028 Taking Over Ethical Oversight of Approved Research
- POLICYI029 National Approach to Single Ethical Review of Multi-Centre Research (National Approach)
Please contact the Bellberry Office if you have any queries regarding these documents.