Monitoring approved research (MAR)
After you have received approval, Bellberry has ongoing monitoring requirements. This area has guidance and forms related to areas such as progress & final reports, safety, protocol violations, site monitoring.
MAR G1
MAR F1.1.2
MAR F1.1.3
MAR F1.1.6
MAR F1.1.7
MAR G2
MAR F2.1.1
MAR G3
MAR F 3.1.1
MAR F 3.1.2
MAR G4
MAR F 4.1.1
MAR F 4.1.2
MAR G5
MAR G6
MAR F1.1.2
MAR F1.1.3
MAR F1.1.6
MAR F1.1.7
MAR G2
MAR F2.1.1
MAR G3
MAR F 3.1.1
MAR F 3.1.2
MAR G4
MAR F 4.1.1
MAR F 4.1.2
MAR G5
MAR G6
Amending Approved Research
Amendment Form (eProtocol application questions)
Amendment Pathways Flowchart
HREC notification template – change in PI
HREC notification template – change in CPI
Safety Reporting
Safety Reporting (eProtocol application questions)
Protocol Violations and Serious Breaches
Serious Breaches Report Form – Sponsor
Serious Breaches Report Form – Third Party
Progress and Final Reports
Progress Report (eProtocol)
Final Report (eProtocol)
Withdrawal or Suspension of Ethical Approval
Site monitoring
Amendment Form (eProtocol application questions)
Amendment Pathways Flowchart
HREC notification template – change in PI
HREC notification template – change in CPI
Safety Reporting
Safety Reporting (eProtocol application questions)
Protocol Violations and Serious Breaches
Serious Breaches Report Form – Sponsor
Serious Breaches Report Form – Third Party
Progress and Final Reports
Progress Report (eProtocol)
Final Report (eProtocol)
Withdrawal or Suspension of Ethical Approval
Site monitoring
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