Monitoring Approved Research (MAR) & Quality Management (QM)

Q: MAR G1 Amending Approved Research

[one-fourth-first]MAR G1 MAR F1.1.2 MAR F1.1.3 MAR F1.1.6 MAR F1.1.7[/one-fourth-first] [three-fourths] Amending Approved Research Amendment Form (eProtocol application questions) Amendment Pathways Flowchart HREC notification template - change in PI HREC notification template - change in CPI

Q: QM G10 Safety Reporting

[one-fourth-first]QM G10 QM F10.1.1[/one-fourth-first] [three-fourths] Safety Reporting Safety Reporting (eProtocol application questions)

Q: QM G11 Serious Breaches

[one-fourth-first]QM G11 QM F11.1.1 QM F11.1.2 QM F11.1.3[/one-fourth-first] [three-fourths] Serious Breaches Serious Breaches Report Form - Sponsor Serious Breaches Report Form - Third Party Serious Breaches (eProtocol questions - PVR)

Q: MAR G4 Progress and Final Reports

[one-fourth-first]MAR G4 MAR F 4.1.1 MAR F 4.1.2[/one-fourth-first] [three-fourths] Progress and Final Reports Progress Report (eProtocol) Final Report (eProtocol)

Q: QM G12 Withdrawal or Suspension of Ethical Approval

[one-fourth-first] QM G12 [/one-fourth-first] [three-fourths] Withdrawal or Suspension of Ethical Approval

Q: MAR G8 Batch submissions

[one-fourth-first]MAR G8 MAR F8.1.1[/one-fourth-first] [three-fourths] Batch submissions Batch submission application

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, serious breaches, site monitoring.