Research process resources: Quality assurance
“Important note: All documents can be found on the METIS Database. You can search using the document code or key words in title.”
In this section
Risk management and safety reporting
Clinical Research Development Office (CRDO) resources
Risk management
Risk assessment and management tool (PDF)- Guidance | Creation of New Standard Operating Procedures (PDF)
Template | Standard Operating Procedure (SOP) / Guidance Document (downloadable word doc)
- Continuous improvement: a corrective and preventive action (CAPA) plan (downloadable word doc)
- Template | Continuous improvement: a corrective and preventive action (CAPA) plan (downloadable word doc)
- Template | CAPA Tracking Log (downloadable word doc)
Safety reporting
- SOP | Safety Monitoring and Reporting Procedure for MCRI-sponsored investigator-Initiated Trials of Medicines/Medical Devices (PDF)
- Template | Expedited Safety Report Form (downloadable word doc)
- Template | Clinical Review of Safety Events form (downloadable word doc)
- Process map | Site PI Safety Reporting (IIT) (PDF)
- Process map | Sponsor Safety Reporting (IIT) (PDF)
- Timeline I Safety Reporting Timelines for IMPs (PDF)
- Timeline I Safety Reporting Timelines for IMDs (PDF)
Non-compliance and serious breach reporting
- SOP | MCRI Sponsor-Investigator Management of non-compliance: Protocol Deviations and Serious Breaches (PDF)
- SOP | MCRI / RCH Site Principal Investigator Management of Non-Compliance: Protocol Deviations and Serious Breaches (PDF)
- Template | Non-compliance report form (downloadable word doc)
- Template | Third Party Suspected Breach report form (downloadable word doc)
- Template | Non-compliance review form (downloadable word doc)
- Template | Site non-compliance log (downloadable word doc)
- Template | Central non-compliance log (downloadable word doc)
- Quick reference | Table of Non-compliance reporting timelines (PDF)
Melbourne Children’s resources
Other resources
Study monitoring and auditing
Clinical Research Development Office (CRDO) resources
- Standard Operating Procedure (SOP) Monitoring Visit Activities (PDF)
- Template | Clinical Monitoring Plan (downloadable word doc)
- Template | Monitoring Visit Report (downloadable word doc)
- Template | Participant Monitoring (downloadable word doc)
- Workshop | Trial Monitoring
- Fact Sheet | Monitoring using Microsoft Teams (PDF)
- Fact Sheet | Monitoring using Parkville Connect (PDF)
Other resources
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