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Policies and procedures


Research management compliance framework

Compliance & governance procedures

Compliance Framework Procedure

Procedure

Compliance Framework Procedure (PDF, 280.67 KB)

PR2017/112

Att 1

Research Management Compliance Framework (PDF, 180.93 KB)

 

Att 2

Research Management Governance/Committee Structure (PDF, 113.22 KB)

 

Att 3Metro South Health Research Council Terms of Reference (PDF, 257.08 KB) 
Att 4Metro South Health Research Committee Terms of Reference (PDF, 256.55 KB) 

Ethical & Scientific Review of Human Research Procedure

ProcedureEthical & Scientific Review of Human Research Procedure (PDF, 371.19 KB)PR2017/113
Att 1Types of research and ethical review requirements  (PDF, 123.53 KB) 
Att 2

Protocol Guides:

 
Att 3MSH HREC Terms of Reference (PDF, 336.03 KB) 
 HREC Application Closing Dates & HREC Meeting Dates 2021 (PDF, 139.87 KB) 

Participant Information & Consent Form Procedure

Procedure

Participant Information and Consent Form Procedure (PDF, 262.09 KB)

PR2017/115

Att 1Participant Infomration and Consent From Compliance Tool (XLSX, 33.3 KB) 

Site Specific Assessment Procedure

ProcedureSite Specific Assessment Procedure (PDF, 360.22 KB)PR2017/116
AttachmentResearch Contracts Approval and Study Execution Form (PDF, 157.97 KB) 

Monitoring Procedure

ProcedureMonitoring Procedure (PDF, 248.54 KB)PR2017/117
AttachmentHREC/RGO Annual Progress/Final Report (PDF, 845.57 KB) 

ieMR Research Support Module (PowerTrials) Procedure

ProcedureieMR Research Support Module (PowerTrials) Procedure (PDF, 260.72 KB)PR2017/118
Supporting DocumentElectronic Health Record Checklist (PDF, 127.17 KB) 

Funding, grants and contracts procedures

Research Grants Administration Procedure

ProcedureResearch Grants Administration Procedure (PDF, 282.79 KB)PR2017/119

Metro South Research Support Scheme (RSS) Procedure

ProcedureMetro South Health Research Support Scheme (RSS) Procedure (PDF, 284.89 KB)PR2017/120

Research Funding, Budgets & Infrastructure Support Procedure

ProcedureResearch Funding, Budgets and Infrastructure Support Procedure (PDF, 350.25 KB)PR2017/121

Research Contracts & Study Execution Procedure

ProcedureResearch Contracts and Study Execution Procedure (PDF, 368.92 KB)PR2017/122

Research Fees Procedure

ProcedureResearch Fees Procedure (PDF, 213.19 KB)PR2017/123

Integrity, quality, reporting and consumer partnering procedures

Research management guidelines

 

Clinical Research Facility Policy Framework

Clinical Research Facility Policy

Policy

Clinical Research Facility Policy (PDF, 190.46 KB)

PL2021-83

Clinical Research Facility Procedures

Governance, Oversight and Management Procedure

Procedure

Governance, Oversight and Management Procedure (PDF, 223.14 KB)

PR2021/238

Application and Use Procedure

Procedure

Application and Use Procedure (PDF, 275.22 KB)

PR2021/239

Participant Admission, Supervision and Clinical Management Procedure

ProcedureParticipant Admission, Supervision and Clinical Management Procedure (PDF, 247.28 KB)PR2021/240

Investigational Product Management and Administration Procedure

ProcedureInvestigational Product Management and Administration (PDF, 295.26 KB)PR2021/241

Adverse Event and Clinical Incident Reporting Procedure

ProcedureAdverse Event and Clinical Incident Reporting Procedure (PDF, 254.39 KB)PR2021/242

 

Research biorepositories governance framework

Research Biorepositories Policy

ProcedurePDF icon Research Biorepositories Policy (PDF, 188.71 KB)PL2017/53
AttachmentMSH Research Biorepositories Glossary (PDF, 331.18 KB) 

Research biorepositories compliance and governance procedures

Governance, Oversight & Management Procedure

ProcedurePDF icon Governance, Oversight and Management Procedure (PDF, 348.67 KB)PR2017/98
AttachmentMSH Research Biorepository Governance Framework (PDF, 122.53 KB) 
AttachmentMSH Research Biorepository Compliance Framework (PDF, 52.47 KB) 

Strategic Oversight Committee & Compliance Procedure

ProcedurePDF icon Strategic Oversight Committee and Compliance Procedure (PDF, 307.86 KB)PR2017/99
AttachmentTerms of Reference (PDF, 137.18 KB) 
AttachmentMSH Research Biorepository Complaint Form (PDF, 113.69 KB) 

Establishment of a Research Biorepository Procedure

ProcedurePDF icon Establishment of a Research Biorepository Procedure (PDF, 346.18 KB)PR2017/100
AttachmentMSH Research Biorepository Financial Plan Template (PDF, 123.8 KB) 
AttachmentEstablishment of a Research Biorepository Checklist (PDF, 58.12 KB) 

Operational Arrangements Procedure

ProcedurePDF icon Operational Arrangements Procedure (PDF, 371.75 KB)PR2017/101

Research biorepositories operations procedures

Acquisition, Attainment & Recruitment Procedure

ProcedurePDF icon Acquisition, Attainment and Recruitment Procedure (PDF, 292.29 KB)PR2017/102
AttachmentUse of Existing Collections of Samples Flowchart (PDF, 222.25 KB) 
AttachmentMinimum Data Set (PDF, 142.12 KB) 
AttachmentMinimum Data Set Template (PDF, 95.19 KB) 
AttachmentAQIS Permit (PDF, 1.7 MB) 

Facility, Equipment, Storage & Security Procedure

ProcedurePDF icon Facility, Equipment, Storage and Security Procedure (PDF, 307.92 KB)PR2017/103
AttachmentMaintenance & Calibration Requirements for Equipment Commonly Use in Research Biorepositories (PDF, 94.39 KB) 
AttachmentFacility, Equipment, Storage & Security Checklist (DOC, 1.05 MB) 

Collection, Processing, Handling & Retrieval Procedure

ProcedurePDF icon Collection, Processing, Handling and Retrieval Procedure (PDF, 397.88 KB)PR2017/104
AttachmentRecommended Quality Control Processes (PDF, 28.26 KB) 
AttachmentRecommended Preservation Methods (PDF, 28.83 KB) 
AttachmentCollection, Processing, Handling & Retrieval Checklist (DOC, 1.11 MB) 

Disposal, Lab/Fridge Merge & Closure Procedure

ProcedurePDF icon Disposal, Lab/Fridge Merge and Closure Procedure (PDF, 256.49 KB)PR2017/105

Access & Applications for Samples Procedure

ProcedurePDF icon Access and Applications for Samples Procedure (PDF, 329.36 KB)PR2017/106
AttachmentApplication for Samples Form (DOC, 1.06 MB) 

Material Transfer Agreements, Packaging & Shipping Procedure

ProcedurePDF icon Material Transfer Agreements, Packaging and Shipping Procedure (PDF, 367.05 KB)PR2017/107
AttachmentMaterial Transfer Agreement Template (DOCX, 37.58 KB) 
AttachmentSample Dispatch Coversheet Template (DOC, 1.06 MB) 
AttachmentTransport of Samples Template (DOC, 649 KB) 
AttachmentMaterial Transfer Agreements, Packaging & Shipping Checklist (DOC, 352.5 KB) 

Research biorepositories quality procedures

Emergency Preparedness and Work Health & Safety Procedure

ProcedurePDF icon Emergency Preparedness and Work Health and Safety Procedure (PDF, 279.29 KB)PR2017/108
AttachmentWork Health and Safety Checklist (DOC, 1.01 MB) 

Databases, Tracking, Records & Documentation Procedure

ProcedurePDF icon Databases, Tracking, Records and Documentation Procedure (PDF, 414.96 KB)PR2017/109
AttachmentSelection of Research Biorepository Informatics Management Systems (PDF, 112.61 KB) 
AttachmentValidation & Operation of Research Biorepository Informatics Systems (PDF, 29.99 KB) 
AttachmentConfidentiality Agreement for Employees (DOC, 1006 KB) 
AttachmentDatabases, Tracking, Records & Documentation Checklist (DOC, 1.07 MB) 

Quality Management System (Assurance & Control) Procedure

ProcedurePDF icon Quality Management System (Assurance and Control) Procedure (PDF, 296.67 KB)PR2017/110
AttachmentQuality Assurance & Quality Control Implementation & Auditing (PDF, 108.38 KB) 
AttachmentQuality Control Considerations for Specific Types of Biospecimens (PDF, 132.78 KB) 

Standard Operating Procedures (SOPs) Procedure

ProcedurePDF icon Standard Operating Procedures (SOPs) Procedure (PDF, 310.87 KB)PR2017/111
AttachmentStandard Operating Procedures Index (DOC, 76.5 KB) 
AttachmentStandard Operating Procedure Template (DOC, 261 KB) 
AttachmentExample Standard Operating Procedure (PDF, 358.11 KB) 
AttachmentStandard Operating Procedure Review Records (DOC, 34.5 KB) 
AttachmentStandard Operating Procedures Distribution Records (DOC, 35 KB) 
AttachmentStandard Operating Procedure Checklist (DOC, 1016.5 KB) 
Last updated 15 April 2021
Last reviewed 23 September 2020