Research Management Policy

Policy	Metro South Health Research Management Policy (PDF, 188.95 KB)	PL2017/55
Att 1	Metro South Health Research Management Glossary (PDF, 318.41 KB)

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 3	Metro South Health Research Council Terms of Reference (PDF, 257.08 KB)
Att 4	Metro South Health Research Committee Terms of Reference (PDF, 249.16 KB)

Ethical & Scientific Review of Human Research Procedure

Procedure	Ethical & Scientific Review of Human Research Procedure (PDF, 371.19 KB)	PR2017/113
Att 1	Types of research and ethical review requirements  (PDF, 123.53 KB)
Att 2	Protocol Guides: Standard Risk (DOC, 272 KB) Low and Negligible Risk (DOCX, 407.54 KB) Exemption - Project Description (DOCX, 404.32 KB)
Att 3	MSH 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 1	Participant Infomration and Consent From Compliance Tool (XLSX, 33.3 KB)

Site Specific Assessment Procedure

Procedure	Site Specific Assessment Procedure (PDF, 360.22 KB)	PR2017/116
Attachment	Research Contracts Approval & Study Execution Form_v4 May 2021 (PDF, 161.57 KB)

Monitoring Procedure

Procedure	Monitoring Procedure (PDF, 248.54 KB)	PR2017/117
Attachment	HREC/RGO Annual Progress/Final Report (PDF, 845.57 KB)

ieMR Research Support Module (PowerTrials) Procedure

Procedure	ieMR Research Support Module (PowerTrials) Procedure (PDF, 260.72 KB)	PR2017/118
Supporting Document	Electronic Health Record Checklist (PDF, 127.17 KB)

Research Grants Administration Procedure

Procedure

Research Grants Administration Procedure (PDF, 282.79 KB)

PR2017/119

Metro South Research Support Scheme (RSS) Procedure

Procedure

Metro South Health Research Support Scheme (RSS) Procedure (PDF, 284.89 KB)

PR2017/120

Research Funding, Budgets & Infrastructure Support Procedure

Procedure

Research Funding, Budgets and Infrastructure Support Procedure (PDF, 350.25 KB)

PR2017/121

Research Contracts & Study Execution Procedure

Procedure

Research Contracts and Study Execution Procedure (PDF, 368.92 KB)

PR2017/122

Research Fees Procedure

Procedure

Research Fees Procedure (PDF, 213.19 KB)

PR2017/123

Research Complaints & Misconduct Procedure

Procedure	Research Complaints and Misconduct Procedure (PDF, 411.17 KB)	PR2017/124
Attachment	Research Integrity Assessment Tool (DOCX, 160.03 KB)

Research Data Management Procedure

Procedure

Research Data Management Procedure (PDF, 287.37 KB)

PR2017/125

Quality Management Framework & Reporting Procedure

Procedure	Quality Management Framework and Reporting Procedure (PDF, 420.78 KB)	PR2017/126
Att 1	Standard Operating Procedure (SOP) Template (DOC, 280 KB)
Att 2	Work Instruction (WI) Example
Att 3	Risk Register Template (PDF, 144.99 KB)

Research Integrity Procedure

Procedure

Research Integrity Procedure (PDF, 236.51 KB)

PR2018/176

Authorship, Peer Review & Open Access Publications Procedure

Procedure	Authorship, Peer Review and Open Access Publications Procedure (PDF, 344.24 KB)	PR2021/259
Att 1	Statement of Authorship (DOCX, 682.31 KB)
Att 2	Memorandum of Understanding (DOCX, 537.96 KB)
SOP	Open Access Journal Publications SOP (internal link) Open Access Assistance Request Form (internal link) Flowchart (internal link)	SOP2021/MSRF.5

Partnering with Consumers in Research Guideline

Clinical Trials Guideline

Guideline

Clinical Trials (PDF, 282.73 KB)

GL2021/77

Clinical Research Facility Policy

Governance, Oversight and Management Procedure

Application and Use Procedure

Participant Admission, Supervision and Clinical Management Procedure

Procedure

Participant Admission, Supervision and Clinical Management Procedure (PDF, 247.28 KB)

PR2021/240

Investigational Product Management and Administration Procedure

Procedure

Investigational Product Management and Administration (PDF, 295.26 KB)

PR2021/241

Adverse Event and Clinical Incident Reporting Procedure

Procedure

Adverse Event and Clinical Incident Reporting Procedure (PDF, 254.39 KB)

PR2021/242

Research Biorepositories Policy

Procedure	Research Biorepositories Policy (PDF, 188.71 KB)	PL2017/53
Attachment	MSH Research Biorepositories Glossary (PDF, 239.17 KB)

Governance, Oversight & Management Procedure

Procedure	Governance, Oversight and Management Procedure (PDF, 348.67 KB)	PR2017/98
Attachment	MSH Research Biorepository Governance Framework (PDF, 84.86 KB)
Attachment	MSH Research Biorepository Compliance Matrix (PDF, 51.16 KB)

Strategic Oversight Committee & Compliance Procedure

Procedure	Strategic Oversight Committee and Compliance Procedure (PDF, 307.86 KB)	PR2017/99
Attachment	Terms of Reference (PDF, 127.54 KB)
Attachment	MSH Research Biorepository Complaint Form (PDF, 101.6 KB)

Establishment of a Research Biorepository Procedure

Procedure	Establishment of a Research Biorepository Procedure (PDF, 346.18 KB)	PR2017/100
Attachment	Research Biorepository Financial Plan Template (DOC, 1.03 MB)
Attachment	Establishment of a Research Biorepository Checklist (PDF, 54.06 KB)

Operational Arrangements Procedure

Procedure

Operational Arrangements Procedure (PDF, 371.75 KB)

PR2017/101

Acquisition, Attainment & Recruitment Procedure

Procedure	Acquisition, Attainment and Recruitment Procedure (PDF, 292.29 KB)	PR2017/102
Attachment	Use of Existing Collections of Samples Flowchart (PDF, 131.2 KB)
Attachment	Minimum Data Set (PDF, 121.48 KB)
Attachment	Minimum Data Set Template (DOC, 1022 KB)
Attachment	AQIS Permit (PDF, 1.7 MB)

Facility, Equipment, Storage & Security Procedure

Procedure	Facility, Equipment, Storage and Security Procedure (PDF, 307.92 KB)	PR2017/103
Attachment	Maintenance & Calibration Requirements for Equipment Commonly Use in Research Biorepositories (PDF, 88.21 KB)
Attachment	Facility, Equipment, Storage and Security Checklist (PDF, 167.72 KB)

Collection, Processing, Handling & Retrieval Procedure

Procedure	Collection, Processing, Handling and Retrieval Procedure (PDF, 397.88 KB)	PR2017/104
Attachment	Recommended Quality Control Processes (PDF, 33.33 KB)
Attachment	Recommended Preservation Methods (PDF, 33.83 KB)
Attachment	Collection, Processing, Handling and Retrieval Checklist (PDF, 255.16 KB)

Disposal, Lab/Fridge Merge & Closure Procedure

Procedure

Disposal, Lab/Fridge Merge and Closure Procedure (PDF, 256.49 KB)

PR2017/105

Access & Applications for Samples Procedure

Procedure	Access and Applications for Samples Procedure (PDF, 329.36 KB)	PR2017/106
Attachment	Application for Samples Form (DOC, 1.06 MB)

Material Transfer Agreements, Packaging & Shipping Procedure

Procedure	Material Transfer Agreements, Packaging and Shipping Procedure (PDF, 367.05 KB)	PR2017/107
Attachment	Material Transfer Agreement Template (DOCX, 40.62 KB)
Attachment	Sample Dispatch Coversheet Template (DOC, 1.06 MB)
Attachment	Transport of Samples Template (DOC, 650.5 KB)
Attachment	Material Transfer Agreements, Packaging & Shipping Checklist (DOC, 1015.5 KB)

Emergency Preparedness and Work Health & Safety Procedure

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

Databases, Tracking, Records & Documentation Procedure

Procedure	Databases, Tracking, Records and Documentation Procedure (PDF, 414.96 KB)	PR2017/109
Attachment	Selection of Research Biorepository Informatics Management Systems (PDF, 100.08 KB)
Attachment	Validation & Operation of Research Biorepository Informatics Systems (PDF, 35.13 KB)
Attachment	Confidentiality Agreement for Employees (DOC, 1010.5 KB)
Attachment	Databases, Tracking, Records & Documentation Checklist (DOC, 5.79 MB)

Quality Management System (Assurance & Control) Procedure

Procedure	Quality Management System (Assurance and Control) Procedure (PDF, 296.67 KB)	PR2017/110
Attachment	Quality Assurance & Quality Control Implementation & Auditing (PDF, 96.86 KB)
Attachment	Quality Control Considerations for Specific Types of Biospecimens (PDF, 120.54 KB)

Standard Operating Procedures (SOPs) Procedure

Procedure	Standard Operating Procedures (SOPs) Procedure (PDF, 310.87 KB)	PR2017/111
Attachment	Standard Operating Procedures Index (DOC, 77.5 KB)
Attachment	Standard Operating Procedure Template (DOC, 261.5 KB)
Attachment	Example Standard Operating Procedure (PDF, 312.33 KB)
Attachment	Standard Operating Procedure Review Records (DOC, 34.5 KB)
Attachment	Standard Operating Procedures Distribution Records (DOC, 35 KB)
Attachment	Standard Operating Procedure Checklist (DOC, 868.44 KB)