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Policies and procedures

Research Policy

PolicyResearch Policy (PDF, 251.81 KB)PL2023-92

Research Excellence

PR2023-411 Research excellence

ProcedureResearch excellence (PDF, 266.02 KB)PR2023-411
Attachment 1Research excellence handbook (PDF, 402.56 KB) 

WI2023-287 Research integrity

Work instruction

Research integrity (PDF, 246.29 KB)

WI2023-287

Attachment 1Research conflict of interest disclosure form (DOCX, 680.78 KB) 

WI2023-288 Research quality management systems

Work instructionResearch quality management systems (PDF, 329.78 KB)WI2023-288
Attachment 1SOP template (DOCX, 231.55 KB) 
Attachment 2Site file index template (DOCX, 661.23 KB) 
Attachment 3AE log (DOCX, 657.54 KB) 
Attachment 4SAE report form (DOCX, 657.04 KB) 

WI2023-289 Research data and privacy

Work instruction Research data and privacy (PDF, 418.73 KB)WI2023-289
Attachment 1Research data risk assessment and management plan (XLSX, 191.26 KB) 

WI2023-290 Research authorship, peer review and publication

Work instruction

Research authorship, peer review and publication (PDF, 180.4 KB)

WI2023-290

Attachment 1

Statement of authorship (DOCX, 686.72 KB)

 

Attachment 2

Research project: contribution statement (DOCX, 539.81 KB)

 

WI2023-291 Research complaints and misconduct

Work instructionResearch complaints and misconduct (PDF, 228.74 KB)WI2023-291
Attachment 1Research integrity assessment tool (DOCX, 668.59 KB) 

WI2023-292 Assessing and managing risk in research

Work instructionAssessing and managing risk in research (PDF, 247.84 KB)WI2023-292
Attachment 1Research risk assessment and management plan (XLSX, 191.17 KB) 

GL2021-75 Partnering with consumers in research

GuidelinePartnering with consumers in research (PDF, 296.54 KB)GL2021-75

GL2023-97 Aboriginal and Torres Strait Islander health research

GuidelineAboriginal and Torres Strait Islander health research (PDF, 205.51 KB)GL2023-97

GL2023-98 Research translation and impact

GuidelineResearch translation and impact (PDF, 162.46 KB)GL2023-98

Research support and management

WI2023-293 Research funding, budgets and infrastructure support

Work instructionResearch funding, budgets and infrastructure support (PDF, 282.17 KB)WI2023-293
Attachment 1Budget tool template (XLSX, 559.96 KB) 

WI2022-226 Open access journal publications in research

Work instructionOpen access journal publications in research (intranet link)WI2022-226
Attachment 1Open access assistance request form (intranet link) 

WI2023-294 Research grants administration

Work instructionResearch grants administration  (PDF, 315.04 KB)WI2023-294

WI2023-295 Research letters of support

Work instructionResearch letters of support (PDF, 407.59 KB)WI2023-295

WI2023-296 Metro South Health Research Support Scheme (MSHRSS)

Work instruction Metro South Health Research Support Scheme (MSHRSS) (PDF, 276.77 KB)WI2023-296

WI2023-297 Gift cards (for use as research incentives)

Work instruction Gift cards (for use as research incentives) (intranet link)WI2023-297
Attachment 1MSH Gift cards - register template (intranet link) 
Attachment 2Memo approval to purchase gift cards for research participants template (intranet link) 

Research administration and compliance

WI2023-299 Ethical and scientific review of research

Work instructionEthical and scientific review of research (PDF, 231.82 KB)WI2023-299
Attachment 1Ethical review guidance document and checklist (DOCX, 593.7 KB) 
Attachment 2MSHREC meeting dates (as updated from time to time) (PDF, 132.46 KB) 

WI2023-300 Exemptions from research review

Work instructionExemptions from research review (PDF, 223.56 KB)WI2023-300
Attachment 1MSH Exemption - project description template (DOCX, 284.16 KB) 

WI2023-301 Site specific assessment of research

Work instructionSite specific assessment of research (PDF, 256.04 KB)WI2023-301
Attachment 1Site Specific Assessment (SSA) guidance document and checklist (DOCX, 600.07 KB) 

WI2023-302 Research contracts and study execution

Work instructionResearch contracts and study execution (PDF, 283.56 KB)WI2023-302
Attachment 1Research Contract and Study Execution Form (RCASE Form) - single site (PDF, 998.34 KB) 
Attachment 2Research Contract and Study Execution Form (RCASE Form) - multi-site (PDF, 442.05 KB) 

WI2023-303 Metro South Health sponsorship of Clinical Trial Notification (CTN) scheme trials

Work instructionMetro South Health sponsorship of Clinical Trial Notification (CTN) scheme trials (PDF, 244.13 KB)WI2023-303
Attachment 1

MSH Sponsorship application form (DOCX, 540.51 KB)

Attachment 2Metro South Sponsorship Committee TOR (PDF, 346.51 KB) 

WI2023-304 PowerTrials - ieMR research support module

Work instructionPowerTrials - ieMR research support module (PDF, 166.81 KB)WI2023-304
Attachment 1Electronic health record checklist (DOCX, 685.36 KB) 

WI2023-305 Research monitoring

Work instructionResearch monitoring (PDF, 267.32 KB)WI2023-305

WI2023-306 Post approval - research amendment, reporting and closure

Work instructionPost approval - research amendment, reporting and closure (PDF, 234.17 KB)WI2023-306
Attachment 1HREC/RGO Annual Progress/Final Report (PDF, 225.29 KB) 
Attachment 2Track change guide (PDF, 485.03 KB) 
Attachment 3Quick guide - submitting an annual progress report (PDF, 473.1 KB) 

GL2023-99 Planning a research project

GuidelinePlanning a research project (PDF, 257.21 KB)GL2023-99
Attachment 1MSH Research protocol template (DOCX, 132.21 KB) 
Attachment 2MSH Clinical trial protocol template (DOCX, 206.15 KB) 
Attachment 3MSH Research protocol template - retrospective study (DOCX, 288.36 KB) 

GL2023-100 Research Participant Information and Consent Form (PICF)

GuidelineResearch Participant Information and Consent Form (PICF) (PDF, 249.93 KB)GL2023-100
Attachment 1PICF compliance tool (XLSX, 33.29 KB) 

GL2023-101 Research contract clauses

GuidelineResearch contract clauses (PDF, 230.82 KB)GL2023-101

GL2023-102 Use of electronic signatures in research contracts

GuidelineUse of electronic signatures in research contracts (intranet link)GL2023-101
Attachment 1Document signing advice (PDF, 171.02 KB) 

GL2021-77 Clinical trials

GuidelineClinical trials (PDF, 295.58 KB)GL2022-77

GL2023-103 Teletrial Support Program (TSP) funding

GuidelineTeletrial Support Program (TSP) funding (PDF, 156.87 KB)GL2023-103

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 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, 84.86 KB) 
AttachmentMSH Research Biorepository Compliance Matrix (PDF, 51.16 KB) 

Strategic Oversight Committee & Compliance Procedure

ProcedurePDF icon Strategic Oversight Committee and Compliance Procedure (PDF, 307.86 KB)PR2017/99
AttachmentTerms of Reference (PDF, 127.54 KB) 
AttachmentMSH Research Biorepository Complaint Form (PDF, 101.6 KB) 

Establishment of a Research Biorepository Procedure

ProcedurePDF icon 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

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, 131.2 KB) 
AttachmentMinimum Data Set (PDF, 121.48 KB) 
AttachmentMinimum Data Set Template (DOC, 1022 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, 88.21 KB) 
Attachment

Facility, Equipment, Storage and Security Checklist (PDF, 167.72 KB)

 

Collection, Processing, Handling & Retrieval Procedure

ProcedurePDF icon Collection, Processing, Handling and Retrieval Procedure (PDF, 397.88 KB)PR2017/104
AttachmentRecommended Quality Control Processes (PDF, 33.33 KB) 
AttachmentRecommended Preservation Methods (PDF, 33.83 KB) 
Attachment

Collection, Processing, Handling and Retrieval Checklist (PDF, 255.16 KB)

 

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, 40.62 KB) 
AttachmentSample Dispatch Coversheet Template (DOC, 1.06 MB) 
AttachmentTransport of Samples Template (DOC, 650.5 KB) 
AttachmentMaterial Transfer Agreements, Packaging & Shipping Checklist (DOC, 1015.5 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, 100.08 KB) 
AttachmentValidation & Operation of Research Biorepository Informatics Systems (PDF, 35.13 KB) 
AttachmentConfidentiality Agreement for Employees (DOC, 1010.5 KB) 
AttachmentDatabases, Tracking, Records & Documentation Checklist (DOC, 5.79 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, 96.86 KB) 
AttachmentQuality Control Considerations for Specific Types of Biospecimens (PDF, 120.54 KB) 

Standard Operating Procedures (SOPs) Procedure

ProcedurePDF icon Standard Operating Procedures (SOPs) Procedure (PDF, 310.87 KB)PR2017/111
AttachmentStandard Operating Procedures Index (DOC, 77.5 KB) 
AttachmentStandard Operating Procedure Template (DOC, 261.5 KB) 
AttachmentExample Standard Operating Procedure (PDF, 312.33 KB) 
AttachmentStandard Operating Procedure Review Records (DOC, 34.5 KB) 
AttachmentStandard Operating Procedures Distribution Records (DOC, 35 KB) 
AttachmentStandard Operating Procedure Checklist (DOC, 868.44 KB) 
Last updated 20 December 2023
Last reviewed 20 December 2023