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Policies and procedures

Research Policy

Policy Research Policy (PDF, 251.81 KB)PL2023-92

Research Excellence

PR2023-411 Research excellence

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

WI2023-287 Research integrity

Work instruction

Research integrity (PDF, 246.29 KB)

WI2023-287

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

WI2023-288 Research quality management systems

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

WI2023-289 Research data and privacy

Work instruction  Research data and privacy (PDF, 616.32 KB)WI2023-289
Attachment 1 Research data risk assessment and management plan (XLSX, 792.9 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 instruction Research complaints and misconduct (PDF, 228.74 KB)WI2023-291
Attachment 1 Research integrity assessment tool (DOCX, 668.59 KB) 

WI2023-292 Assessing and managing risk in research

Work instruction Assessing and managing risk in research (PDF, 247.84 KB)WI2023-292
Attachment 1 Research risk assessment and management plan (XLSX, 792.67 KB) 

GL2021-75 Partnering with consumers in research

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

GL2023-97 Aboriginal and Torres Strait Islander health research

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

GL2023-98 Research translation and impact

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

Research support and management

WI2023-293 Research funding, budgets and infrastructure support

Work instruction Research funding, budgets and infrastructure support (PDF, 422.35 KB)WI2023-293
Attachment 1 Budget 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 instruction Research grants administration  (PDF, 315.04 KB)WI2023-294

WI2023-295 Research letters of support

Work instruction Research 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) 

WI2023-298 Scientists in the Clinic program (MSH/TRI)

Work instruction  Scientists in the Clinic program (MSH/TRI) (PDF, 237.66 KB)WI2023-298
Attachment 1 Scientists in the Clinic program (MSH/TRI) Information Sheet (DOCX, 697.54 KB) 
Attachment 2 Request to appoint - Scientists in the Clinic program (MSH/TRI) (DOC, 742 KB) 

Research administration and compliance

WI2023-299 Ethical and scientific review of research

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

WI2023-300 Exemptions from research review

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

WI2023-301 Site specific assessment of research

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

WI2023-302 Research contracts and study execution

Work instruction Research contracts and study execution (PDF, 283.56 KB)WI2023-302
Attachment 1 Research Contract and Study Execution Form (RCASE Form) - single site (PDF, 998.34 KB) 
Attachment 2 Research 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 instruction Metro 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 2 Metro South Sponsorship Committee TOR (PDF, 346.51 KB) 

WI2023-304 PowerTrials - ieMR research support module

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

WI2023-305 Research monitoring

Work instruction Research monitoring (PDF, 267.32 KB)WI2023-305

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

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

GL2023-99 Planning a research project

Guideline Planning a research project (PDF, 257.21 KB)GL2023-99
Attachment 1 MSH Research protocol template (DOCX, 132.96 KB) 
Attachment 2 MSH Clinical trial protocol template (DOCX, 206.43 KB) 
Attachment 3 MSH Research protocol template - retrospective study (DOCX, 278.44 KB) 

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

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

GL2023-101 Research contract clauses

Guideline Research 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 1 Document signing advice (PDF, 171.02 KB) 

GL2021-77 Clinical trials

Guideline Clinical trials (PDF, 295.58 KB)GL2022-77

GL2023-103 Teletrial Support Program (TSP) funding

Guideline Teletrial 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

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 compliance and governance procedures

Governance, Oversight & Management Procedure

ProcedurePDF icon 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

ProcedurePDF icon 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

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
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

ProcedurePDF icon 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

ProcedurePDF icon 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

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
Attachment Application 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
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) 

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
Attachment Work 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
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

ProcedurePDF icon 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

ProcedurePDF icon 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) 
Last updated 17 June 2024
Last reviewed 20 December 2023