Research handbook
Research Governance Framework and Guidelines for Conducting Human Research at Epworth HealthCare
The Epworth Office for Research (OfR) has implemented a clinical research quality management system (QMS) across all Epworth sites. Underpinning the QMS is a suite of Standard Operating Procedures (SOPs) that underpin the objective of upholding the highest standards of research practice in accordance with Australian and International standards.
All researchers and support staff at Epworth are required to be familiar with these resources and conduct research in accordance with the relevant SOPs.
Please contact the OfR for any queries or suggestions for improvements: [email protected]
Standard Operating Procedure (SOP) documents - Research
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Master Training Curricula
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SOP - Administrative
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SOP - Quality
- SOP - QA - 01 Documentation of Qualifications and Training Records (PDF)
- SOP - QA - 02 Management of Serious Breaches and CAPA Process (PDF, 1.61MB)
- SOP - QA - 03 Hosting an Audit or Inspection (PDF, 556KB)
- SOP - QA - 04 Vendor Assurance and Oversight (PDF, 790KB)
- SOP - QA - 05 Clinical Trial Internal Quality Assurance (DOC, 76KB)
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SOP - Research Governance
- SOP - RG - 01 Research Governance (PDF, 830KB)
- SOP - RG - 02 Clinical Indemnity and Insurance (PDF, 803KB)
- SOP - RG - 03 Developing Contracts and Budgets (PDF, 857KB)
- SOP - RG - 04 Research Personnel Credentialing (PDF)* updated
- SOP - RG - 05 Conducting Research with Ionising Radiation (PDF) * updated
- SOP - RG - 06 Managing and Investigating Potential Breaches of the Code* updated (PDF)
- SOP - RG - 07 Research Related Complaints* updated (PDF)
- SOP - RG - 08 Non-HREC Review (PDF, 754 KB)
- SOP - RG - 09 Honorary Research Appointments* new (PDF)
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SOP - Research and Trial Management
- SOP - RTM - 01 Study Feasibility and Start-Up* updated (PDF)
- SOP - RTM - 01 TEMPLATE 01 Site Feasibility Checklist (DOC)
- SOP - RTM - 02 Investigator Site File and Essential Documentation (PDF, 806KB)
- SOP - RTM - 03 Informed Consent* updated (PDF)
- Guidance for writing Participant Information in Plain Language (DOC)
- SOP - RTM - 04 IMP Receipt Storage Dispensing Return and Destruction (PDF, 508KB)
- SOP - RTM - 05 Handling and Shipping of Biological Samples* updated (PDF)
- SOP - RTM - 06 Management and Reporting of Safety Events (PDF)
- SOP - RTM - 07 Source Document Management* updated (PDF, 860KB)
- SOP - RTM - 08 Data Entry and Query Resolution (PDF, 763KB)
- SOP - RTM - 09 Remote and On-site Monitoring (PDF, 1.53MB)
- SOP - RTM - 10 Maintenance of Equipment used in Clinical Research (PDF, 1.05MB)
- SOP - TM - 11 Monitoring of Temperature Controlled Areas (DOC, 972KB)
- SOP - RTM - 12 Study or Recruitment Pause/Close and Closeout Activities (PDF, 535KB)
- SOP - RTM - 13 Archiving of Study Documentation* updated (PDF)
- SOP - TM - 14 Delegation of Duties (PDF, 918KB)
- SOP - TM - 15 - Working with Cancer Trials Australia (PDF, 1.15MB)
- SOP-TM-16 SiteDocs Portal Management (PDF, 1.43MB)
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Related SOP forms and templates
- SOP - AD - 01 - FORM - 01 SOP Feedback (DOC, 46KB)
- SOP - AD - 01 - FORM - 02 SOP Waiver (DOC, 32.1KB)
- SOP - AD - 01 - TEMPLATE - 01 SOP Standard template (DOC 52.0KB)
- SOP - AD - 01 - TEMPLATE - 02 Work Instruction template (DOC, 52.3KB)
- SOP - QA - 01 - TEMPLATE - 01 Epworth Researchers Training Plan (DOC, 37KB)
- SOP - QA - 02 - FORM - 01 CAPA Form (DOC, 42KB)
- SOP - RG - 01 - FORM - 01 PICF Checklist (DOC, 89KB) * updated
- SOP - RG - 01 - FORM - 02 Research Governance Application Form (DOC, 55KB)
- SOP - RG - 01 - FORM - 03 Research Support Form (DOC, 55KB)
- SOP - RG - 01 - FORM - 06 Research Governance Checklist
- SOP - RG - 04 - FORM - 01 Research Credentialing Form (DOC, 50KB)
- SOP - RG - 04 - TEMPLATE - 02 - VMO PI Agreement (DOC, 49KB)
- SOP - RG - 04 - TEMPLATE - 04 - Epworth Researcher CV (DOC, 51KB)
- SOP - RG - 05 - TEMPLATE - 05 - MPRAF (DOC, 63KB)
- SOP - RG - 08 - FORM - 01 Non-HREC Ethical Review Request (DOC, 40KB)
- SOP - RG - 08 - FORM - 02 Case Study Notification (DOC, 30.2KB)
- SOP - RG - 08 - FORM - 03 Non HREC Ethical Review Checklist
- SOP - RG - 08 - TEMPLATE - 01 Case Study Consent (DOC, 31.1KB)
- SOP - RTM - 03 - FORM - 21 - Documentation of Consent * new (DOC)
- SOP - RTM - 07 - TEMPLATE-01 Source Document Plan * new (DOC)
- SOP - RTM - 10 - TEMPLATE - 01 Research Equipment Maintenance (XLS, 19KB)
- SOP - RTM - 13 - TEMPLATE - 01 - Archive Document Log (DOC, 59KB)
- SOP - RTM - 13 - TEMPLATE - 02 - Archive Box Label (DOC, 33KB)
- SOP - RTM - 13 - TEMPLATE - 03 - Archive Destruction Request
- SOP - RTM - 14 - FORM - 01 Delegation of Duties Log
- SOP - RTM - 14 - FORM - 02 Notification of Change of PI (DOC, 47KB)
- SOP - RTM - 14 - FORM - 02 Notification Temporary Delegation of PI Responsibilities (DOC, 47KB)
- TEMPLATE - 03 - Budget Template (DOC, 34KB)