Research handbook
Research Governance Framework and Guidelines for Conducting Human Research at Epworth HealthCare
QMS protocol
Epworth Research QMS Implementation and Maintenance Protocol
Research policy
This policy applies to any person conducting research involving Epworth patients, staff and/or resources.
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 list
- Epworth Research SOP Master List (PDF, 424KB)
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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, 814KB)
- 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 Researcher Credentialing (PDF, 2.91MB)
- SOP - RG - 05 Conducting Research with Ionising Radiation (PDF, 691KB)
- SOP - RG - 06 Research Misconduct (PDF, 1.19MB)
- SOP - RG - 07 Research Related Complaints (PDF, 788KB)
- SOP - RG - 08 Non-HREC Review (PDF, 754 KB)
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SOP - Trial Management
- SOP - TM - 01 Feasibilities and Trial Start-Up (PDF, 767KB)
- SOP - TM - 02 Investigator Site File and Essential Documentation (PDF, 806KB)
- SOP - TM - 03 Informed Consent (PDF, 486KB)
- SOP - TM - 04 IMP Receipt Storage Dispensing Return and Destruction (PDF, 508KB)
- SOP - TM - 05 Handling and Shipping of Biological Samples (PDF, 748KB)
- SOP - TM - 06 Management and Reporting of Safety Events (PDF, 997KB)
- SOP - TM - 07 Source Document Management (PDF, 860KB)
- SOP - TM - 08 Data Entry and Query Resolution (PDF, 763KB)
- SOP - TM - 09 Remote and On-site Monitoring (PDF, 1.53MB)
- SOP - TM - 10 Maintenance of Equipment used in Clinical Research (PDF, 1.05MB)
- SOP - TM - 11 Monitoring of Temperature Controlled Areas (DOC, 972KB)
- SOP - TM - 12 Trial Closeout (PDF, 535KB)
- SOP - TM - 13 Trial Archiving (PDF, 506KB)
- 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)
- SOP - RG - 01 - FORM - 02 Researcher Project Declaration (DOC, 55KB)
- SOP - RG - 01 - FORM - 03 Research Support Form (DOC, 55KB)
- SOP - RG - 01 - FORM - 04 PI Amendment Acknowledgement (DOC, 52KB)
- SOP - RG - 04 - FORM - 01 Research Credentialing Form (DOC, 50KB)
- SOP - RG - 04 - TEMPLATE - 02 - VMO PI Agreement (DOC, 49KB)
- SOP - RG - 04 - TEMPLATE - 03 - External Research Student or Contractor Agreement (DOC, 25.7KB)
- 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 - TEMPLATE - 01 Case Study Consent (DOC, 31.1KB)
- SOP - TM - 03 - FORM - 01 - Clinical Trial Financial Consent (DOC, 24KB)
- SOP - TM - 10 - TEMPLATE - 01 Research Equipment Maintenance (XLS, 19KB)
- SOP - TM - 13 - TEMPLATE - 01 - Archive Document Log (DOC, 59KB)
- SOP - TM - 13 - TEMPLATE - 02 - Archive Box Label (DOC, 33KB)
- SOP - TM - 14 - FORM - 02 Notification of Change of PI (DOC, 47KB)
- SOP - TM - 14 - FORM - 02 Notification Temporary Delegation of PI Responsibilities (DOC, 47KB)
- TEMPLATE - 03 - Budget Template (DOC, 34KB)