Forms and templates
Submission Forms
- Case Report Consent & Registration Form
- non-HREC Amendment Request Form
- non-HREC Ethical Review Request Form
- Quality Assurance (QA) Proposal Form
- Research Governance Checklist & Cover Letter
- Research Investigator CV template
- Research site file template
- Medical Physics Risk Assessment Interventional, Diagnostic & Nuclear Medicine Procedures Supporting Information form
Protocol Templates
Participant Facing Documentation
- NH Patient Information and Consent Form (PICF)
- QA-Audit information statement for verbal or implied consent process
- Record of verbal consent template
Budget/ Fee Form
Data Collection Tools
Agreements
- Northern Health Material Transfer Agreement
- Northern Health Data Transfer Agreement
- Northern Health Research Collaboration Agreement
- Northern Health Services Agreement
- Memorandum of Understanding (MOU)
- Northern Health Approval to Examine Records of the Purpose of Research
- Northern Health Confidentiality Deed.
- MACH Research Collaboration Agreement.
- MACH Research Collaboration Agreement (Non-Commercial) – Guidelines for Use
- Additional Template for collaborative agreement including interstate collaboration – Multijurisdictional Collaborative Agreement, click here.
Ethical Review Manager (ERM)
The ERM website is used by research applicants (researchers, trial coordinators, sponsors, Contract Research Organisations and others). It is also used by research office administrators and ethics committee members to manage the review, processing and approval/authorisation of all applications.
Ethics and Governance Resources
Learn about the code, regulations and guidelines that govern clinical research in Australia. Health services that oversee research must also comply with governance principles.
- National Mutual Acceptance
- Glossary List for Researchers
- Clinical trial feasibility tool (used with permission)
- NHMRC National Statement on Ethical Conduct in Human Research (updated 2018)
REDCap
REDCap is a free, secure web application for building and managing research databases and surveys. REDCap can be used to collect any type of data in any environment and it is specifically geared to support data capture for research studies and operations.
- FAQ Sheet
- Email NH.Research@nh.org.au for access
Clinical Trial Research Tools & Support
The National Standard Operating Procedures will help anyone working on clinical trials and teletrials. They provide a clear and consistent approach. The procedures will be reviewed every two years and can be found here.
The national SOPs have been formally adopted and endorsed by Northern Health to support consistency in procedures across various departments of the Northern hospital.
Research – Standard Operating Procedure for Clinical Trials
Clinical Trial Resources
- Principles, regulations and governance of clinical trials
- Therapeutics Goods Administration (TGA) ICH-GCP Guidelines
- TGA Clinical Trial Handbook
- Australian Code for the Responsible Conduct of Research
- Common Terminology Criteria for Adverse Events (CTCAE)
- AustralianClinicalTrials.gov
- Resources for the National Clinical Trials Governance Framework
Specific Research Procedures on PROMPT
Standard Operating Procedure (SOPs) are a vital resource within the realm of clinical research, by following SOPs research teams uphold ethical standards, maintain data integrity and adhere wo Good Clinical Practice (GCP) guidelines. Following are the SOPs maintained by the RDGU at Northern Health:
PROMPT Doc No: | Policy/Procedure | Title | Approved by | Review & Update by: |
NHS0076768 v9.1 | Policy | Research | Northern Health Board | 24/08/2027 |
NHS0220113 v1.0 | Procedure | Research – Standard Operating Procedure for Clinical Trials | Research Executive Committee | 16/01/2027 |
NHS0075302 v4.0 | Procedure | Research – Research Standard Operating Procedures | Executive Research Governance Committee | 04/04/2024 |
NHS0075731 v6.1 | Procedure | Research – Complaints | Executive Research Governance Committee | 29/01/2027 |
NHS0183066 v4.1 | Procedure | Research Integrity & Compliance with the Code | Director of Research Operations | 29/01/2025 |
Supporting Department SOPs
The supporting departments at Northern Health collaborate closely with researchers to facilitate the successful execution of clinical research, their collective efforts are essential for advancing research and improving patient care. Here are the specific SOPs which have been developed for researchers at Northern Health:
- Pharmacy – Pharmacy SOP – Clinical
- Pharmacy – Pharmacy SOP – Clinical Trials
- Imaging – Research – Studies Requiring Input from Medical Imaging
- Imaging – Radiation Management Plan
- Health Information Services – Records Management – Clinical
- Health Information Services – HIS – Program Operations
- Health Information Services – Data Management
- Library – Library – Services
Northern Health Policies
By establishing clear and well-defined policies, Northern Health can promote consistency, transparency and accountability within the Health Service and provide a positive organizational culture while mitigating risks. Below are the policies which set researchers with a solid foundations for the conduct of research at the hospital:
- Policy: Research
- Policy: Governance
- Policy: Code of Conduct and Ethics
- Policy: Consumer Participation and Patient Experience
- Policy: Workforce Management
- Policy: Financial Administration and Management
- Policy: Workforce Education
- Policy: Knowledge and Information Management
- Policy: Safe, Effective & Appropriate Clinical Care
- Policy: Occupational Health & Safety
- Policy: Community Partnerships
Hospital-wide Procedures
Reference frameworks and procedures help to standardise processes, improve efficiency and promote consistency. This is a selection of SOPs which may be referenced when conducting research at Northern Health:
Frameworks
- Corporate Governance Framework
- Risk Management Framework
- Audit and Review Framework
- Digitisation Framework
Procedures
- Planning – Strategic Plan Development
- Partnering with Consumers at Northern Health
- Short Notice Accreditation Assessments and Action Cards
- HR – Conflict of Interest
- COVID – Education & Training: Safe Environment
- Evidence Based Practice – Guidance for Clinical Procedures
- Clinical Governance & Patient Experience – Trusted Care
- Clinical Incident Management – Patients
- Transcultural, Equitable, Diverse & Inclusive Health Care
- EMR – Business Continuity Downtime
- Consumer Feedback: Compliments, Suggestions, Complaints
- HR – Staff Complaints & Internal Investigations
- HR – Honorary Appointments