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

• • Protocol template – High risk
  • Protocol template – Low risk

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

• • Governance Fee form
  • Research budget template

Data Collection Tools

• • Data collection tool – excel template
  • Study ID linking tool – excel template

Agreements

• Northern Health Data Sharing Agreement
• Northern Health Memorandum of Understanding (MOU)
• Northern Health Material Transfer Agreement
• Northern Health Services Agreement 
• 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.

• ERM login
• ERM information and user guides

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 2023 (effective 01JAN2024)
• NMHRC National Certification Scheme for the ethics review of multi-centre research
• Australian Privacy Principles- a summary for APP entities 

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.

Clinical Trial Resources 

• Principles, regulations and governance of clinical trials
• Therapeutics Goods Administration (TGA) Website- Clinical Trials
• Therapeutics Goods Administration (TGA) ICH-GCP Guidelines
• TGA Clinical Trial Handbook
• Australian Register for Therapeutic Goods (ARTG)
• Good Clinical Practice (GCP) inspection program for clinical trials
• 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
• VMIA Clinical Trials- Risk and Insurance Guide (July 2024)
• Safety monitoring and reporting in clinical trials involving therapeutic goods
• Data Safety Monitoring Boards (DSMBs) (2018) 
• Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods (2018)

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 v5.1	Procedure	Research – Research Standard Operating Procedures	Executive Research Governance Committee	04/04/2027
NHS0074670 v6.0	Procedure	Research – Studies Requiring Input from Medical Imaging	NH Research & NH Medical Imaging Services	29/11/2024

Supporting Department SOPs and Guides

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
• Health Information Services- WILD User Training Manual
• 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: 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