Research Forms, Templates & Guidelines
Ethics
Forms & Templates
- Ethics Eligibility Checklist - MANDATORY with every submission
- Method of Payment Form - MANDATORY with every submission
- Template - Data Custodian Request
- Protocol Template - Non-Clinical Trials
- Alternate Protocol Template
- PISCF - Clinical Trials/Clinical Research
- PISCF - Research Involving Genetic Testing/Tissue Collection
- PISCF - Low/Negligible risk (LNR) study
- NHMRC Standardised Participant Information Sheet and Consent Forms
- Participant Invitation Letter
- Participant Withdrawal Form
- Style Guide for Participant Information
Policies & Guidelines
- SESLHD Research Fees Policy
- SESLHD Research Fees Decision Map
- NHMRC National Statement on Ethical Conduct in Research Involving Humans
- Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations
- Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods
- Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods
- Australian Clinical Trial Handbook
- Australian Code for the Responsible Conduct of Research
- Ethical Considerations in QA and Evaluation Activities - NHMRC Guide
- Quality Improvement & Ethical Review: A Practice Guide for NSW
- Requirements of the Human Tissue Act 1983 in relation to research and use of tissue
- Research - Ethical & Scientific Review of Human Research in NSW Public Health Organisations
- Operations Manual: Human Research Ethics Committee Executive Officers
- Operations Manual: Human Research Ethics Committees
- Standards of Scientific Review of Clinical trials
- Data Safety Monitoring Boards (DSMBs)
- National Mutual Acceptance Scheme
- International Conference on Harmonisation (ICH) - Good Clinical Practice Guidelines (E6)
- The Declaration of Helsinki (2008)
Governance
Forms & Templates
- Template - Data Custodian Request
- Research Governance Checklist
- Method of Payment Form
- SESLHD Research Project Budget Template
- Access Request Form
- Significant Safety Issue (SSI) Notification Form
- SUSAR/USADE/URSAE Notification Form
- Medicines Australia Form of Indemnity - Standard
- Medicines Australia Form of Indemnity - HREC Review only
- Medicines Australia Clinical Research Agreement Templates
- Non-clinical trial collaborative agreement template
Policies & Guidelines
- SESLHD Research Fees Policy
- SESLHD Research Fees Decision Map
- Research - Authorisation to Commence Human Research in NSW Public Health Organisations
- Clinical Trial Research Agreements for Use in NSW Public Health Organisations
- Clinical Trials - Insurance and Indemnity
- NSW Health Research Ethics and Governance
- Operations Manual: Research Governance Officers
- Research Governance in NSW Public Health Organisations
- Fee Policy for Review of Commercially Sponsored Research
- Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations
- Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods
- Australian Code for the Responsible Conduct of Research
- Ethical Considerations in QA and Evaluation Activities - NHMRC Guide
All Research related SESLHD policies and guidelines can be located here.
The inclusion of links to external websites does not imply any endorsement or support by South Eastern Sydney Local Health District or Ministry of Health or the State of New South Wales. See our Disclaimer for more information.