clinicaltrialsNSW provide operational support for your clinical trial with centralised, standardised resources that support high quality trial conduct.
Our Clinical Trial Toolkit has the essential tools you need to establish your clinical trial in New South Wales.
Standard Operating Procedures for sites
The Office for Health and Medical Research (OHMR) have developed a suite of clinical trial (Site) Standard Operating Procedures (SOPs) for use in NSW Public Health Organisations.
They were developed to assist sites to conduct trial activities in accordance with Good Clinical Practice (GCP) and any relevant local and national requirements.
The SOPs also help to ensure that sites meet the dual requirements of GCP:
- to protect the rights, safety, and wellbeing of participants; and
- to ensure the reliability of trial data.
How will these SOPs be implemented?
The SOPs can be downloaded and used at any time. All users are encouraged to provide feedback and suggestions for improvement, as well as any suggestions for additional SOPs during the current six month review period.
Standard Operating Procedures templates
The zip files contains the following templates in PDF or Word format:
- clinical trial training and qualification
- hosting an audit or regulatory inspection
- sub-contracting of external vendors
- trial feasibility and start-up
- delegation of duties by the principal investigator
- informed consent
- managing and reporting safety events
- reporting non-compliance and suspected breaches of GCP or the protocol
- investigational medicinal product management and emergency unblinding
- source data and case report form completion
- handling and transporting biological specimens
- investigator site file and essential documents
- close-out at a trial site
- clinical trial archiving
- work instruction site templates (customisable Word document for use by sites to document site-specific activities/procedures).
GCP, safety and compliance guidance
- Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2)
Internationally accepted standard for the designing, conducting, recording and reporting of clinical trials
- ISO 14155 Clinical investigation of medical devices for human subjects – Good Clinical Practice
Good clinical practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes
- Australian code for the responsible conduct of research
Establishes a framework for responsible research conduct that provides a foundation for high-quality research, credibility and community trust in the research endeavour
- National statement on ethical conduct in human research 2007 (updated 2018)
- Australian clinical trial handbook
Guidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using ‘unapproved’ therapeutic goods
- Therapeutic Goods Administration clinical trial notification/clinical trial exemption schemes
Notification of a clinical trial to Australia’s regulatory agency the Therapeutic Goods Administration
- NHMRC safety monitoring and reporting in clinical trials
Clarifies the responsibilities of those involved in clinical trials to monitor and report adverse events and other safety issues
- Data safety monitoring boards (DSMBs)
Advice from regulatory authorities, clinical trial groups and industry organisations on the use of DSMBs
- Risk-based management and monitoring of clinical trials involving therapeutic goods 2018
Advice from regulatory authorities, clinical trial groups and industry organisations on the application of risk-based trial processes
- Reporting of serious breaches of GCP or the protocol for trials involving therapeutic goods
Advice from regulatory authorities, clinical trial groups and industry organisations on the reporting of deviations from GCP or the protocol
The Protocol is the document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organisation of a clinical research project.
- See section 6 of Guideline for Good Clinical Practice
- TransCelerate Common Protocol Template
- NIH e-Protocol Writing Tool
- SPIRIT Statement – evidence-based recommendations for the minimum content of a clinical trial protocol
- CONSORT Statement for reporting randomised clinical trials
- Good ReseArch for Comparative Effectiveness (GRACE)
The investigator’s brochure is a compilation of the clinical and non-clinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects:
- See section 7 of Guideline for Good Clinical Practice
Finance, contracts and intellectual property
- NSW Health clinical trial budget costing tool
- NSWHP pricing tool
- Clinical trial research agreements for sponsors, clinical research organisations, collaborative research networks and Phase IV trials
- Indemnity and compensation guidelines
- IP Australia non-disclosure agreement – is a legal contract, which should be used when sensitive information needs to be shared between two parties
Provides information about a clinical trial to prospective participants and a mechanism for obtaining their written consent to participate.
Updated 3 months ago