1. Standard Operating Procedures

A standard operating procedure (SOP) is a set of instructions to help researchers carry out operations associated with the research. SOPs aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with regulations.

A national approach to implementing SOPs at public health organisations has been developed and a generic version of SOPs, and associated templates, are now available (see below). The national SOPs have been formally adopted and endorsed by Barwon Health to support uniformity in systems and procedures in the organisation in preparation for accreditation.

• National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia
• Standard Operating Procedures 1 -13 for Clinical Trials, including Teletrials at Barwon Health

 

2. Templates (click to download in Word)

• BH-ACCTC Archiving Template
• BH-ACCTC CV Template
• BH-ACCTC _DelegationLog_Template
• BH-ACCTC Feasibility_Start_Up_Worksheet
• BH-ACCTC informed consent Template
• BH-ACCTC_Investigator Site File Table Of Contents Template.docx
• BH-ACCTC _Laboratory training in the ACCTC laboratory
• BH-ACCTC _NoteToFile_template
• BH-ACCTC _Protocol_Deviation_Log Template
• BH-ACCTC re consent Template
• BH-ACCTC _SAE_form Template
• BH-ACCTC _Sample Inventory Log Template
• BH-ACCTC _Sample Storage Log Template
• BH-ACCTC _Subject_Screening_enrolment_Log Template
• BH-ACCTC-Supervision Plan Template
• BH-ACCTC _temp_log_freezer_Template
• BH-ACCTC _temp_log_fridge_Template
• BH-ACCTC Training Log Template
• BH-Clinical Researcher new starter checklist
• BH-Orientation Checklist - Part A, Part B
• BH letterhead banner template.docx
• BH-ACCTC Desktop Audit checklist
• BH-ACCTC PICF Standard Wording
• BH-ACCTC Medical Treatment Decision Maker checklist and instructions

 

3. Ask an expert

Barwon Health has been conducting Clinical Trial Research for over 25 years. Many of the Clinical Trial Managers and Coordinators are a valuable resource to support those new to the areas of Clinical Trials. The table below lists individuals involved in clinical trial research willing to provide advice and support to those new to Clinical Trials or those embarking on new type of project, area, role or scope within Clinical Trials.

Name & Role	Areas of Advice	Contact Information
Bree Sarah Research Operations Manager	Budgets & Contracts Ethics and Governance Finance & fees Resourcing & Operations	[email protected] (03) 4215 2875
Natasha Savvides Research Safety and Quality Manager	National Clinical Trials Governance Framework Research related safety or quality	[email protected] (03) 4215 3040
Research Development Unit	Data management and analysis Ethics and governance applications Research design	[email protected] 0403 091 074
Beena Jeevan Raj CTRSS-ATP Project Lead	Ethics Review Manager (ERM) Feasibilities Laboratory Operations Teletrials Training and education	[email protected] (03) 4215 0742
Olivia Dean Director of Clinical Trials, Deakin University	Biological psychiatry Grants Investigator Initiated Clinical Trial Research Publications	[email protected] (03) 4215 3300
Peter Schoch Barwon Health Clinical Lead Physiotherapist (Orthopaedics) Faculty McKenzie Institute Australia / McKenzie Institute International	Use of IPM, Datawarehouse Publication Musculoskeletal / orthopaedic research	[email protected] (03) 4215 0826
Adrian Costa Clinical Trials Centre	​Advice and support on the conduct and set up of clinical trials Book clinical rooms, offices, lab space or meeting room	[email protected] (03) 4215 3053

 

4. Resources

There are numerous resources available to you to support your role in clinical trial research. Links to some of the key resources are listed below.

Key Barwon Health Policies:

Financial Management Policy

Governance Policy

Operational Service Delivery Policy

Research Policy

Safety & Quality Policy

Workforce Policy

 

Key References

Therapeutics Goods Administration (TGA) ICH-GCP Guidelines

TGA Clinical Trial Handbook

National Statement on Ethical Conduct in Human Research

Australian Code for the Responsible Conduct of Research

The National Teletrials Compendium

Barwon Health Research Handbook

Barwon Health Research Safety Monitoring, Reporting and Management Procedure

Riskman - How To Enter A Clinical Trial Incident

 

Training & education

ICH GCP Training on GROW

Australian Clinical Trials Education Centre

Global Health Training Centre

Mayo Clinic Labs - Dangerous Goods Training

NHMRC - Clinical Trials eLearning Modules

 

Other useful links:

Clinical Trials and Research

Ethical Review Manager

Investigator Initiated Trials Toolkit

Australian Clinical Trials Alliance

Clinical Trials – Improving Quality (CT-IQ)

Health Workforce Locator

Common Terminology Criteria for Adverse Events (CTCAE)