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.

2. Templates (click to download in Word)

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

 bree.sarah@barwonhealth.org.au

(03) 4215 2875
Natasha Savvides Research Safety and Quality Manager National Clinical Trials Governance Framework

Research related safety or quality

 natasha.savvides@barwonhealth.org.au

(03) 4215 3040
Research Development Unit Data management and analysis

Ethics and governance applications

Research design

 RDU@barwonhealth.org.au

0403 091 074
Beena Jeevan Raj

CTRSS-ATP Project Lead

 Ethics Review Manager (ERM)

Feasibilities

Laboratory Operations

Teletrials

Training and education

 beena.jeevanraj@barwonhealth.org.au

(03) 4215 0742
Olivia Dean

Director of Clinical Trials, Deakin University

 Biological psychiatry Grants

Investigator Initiated Clinical Trial Research

Publications

 o.dean@deakin.edu.au

(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

 peter.schoch@barwonhealth.org.au

(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

 acctc@barwonhealth.org.au

(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)

Page last updated: July 22, 2024