Research and Ethics Office

Clinical Trials Support Unit

1.  UPDATES
2.  ESSENTIAL CONTACTS
3.  CLINICAL TRIAL SPECIALITY GROUPS
4.  USEFUL LINKS
5.  CLINICAL TRIALS STANDARD OPERATING PROCEDURES (SOP)
6.  CLINICAL TRIAL FORMS
7.  TRAINING

8. CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS)

 

1. Updates

COVID-19:  Guidance on clinical trials for institutions, HRECs, researchers and sponsors is now available on the NHMRC's website at:  www.nhmrc.gov.au/research-policy/COVID-19-impacts

This guidance reflects the shared views of all state and territory Departments of Health, the Clinical Trials Project Reference Group (CTPRG), NHMRC and the Therapeutic Goods Administration (TGA). This is also reflective in our contingency plan.  South Western Sydney Local Health District (SWSLHD) is taking every precaution for the safety and health of our clinical trial participants and staff.  Due to the evolving situation with COVID-19 we are continually assessing how to approach each individual clinical trial using the below criteria:

  1. Business as usual:  protocol requirements remain unchanged and participants will have all assessments with the clinic/hospital as planned.
  2. Participants will be seen in an alternative location:  there may be a need to see participants in a different hospital or one of the SWSLHD community centres.  You will be informed of this prior to this occurring and of any impact on the protocol requirements will be communicated.  Onsite monitoring will cease and ongoing discussions with sponsors regarding remote monitoring will take place.
  3. Remote visits:  in the event participants cannot attend their scheduled visits, a telephone or tele-health visit may be conducted.  You will be informed of this prior to this occurring.  The SWSLHD clinical trials team will discuss with you the supply of investigation product and logistics of administering the protocol requirements.
  4. Withdrawal from the clinical trial and investigation product:  there may be circumstances where it is in the best interest of the participant to withdraw from the clinical trial and your SWSLHD clinical trials team will notify you of this.

Thank you to everyone for working to identify the risks for each clinical trial and making decisions on continuing or stopping recruitment.  It is important that we can support the continuance of our clinical trials in accordance with good clinical practice while we safeguard the health and well-being of participants and our teams.

2. Essential Contacts 

Annamarie D'Souza
Research Development Manager
T: 02 8738 8303

E: Annamarie.DSouza@health.nsw.gov.au 
E: SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au  

Erfan Jaberiyanfar
Manager, SWSLHD Clinical Trials Support Unit
T: 02 8738 3920
M: 0477 549 761
E: SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au

Stephen Millard
Manager, SWSLHD Clinical Trial Support Unit
T: 02 8738 8306
M: 0475 959 937
E: SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au

Md Masud Anwar
Clinical Trials Finance Officer, SWSLHD Clinical Trials Support Unit
T: 02 8738 8151
E: SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au

Shivani Mani
Research Assistant, SWSLHD Clinical Trials Support Unit
T: 0467 772 595
E: SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au

3. Clinical Trial Speciality Groups

          • Medical Oncology
          • Radiation Oncology
          • Palliative Care
          • Haematology
          • Intensive Care 
          • Emergency 
          • Neurovascular
          • Neuroimmunology and Multiple Sclerosis 
          • Respiratory and sleep disorders
          • Cardiology 
          • Gastrointestinal and Liver Disorders
          • Renal 
          • Diabetes and Endocrine Disorders 
          • Rheumatology
          • Immunology
          • Orthopaedics
          • Mental Health 

4.  Useful Links

The Therapeutic Goods Administration Website

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. We carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.

The Therapeutic Goods Administration (TGA) has developed a helpful tool called SME Assist to help those unfamiliar with regulation to understand their regulatory and legislative obligations.

Clinical Trial Budgeting Manual - User Guide: NSW Budget Costing Tool
Clinical Trial Budgeting Template

Medicines Australia Website (Clinical Trial Contracts)

Medicines Australia Clinical Trial Research Agreement and Indemnity templates

Australian Clinical Trials Website

An Australian Government website with information about clinical trials in Australia. The website includes information for clinical trial sites, sponsors and consumers.

International Federation of Pharmaceutical Manufacturers Association (IFPMA) Clinical Trials Portal

This service is provided by the IFPMA, on behalf of its Member Companies and Associations. The portal has been designed as a single entry allowing you to search for comprehensive information on on-going clinical trials (registry) or results of completed trials (database) conducted by the innovative pharmaceutical industry.

Maridulu Budyari Gumal - SPHERE Clinical Trials Support and Enablement 

A strategic platform of Maridulu Budyari Gumal. The Sydney Partnership for Health, Education, Research and Enterprise SPHERE.
 

5.  Clinical Trials Standard Operating Procedures (SOP) 

Standard Operating Procedures (SOPs) are uniformly written procedures, with detailed instructions to record routine operations, processes and practices followed within an organisation . In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional and ICH-GCP guidelines.

NHMRC Safety monitoring and reporting in clinical trials involving therapeutic goods
NHMRC Guidance on the Reporting of Serious Breach of GCP
NSW Health Biobanking Standard Operating Procedures

SOP_CTSU_01 Risk Assessment for Clinical Trials
SOP_CTSU_02 Investigator Responsibilities
SOP_CTSU_03 Communication with Human Research Ethics Committee, Trial Sponsor and Insurer
SOP_CTSU_04 Clinical Trial Start Up
SOP_CTSU_05 Budgets and Contracts
SOP_CTSU_06 Financial Management; billing compliance, invoicing, financial conflict for interest
SOP_CTSU_07 Identifying and Contracting Suppliers and Sub-contractors
SOP_CTSU_08 Documentation of Training and Clinical Handover
SOP_CTSU_09 Investigator Site File and Essential Documents
SOP_CTSU_10 Site Initiation and Activation
SOP_CTSU_11 Monitoring Visits
SOP_CTSU_12 Site Close-out
SOP_CTSU_13 Participant Recruitment
SOP_CTSU_14 Informed Consent Procedures
SOP_CTSU_15 Managing Investigational Product
SOP_CTSU_16 Managing Medical Devices
SOP_CTSU_17 Data Recording - Source Case Report Forms, Record Keeping and Archiving
SOP_CTSU_18 Specimen Collection and Management
SOP_CTSU_19 Retired. Link: NHMRC Safety monitoring and reporting in clinical trials involving therapeutic goods
SOP_CTSU_20 Non Compliance
SOP_CTSU_21 To be revised
SOP_CTSU_22 CAPA Completion 
SOP_CTSU_23 Sponsor Audits and Regulatory Inspection 

WI_001 Veeva Site Vault Working Instructions                 

6. Clinical Trial Forms

FM_001_Source Data Location Plan v1.0 Word
FM_002_Contact Report v1.0 Word
FM_003_Subject Identification Log v1.0 Word
FM_004_ To be revised
FM_005_Records Management Form
FM_006_Protocol Specific Training Log v1.0 Word
FM_007_Delegation of Responsibilities Log v2.0 Word
FM_008_Individual Training Log v1.0 Word
FM_009_Essential Documents for Conduct of Clinical Trials Checklist Word
FM_010_Overall ISF Management in Clinical Trials PDF
FM_010_Overall ISF Management in Clinical Trials v1.0 Word
FM_011_ISF Contents Template PDF
FM_011_ISF Contents Template v1.0 Word
FM_012_Essential Document Storage Location v1.0 Word
FM_013_To be revised
FM_014_To be revised
FM_015_Protocol Amendment Decision Tool PDF
FM_015_Protocol Amendment Decision Tool Word
FM_016_To be revised
FM_017_To be revised
FM_018_Corrective and Preventative Action (CAPA) Plan Word
FM_019_Participant IP Accountability Log v1.0 Word
FM_020_Batch IP Accountability Log v1.0 Word
FM_021_IP Returns Log PDF Word
FM_022_IP Destruction Log v1.0 Word
FM_023_Site Initiation Visit Checklist Word
FM_024_To be revised
FM_025_Orientation Manual PDF
FM_026_Biological Specimen Tracking Log Word
FM_027_Non-Compliance Log Word
FM_028_Handover Form Word
FM_029_Core Competencies Form PDF
FM_029_Core Competencies Form Word
FM_030_eISF Contents Template PDF
FM_031_Veeva Vault Document Types Excel
FM_032_Risk Assessment Log Version 2 Excel
FM_033_Competency Assessment Word
FM_034_Vital Signs for non-nursing Clinical Trial coordinators Word
FM_035_Participant Medical Device Accountability Word
FM_036_Medical Device Receipt and Returns Log Word
FM_037_Site Monitoring Checklist - Essential Documents Word
FM_038_Monitoring Checklist Source Word
FM_039_To be revised
FM_040_Participant Screening Log Word
FM_041_Participant Enrolment Word
FM_042_Site Feasibility Checklist Word
FM_043_Study Close Out Premature Termination Checklist Word
FM_044_Document Destruction Log Word
FM_045_Note to File Word
FM_046_Supervision Plan Tele-Trials Word
FM_048_Signature Log_Word
FM_049_Supervision Plan SWSLHD Sites Word
FM_050_Veeva Site Vault Training Declation Word
FM_051_CTMS Training Declaration Part A_Patient Configuration and Visit Management Word

 

7. Training

7a) Clinical Trials Training Program for new-to-SWS Clinical Trial Coordinators


We have a Clinical Trials Training Program as onboarding for new-to-SWS coordinators. Our custom-designed content is unlike any other. With our theory part of a globally recognised clinical researchers accreditation scheme, and 3 days face-to-face facilitated workshops delivered by our local team we provide the practical trial coordination education and skills required for best practice Clinical Trial Coordination customised specifically for our LHD.
Our workshops are intensive, run by our local Clinical Trials Support Unit (CTSU) training manager which will give you the details necessary to coordinate clinical trials in SWSLHD, referencing our local LHD policies, SOP’s, forms, and activities directly relevant to working with us.

Please contact the Clinical Trials Support Unit at SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au for further information. 


7b) Good Clinical Practice (GCP) training for SWSLHD, Ingham Institute, UNSW and WSU staff


These programs are tailored to all staff involved in clinical research and their supporting departments such as Pathology, Nursing and Pharmacy. The course content promotes a depth of understanding about conducting research involving humans within the Australian environment.

All Researchers are ethically responsible to conduct clinical research of the highest quality. This includes the collection of high quality, credible data that contributes to the answering of specific scientific questions, while protecting the rights, safety, and well-being of clinical trial participants. These principles have their origin in the World Medical Association’s Declaration of Helsinki.

GCP standards exist to provide a benchmark of clinical research quality that can be relied upon throughout the world. As endorsed by SWSLHD Chief Executive, GCP training is a mandatory requirement for all staff involved in clinical trials in South Western Sydney. The Course is available to all clinical trials staff.

Upcoming SWSLHD GCP training dates are to be confirmed. Contact the Clinical Trials Support Unit at SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au for more information and to register for future sessions.

  • You can now access free, online, self-directed GCP training modules in Refresher GCP and GCP for associated staff - nursing, pathology, pharmacy and radiology. These modules have been developed by Sophie Mepham GCP in line with her GCP training materials.

Information about the modules and how to access them via the Sophie Mepham GCP website is available here. The Refresher GCP is TranCelerate accredited, the modules for nursing, pathology, pharmacy and radiology aren’t, but are based on the material for the other modules. The Refresher GCP module has a voice over version and a slide only version.

Users will need to set up an account and make the link to the SPHERE partner organisation to access these modules for free. There is information about how to do that on the web page noted above.

The following link provides access to the SMGCP online Refresher & Short course modules

Some additional key points:

  • To enrol click on ‘Enrol Free’ button right underneath the header. Don’t click on individual courses first, that way they can access the full list of courses.
  • Please enter full name as it will appear on the certificate, use work email ONLY to create the account, enter SPHERE related organisation as place of work.
  • Some SPHERE partners include SWSLHD, UTS, WSU, UNSW and the Ingham Institute

The following link provides further information on:

  1.  GCP Training FAQs
  2.  GCP Training Suite

Alternatively interested parties can easily search for a GCP course via the following platforms;

  1. ARCS
  2. Praxis

8. Clinical Trial Management System (CTMS) 

SWSLHD has implemented a Clinical Trial Management System (CTMS) for hospitals and health services within the district conducting clinical trials. The CTMS will manage clinical trials in maintaining and managing planning, performing and reporting functions, as well as tracking deadlines and capturing metrics and milestones. The infrastructure of CTMS will also assist clinical trial departments with increased visibility of clinical trial activity and improved financial management.

In order to enter your study on CTMS please provide the relevant information by filling in the Clinical Trial Study Build form. The CTMS team will build the study in the system on your behalf. Please complete the form below and email with supporting documents to the CTMS team at SWSLHD-CTMS@health.nsw.gov.au.

2024 CTMS Training dates:

Wednesday, 27 March
Thursday, 9 May
Wednesday, 19 June
Wednesday, 31 July
Thursday, 12 September
Wednesday, 24 October
Wednesday, 4 December

CTMS Team Contacts
Grace Micali
CTMS Manager

T: 02 8609 7488
E: SWSLHD-CTMS@health.nsw.gov.au

Vaishnavi Dayalan
CTMS Administrator

T: 02 8609 7495
E: SWSLHD-CTMS@health.nsw.gov.au

 

© 2016 South Western Sydney Local Health District
Last Updated: 19 May, 2016
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