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EMERGENCY

In an emergency, always call triple zero (000). It’s a free call from any phone, mobile or phone box.

For other urgent medical issues, go to an Emergency Department.

Our Emergency Departments are open 24 hours a day, seven days a week:

Cancer Clinical Trials

Associated departments – Tweed

Research governance and contract information

Research staff – Tweed

Site visits – Tweed

Research staff
  • Roles: Research Nurses / Study Coordinators
  • Institution: NNSWLHD The Tweed Hospital, 16-18 Powell Street, Tweed Heads NSW 2485
  • Office Hours: the Clinical Trial’s office is open 8:00am to 4:30pm Monday to Friday
  • Telephone: (07) 5506 7374
  • Global Fax: (07) 5506 7812

Charmayne Chorlton

Rachael Rowse

Emma Langshaw

Tracey Foo

 

Site training, equipment and experience
Standard operating procedures

A standard set of operating procedures has been developed for all NNSWLHD Haematology Oncology Trials Team, The Tweed Hospital.

GCP

All research staff have attended numerous Investigator Meetings which include GCP training.

Shipping

All research staff have completed the Covance Shipping Training for Rad Pharm, Virtual Scopics, ICON and have extensive experience shipping blood, tumour, slides, discs (imaging) and films.

Trials experience

Clinical Trial staff have a combined total of over 26 years Medical Oncology, Haematology and Radiation Oncology clinical trial experience working with Collaborative Groups, Pharmaceutical Companies and Contract Research Organisations in all aspects of Phase II, III and IV studies from feasibilities and Ethics submissions to Study Close Outs.

ECGs

Staff have access to and experience with performing ECGs.

Electronic CRFs
  • Inform
  • RAVE
  • Medidata
  • IWRS
  • Oracle
  • ClinPhone
  • OC-RDC
  • Citrix.
IVRS

All staff have experience with IVRS.

Audits

The NNSWLHD Haematology Oncology Clinical Trials Team, The Tweed Hospital, has never been audited by any regulatory bodies. It has, however, been audited by the Pharmaceutical sponsors and Collaborative Groups on several occasions.

MosaiqTM

The Tweed Cancer Unit utilises an electronic Medical Record (MosaiqTM). This has been assessed to comply with the FDA code 21 CFR part 11. The assessment worksheet can be found here, whilst the signature page of the assessors can be accessed by this link. This letter summarises how MosaiqTM complies and is signed by the Director of Area Cancer Services, A/Prof Tom Shakespeare.

This letter, sent to the FDA, is signed by the A/Prof Thomas Shakespeare, Director Area Cancer Services NCAHS to certify that electronic signatures are legally binding. This letter is based on a template issued by the FDA.

IT & telecommunications

Computer with high-speed internet access is used for the clinical trial staff. An international fax line is available; however, an international phone line is not available.

Site equipment
  • Centrifuge (refrigerated)
  • -80oC freezers
Archiving

Off-site archiving is preferred and organised by the sponsor.