Sponsor Information
Site Explanation
Dr Michael Chia works in the private sector and is the Director of Respiratory SA, Northern Respiratory Function Unit (NRFU) and Respiratory Clinical Trials.
Patients are referred to either ‘Northern Respiratory Function Unit (NRFU)’ or alternatively ‘Respiratory SA’ depending on the demographics in Adelaide. NRFU has easier access demographically for patients in the northern suburbs and Respiratory SA has easier access to patients in the eastern suburbs which determines where patients are seen.
Site Logistics
Participants can be recruited from either practice for clinical trials (Respiratory Clinical Trials Pty Ltd) which conducts all activities at the working site at RCT (Suite 2, 75 Fullarton Road, Kent Town) where patient visits, site investigator files, pharmacy (formerly EPIC), site evaluation (SEV), site initiation (SIV) and monitoring of participant source notes etc are conducted. All RCT investigator procedures are performed at RCT (Kent Town) which may include: consent, medical history and physical examination.
Locations
Respiratory Clinical Trials Pty Ltd (ABN 11-090-489-802)
Suite 2, 75 Fullarton Road Kent Town South Australia Australia 5067
P: +61 8 8331 1926 F: +61 8 8331 2827
E: rctrials@rctc.com.au
Northern Respiratory Function Unit (ABN 11 725 737 416 )
Unit 2, 23 Philip Highway Elizabeth South Australia Australia 5112
Legal entity: also NRFU Pty Ltd as trustee for Northern Respiratory Function Unit Trust (trading as Northern Respiratory Function Unit)
Procedures
Respiratory Clinical Trials is able to perform trials in numerous therapeutic indications and are able to conduct studies which include: respiratory, oncology, sleep, PK, exercise and behavioural modification programs in accordance with the protocol and site’s SOP’s.
Protocol defined procedures are conducted using various equipment (sponsor and/or site) and include: Lung Function (spirometry, body plesthmography and DLCO), 6 minute walk test, Incremental and Endurance Shuttle Walk Tests, exercise testing (bike), ECG, freezer(s) -20˚ unarmed & armed and a Refrigerated Centrifuge. Associated temperature, calibration and maintenance are performed in association with the site’s SOP’s. Calibration certificates (compliance check July yearly) can be requested from site staff.
Site staff have both current TransCelerate (GCP) and CASA certification, available upon request.
The photo gallery will provide useful information to show what is available at site.
Regulatory Information
Respiratory Clinical Trials Pty Ltd (ABN 11-090-489-802)
Suite 2, 75 Fullarton Road Kent Town South Australia 5067, Australia
P: +61 8 8331 1926 F: +61 8 8331 2827
Northern Respiratory Function Unit (ABN 11 725 737 416 )
Unit 2, 23 Philip Highway Elizabeth South Australia Australia 5112
Legal entity: also NRFU Pty Ltd as trustee for Northern Respiratory Function Unit Trust (trading as Northern Respiratory Function Unit)
P: +61 8 8331 1926 F: +61 8 8331 2827
Site - Regulatory Documentation outcomes:
CTN
Additional page(s) 5 and 9 included to reflect all clinical trial addresses. (Refer new TGA process effective 01/07/15)
Indemnities
The RCT clinical trial site is indemnified plus Ethics.
Ethics
Require that the front page of the Participant Information and Consent form includes the clinical trial address to ensure that the participant understands that they will be attending trial visits at the specified address.