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 1, 83 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. RCT investigator procedures are performed at either NRFU (Elizabeth) and RCT (57 Fullarton Road, Kent Town) which may include: consent, medical history and physical examination. The procedures undertaken at either NRFU (Elizabeth) or RCT (Kent Town) are documented on a proforma which is delivered to the main site in the Clinical Trials Centre each evening post participant review and included in the source notes.

Locations

Respiratory Clinical Trials Pty Ltd (main site and correspondence - ABN 11-090-489-802)
Suite 1, 83 Fullarton Road Kent Town South Australia Australia 5067
P: +61 8 8331 1926 F: +61 8 8331 2827
E: clinicaltrials@rctc.com.au

 

Respiratory Clinical Trials Pty Ltd (business address - ABN 11-090-489-802 )
57 Fullarton Road Kent Town South Australia Australia 5067
P: +61 8 8364 4434 F: +61 8 83322236
E: clinicaltrials@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 May 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  (main site and correspondence - ABN 11-090-489-802)

Suite 1, 83 Fullarton Road Kent Town South Australia 5067, Australia

P: +61 8 8331 1926  F: +61 8 8331 2827 

E: clinicaltrials@rctc.com.au

 

Respiratory Clinical Trials Pty Ltd   (business address - ABN 11-090-489-802 )

57 Fullarton Road Kent Town South Australia Australia 5067

P:  +61 8 8364 4434 F: +61 8 83322236

E: clinicaltrials@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)

P: +61 8 8331 1926  F: +61 8 8331 2827 

E: clinicaltrials@rctc.com.au

 

Site - Regulatory Documentation outcomes:

CTN

Additional page(s) 5 and 9 included to reflect all 3 clinical trial addresses. (Refer new TGA process effective 01/07/15)

Indemnities

All 3 clinical trial sites- RCT (x 2 addresses) and NRFU are indemnified plus Ethics.

Note: If sponsor legal department(s) wish to combine RCT and CTC on 1 indemnity then that is acceptable.

Ethics

Require that the front page of the Participant Information and Consent form includes all 3 clinical trial addresses to ensure that           the participant understands that they may be attending trial visits at ‘any’ of these addresses.