Momentum Clinical Research-Taringa

-27.489811899907398, 152.98142737930692

Is your Facility able to initiate study activities prior to HREC (IRB/ERB/ETHICS) Committee protocol approval?: Yes

Please provide the short promotional description of your Clinical Trial Site for marketing purposes.:

What types of HREC (IRB/ERB/ETHICS) Committee does your Facility use? Select all that apply. If QH choose Central Acting as Local-For National Mutual Acceptance (NMA): Local, Does your institution and/or local regulation mandate the distribution of safety reports e.g., Development Safety Update Report (DSUR), Suspected Unexpected Serious Adverse Reaction (SUSAR) to a local review only HREC (IRB/ERB/ETHICS) Committee?: Yes, If Other was selected for the HREC Committee Name, please name here.: Bellberry HREC, What is the meeting frequency of your Local HREC Committee?: Weekly

Does your Facility have a training program for the research staff?: No, Does the course content include GCP?: Yes, Does the study staff that prepares or transports dangerous goods have training that meets the IATA International Air Transport Association (US) or other countries hazardous training requirements for shipping dangerous goods?: Yes, Is your Facility adequately staffed to support studies with both blinded and unblinded Investigational Product?: Yes

Does the Facility have the required licenses or registrations to receive, store, dispense and return controlled substances as required by local law?: Yes, Does the Facility have the ability to handle radio-labelled Investigational Products?: No

Do you have centrifuge available at the Facility to support Research studies?: Yes, Do you have refrigerated centrifuge available at the Facility to support Research studies?: Yes, Please identify the Investigational Product preparation capabilities at your Facility: Extemporaneous Preparation, Horizontal laminar flow hood (non-hazardous drug preparation)

Does your Facility have patient record archiving on-site?: No, Do you have Electronic Health Records (EHR)/ Electronic Medical Records (EMR)?: Yes

Do you have a refrigerator (2 to 8 Degrees C) available at the Facility to support Research studies?: Yes, Refrigerator 2 to 8 Degrees C | Do you have the ability to generate a temperature monitoring log for this equipment?: Yes, Refrigerator 2 to 8 Degrees C | Does this equipment provide Min/Max Temperature Monitoring?: Yes, Refrigerator 2 to 8 Degrees C | Does this equipment have a temperature alarm?: Yes, Refrigerator 2 to 8 Degrees C | Do you have an SOP that supports the calibration of this equipment?: Yes, Do you have a freezer (-20 to -30 Degrees C) available at the Facility to support Research studies?: Yes