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FAQ

 

Frequently Asked Questions

1.Taking Part

 

Do sites get paid for taking part in the Boost II trial?

Yes, please contact BOOSTII Project Manager for details.

When did the recruitment start and when does it finish?

Recruitment began in March and will continue until December 2009 with the aim of recruiting 1200 babies within Australia.

What do we do once we receive ethics approval?

Please send a copy of the ethics committee approval to BOOSTII Trials Co-ordinating Centre. We will send you all trial materials and the BOOSTII oximeters. Your hospital will then be ready to start randomising patients.

Issues surrounding Indemnity?

Boost II is an investigator initiated collaborative group study for which there is no industry sponsor designated to provide indemnity for the trial. Therefore each participating institution must provide its own indemnity for the study.

Issues surrounding consent?

Boost II involves preterm babies therefore parents will need to provide informed consent. The baby needs to be enrolled as soon as possible (within 24 hours of birth).

 

2. Enrolling babies

 

How do I enrol a baby?

Please complete the Randomsation sheet then phone 1800 821 855. Use the keypad when prompted. Please note the IVRS (Interactive Voice Randomisation System) questions do not need to be heard in their entirety so you may key in the answers ahead of time.

What happens if the IVRS system is not working?

Please call 9562 5341

 

3. Organisational Issues

 

What if supplies run low?

Please contact the BOOSTII team members at the BOOSTII Cordinating Centre at 02-9562 5000.

What do we do if we run low on study oximeters?

The Boost II co-ordinating team will monitor the number of study oximeters at your site via our database and will ensure that adequate numbers are maintained at all times. However, if they appear to be running low then additional stock can be obtained by contacting the Boost II Co-ordinating Centre.

What happens if the study oximeter is removed for any period of time?

All interruptions to oximetry monitoring are to be recorded in Oximeter Tracking Log