Australian Central Over-Reading Centre FAQs

• Operators must first attend a training, then submit MBWN₂ qualification tests to the Centre for review. Once qualification tests are deemed successful (with an 80% success rate), this operator will be considered qualified for MBWN₂ testing in subjects 6 years and older.
• The subjects asked to perform MBWN₂ for your qualifications should be representative of the study population. Hence, if you are from a paediatric site, at least 1 paediatric patient should be included in your qualifications.
• It is up to the site to ensure they have appropriate research ethics approvals to test subjects for certification.
• To complete the certification process, the Post-training knowledge test must also be completed.
• Please download the MBW Training and Certification Requirements document in the MBW Resources section for further details.

• The operator must have attended a training, have completed the online pre-school training module and be certified in MBWN₂ testing for adults and children (6+ years).
• Preschool testing requires 2 operators at the time of test; thus both operators must submit a total of 5 preschool qualification tests to the Centre for review. Both operators wishing to become certified in preschool testing must be present at the test. Once qualification tests are deemed successful (with an 80% success rate), both operators will be considered qualified for MBWN₂ testing in preschool children.

• For a new site to become qualified in MBW testing for subjects 6 years and above, at least 10 test occasions must be submitted for site qualification. If there is a single operator, they must submit 10 test occasions. If there are multiple operators, each operator must submit 5 test occasions.
• For any additional operator at a qualified site, the new operator must submit 5 test occasions.
• Each operator should include at a minimum: 2 CF patients and 1 subject must be in the range of the study population (e.g. at paediatric centres)
• Please download the MBW Training and Qualification Requirements document in the MBW Resources section for further details.

• Qualification tests for adults and children (6+ years) should be submitted and approved by the MBW centre before preschool qualification measurements are collected.
• Sites participating in a preschool study are SUBSEQUENTLY required to send an additional 5 test occasions from preschool children (3-6 years of age).
• Subjects tested for qualification should be representative of study population and sites should aim to test as many subjects belonging to this group as possible. Sites must include at a minimum: 2 children with CF and one child <4 years
• Please download the MBW Training and Qualification Requirements document in the MBW Resources section for further details.

In our experience it is beneficial for both operators performing MBW testing in preschool children to be certified and experienced in testing. However, we understand there are extenuating circumstances when two certified operators are not available. In this event an inexperienced member of the team may hold the mask. **PLEASE NOTE this does NOT apply to qualification testing. It is recommended that sites participating in preschool studies have at least 3 operators trained to ensure trained operators are available for all study visits.

Individuals within each site will be certified to perform MBW for the sponsored studies. If new individuals join the team and will perform MBW measurements, they must attend training and successfully collect and submit the requisite number of test occasions before they can test study participants.

• Operators cannot submit study data in place for their qualification test occasions. Operators must demonstrate that they can collect original, technically acceptable data as the primary operator (Subjects < 6years) or on their own (Subjects > 6years). Data will be collected under unique qualification ID’s, solely for the purpose of operator certification.
• Please download the MBW Training and Certification Requirements document in the MBW Resources section for further details

• Consumables required to test subjects >6 years of age for the certification protocol come standard with the purchase of the equipment. For further information see the MBW SOP for details (this is available once you register for training). For qualifications, a generic mouthpiece may be used and the filter used for testing is available through Eco Physics. Please note, there are study specific consumables that must be used when collecting study data.
• Consumables required to test subjects <6 years of age for the qualification protocol will be provided to you either by the MBW centre during training or by the CRO after training, this will depend on the study.
• Please recall: Qualification MBW tests for testing subjects (>6 years old) should be collected, submitted AND DEEMED successful prior to collection of preschool qualification tests.

• Please contact the study specific CRO to request an FTP account. The request for FTP accounts will be processed weekly, usually on Fridays.