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Australian Central Over-Reading Centre FAQs

Do I need to attend the MBW training in person?

  • Anyone who will be performing MBW testing for a sponsored study (i.e. PROSPECT, SHIP, Vertex etc.) MUST attend a one-day training session and complete qualification requirements.
  • An experienced operator can train new staff on-site if they have completed 50 test occasions with an 80% success rate. It is the responsibility of the operator to collect the QC reports and demonstrate they have fulfilled the requirements to the MBW centre prior to training new staff.
  • Operators who are training by a team member on-site are required to complete the Post-training knowledge test (80% pass mark required), and demonstrate the ability to perform technically acceptable MBW tests. It is also recommended that these operators complete the Pre-training modules.
  • Please download the MBW Training and Certification Requirements document in the MBW Resources section for further details.

How do I become a qualified MBW operator for adults and children (6+ years)?

  • 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.

How do I become qualified in MBW testing for preschoolers (3-6 years)?

  • 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.

How many test occasions must be submitted per operator for adult and children (6+ years) MBW qualification?

  • 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.

How many test occasions must be submitted per operator for preschool MBW qualification?

  • 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.

Once my site is qualified for preschool testing, can I have someone who is not trained hold the mask?

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.

Who will be qualified; the site or the individual?

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.

Can operators submit study data in the place of qualification test occasions?

  • 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

Where do I get consumables for the qualification test occasions?

  • 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.

How do I get a username and password to transfer data via FTP?

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