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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12625001086459
Ethics application status
Approved
Date submitted
16/07/2025
Date registered
7/10/2025
Date last updated
7/10/2025
Date data sharing statement initially provided
7/10/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The RApid PoInt-of-care Diagnosis of maternal Group B Streptococcus (GBS): The StrepSureTM diagnostic accuracy study
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Scientific title
The RApid PoInt-of-care Diagnosis of maternal GBS: The StrepSureTM diagnostic accuracy study in participant pregrant with a fetus.
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Secondary ID [1]
314898
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Group B Streptococcus (GBS)
338205
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Condition category
Condition code
Reproductive Health and Childbirth
334480
334480
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0
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Antenatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a diagnostic accuracy study of a point of care device for group B streptococcus. The StrepSure™ test will be tested and compared to the gold standard culture method.
StrepSure Rapid GBS Test is a qualitative immunochromatographic assay that detects GBS antigens from a rectovaginal swab collected in the same manner as current GBS culture-based methods.
In this study, two rectovaginal swabs will be collected after informed consent. A standard GBS swab for culture will be taken first as the gold standard, followed immediately by collection of a StrepSure swab sample using the same technique. There is no other active involvement of the participant after collection of the 2 samples.
The samples will be collected at the time of admission for birth (either induction of labour, planned prelabour Cesarean section, early labour) or other hospital admission (eg for assessment of prelabour rupture of membranes, or threatened preterm labour).
The samples will be collected by the research midwife or the treating clinician. If preferred, self-collection by the participant is an option as for current routine GBS screening.
The StrepSure test will be analysed away from the bedside by the research midwife. It will take 30 minutes for a visual readout of the result. The results of the StrepSure test will not be revealed to the participant or the clinical team. The results of the control sample (GBS culture) will be revealed to the clinical team and be included in the electronic medical record.
Only participants who enrol in the study will receive access to the StrepSure™ test.
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Intervention code [1]
331502
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Diagnosis / Prognosis
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Comparator / control treatment
The standard selective enrichment culture method for diagnosing GBS will serve as the comparator (reference) test. The reference test swab and StrepSure™ test swab will be collected on the same day. The standard enrichment for processing the reference test takes 24-48 hours for a result to be generated after standard laboratory procedures have been implemented.
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Control group
Active
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Outcomes
Primary outcome [1]
342176
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Sensitivity of the StrepSureTM compared with the comparator/reference test
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Assessment method [1]
342176
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Sensitivity is calculated as the proportion of true positives identified by StrepSure™ among all cases that tested positive by the reference (comparator) method.
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Timepoint [1]
342176
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After all participants have completed both testing methods
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Primary outcome [2]
342177
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Specificity of the StrepSureTM compared with the reference test
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Assessment method [2]
342177
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Specificity is calculated as the proportion of true negatives identified by StrepSure™ among all cases that tested negative by the reference (comparator) method.
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Timepoint [2]
342177
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After all participants have completed both testing methods
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Primary outcome [3]
342178
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Overall accuracy of the StrepSureTM (derived from sensitivity and specificity)
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Assessment method [3]
342178
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Overall accuracy is calculated as the proportion of true positive and true negative results identified by StrepSure™ out of all tested cases, combining both sensitivity and specificity.
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Timepoint [3]
342178
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After all participants have completed both testing methods
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Secondary outcome [1]
449818
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The GBS prevalence in the study cohort
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Assessment method [1]
449818
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The GBS prevalence in the study cohort will be assessed as the proportion of participants who test positive for GBS by the reference (comparator) method out of the total number of participants tested.
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Timepoint [1]
449818
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After all participants have completed both testing methods
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Secondary outcome [2]
449819
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Positive predictive value (PPV) of StrepSureTM test in our study cohort
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Assessment method [2]
449819
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The positive predictive value (PPV) of the StrepSure™ test will be assessed as the proportion of participants who tested positive by StrepSure™ and were confirmed positive by the reference method, out of all participants who tested positive by StrepSure™
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Timepoint [2]
449819
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After all participants have completed both testing methods
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Secondary outcome [3]
449820
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Negative predictive value (NPV) of StrepSureTM test in our study cohort
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Assessment method [3]
449820
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The negative predictive value (NPV) of the StrepSure™ test will be assessed as the proportion of participants who tested negative by StrepSure™ and were confirmed negative by the reference method, out of all participants who tested negative by StrepSure™.
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Timepoint [3]
449820
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After all participants have completed both testing methods
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Secondary outcome [4]
449821
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“No result” rate of StrepSureTM results
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Assessment method [4]
449821
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The “no result” rate of the StrepSure™ test will be assessed as the proportion of tests that failed to produce a valid result (e.g., due to test errors or inconclusive outcomes) out of the total number of tests performed.
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Timepoint [4]
449821
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After all participants have completed both testing methods
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Secondary outcome [5]
449822
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Concordance rate of the reference test performed as part of routine care at 35-36 weeks with the reference test collected at the time of StrepSureTM testing (where applicable).
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Assessment method [5]
449822
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The concordance rate will be calculated as the proportion of participants with matching GBS results (both positive or both negative) between the reference test performed at 35–36 weeks (routine care) and the reference test collected at the time of StrepSure™ testing, out of all participants who had both reference tests performed.
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Timepoint [5]
449822
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After all participants have completed both testing methods
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Eligibility
Key inclusion criteria
Each person must meet all of the following criteria to be enrolled in this study:
1. Is at least aged 18 years or older at the time of recruitment
2. Is pregnant with a live fetus
3. Presents to hospital for one of the following conditions:
- Assessment for suspected spontaneous term or preterm labour
- Assessment for suspected term or preterm prelabour rupture of membranes
- Admission for removal of cervical cerclage
- Admission for induction of labour (IOL)
- Admission for elective Cesarean section (CS)
- Antenatal inpatient admission for other indication
4. Provides a signed and dated informed consent form.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants meeting any of the following criteria will be excluded from the study:
1. Has been diagnosed with a fetal death
2. Has a known hypersensitivity to Rayon or Nylon vaginal swab material
3. Has a high acuity medical/obstetric/mental health presentation that precludes adequate consent and participation, such as second stage of labour or placental abruption
4. Unable to provide informed consent in English, or with the assistance of an appropriate interpreter (a paid professional, not a family member).
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
10/10/2025
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Actual
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Date of last participant enrolment
Anticipated
29/09/2027
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Actual
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Date of last data collection
Anticipated
29/09/2027
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Actual
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Sample size
Target
2171
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
28211
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The Northern Hospital - Epping
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Recruitment postcode(s) [1]
44423
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3076 - Epping
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Funding & Sponsors
Funding source category [1]
319460
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Government body
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Name [1]
319460
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Commonwealth Government Collaborative Research Centres Project grant Round 15
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Address [1]
319460
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Country [1]
319460
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Australia
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Funding source category [2]
319462
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Commercial sector/Industry
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Name [2]
319462
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NEXSEN Biotech
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Address [2]
319462
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Country [2]
319462
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Australia
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Primary sponsor type
Hospital
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Name
The Northern Hospital - Epping
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Address
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Country
Australia
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Secondary sponsor category [1]
321952
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None
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Name [1]
321952
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Address [1]
321952
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Country [1]
321952
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318034
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The Royal Children’s Hospital Human Research Ethics Committee
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Ethics committee address [1]
318034
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http://www.rch.org.au/ethics
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Ethics committee country [1]
318034
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Australia
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Date submitted for ethics approval [1]
318034
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14/02/2025
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Approval date [1]
318034
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07/05/2025
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Ethics approval number [1]
318034
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116122
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Summary
Brief summary
This study will test how accurately a new rapid test, StrepSure™, detects group B streptococcus (GBS) in pregnant women. GBS is a common bacteria that can be passed to babies during birth and sometimes cause serious illness. The current test takes up to two days, while StrepSure™ may give faster results at the point of care. Researchers will compare StrepSure™ to the standard test to see how reliable it is. The study will take place at Northern Hospital in Epping and involve women already receiving care there. The results of the StrepSure™ test will not be revealed to the participant or the clinical team. There will be no allocation to an intervention; therefore, this is not a clinical trial.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
142910
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Prof Lisa Hui
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Address
142910
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Northern Hospital Epping, 185 Cooper St Epping VIC 3076
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Country
142910
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Australia
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Phone
142910
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+61 426865343
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Fax
142910
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Email
142910
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[email protected]
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Contact person for public queries
Name
142911
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Prof Lisa Hui
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Address
142911
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Northern Hospital Epping, 185 Cooper St Epping VIC 3076
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Country
142911
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Australia
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Phone
142911
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+61 3 8405 8000
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Fax
142911
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Email
142911
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[email protected]
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Contact person for scientific queries
Name
142912
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Prof Lisa Hui
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Address
142912
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Northern Hospital Epping, 185 Cooper St Epping VIC 3076
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Country
142912
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Australia
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Phone
142912
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+61 3 8405 8000
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Fax
142912
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Email
142912
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
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Requires a scientifically sound proposal or protocol
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Requires approval by an ethics committee
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Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
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All de-identified individual participant data
What types of analyses could be done with individual participant data?
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Any type of analysis (i.e. no restrictions on data re-use)
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Systematic reviews and meta-analyses
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Studies exploring new research questions
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Health economic analyses
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Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
Yes:
The study recognises the value of open data sharing and adherence to data sharing principles that align with applicable laws, regulations, and ethical guidelines, therefore, anonymised data from this clinical study will be made available via a controlled access data sharing mechanism. Interested researchers may request access to the data by submitting a formal data sharing request to the Sponsor. The request will be reviewed by the Sponsor and the Sponsor-Investigator, and any relevant data sharing committee, considering factors such as scientific merit, data security, and adherence to the approved research objectives.
The following will be made available long-term for use by future researchers from a recognised research institution:
- Individual participant data that underlie the results reported after anonymisation (text, tables, figures, and appendices)
- Study protocol
- PICF
- Statistical code/syntax
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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