Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001564842
Ethics application status
Approved
Date submitted
4/03/2021
Date registered
17/11/2021
Date last updated
30/11/2023
Date data sharing statement initially provided
17/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Australian Arthritis and Autoimmune Biobank Collaborative (A3BC): a national study collecting broad data and biological samples from individuals with arthritis and autoimmune diseases for research towards safer, more effective and evidence-based prevention, diagnosis, treatment and outcome strategies.
Scientific title
The Australian Arthritis and Autoimmune Biobank Collaborative (A3BC): a national best-practice biobank-registry network for multi-centre prospective longitudinal collection, processing and storage of broad patient-reported and clinical/health data, and high-quality biospecimens from participants with inflammatory arthritis and autoimmune diseases
Secondary ID [1] 303379 0
Nil known
Universal Trial Number (UTN)
Trial acronym
A3BC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 320652 0
Psoriatic Arthritis 320653 0
Ankylosing Spondylitis 320654 0
Juvenile Idiopathic Arthritis 320655 0
Vasculitis 320656 0
Polymyalgia Rheumatica 320657 0
Giant Cell Arteritis 320658 0
Sjogren’s Syndrome 320659 0
Gout 320660 0
Scleroderma 320661 0
Systemic Lupus Erythematosus 320662 0
Myositis 320663 0
Osteoarthritis 320664 0
Lower Back Pain 320665 0
Condition category
Condition code
Inflammatory and Immune System 318503 318503 0 0
Rheumatoid arthritis
Inflammatory and Immune System 318504 318504 0 0
Autoimmune diseases
Inflammatory and Immune System 318505 318505 0 0
Connective tissue diseases
Musculoskeletal 318506 318506 0 0
Other muscular and skeletal disorders
Musculoskeletal 318507 318507 0 0
Osteoarthritis
Human Genetics and Inherited Disorders 319449 319449 0 0
Other human genetics and inherited disorders
Skin 319450 319450 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
20
Target follow-up type
Years
Description of intervention(s) / exposure
Multi-centre prospective cohort of case and control biospecimens linked to longitudinal personal, patient-reported, clinical and health information. Biospecimens and data are collected 6-monthly up to 24 months, then data yearly afterwards for the life of the project – at least 20 years (open-ended). The questionnaires gather information on disease status, quality of life, function, medication history, medical illnesses, malignancy history, infections, lifestyle, diet and environmental/exposure history. Valid and reliable quality of life/function instruments are used, such as the PROMIS-29, the European Quality of Life (EQ-5D) and the PROMIS Paediatric Profiles. Participants’ health records are also accessed periodically through record linkage with federal/state health services and registries including Services Australia (Medicare Benefits Schedule, Pharmaceutical Benefits Scheme and Australian Immunisation Register), National Death Index, National Cancer Statistics Clearing House and the Population Health Research Network.
Intervention code [1] 319689 0
Diagnosis / Prognosis
Intervention code [2] 319690 0
Early Detection / Screening
Comparator / control treatment
Control participants will be recruited, largely on a project-specific basis. Inclusion and exclusion criteria will be defined within the accessing project’s protocol through HREC application within the A3BC Access process.

Control biospecimen and data collections will mirror those collected from participants with arthritis and autoimmune diseases with the exception of observations that are only applicable to people with disease e.g. disease-specific data collection instruments such as the Rheumatoid Arthritis Flare Questionnaire, the Bath Ankylosing Spondylitis Disease Activity Index and the Psoriatic Arthritis Impact of Disease-9.
Control group
Active

Outcomes
Primary outcome [1] 326459 0
Collect blood samples from arthritis and autoimmune disease patients (children and adults), stored as plasma, serum, peripheral blood mononuclear cells - PBMCs, buffy coat DNA (adults only), stabilised blood RNA (adults only) and whole blood DNA (children only).
Timepoint [1] 326459 0
Routine blood collections occur at baseline (0 months), 6 months, 12 months and 24 months.
Primary outcome [2] 327314 0
Quality of life (QoL) assessed by PROMIS-29 (adults), PROMIS-25 (children), EQ-5D-5L (adults), EQ-5D-Y (children)
Timepoint [2] 327314 0
Collected within an online emailed questionnaire at 0, 6, 12, 18 and 24 months, then 12-monthly for the life of the project.
Primary outcome [3] 327784 0
Patient-reported disease activity and functional outcomes assessed by Patient Global Health VAS, Patient Global Pain VAS, Patient Global Disease Activity VAS, Routine Assessment of Patient Index Data (RAPID-3), Rheumatoid Arthritis Flare Questionnaire (RA-FQ), Rheumatoid Arthritis Disease Activity Index (RADAI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), ANCA-associated vasculitis (AAV-PRO), Polymyalgia Rheumatica & Giant-cell arthritis (PMR & GCA PRO), The EULAR Psoriatic Arthritis Impact of Disease 9 (PsAID9), Childhood Health Assessment Questionnaire (CHAQ) (children)
Timepoint [3] 327784 0
Collected within an online emailed questionnaire and case report form at 0, 6, 12, 18 and 24 months, then 12-monthly by questionnaire for the life of the project.
Secondary outcome [1] 394590 0
Clinical disease activity and severity assessed by physician global and composite disease activity scores (Ankylosing Spondylitis Disease Activity Score (ASDAS), DAS28-CRP, DAPSA, ASDAS-CRP, ASDAS-ESR, BASDAI, CDAI, SDAI, JADAS-10, Birmingham Vasculitis Activity Score, (BVAS, version 3), clinical indices (Leeds Enthesitis Index; LEI, Spondyloarthritis Research Consortium of Canada index; SPARCC, Dactylitis (tender digit count), Psoriasis Area and Severity Index (PASI), Psoriasis body surface area (%BSA), Vasculitis Damage Index (VDI).
Timepoint [1] 394590 0
Collected within a Case Report Form (CRF) at 0, 6, 12, and 24 months.
Secondary outcome [2] 394591 0
Healthcare resource utilisation assessed by questionnaire (designed specifically for this study) and linkage to MBS, PBS, AIR and state health linkage agencies for hospitalisation data, electronic medical records (EMR), pathology and medical imaging.
Timepoint [2] 394591 0
Patient-reported information collected within an online emailed questionnaire and case report form at 0, 6, 12, 18 and 24 months, then 12-monthly for the life of the project. Periodic linkage will occur at adhoc timepoints.
Secondary outcome [3] 394593 0
Morbidity and comorbidity assessed by questionnaire (designed specifically for this study), case report form and linkage to national cancer and state health administration datasets.
Timepoint [3] 394593 0
Patient-reported information collected within an online emailed questionnaire and case report form at 0, 6, 12, 18 and 24 months, then 12-monthly for the life of the project. Periodic linkage will occur at adhoc timepoints.
Secondary outcome [4] 401987 0
Mortality assessed by linkage to National Death Index (NDI)
Timepoint [4] 401987 0
Periodic linkage will occur at adhoc timepoints.
Secondary outcome [5] 401991 0
Medication utilisation (prescription, non-prescription and complementary) assessed by questionnaire (designed specifically for this study), case report form and linkage to PBS (Services Australia)
Timepoint [5] 401991 0
Collected within an online emailed questionnaire and case report form at 0, 6, 12, 18 and 24 months, then 12-monthly by questionnaire for the life of the project. Periodic linkage will occur at adhoc timepoints.
Secondary outcome [6] 402141 0
Medication adherence assessed by Compliance Questionnaire for Rheumatology (CQR5)
Timepoint [6] 402141 0
Collected within an online emailed questionnaire at 0, 6, 12, 18 and 24 months, then 12-monthly for the life of the project.
Secondary outcome [7] 402142 0
Diet assessed by Dietary Questionnaire for Epidemiological Studies (DQES v3.2)
Timepoint [7] 402142 0
Collected within an online emailed questionnaire at 0, 12 and 24 months.
Secondary outcome [8] 402143 0
Collect stool and oral swab samples from arthritis and autoimmune disease patients (children and adults), stored in nucleic acid preservation media as frozen aliquots for microbiome analysis.
Timepoint [8] 402143 0
Collect in-person or via reply paid postage collection kit at 0, 6, 12 and 24 months.
Secondary outcome [9] 402144 0
Lifestyle, genetic and environmental risk factors assessed by questionnaire (designed specifically for this study) for smoking, alcohol, family history, occupational history, obstetric and hormonal history, infection and animal exposure history, sleep, diet, physical activity, secondhand smoke exposure, immunisations and psychological stress.
Timepoint [9] 402144 0
Collected within an online emailed questionnaire at 0, 6, 12, 18 and 24 months, then 12-monthly for the life of the project.
Secondary outcome [10] 402145 0
Pregnancy and early childhood outcomes assessed by questionnaire (designed specifically for this study) in child participants (parent/guardian completion).
Timepoint [10] 402145 0
Collected within an online emailed questionnaire at 0 months.
Secondary outcome [11] 402151 0
Collect synovial fluid and biopsy samples for assessing molecular tissue biomarkers of disease activity, stored as frozen aliquots or frozen tissue fragments in RNALater, Cryostor, paraffin and cryomolds.
Timepoint [11] 402151 0
Collected on an adhoc basis at the Flinders Medical Centre site.

Eligibility
Key inclusion criteria
ALL DISEASES

Case Inclusion Criteria
• Male, female or non-binary
• Aged from 0-18 years for childhood musculoskeletal and autoimmune diseases.
• Aged over 18 years for adult musculoskeletal and autoimmune diseases.
• Allow their rheumatologist/ specialist to be notified of participation.
• Formally diagnosed under validated classification systems related to the disease.
• Able (in the Investigator’s opinion) and willing to comply with all study requirements.
• Participant (or parent/guardian) is willing and able to give informed consent for participation.

Control Inclusion Criteria
• Aged over 18 years
• Controls are classified into three main subtypes:
a. At-Risk* first-degree and second-degree relatives of existing A3BC participants.
b. Healthy or at-risk* family and friends accompanying existing A3BC participants to their routine clinic visits.
c. Healthy or at-risk* general members of the community.
*Definitions of healthy or at-risk controls are detailed on a project-specific basis

---------------------------------

RA
Inclusion Criteria
RA after symptom onset
• Diagnosed with RA under the 2010 Rheumatoid Arthritis Classification Criteria published by the American College of Rheumatology (Group 1).
RA before symptom onset
• Participants without RA who have at-risk RF and/or ACPA antibodies.

JIA
Inclusion Criteria
• Children and adolescents aged 0-18 years.
• Diagnosis of JIA (under ILAR Classification

PsA
Inclusion Criteria
• At least 18 years of age
• Diagnosis of PsA under the CASPAR Classification System

AS, nr-axSpA or PERIPHERAL SpA
Inclusion Criteria
• At least 18 years of age
• Diagnosis of AS under the modified New York Classification System or nr-axSpA / Peripheral SpA under the ASAS Classification Criteria

VASCULITIS
Inclusion Criteria
• Diagnostic classification will be according to EULAR/ACR Criteria for each subtype of vasculitis:
- Small blood vessel vasculitis - Granulomatosis with polyangiitis (Wegener’s granulomatosis), Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), Goodpasture’s syndrome (Anti-glomerular basement membrane disease), Henoch-Schonlein purpura (IgA Vasculitis), Microscopic polyangiitis, Cogan’s disease, Cryoglobulinaemic vasculitis and Urticarial vasculitis
- Medium blood vessel vasculitis - Behcet’s disease, Central nervous system vasculitis, Kawasaki disease, Polyarteritis nodosa
- Large blood vessel vasculitis - Giant cell (temporal) arteritis, Takayasu arteritis, Polymyalgia rheumatica
• In addition to EULAR/ACR Criteria, the rarer form of small blood vessel vasculitis, known as anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, will be identified by:
- Myeloperoxidase (MPO) or proteinase 3 (PR3) positive blood test (ELISA detection)
- ANCA-associated disease via vasculitis activity/ damage scoring (BVAS, DEI or VDI)

IDIOPATHIC INFLAMMATORY MYOPATHIES
Inclusion Criteria
• Diagnosis under the 2017 EULAR/ACR IIMs Criteria Adult and Juvenile Idiopathic Inflammatory Myopathies

SJOGREN'S SYNDROME
Inclusion Criteria
• Adults diagnosed under the 2016 EULAR/ACR Sjogren’s Syndrome Criteria or the American-European Consensus Sjögren’s Classification Criteria

GOUT
Inclusion criteria
• Adults diagnosed under the 2015 ACR/EULAR Gout Classification Criteria
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
ALL DISEASES

Exclusion Criteria for Cases and Controls
• Unable to speak English at a level capable of understanding the informed consent process, or lack of access to an interpreter to enable this level of understanding.
• Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. For example, cognitive impairment that would interfere with completing a self-administered questionnaire.
• Legacy/existing samples collected through participating sites will only be included in the A3BC network’s collections if they meet the current SOP parameters.

Exclusion Criteria Specific to Microbiome Collection – Cases and Controls
• Given the inherent variability in microbiome populations and the myriad external factors which are thought to affect human microbial populations, the A3BC will carefully document and adjust for these in planned microbiome-related analyses. Microbiome research is a rapidly evolving field and therefore these criteria will be updated as levels of evidence evolve. Particular confounding variables to be minimised/documented in both faecal and saliva collections include antibiotic use, use of commercial probiotic/prebiotic products and infections (all in the last 3 months).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A sample size calculation has not been calculated for A3BC. The database is established as a ongoing registry for monitoring biological and environmental health factors against phenotypic disease consequences, to uncover unknown associations and trends for safer, more effective and evidence-based prevention, diagnosis, treatment and prognosis strategy. The A3BC's holistic and inclusive design will enable a wide variety of simple to complex research questions, especially those involving biologic therapies, rather than being limited to a single specific research question.

Where specific research questions are identified, sample size calculations will be performed to answer those questions with sufficient statistical power. The A3BC will therefore continue to recruit patients for as long as infrastructure and funds are available.

The A3BC does not have a defined hypothesis, therefore a description of statistical techniques is not applicable. In accordance with the data collected and the specific research design, appropriate statistical techniques will be applied at that time.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/05/2019
Date of last participant enrolment
Anticipated
3/01/2039
Actual
Date of last data collection
Anticipated
3/01/2059
Actual
Sample size
Target
20000
Accrual to date
425
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 18588 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 18589 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [3] 18590 0
Mater Sydney - North Sydney
Recruitment hospital [4] 18591 0
North Shore Private Hospital - St Leonards
Recruitment hospital [5] 18592 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 18593 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [7] 18594 0
St George Hospital - Kogarah
Recruitment hospital [8] 18595 0
Prince of Wales Hospital - Randwick
Recruitment hospital [9] 18596 0
Westmead Hospital - Westmead
Recruitment hospital [10] 18597 0
Blacktown Hospital - Blacktown
Recruitment hospital [11] 18599 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [12] 18600 0
Sydney Children's Hospital - Randwick
Recruitment hospital [13] 18601 0
John Hunter Hospital - New Lambton
Recruitment hospital [14] 18602 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [15] 18603 0
Concord Repatriation Hospital - Concord
Recruitment hospital [16] 18604 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [17] 18605 0
The Canberra Hospital - Garran
Recruitment hospital [18] 18606 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [19] 18607 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [20] 18608 0
Logan Hospital - Meadowbrook
Recruitment hospital [21] 18609 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [22] 18610 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [23] 18611 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [24] 18612 0
Gold Coast University Hospital - Southport
Recruitment hospital [25] 18613 0
Royal Perth Hospital - Perth
Recruitment hospital [26] 18614 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [27] 18615 0
Perth Children's Hospital - Nedlands
Recruitment hospital [28] 18616 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [29] 18617 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [30] 18618 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [31] 18619 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [32] 18620 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [33] 18621 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [34] 18622 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [35] 18624 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [36] 18726 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 32961 0
2065 - St Leonards
Recruitment postcode(s) [2] 32962 0
2077 - Hornsby
Recruitment postcode(s) [3] 32963 0
2060 - North Sydney
Recruitment postcode(s) [4] 32964 0
2170 - Liverpool
Recruitment postcode(s) [5] 32965 0
2560 - Campbelltown
Recruitment postcode(s) [6] 32966 0
2217 - Kogarah
Recruitment postcode(s) [7] 32967 0
2031 - Randwick
Recruitment postcode(s) [8] 32968 0
2145 - Westmead
Recruitment postcode(s) [9] 32969 0
2148 - Blacktown
Recruitment postcode(s) [10] 32970 0
2305 - New Lambton
Recruitment postcode(s) [11] 32971 0
2050 - Camperdown
Recruitment postcode(s) [12] 32972 0
2139 - Concord
Recruitment postcode(s) [13] 32973 0
2076 - Wahroonga
Recruitment postcode(s) [14] 32974 0
2605 - Garran
Recruitment postcode(s) [15] 32975 0
3144 - Malvern
Recruitment postcode(s) [16] 32976 0
4102 - Woolloongabba
Recruitment postcode(s) [17] 32977 0
4131 - Meadowbrook
Recruitment postcode(s) [18] 32978 0
4029 - Herston
Recruitment postcode(s) [19] 32979 0
4020 - Redcliffe
Recruitment postcode(s) [20] 32980 0
4101 - South Brisbane
Recruitment postcode(s) [21] 32981 0
4215 - Southport
Recruitment postcode(s) [22] 32982 0
6000 - Perth
Recruitment postcode(s) [23] 32983 0
6150 - Murdoch
Recruitment postcode(s) [24] 32984 0
6009 - Nedlands
Recruitment postcode(s) [25] 32985 0
5042 - Bedford Park
Recruitment postcode(s) [26] 32986 0
5168 - Noarlunga Centre
Recruitment postcode(s) [27] 32987 0
5000 - Adelaide
Recruitment postcode(s) [28] 32988 0
5011 - Woodville
Recruitment postcode(s) [29] 32989 0
5006 - North Adelaide
Recruitment postcode(s) [30] 32990 0
3052 - Parkville
Recruitment postcode(s) [31] 32991 0
3168 - Clayton
Recruitment postcode(s) [32] 33169 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 307793 0
University
Name [1] 307793 0
The University of Sydney
Country [1] 307793 0
Australia
Funding source category [2] 307795 0
Government body
Name [2] 307795 0
NSW Ministry of Health
Country [2] 307795 0
Australia
Funding source category [3] 307796 0
Charities/Societies/Foundations
Name [3] 307796 0
Hospital Research Foundation Group
Country [3] 307796 0
Australia
Funding source category [4] 307797 0
Hospital
Name [4] 307797 0
Goatcher Clinical Research Unit, Royal Perth Hospital
Country [4] 307797 0
Australia
Funding source category [5] 307798 0
Hospital
Name [5] 307798 0
Flinders Medical Centre, SA Health
Country [5] 307798 0
Australia
Funding source category [6] 307799 0
University
Name [6] 307799 0
University of Queensland
Country [6] 307799 0
Australia
Funding source category [7] 307800 0
Commercial sector/Industry
Name [7] 307800 0
Janssen-Cilag
Country [7] 307800 0
Australia
Funding source category [8] 307801 0
Commercial sector/Industry
Name [8] 307801 0
Roche Australia
Country [8] 307801 0
Australia
Funding source category [9] 307802 0
Commercial sector/Industry
Name [9] 307802 0
AbbVie Australia
Country [9] 307802 0
Australia
Funding source category [10] 312473 0
Government body
Name [10] 312473 0
Australian Government, Department of Health, National Health and Medical Research Council, Medical Research Future Fund (MRFF)
Country [10] 312473 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 308504 0
None
Name [1] 308504 0
Address [1] 308504 0
Country [1] 308504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307808 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 307808 0
Ethics committee country [1] 307808 0
Australia
Date submitted for ethics approval [1] 307808 0
Approval date [1] 307808 0
04/07/2018
Ethics approval number [1] 307808 0
2019/ETH10386; HREC/17/HAWKE/339

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108574 0
Prof Lyn March
Address 108574 0
Department of Rheumatology Level 7C, Acute Services Building, Royal North Shore Hospital Reserve Rd, St Leonards, NSW, 2065
Country 108574 0
Australia
Phone 108574 0
+61 2 9463 1887
Fax 108574 0
+61 2 9463 1077
Email 108574 0
[email protected]
Contact person for public queries
Name 108575 0
Lyn March
Address 108575 0
Department of Rheumatology Level 7C, Acute Services Building, Royal North Shore Hospital Reserve Rd, St Leonards, NSW, 2065
Country 108575 0
Australia
Phone 108575 0
+61 2 9463 1887
Fax 108575 0
+61 2 9463 1077
Email 108575 0
[email protected]
Contact person for scientific queries
Name 108576 0
Lyn March
Address 108576 0
Department of Rheumatology Level 7C, Acute Services Building, Royal North Shore Hospital Reserve Rd, St Leonards, NSW, 2065
Country 108576 0
Australia
Phone 108576 0
+61 2 9463 1887
Fax 108576 0
+61 2 9463 1077
Email 108576 0
[email protected]

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:
• Deidentified data and samples are available to all bona fide researchers who wish to conduct research in the public interest relating to musculoskeletal and autoimmune conditions. All approved researchers will undergo the same application and approval processes as described in the A3BC Access Policy.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Samples Available
Plasma, serum, PBMCs, buffy coat DNA, stabilised blood RNA, whole blood DNA, synovial tissue, synovial fluid, oral swab, stool, newborn card, urine

Data Available
Demographics, disease history, treatment history, cancer history, obstetric history, quality of life, environment, lifestyle, sleep, diet, physical activity, MBS Claims, PBS Claims, immunisations, death

What types of analyses could be done with individual participant data?
• Participant consent is given for any type of analysis that is in the public interest relating to musculoskeletal and autoimmune conditions. All analyses must be reviewed and approved by an human research ethics committee, the A3BC Consortium Committee and Access Committee prior to prior to release of samples and/or data.

When can requests for individual participant data be made (start and end dates)?
From:
Routine data is available from the date of ethics approval for the Australian Rheumatology Association Database, 24th April 2001. Samples are available for participants recruited into the A3BC after the 3rd November 2020. No end date is specified given this is an long-term observational study with ongoing recruitment.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Bona fide researchers can apply for sample and/or data access through a 5-step application process:
1. Registration of Approved Researchers
2. Preliminary (Pre-HREC) Application
3. HREC Application
4. Main (Post-HREC) Application
5. Material Transfer Agreement (MTA) and Access Fees

The full A3BC Access Policy can be found on the study website (https://a3bc.org.au/applications-and-access/)

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?



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.