PBC Patient Registry
The PBC Patient Registry is a secure, voluntary database that collects health information from people living with Primary Biliary Cholangitis (PBC). Its goal is to better understand how PBC affects patients, from symptoms and treatments to quality of life. By gathering this information directly from patients, the registry supports vital research, helps improve care, and gives people with PBC a stronger voice in healthcare decisions. All data is kept strictly confidential and used only for approved, ethical research.
PBC Patient Registry- Statement on Ethical Oversight
PBC Patient Registry- Data Use Policy
Frequently Asked Questions
What is a patient registry?
A patient registry is a secure database that collects important health information from people living with a specific condition, in our case, Primary Biliary Cholangitis (PBC). It can help doctors and researchers understand more about the condition, track how it affects people over time, and find better ways to treat it. By joining the PBC patient registry, you're helping improve care, support research, and raise awareness of PBC. All personal information is kept private and secure.
When will the patient registry be available?
The PBC Patient Registry is expected to launch in late summer 2025. While the exact date hasn't been confirmed, preparations are underway to make it a success from day one.
Why a patient registry for PBC?
Primary Biliary Cholangitis (PBC) is a rare, long-term liver disease. Right now, it's not known how many people in Ireland are living with PBC or how it affects their daily lives. That makes it harder to improve care, support services, and research. A patient registry can help change that.
By collecting anonymous health information from people with PBC, we can:
• Understand how many people in Ireland have PBC
• Learn more about symptoms, treatments, and quality of life
• Support research into better care and new treatments
• Give patients a stronger voice in health policy
• Make sure PBC is not overlooked by the healthcare system
The more people who join the registry, the more we can do to improve life with PBC for everyone.
Who can join the PBC Patient Registry?
Anyone diagnosed with Primary Biliary Cholangitis (PBC) can join. You must be 18 or older.
Will I be paid for participating?
No. There are no financial rewards for participating in the PBC patient registry.
How will my data be used?
Your data will be used to support research and improve care for people living with Primary Biliary Cholangitis (PBC).
Specifically, your information may help:
• Understand how PBC affects people
• Identify patterns in symptoms, treatments, and outcomes
• Support the development of new treatments and care guidelines
• Inform healthcare planning and policy
• Raise awareness of PBC among doctors and decision-makers
All data is used anonymously. Your personal identity is never shared with researchers. Every study must be approved and follow strict ethical and legal standards.
Your data will never be used for marketing, and you will not be contacted without your permission.
Is it free to join the registry?
Yes, there is no cost to participate.
Do I need my doctor's permission to join?
No. You can join on your own. Participation is voluntary and based on your consent.
What kind of information do I need to provide?
You will be asked to share details about your diagnosis, symptoms, treatments, and how PBC affects your daily life.
Can I stop participating later?
Yes. You can withdraw from the registry at any time. Your choice will not affect your medical care in any way.
Is the registry only for research?
Yes. The registry is used to support ethical, approved research that aims to improve understanding, care, and treatments for PBC.
Will my information be used to contact me for clinical trials or studies?
Only if you give permission. You can choose whether or not you’d like to hear about future research opportunities.
How is the registry funded and managed?
The registry is managed by PBC Ireland, with financial and technical support from Gerry Nesbitt.
How is the research data requested?
Researchers can apply to use information from the PBC Registry to support studies that aim to improve understanding, treatment, and care for people with PBC. Every request goes through a careful review process to ensure the study is scientifically sound and uses the data responsibly. If a request is approved, only the minimum necessary information is shared, and never any personal details. All data is handled with the highest standards of security, privacy, and ethics, following all regulatory guidelines.
Will registry data highlights be shared regularly?
Yes. We plan to share regular high-level updates on key findings from the PBC Registry. These updates will highlight trends, insights, and progress, such as how PBC is affecting people, what symptoms are most common, or how treatments are being used. All shared information will be anonymous and summarised, never linked to individual patients. By keeping the community informed, we hope to raise awareness, support advocacy, and show the value of everyone's contribution.
How does the PBC Registry Protect my Privacy?
Your privacy is our top priority. The PBC Registry is designed with strong security safeguards to keep your personal information safe and confidential.
Here's how we protect your privacy:
• No identifying information is ever shared. Contact detail details are never included in research data.
• Data is stored securely using encrypted systems (housed in a secure AWS data center in Ireland) and strict access controls.
• Only approved researchers can request data, and only after their study is reviewed and approved.
• All research must follow strict legal and ethical standards, including data protection regulations like GDPR.
You're always in control. Joining the registry is voluntary, and you can withdraw at any time.
Why is the PBC Patient Registry Important?
The PBC Patient Registry helps shine a light on a rare and often overlooked disease. By collecting information from people living with Primary Biliary Cholangitis (PBC), the registry helps us:
• Understand how many people in Ireland are affected
• Track symptoms, treatments, and quality of life
• Support research into better care and new therapies
• Give patients a stronger voice in healthcare planning
• Raise awareness among doctors, policymakers, and the public
Every person who joins the PBC registry makes a difference. Together, we can improve care, influence policy, and work toward a better future for everyone living with PBC.
Do we collect any data from your healthcare provider?
No. All information in the PBC Patient Registry comes directly from you. We do not collect any data from your doctor, hospital, or medical records. You choose what to share, and you stay in control of your information at all times.
What is a CRID unique patient ID and why am I being asked to register on CRID?
CRID stands for Clinical Research ID. When you register on CRID, you are given a unique patient ID, a secure, private identifier that allows your research data be shared with other approved studies without using your name or personal details. We use CRID to help protect your privacy. It is OPTIONAL and doesn't affect your ability to enrol in this patient registry. Your CRID identifier links your information across research studies without revealing your identity.
By registering on CRID at www.theCRID.org, you're helping make sure your data stays safe, anonymous, and useful for research.
Proposed Data Collection Instruments
Demographics
Medical History
Fatigue Fatigue Impact Scale Modified (MFIS - 21 Item) PROMIS-Fatigue SF-7a scale Pruritis/Itch Pruritus Severity Scale (12 Item) Quality of Life PBC-40 Quality of Life Chronic Liver Disease Questionnaire: CLDQ-PBC
Fatigue Impact Scale (FIS - 8 Item)
Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994;18 Suppl 1:S79-S83. doi:10.1093/clinids/18.supplement_1.s79
Fischer JS, LaRocca NG, Miller DM, Ritvo PG, Andrews H, Paty D. Recent developments in the assessment of quality of life in Multiple Sclerosis (MS). Multiple Sclerosis Journal. 1999;5(4):251-259. doi:10.1177/135245859900500410
Feagan BG, et. al., 2023, Qualitative and psychometric evaluation of the PROMIS®-Fatigue SF-7a scale to assess fatigue in patients with moderately to severely active inflammatory bowel disease. J Patient Rep Outcomes. 2023 Nov 14;7(1):115. doi: 10.1186/s41687-023-00645-0.
5-D Pruritis Scale
Elman S, Hynan LS, Gabriel V, Mayo MJ. The 5-D itch scale: a new measure of pruritus. Br J Dermatol. 2010;162(3):587-593. doi:10.1111/j.1365-2133.2009.09586.x
Reich, A., Bożek, A., Janiszewska, K., & Szepietowski, J.C. (2017). 12-Item Pruritus Severity Scale: Development and Validation of New Itch Severity Questionnaire. BioMed Research International, 2017.
PBC-10 Quality of Life
Alrubaiy L, Mells G, Flack S, Bosomworth H, Hutchings H, Williams J, Jones D; UK-PBC Research Consortium. PBC-10: a short quality of life measure for clinical screening in primary biliary cholangitis. Aliment Pharmacol Ther. 2019
Jacoby A, Rannard A, Buck D, Bhala N, Newton JL, James OFW, Jones DEJ. Development, validation and evaluation of the PBC-40, a disease specific health related quality of life measure for primary biliary cirrhosis. Gut 2005;54:1622-1629
Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of a Primary Biliary Cholangitis-Specific Version of Chronic Liver Disease Questionnaire: CLDQ-PBC. Clin Transl Gastroenterol. 2024;15(9):e1. Published 2024 Sep 1. doi:10.14309/ctg.0000000000000709
