Professionals

Scientific Advisors

John Ryan PhD. FRCPI
Consultant Hepatologist
Beaumont Hospital

Dr. Mark Robinson PhD.
Associate Professor
Maynooth University

Data Repository

The PBC Ireland Patient Registry is a secure, patient-led, observational registry designed to collect real-world data from individuals diagnosed with Primary Biliary Cholangitis (PBC). The registry is built and managed by PBC Ireland, a patient advocacy group, and has received ethics approval via an IRB.

The registry provides a valuable resource for researchers seeking to conduct high-quality, patient-centered research using research-grade data. All data are contributed directly by individuals living with PBC, using structured forms and internationally validated patient-reported outcome measures.

Key Features

Patient-Reported Data
Participants self-enroll and complete structured surveys, capturing data in their own words and on their own terms.
Ethically Governed
The registry operates under IRB oversight, with consent procedures and data governance aligned to international standards.
Powered by CLIRINX
The platform used (CLIRINX https://clirinx.com) is specifically designed for rare disease research and enables secure data entry, audit trails, and customizable data forms.
GDPR Compliant
The platform complies with all aspects of GDPR compliance.
Unique Identifiers
Patients have the option of creating a unique, anonymous CRID (Clinical Research ID https://TheCRID.org) to allow linkage of data across studies without exposing personal information.

Data Collected

• Demographic Information
• Medical History
• Standard of Care
• Follow-up Data (annual)

The registry includes several validated tools to track quality of life, fatigue, and pruritis severity:

• PBC-10: 10-item measure of quality of life specific to PBC.
• PBC-40: Comprehensive 40-item PBC-specific quality of life questionnaire.
• CLDQ-PBC: Chronic Liver Disease Questionnaire, adapted for PBC.
• Fatigue Impact Scale – 8 Item (FIS-8): Short form for assessing the impact of fatigue.
• Modified Fatigue Impact Scale – 21 Item (MFIS-21): Evaluates physical, cognitive, and psychosocial fatigue.
• 5-D Itch Scale: Captures multiple dimensions of pruritus (itch).
• Pruritus Severity Scale (12-Item): Assesses severity and daily impact of itch.

Data Request

PBC Patient Registry - Information for Researchers

PBC Patient Registry - Statement on Ethical Oversight

PBC Patient Registry - Data Use Policy

 Data Request Form

To request access to data from the PBC Ireland Patient Registry, researchers must complete the Data Request Form and submit any required supporting documents, such as ethics approval. All requests are subject to review and approval by the registry's governance team. If approved, access to the appropriate de-identified dataset(s) will be granted under the terms of the Data Use Agreement (DUA), which outlines permitted uses, confidentiality requirements, and obligations regarding data protection and intellectual property. Participant identifying data is never disclosed.