Data platforms

We make use of computing resources such as relational databases and cloud-based services to develop data collection and management systems to record, store and analyze clinical trial data. We are compliant with the General Data Protection Regulation (GDPR) and implement the highest standards to ensure data integrity across the clinical studies we sponsor and research projects we support.

Electronic case report forms

Our custom-built electronic case report form (eCRF) platform provides a secure and private workspace for clinical researchers to capture and manage demographic and clinical data including laboratory reports, medications and adverse events during the course of ongoing patient care or as part of a clinical trial.

Features:

  • Desktop-optimized interface
  • Access to approved users (i.e., members of the clinical research team at participating centers)
  • Repository of documentation and resources
    • Clinical study protocols describe the study objectives, design, methods, schedule for the collection of data and samples, and statistical considerations for analyzing data while ensuring the patient safety and research integrity
    • Laboratory manuals contain information regarding the procedures for sample collection, handling, and shipping
    • Informed consent documents for individuals and patients who participate
    • European Quality of Life-5 (EQ-5D) questionnaire is available in more than 150 languages to assess the health status of individuals and patients participanting in all our sponsored clinical trials
    • Frequent asked questions addressing topics relevant to healtcare professionals who carry out research within our clinical trials
  • Integrated follow-up visit calendar and push notifications
  • Tools for query management are restricted to authorized personnel only

Data Hub

The EF CLIF Data Hub is a web-based environment, where researchers can access omics and clinical data securely. When patients give consent to having blood and other tissue samples collected, processed, and analyzed as part of any of our large observational studies, genomic, transcriptomic, proteomic and/or metabolomic data is pseudoanonymized and stored along with any other data in our servers accessible through the EF CLIF Data Hub. Clinical data complements omics data providing in-depth information about patients’ management and disease progression.

Features:

  • Desktop-optimized interface
  • Data access to approved users
  • Online application form

What you will be able to access?


Clinical data

Clinical data complements genomic data providing in-depth information about patients’ management and disease progression. Through our elecronic case report forms, we collect patient clinically relevant data including:

  • Stages of cirrhosis
  • Complications of cirrhosis (all etiologies)
  • Treatment regime
  • Laboratory test results
  • Imaging data such as CT and MRI scans
  • Mortality data

Patients with acute decompensation of cirrhosis (without ACLF)Patients with ACLF (at hospital admission)Patients that develop ACLFTotal
No. of participants25048994323835

Quality of life data
EQ-5D assessess self-reported health status of participants in our studies considering mobility, self-care, usual activities, pain/disconfort and anxiaty/depression.


Samples and omics data

European origin (no. of participants) Latin American origin (no. of participants)Total amount of data
Genomic data16071274123 Gb
Lipidomic data16071274-
Metabolomic data1787589-
Proteomic data150--
Transcriptomic data94576615 Tb
Samples available--227,740

Samples available include blood RNA, peripheral blood mononuclear cells, buffy coat, serum, plasma, urine, saliva, ascitic fluid, hair, stool, and solid tissue from liver biopsy.

To access EF CLIF datasets and biological samples, researchers must first submit a project proposals through the EF CLIF Data Hub. Proposals are then assessed by the Sample and Data Usage Committee (SDUC) who approves access to our samples and data. Researchers who are granted access to the EF CLIF Data Hub can use the data we store to generate further knowledge that can lead to improve diagnosis, prognosis, and treatment of chronic liver disease.