Scalable, Standard based Interoperability Framework for Sustainable Proactive Post Market Safety Studies
Final project results
SALUS is an R&D project co-funded by European Commission 7th Framework Programme involving 10 partners from 8 countries. SALUS Project’s main objective is to provide a comprehensive solution supported with ready-to-use tools in order to enable the secondary use of the already available Electronic Health Record (EHR) data in patient care domain, for clinical research purposes. SALUS particularly aimed to strengthen the spontaneous reporting process by automated adverse drug event (ADE) detection on disparate EHR systems; enable standards based ADE reporting by automatically extracting the available information from the EHRs; realize the execution of post-market analysis and effectiveness queries for different subpopulations selected from multiple, distributed EHRs as target cohorts; contribute to the signal detection processes; and facilitate wide scale outcome and effectiveness research to be able to observe selected cohorts of patients over an extended period of time screening multiple, distributed, heterogeneous EHR systems to identify long term safety issues of a product.
SALUS project has successfully developed the following components which are deployed to two different pilot sites and validated by the end-users of the SALUS system:
- ADE Detection & Notification Tool (ANT) and The ICSR Reporting Tool (IRT) supports the detection and reporting of adverse drug events to regulatory authorities with services enabling automatic pre-population of ICSR by extracting data available in the patient EHR and converting this data to the data model requested for reporting, providing assistance to the manual completion of information that couldn’t be automatically prefilled, and providing assistance for transmitting the reporting form to regulatory authorities.
- The Case Series Characterization Tool (CSCT) enables the query of data sources for EHR extracts of selected patient populations to characterize ADE cases that originate from SALUS EHR data and compares the statistics against a custom background population
- Temporal (Association Screening)/(Pattern Characterization) Tool (TPT) which enables broad scale screening of EHR data for potential signals, i.e. potential drug related problems without any prior hypothesis
- Post Market Safety Study Tool enables clinical researchers to set-up a new clinical research study via the clinical data models and terminology systems in the clinical research domain (such as CDISC standards and MedDRA terms), and seamlessly collect the study data from heterogeneous EHR sites.
- Patient History Tool: During signal evaluation, the possibility to view individual patient histories is essential for ensuring that the evidence of a possible causal association between a drug and an event is not confounded by something in the patient. The patient history tool enables the safety analyst to view the drugs, events, lab tests and patient demographics for single patients to confirm or refute the evidence of potential signals.
- SALUS Common Data Element Repository implemented as a semantically enabled metadata repository conforming to ISO/IEC 11179 Metadata Registries standard, hosts the semantic dictionary of the SALUS components as a set of Common Data Element definitions.
- The SALUS Semantic Interoperability Layer (SIL) is built with a number of RESTful semantic services that enables semantic interoperability between clinical research systems (e.g. Case Series Characterization Tool) and EHR sources
- Technical Interoperability Layer (TIL) sets up the communication layer between external parties and SALUS Semantic Interoperability Layer as well as the SALUS Semantic Interoperability Layer and EHR systems by using existing international standards.
SALUS project has collaborated with CDISC, and jointly prepared an IHE Integration profile, named as Data Element Exchange (DEX) Profile which leverages the power of an ISO/IEC 11179 Metadata Registry to search and retrieve data element metadata.
The following page contains the project deliverables as approved by the EC, presentations and publications relating to the project.
Queries about future developments, access to tools and models should be addressed in the first instance to the project Coordinator Dr. Gokce Banu Laleci Erturkmen from SRDC A.S. via firstname.lastname@example.org.
The SALUS project deliverables as approved by the EC, presentations and publications can be found here:
Published on: 28 September 2017