12.12.2013

Clinical (Disease) Registry Checklist

OCQMS was developed with the aim to build a robust and sustainable framework for clinical registries.

The table below shows how OCQMS scores according to a disease registry checklist: http://www.scfbm.org/content/8/1/21

Learn more about OCQMS: www.healthdata.ai

1Technology Choices

|
---|---
Web-based or Desktop Application | Web-based, no Client Software Installation required
Relational Database or Unstructured Data | Relational Database (e.g. PostgreSQL)
Programming Language | Python
Cloud deployment vs Physical ICT Infrastructure | (Private) Cloud Deployment
Open Source vs Proprietary | Open Source Software Stack

2Professional Software Development

|
Appropriate Software Project Management | Agile Development Methods
Well-structured, Commented Code | The Zen of Python (PEP 20), Style Guide for Python Code (PEP 8)
Version Control | Git
Issue Tracking | Trac
Documentation | Sphinx, Markdown
Software Deployment Instructions | Migration Scripts
Functional and Unit Testing | Test Coverage >99%, >2'250 Unit Tests
Deployment Process Documented | Configuration Management with Puppet
Strategies to Capture Community Feedback
| Release Manager, Ticketing System

3Interoperability

|
Export/Import Functionality | CSV, JSON, Excel Export
Webservice API | Export API (REST)
Data Standards | SQL, XML, PDF
Ontology (Data Elements, Disease elements) | ICD-10, SNOMED CT
XML Interfaces* | DICOM, HL7

4System Design

| __
Customisable for a Specific Disease, Patient Registry, Clinical Registry | For Medical Practice and Clinical Research
Modular Design (New Features, New Data Elements, New Ontologies) | >30 Clinical Modules Available
Internationalization | i18n
Data Model
| Entity-Attribute-Value (EAV) Approach Combined with a Object Relational Mapper (ORM)

5Security

| __
De-Identification Process | Research Database incl. De-Identification Transformation
Two Factor Authentication | YubiKey
Multi-level User Access | Role-based Access Control (RBAC)
Work Groups | Group based Permissions on Hospital Level
Encryption | AES (Advanced Encryption Standard), 256-bit SSL Encryption
Audit Trail* | Full Audit Trail (TTW)

6. Sustainability

|
Ease of Exchange | Online Data Dictionary, Tabular Data Export
Effort Required | Seamless Integration into the Clinical Workflow, Report Generator

Future Proofing | Standard SQL Database for Data Storage

"Business Model"* | Software as a service (SaaS)

  • added to the list
    OCQMS is (not yet) open source: therefore the open source part has been omitted