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To fullfill the aims of the original project, the openCDMS Informatics team has developed a system for clinical data capture and clinical trial management. The system is still being actively developed with the next major release (R7.0) due January 2009.

The openCDMS system offers the following capabilities:

Features

Security

•    Role based access control policy independently configurable for each project.
•    What You See Is What You Can Access (WYSIWICA) security paradigm
•    User privileges allocated independently for each project.
•    Standards based - signed SAML assertions used to communicate user privileges.
•    Single sign-on across openCDMS systems and Document Libraries
•    Compliant with ISO 27001
•    Mutually-authenticated SSLv3 used to secure all service access and data exchange.
•    Full access audit trail recorded and archived
•    Security Manager tools provides easy to use graphical front end for user management

Governance

•    Compliance with FDA 21CFR part 11; EMEA GCP; ISO 27001.
•    Full audit trails of all changes.
•    Data control system; can lock data with elevated privileges required for making editable again.
•    Full support for electronic signatures.
•    Separate participant register stores patient contact details independently of the study data and has its own configurable access policy.
•    Data transformation services map identifiable items (e.g. dates, postal codes) to lower resolution.
•    Data read/write privileges based on user role, configurable at document level and individual entry level.

Data Management and Quality Control

•    Data quality and completion reports
•    Scheduled email reminders (monthly summary or individual document level) for when data has to be collected in longitudinal studies.
•    Scheduled report generation and delivery by email.
•    Configurable data “Review and Approve” workflow for data management.
•    On-line or off-line data entry with automatic resynchronisation

Reporting

The reporting system provides a flexible service for generating highly customisable reports within a project.

Three main types of reports are available, which can be used to show:

•    The progress of individual clients, by showing the replies to a selected document.
•    The trends in replies across time, by summarising all results from clients for a selected document.
•    Project management reports, giving a high level overview of a project and can be used to help fulfil auditing requirements.

Trends reports can show the mean or median of replies to a given question/document, or alternatively the highest or lowest answers, as well as the total number of replies.
The project management reports include, but are not limited to:

•    Recruitment progress reports, which compare project recruitment levels with targets.
•    UKCRN accrual reports, suitable for submission directly to the UKCRN.

Reports can be output in as raw data in Microsoft Excel format or graphically in a PDF format. A variety of different charts can be produced, including: bar charts, line graphs, tables, pie charts, gantt charts and stacked bar charts. Bar and line charts can be configured to be displayed horizontally or vertically, and can show original figures or percentages.

All reports can be accessed through the OpenCDMS-web portal, which provides secure access to customised reports and is integrated with OpenCDMS's role-based security model. Individual client reports can also be generated through COCOA, whereas project management reports can be emailed to selected people on a regular (and customisable) basis.

As of Release 7 openCDMS will support Trial Feasibility and Eligibility search tools enabling the planning and recruitment of subjects to trials.

Input and Output

•    Data export to Excel, Stata, SAS, SPSS
•    Data import from file or URL
•    Bulk data import allows migration of studies to openCDMS
•    Data transformations on export or import based on user role, configurable at individual entry level
•    Call out to 3rd party application data processors

Study definition

•    Full study lifecycle management via easy to use graphical tools. No programming skills required.
•    Patching tool supports modification of live study definitions without service interruption.
•    Study versioning, publication and resynchronisation. Full audit trail of changes.
•    Fully customisable data set definition including data elements, validation rules and scheduling
•    Flexible object model that allows any data collection project to be represented.
•    All common response types available (numeric, date, text, multi-select, tabular).
•    Special derived responses that allow a value to be generated automatically by performing a calculation using previous responses as inputs.
•    Document workflow by specifying questions that are made (in)active in response to particular values being entered (e.g. "If Yes, continue; if No goto Qu. X").
•    Support for custom data validation rules from simple numeric less than, greater than rules to complex regular expression rules (e.g. validation of UK Postcode).
•    External calculated entries
•    Flexible consent model allows consent for each document to be configured in groups.
•    Validation test and approval of user developed validation rules and calculated entries.
•    Conversion of documents to PDF format for printing.
•    Element and form library allows forms and questions to be validated, versioned and reused across studies.

Trials

•    Fully integrated randomisation system with generic, configurable Stratified Random Permuted Block of Random Block Length algorithm. Minimisation algorithm will be implemented when required.
•    Extension of above for stratified randomization.
•    Extensible for other randomization algorithms.
•    Randomizers are persistent between sessions.
•    Production of randomizer statistics i.e. how many subjects in each treatment arm.
•    Optionally, interacts with a randomisation service to: setup randomisation for a trial, randomise participants and retrieve information about randomisations. System users can opt to be notified of randomisation events via email.
•    SMS/Email notification of randomisation events,
•    Trial feasibility planning
•    Trial eligibility search function

Operations and deployment

•    High availability deployment, with no single point of failure
•    NHS N3 compatible
•    Open source – no license fees for any component; anyone can develop new software features but they must make them available to the openCDMS community.
•    Modular web service architecture enables interoperability
•    OS – Linux, Windows (all variants), Mac OS X
•    Database – SQL Server, mySQL, DB2, PostgresSQL, Oracle.
•    Integrated with Microsoft Active Directory and any other standards compliant LDAP server
•    Installation and upgrade tool
•    Deployment configuration catalogue and installation document
•    On-line training materials
•    Full user documentation
•    Scheduled email reminders (monthly summary or individual document level) for when data has to be collected in longitudinal studies.
•    Scheduled report generation and delivery by email.


Architecture

openCDMS employs a Service-Oriented Archiecture and is highly modular. All major components are developed as web services using Apache Axis.
The key components of the system are:
Last Updated ( Sunday, 23 November 2008 08:34 )