Institional Review Board/IRB Software and Research Ethics Software

The Research Ethics Database (RED) was originally developed by Infonetica Research Systems  for the National Research Ethics Service (NRES) in the UK. It has now been licensed and is available worldwide to Institutional Review Boards (IRBs) and Ethics Committees. RED provides administrative support for IRB/ethics committee administrators, and regional and national management information. It is available as a single, multi-site or national system, providing each administrator with their own unique view of their IRB/committee.

The Complete Solution

RED is a complete, web-based solution for research ethics application processing, handling both committee administrator tasks and management information. When used in conjunction with the Integrated Online Form Framework, the system provides an ‘end to end’ solution that also handles the information requirements of the applicant.

RED allows administrators to manage the application process to an IRB/ethics committee. It constantly monitors the elapsed time on all projects simultaneously, warning of studies that are in danger of over running the contracted timescales. RED takes a stepwise approach to managing every part of the process taking into account, provisional decisions, rejections, approvals, amendments and site specific assessments.

Nationally RED can provide information on every IRB/committee and comes with a powerful suite of Management Reports It gives managers important real time information on any studies that are in danger of breaching the timescales set by the EU directive – allowing managers to intervene early on to avoid any breaches before they happen. The report suite also allows trend analysis, giving the ability for long-term capacity planning in the ethics committee network.

Proven Technology

The system has been in use – handling all clinical research ethics applications in the UK’s NHS - since 2004. It now handles over 20,000 applications per year, 40,000 registered users and more than 200 IRB/Research Ethics Committees. Infonetica’s research ethics software is deployed in the UK, Australia, Canada and Germany.

Management Information

Users of the system can be given defined management roles ranging from administration of a single IRB/committee, manager of a group of IRBs/committees, to manager of all IRBs/committees in the system. Activity logging and flexible write and read-only permissions ensure data is protected from unauthorised access. At the same time, the ability to share information between users on the system when necessary enables collaborative working and experience sharing.

Statistics on activity vary depending on the role of a user. At higher levels, a selection of functions and management information are:

• View decision outcome statistics
• View average processing time statistics
• Geographical application information of both applicant and committee activity
• Overview of committee activity
• Visibility of meeting activity and attendance
• Operational alerts to identify non-compliant/vexatious applications
• Real time views of committee work areas
• Ability to search for applications across all committees and view processing logs
• Overview of Appeals and Serious Adverse Events
• Define decision timelines and targets
• Ability to send messages to all system users
• Optional module to interface with a country’s Competent Authority to automatically inform them of ethics committee decisions

Statistics and Charts

Group Management

IRBs/Committees can be grouped together in administrative or geographical units. While each IRB/committee within a unit can be controlled independently, it is possible to assign managers to oversee the groups.  Such managers have the ability to:

• View activity of their committees
• View meeting activity and assign applications to committees based on ‘next available slot’
• Transfer applications and committees to the control of another administrator
• View management information on their committees
• Take over control of a committee

Integrated Geographical Information System

Committee Administration Functions

The majority of the core of the application is designed to make an IRB/ethics committee administrator’s work easier and less prone to error. Years of development have resulted in a solution that encompasses the entire ethical review process and integrates automatically with key participants. The following list is just a sample of the functions provided to IRB/committee administrators:

• Support for ‘Single Ethical Opinion’ model
• View of linked processing for multi-site applications
• Automatic monitoring of application processing time
• Ability to check in documents and applications
• Facility to upload all application documents
• Automatic import of data into the database from the electronic application form
• Control of committee meetings – agendas, minutes, attendance, decisions
• Generation of committee activity reports
• Alerts for all aspects of application processing
• Automatic correspondence generation
• Serious Adverse Event handling
• Appeal handling
• Amendment handling
• Post approval monitoring
• Ability to transfer applications or entire committee under the control of another committee
• View of management statistics for individual committee
• Access to a fully functional contacts database
• Ability to feedback information and decisions directly to applicant through online form system
• Automatic generation of annual reports
• Optional access to accreditation system

Ready to Deploy and Use

As the system is totally configurable, it can be deployed ‘off the shelf’ in most situations and is flexible enough to be used by either a single committee or a large network of committees. When deployed in large networks, various levels of access enable strategic management information to be provided to those that need it instantly. These management views of activity provide the basis for improving the process, ensuring standardisation, investigating problem areas and accrediting committees.

Proven benefits

RED was designed to alleviate the large workload associated with the management of the ethical review process, especially important with the advent of the EU directive on clinical trials. RED has been incredibly successful in doing this, both dramatically cutting back on the time taken to process new applications and in providing a consistent and structured service to the applicants from all ethics committees.

The Decision

RED enables control over the ethics application process which leads to efficiencies in both time and resources. But more importantly, RED helps make the process consistent and reliable. Supporting accreditation of committees and instant feedback to applicants, RED will result in measurable benefits to both ethics committees and applicants. In addition, the use of this proven technology reduces risk – not only in the process of re-engineering the business of ethics application processing – but also in exposure to legal challenge due to uncontrolled and unregulated committee activity.

Implementing RED across your committees is a cost effective and low risk strategy that will deliver measurable benefits.

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