Integrates with Customer Defined Web Based Application Forms
Our unique online form technology allows us to design and build dynamic web-based application forms to your specification which will import directly into RED – thus saving hours of data entry, improving security and accuracy of data.
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Regulatory Compliance
Infonetica software is designed to be compliant with most national standards including HIPAA and 21 CFR Part 11.
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Alerting and Monitoring
RED promotes smooth work flow and effective application and meeting management by means of a comprehensive alert system which notifies users of outstanding IRB actions, monitoring both the ethical review process and post approval actions. As an example, in current RED systems, users are reminded when an application’s documentation has not been checked in, or when an application has not been validated, or when a decision has not been recorded on RED after the allocated meeting date.
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Adapts to Local IRB Needs
RED adapts to localised requirements in allowing the customer to create a suite of standard letters that can be populated automatically with application specific information. Users are prompted at the appropriate stages to generate and save correspondence. Pre- populated agendas and minutes can also be defined by the user and saved against each meeting.
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Advanced and Flexible Reporting
RED includes full search and reporting facilities with statistics and graphing that use consistent metrics and enable long-term analysis of data and assessment of IRB competency and quality. Data can be exported to MS Excel or Word and tiered levels of access to management reports can be defined by a nominated administrator.
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Full User Support
Your move to RED could not be easier. Data can be migrated from your old system to RED so that your operations are not disrupted in any way. Personnel can be trained on or off site, and our systems are backed up with full helpdesk services manned by trained staff.
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RED promotes smooth work flow and effective application and meeting management by means of a comprehensive alert system which notifies users of outstanding IRB actions, monitoring both the ethical review process and post approval actions. As an example, in current RED systems, users are reminded when an application’s documentation has not been checked in, or when an application has not been validated, or when a decision has not been recorded on RED after the allocated meeting date.
In addition, the alert system notifies RED users of any upcoming or overdue paperwork from researchers – such as responses to request for further information, progress reports and safety reports – and allows email or letter reminders to be generated.
A full per-application history of IRB actions and associated correspondence is available. Importantly, linked to application history, RED tracks the time taken by the IRB to issue decisions. This time data can be invaluable in demonstrating an IRB’s efficiency in managing the ethical review process.