OneAegis (f/k/a IRBManager) has been available since 2002, and was initially developed in association with the Biomedical Research Alliance of New York (BRANY). As IRB Administrators face an ever increasing amount of paperwork and mandated requirements, OneAegis provides a tool to help manage the information, remind the administrator of tasks at hand and communicate with the investigators and reviewers through a common base of information, document generation, document attachments and event tracking as well as the Central Review Board through event tracking and agenda generation. For example, when an agenda item event (Informed Consent Form Change, Serious Adverse Event) occurs, the item automatically appears on the agenda for the next meeting of that IRB. Which items are agenda items is table driven and chosen by the customer.
OneAegis allows users to enter protocols and protocol related information such as: Investigator, Site (Multiple sites and Investigators), reviewers, events, sponsor or funding source, Title, Grants Manager, category of the study, attachments, approval dates, descriptions, comments, generated documents and statuses. Attachments, documents and events can be associated with either an individual site in a study or all the sites participating in the study.
When the user logs into OneAegis they see a list of recent actions, alerts, such as if a study setup is not complete and finally a key item, open items this week. The open items list is built against events that have occurred for studies and require actions, whether it is receipt of a form from an investigator or setup of a continuing review for a soon to expire study. The IRB Administrator always has available to them the “must complete actions” to keep studies running smoothly.
Investigators have access to see the protocols they’re investigating as well as attachments, events and documents generated for their study but do not have the authority to edit them.
OneAegis is not a legacy or “dos based” application that was ported to the web. It was designed in conjunction with BRANY to fulfill the requirements of the modern day IRB Administrator. The relational database is designed to store information and attachments and function at the speed of today’s technology. The design team was not constrained by the limitations of old technology, processor power or storage capacity. Interfacing between the OneAegis and other commonly used applications was the expectation not the exception.
By following these techniques, OneAegis is prepared to easily support large scale implementations and was built to be easily expanded to handle new or different information as the customer base requires.
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