Product Overview

Web-based Software for

Institutional Reveiew Board Management

Institutional Review Board Activity Negotiation Accountability (IRBANA©) is a comprehensive Web-based data management system for Institutional Review Boards (IRB). 

A complete protocol data table includes protocol title, investigators, date of IRB approval and provides the information for extensive reports modules.  This incorporates dates for continuing reviews, protocol status (active, inactive, closed), etc. IRBANA© records and tracks revisions, addenda and adverse events. From this information, the IRB meeting agenda is automatically generated. 

	Base Data Captures the National identifier, Sponsor, Disease Site, Title, Local Coordinator, Date of Initial Approval, and initial status.
	Continuing Reviews Each protocol can have a unique number of days before being required for next approval. Typically, 330 days sets the protocol up for an 11 month review. These protocols are automatically sent to the Principal Investigator (PI) a month prior to the meeting. For the required meeting, the protocol is inserted into the agenda.
	Revisions and Addenda These logs are kept associated with IRB actions. They may be approved by "Expedited, Full Board, or Administration". IRBANA comes with initial approval types (which can be modified): "Approved, Not Approved, Deferred, Tabled, Sent to IRB, Pending".
	Adverse Event Tracks all adverse events logged for each protocol. Appropriate events are automatically included in the IRB meeting agenda.
	IRB Membership Tracks all staff serving on the IRB committee. History recall of events that took place while any given member was active. Members have a "Joined Date" and a "Resigned Date". Automatically included in the IRB meeting agenda.
	Protocol Teams Each protocol has a research team available. This is where the Principal Investigator (PI) is flagged. When a protocol is due for review, the PI automatically receives notification and (if requested) can complete the preliminary review documents on the intranet. Hard, signed copy will follow.

	Agenda Create any meeting agenda in seconds. Protocols and supporting events requiring IRB action are inserted automatically into the agenda. Protocols that have been approved "Expedited or Administration" are included in the "FYI" section of the agenda. New studies, by default are also included.
	Actions As the IRB acts on items in the agenda, a laptop link to the intranet updates activities as they occur.
	Minutes  Because the actions at a meeting are immediately recorded, the follow-up documentation of actions and activities is reduced to a few lines of clean up. At meeting end, printouts of the complete board actions are available. Default values are assigned in the System Setup that make recording common motions automatic.  Board statements can even be "Consent Change" specific.
	Follow-up Letters Creates all meeting Follow-up Letters for all Principal Investigators whose studies were involved in the meeting.  Board actions are gleaned from the Minutes and populated into the personalized letters.  Letters include the PI's mailing addresses. Documents are generated for all Protocols of the meeting with Adverse Events, Revisions, Annual Reviews, and New Studies.

.......................................................................................................... 

Who should use IRBANA©?

	All sites conducting clinical trials including university settings, community hospitals; any organization with an Institutional Review Board
	Research sites involved with products and projects that require periodic review

Why is IRBANA© so important?

	Tightening guidelines associated with Clinical Research demand flawless accountability.  IRBANA's data set and browser interface assure accountability.
	Whatever your Institution's decision, an efficient system to 'track' protocol submissions is essential. The IRBANA© software is capable of handling thousands of active protocols and ancillary reports.

..........................................................................................................


Specifications:

	Windows 2000/2003 Server
	SQL Server 2000
	WebEditPro 4.1+
	Internet Explorer 6.x
	Cold FusionMX 7.x

	1ghz Processor
	1gb RAM
	5gb Drive Space

	If Windows based, Windows 98, Windows 2000, Windows XP
	450mhz Processor
	64mb RAM (preferred 128mb)
	Internet Explorer 6.x