IRBANA Details

IRBANA Details

IRBANA© is a comprehensive Web-based data management system for Institutional Review Boards (IRBs).  

All institutions and persons involved in clinical trials are cognizant of the ever-increasing complexity and time-intensity required to ensure compliance with federal regulations for the protection of human subjects. Tightening guidelines demand flawless accountability. There is no better solution to streamline the workload and management of the IRB than IRBANA©.

IRBANA© can be utilized as a stand-alone system or infused into CREDIT©, the clinical trials administration and patient scheduling software developed by DDOTS. It enables the entire protocol tracking elements required of the IRB and facilitates easy communication between research and regulatory staff members.

 

IRBANA Main Menu

 

OVERVIEW OF CAPABILITIES

Institutional Review Board 

Continuing Review Reports: This form is automatically created for each study due for review at the selected meeting and is addressed to the Principal Investigator.

Agenda: Creates 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 the agenda items, a laptop link to the intranet updates activities and decisions as they occur.

Minutes: Because the actions at a meeting are immediately recorded, the follow-up documentation is reduced to a few lines of clean-up. Printouts of complete board actions are available at the end of the meeting.

Follow-Up Letters: Creates all meeting follow-up letters for Principal Investigators whose studies were discussed in the IRB meeting. Board actions documented in the Minutes automatically populate the personalized letters to the PIs. Appropriate documents are generated for all adverse events, revisions, annual reviews and new studies.

On-Line Consent Forms: Maintains a complete library of patient consent forms. Because IRBANA© is web-based, these forms can be made available throughout the organization or beyond. The Consent Forms module requires logon authority and is password protected. Documents are in PDF format.

Protocols

Base Data: Includes the national identifier, sponsor, disease site, title, local coordinator, date of initial approval, and initial status.

Continuing Reviews: Each protocol is able to have a unique number of months’ notification that the annual review is due. Notification of continuing review dates are automatically sent to the PI in accordance with the requested timeframe. The protocol is inserted into the appropriate IRB meeting agenda.

Revisions and Addenda: These logs are kept and linked to IRB actions. IRBANA© comes with initial approval types (Approved, Not Approved, Deferred, Tabled, Sent to IRB, Pending).

Adverse Events: Tracks all adverse events logged for each protocol. AEs are automatically included in the IRB meeting agenda as appropriate.

IRB Membership: Tracks all IRB members including date joined and date resigned. Includes recall of events occurring while any given member was active.

Protocol Teams: A research team is assigned to each protocol. The PI is automatically notified when a protocol is due for review, and s/he can complete the preliminary review documents on the intranet; a hard, signed copy will follow if required.

Generate Reports

 A complete protocol data table includes protocol title, investigators, date of IRB approval; it provides the information for the extensive reports modules.

File Operations

 Allows IRBANA© pull-down menu options to be individualized for an organization and default information selected. Staff and Assignments section permits determination of an individual’s degree of access, manages passwords and staff information.

Institutional Calendar

A web-based comprehensive calendar is automatically populated with pertinent IRB dates (e.g., IRB meeting dates, submission cut-off dates, etc.). Reviewers can be linked to studies and notified by email of IRB activities and actions.

IRBANA Plus CREDIT

 The worth of IRBANA© is even greater when installed in parallel with of CREDIT©, DDOTS’ clinical trials management and patient scheduling software. Data entry time is significantly decreased as protocol information required by the IRB is accessed via CREDIT©. Using CREDIT©, research staff can log submissions and upload documents to the IRB, and submissions are flagged for inclusion in a targeted IRB meeting agenda. When the IRB meeting is concluded, IRB staff log the meeting minutes and line-item actions into IRBANA©. IRBANA© produces letters of approval for all submissions, meeting documents are attached to specific studies, and the CREDIT© research team is notified via automatic emails that the review process has been completed.

IRBANA© is a user-friendly, comprehensive IRB management system that streamlines all processes. Ensuring timely action is critical, and IRBANA© is unsurpassed in its ability to simplify and enable the work of the IRB – from scheduling and tracking functions to the production of meeting agendas, minutes, and action letters.

SUPPORT SERVICES

DDOTS offers full support services including:

Installation and an individualized roll-out plan. The IRBANA© IT team works with you each step of the way to design and implement an installation plan that considers what is best fro you, from research probram, pharmacy staff to your institution's IT departmental needs.

On-site training as well as individualized web-based training. Recognizing that it is never easy to adapt to new software irrespective of the “user friendliness” of the program, DDOTS conducts on-site training for staff concurrent with the installation of IRBANA© to provide the support necessary for a successful transition. Web-site training is available on an ongoing basis.

Unrivaled technical support. DDOTS recognizes that critical to our success has been our commitment to provide the best technical support in the field – and in this regard we remain steadfast. We are resolute in our promise to provide a quick response when needed – staff should not have to wait 24 or 48 hours to get an answer. Just ask IRBANA© users; we’ll be happy to provide a list of references. And there is never any charge for technical support.

AFFORDABILITY

Today’s health care milieu is one of unmitigated cost containment pressures irrespective of top notch technology to aid work product efficiency and effectiveness. DDOTS understands the institutional need to limit capital outlay and has designed its clinical trials software pricing accordingly.

 It can be argued that IRBANA© is the most affordable institutional review board program on the market. There is no purchase required.

The annual licensing fee for IRBANA© is $9,500. As always, the number of affiliates and staff covered by one license is unlimited.