ProIRB^®
                        for the IRB professional

• Helps you plan Meeting Agenda, record Meeting activities, and generate notification letters of IRB Meeting actions.
  
  
• Allows for the recording and creation of a permanent record of Serious Adverse Events, IND Reports, and Medwatch numbers, and automatically places Study on agenda for on-site and user-specified event types.
  
  
• Features an Informed Consent Checklist for review of the FDA (and provision for your own) required elements.
  
  
• Education tracking for all participants with reminder letter capabilities.
   
   
• Provides for Printing, E-mailing, and Customization of Letters via integration with MS Word templates.
  
  
• Provides for recording Protocol Revisions and other changes and automatically places the Study on the agenda.
  
  
• Generates Continuing Review notification letter(s) and provides for follow-up on receipt of a Progress or Final Report.
  
  
• ProIRB^® software is transaction oriented to provide a documented trail for every event or activity affecting the status of a Study.
  
  
• Allows for the reporting and querying of Studies in virtually unlimited ways.
   
   
• ProIRB^® software maintains a database of Investigators, Sponsors, and Study Coordinators.
  
  
  
• Support for multiple Boards.

CyberIRB^®
                        the next generation

• Provides for the electronic submission of new protocols by Investigators, including Protocol Summaries, Protocol Checklists, Consent Documents Templates, Drug Information Sheets, Device Information Sheets, and Routing Sheets.
  
  
• Each document or submission reported to the Study remains as part of the electronic record, thus creating an audit trail.
  
  
• Designed from the ground up with the practical experience of Tulane University Health Science IRB along with Rutgers, The State University Office of Research and Sponsored Programs.
  
  
• Allows for online review of protocols and related correspondence by IRB members when reviewing upcoming Meeting Agenda.
  
• Permits individual investigators to query the status of protocols they have submitted (expiration date, next meeting date, etc), view upcoming IRB Meeting agendas and prior sets of Meeting minutes, access and print the most recent IRB-approved version of the Consent document (including approval and expiration date).
  
  
• Provides electronic submission of Serious Adverse Events, Continuing Review Applications, Protocol Revisions, Consent Revisions, and other correspondence utilizing Custom User-Specific Templates.
  
  
• Designed to be tailored to meet the needs of any academic biomedical IRB.
  
  
• Accommodates Manual Review before release to ProIRB^® module and placement on Agenda.
  
  
• Accommodates User-Customized Forms and uploading for support documents.
  
  
• Supports the use of notebook computers for all IRB members so that, during the meeting, all members have online access to Study documents, Study histories, and reviewer comments.
  
  
• Allows authorized IRB members, PIs, and Administrative personnel the ability to view a complete Protocol history.
  
  
• Helps manage the work flow process by routing electronic submission to predetermined individuals and provides for the monitoring of the Status of the submission prior to submission to ProIRB^® for processing and placing on the Agenda.
  
  
• Provides for a minimum of 3 levels of security to access/submit data: User/Password on the Web Site itself; Client maintained table of authorized users and passwords designating their respective permissions to execute various functions; and transactions stamped with the user, date, and time to provide complete audit trails of transactions effecting the state of the database.
  
  
• Support for multiple boards and research sites.
  
  
• Integrated Board Meeting Minutes, attendance, and vote/quorum tracking.