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Electronic IRB System Redesign Project
General Information and Status
The Office of Regulatory Affairs (ORA) and University Information Services (UIS) have initiated a project to implement Click Commerce IRB software to streamline Georgetown University’s Institutional Review Board (IRB) activities.
The Click Commerce IRB Software provides a paperless, electronic method for the submission, tracking, and review of information related to IRB activities. The IRB Software will provide a single-source collaboration platform supported by administrative capabilities that will improve the efficiencies of Georgetown University Institutional Review Board and administrative office activities, as well as those of the Georgetown University research community.
The new system will replace eRIC, the current researcher portal.
Below you will find answers to some frequently asked questions regarding the design and deployment of the new web application.
If you have a question that is not listed below, please call the IRB office at 202.687.1506 or send an email to the project team at rrcs-l@georgetown.edu
- What is Click Commerce?
- Who will have access to the new portal?
- Who will be required to use this system?
- When will the new system be available?
- What new features will be available to researchers?
- How will the new system save me time?
- Will paper forms and signatures still be involved in the IRB process?
- How much of my existing study paperwork will be transferred into the new system?
- What web browsers will be supported?
- Will training be available for the new system?
- Can my external collaborators access the system?
- How will this system streamline the IRB administrative process?
- How will the new system affect the review process?
- Will IRB committee meetings be conducted with the new system?
- What is Click Commerce?
Click Commerce is an industry leader for electronic research management systems. The majority of top-tier research institutions use their products. Following an in-depth survey of the competition, it is our opinion that Click Commerce provides the best-in-class solution for Electronic IRBs. In addition to purchasing the "starter site", consulting services from Click Commerce will help us customize the product to meet the exact needs of the Georgetown IRB. Click Commerce is located in Beaverton, Oregon.
- Who will have access to the new portal?
All researchers and collaborators who currently interact with the IRB, regardless of their institutional affiliation. University NetIDs will be required in order to use the new system. Individuals who are not currently affiliated with Georgetown can request affiliate status from the IRB in order to obtain a NetID.
- Who will be required to use this system?
All researchers who have active studies with the IRB will be migrated to the new electronic system. From launch until January 1st, 2010 electronic filing will be voluntary, and after January 1st 2010 it will be mandatory. At that point the Ffiling of paper forms with the IRB will no longer be an option.
- When will the new system be available?
The current projected launch of this system is January 2010. Pre-production testing is currently in progress. If you would like to participate in testing and tuning, please contact us.
- What new features will be available to researchers?
Real-time status checking on filings, 24/7 access to your own personal archive of current and past electronic filings, speedier review and enhanced on-line help and tutorials to guide you through the process.
- How will the new system save me time?
A major time savings will be realized after the first year as the renewal process becomes significantly streamlined. In the first year, the benefits of the system will be seen through more efficient routing of the paperwork between relevant parties. Feedback will be instant and email notifications will provide people links with which to access, update and review their material immediately. Overall we anticipate a significant time savings for the average researcher.
- Will paper forms and signatures still be involved in the IRB process?
No. To enhance electronic reporting and audit capabilities, as well as cut down on paper archives, there will no longer be any paper forms. Your NetID, or other system credentials, will serve as an electronic signature for filings. The average IRB that goes electronic saves 5.7 tons of paper annually, and $50K in printing expenses.
- How much of my existing study paperwork will be transferred into the new system?
The only information currently planned to be imported into the new system will be basic descriptive information (e.g., protocol number, title, PI, etc.) identifying your current study. When your study is due for continuing review, you will need to enter a complete set of information for the study (i.e., the information found on the new protocol submission application form). We realize that this will be a time consuming process at first, but it will result in speedy renewals (during the renewal process you will only need to pull up the study in the system and provide the necessary updates), and efficient routing of your paperwork between relevant parties. In the long-run, all time invested in re-entering material will be saved in multiples over the course of the life of a study.
- What web browsers will be supported?
All major browsers are supported by the system, including Internet Explorer, Firefox, Safari. There are some 20 browsers supported.
- Will training be available for the new system?
Yes. The IRB will be launching a multi-site training initiative in January 2010 to familiarize the research community with the new system.
- Can my external collaborators access the system?
Yes. During the deployment process all existing IRB contacts will be given logins in the new system and links to the appropriate studies. Additional individuals can be associated with your filings by contacting the IRB.
- How will this system streamline the IRB administrative process?
The system will provide document management and routing functionality to steer paperwork immediately to its intended recipient, and present that individual with relevant menus to operate quickly on the material. Enhanced audit functionality will allow the IRB to call up any past change to the paperwork and act upon it. Automated email notifications will be used to communicate with both the research community, reviewers and the IRB staff. These notices will quickly move information along its intended path without delay.
- How will the new system affect the review process?
First of all, the physical step of moving paperwork around will disappear, providing a clear increase in process efficiency. Secondly, reviewers will have the entire protocol and its history at their fingertips, which will enable them to make informed decisions quickly. Thirdly, researchers and their teams will be able to track the progress of their submission in real time. The system will ensure correct routing of correspondence resulting from reviews and clean, up to date consent forms will be available instantly.
- Will IRB committee meetings be conducted with the new system?
It is our plan to examine the committee meeting structure and best adapt it to use of the new system. However, we would like to first focus on the tuning of the system for the basic IRB process. Moving meetings to all-electronic is a secondary goal of the project that we expect to address in the first half of 2010.
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