eRA@TU Faculty Advisory Board Convenes
The eRA@TU Faculty Advisory Board held their kickoff meeting on Wednesday, May 2nd. The advisory board is made up of some of Temple's leading faculty researchers and is tasked with providing a faculty perspective to issues arising from the deployment of the electronic research adminstration system (eRA@TU) as well as providing advice on software configuration, training and deployment issues. The initial meeting was to provide background on the eRA@TU project as well as address some early issues relating to use of the the initial modules.

eRA@TU Proposal Development Pilot Departments Announced
The Vice President for Research and Graduate Studies has announced the departments to be included in the kickoff of the eRA@TU pilot program. The Cardio-Vascular Research Center, Departments of Physiology, Pharmacology and Public Health will all be the first to use the new web based proposal development system for their NIH Grants.Gov submissions. Dr. Kenneth Soprano said the first departments are "uniquely qualified to lead Temple's electronic research administration initiative due to their strong leadership, broad research portfolios, and experienced administrators. It's a win for everyone involved. The chairs will have a birds-eye view of all of the research activity within their department, the PI will be eased of much of the tedium in developing the administrative portion of the proposal and the administrators can collaborate electronically with both the faculty and the central SPA office". The eRA@TU team will be working closely with the departments to train and support their administrators in preparation for the coming June deadlines. Training will be focused on the administrator and building the first line of support for the faculty within the department. Other departments will be included in the rollout in the coming months.

Training for SPIN, SMARTS and GENIUS will begin in late April. This will be open to the entire research community and will provide most faculty with their first contact with the new systems. SPIN is a funding opportunity database that is integrated with the Proposal Development module. One click will load all of the opportunity and sponsor information directly into the sponsors proposal template. SMARTS is a funding matching system that will deliver daily emails of funding opportunities geared to the specific interests of the investigator. GENIUS will allow for University wide or worldwide search for expertise and collaboration based on investigators research interests.

Don't Miss the eRA@TU Road Show
The eRA@TU Proposal Development team will come to your departmental or staff meeting to answer your questions on the eRA@TU project and what it will mean to Temple's research community. A 15 minute presentation is followed by a question and answer session fielded by members of the eRA@TU Planning Group. Don't be left in the dark on electronic research administration and how it will make your research enterprise more productive. Contact us at research@temple.edu to arrange a presentation.

eRA@TU Successfully Submits R21 System-to-System
On February 16th, eRA@TU successfully submitted a proposal to NIH using the system-to-system proposal submission capabilities included in the eRA system. Dr. George R. Baran's (Mechanical Engineering, College of Engineering) proposal was submtted without error through Grants.Gov and NIH Commons. Dr. Baran's proposal was Temple's first system-to-system application submitted using the eRA@TU software.

eRA@TU Proposal Development Coming to Temple
The eRA@TU team is gearing up for deployment of the Proposal Development module beginning in February, 2007. The Proposal Development module will

-- Integration with funding opportunities, that is eRA will pull all of the information from the funding opportunity into the proposal as it is being developed online.
-- Electronic routing for internal approval and integration with other University offices such as IRB, IACUC, EHRS, etc for approvals as well as routing to appropriate chairs, business administrators, deans etc.
-- Cleaner submissions, edit checking at the proposal level before it is routed for review or submission.
-- Elimination of the current SPAF
-- Collaboration with administrative personnel as well as colleagues on proposal development.
-- Electronic notification of impending milestones such as due date, project and protocol renewals.
-- Ability to track all components of your research portfolio (proposals, awards, protocols) in one place

The Proposal Development Working Group is a cross-section of leading University administrators who will help guide the deployment of the Protocol Development module. This group will be tasked with using their knowledge of research at Temple to help guide the configuration of the software, identify and raise issues with the software, implementation and business processes.

In December, the eRA@TU team successfully did their first system-to-system submission to grants.gov. The submission to the NIH Acceptance/Test site was successful with no errors or warnings. Although this was a test proposal, establishing system-to-system contact was a major milestone for the project.

eRA@TU Lab Animals Deployment
The eRA@TU team deployed the latest Lab Animal Tracking Module in November, 2006. This module will change how the IACUC manages the animal subject protocols review process. The Lab Animal module will allow the IACUC staff to better track all animal protocols and seamlessly integrates with the Proposal Tracking module implemented in August of 2005. There were several changes that came out of the deployment, the most important for our faculty is that protocols numbers will not be reused after the 3 year life cycle of a protocol has been completed. With the new system, faculty will be able to be notified of impending milestones such as upcoming reviews at 90, 60, and 30 days to expiration date. Approval letters from the board will also be generated from the software and be delivered by email to the PI. In January of 2007, lab animal protocol status will be available to the PI by using Protocol Status on the Web, as the human subjects protocol status is currently available. Other features will be added to the IACUC Protocol Tracking module as they are developed and will include system built agendas, minutes and other compliance type notifications mailed directly to the PI.

eRA@TU Provides Email Notifications of Protocol Milestones
A critical component of any ongoing research project is keeping the IRB board informed of the progress of the research and maintaining a continuous IRB certification for the life of the research project. The electronic research administration initiative at Temple University, eRA@TU, will begin providing automatic notifications of protocol milestones. A PI will be sent a notification at 90, 60, and 30 days of when a protocol is about to expire. The PI will receive an email from irb@temple.edu informing them of the coming expiration and what is required to continue their research and that the reapproval form will be sent to the PI's emaill account on record. To see what this notification will look like click here. Look for these messages sent to your Temple email account.

Human Subjects Tracking Module Deployment Means Changes for Researchers
The deployment of the eRA@TU Human Subjects Tracking module will mark changes in how the IRB manages the human subject protocol review process. Human Subjects Tracking module will allow Temple's IRB staff to better track all human subjects protocols by integrating seamlessly with the Proposal Tracking system implemented last fall and providing better tools for tracking and review of a protocol during its lifetime. One of the first things our faculy will see will be automatic electronic notification of upcoming milestones in the protocol such as a protocols upcoming continuation review within 90, 60 and 30 days. Issuing letters due to a result of a board action will be done from within the system using information captured during the IRB meeting in real time. In addition, agendas and minutes will be automatically generated. The deployment will have an effect in several other modules currently being used by our research community. Both the Adverse Events Reporting system and Protocol Status on the Web will be receiving their respective data from the new eRA@TU protocol system. Users of the AE reporting system will notice that protocols that have been closed/teminated for more than 3 years will no longer be part of the report. Same holds for the Protocol Status system but these users will be able to track the progress of their current protocol more closely. Also, Protocol Status on the Web users will notice that one screen has been eliminated; all human subject protocols, whehter they are medical intervention or socio-behavioral will be in one list. Adding additional fields to track the administrative progress of a protocol as it moves to the IRB will keep the PI informed as to when a review is scheduled, which types of administrative activities are taking place and of course the final outcome of the review.

Next up in the eRA@TU deployment schedule is single sign on for the eRA@TU modules, SPIN, a new funding opportunities database, and a C.V. builder that will allow faculty to start building their C.V.s online in anticipation of Proposal Development later this year.

Deployment of the Proposal Tracking module
The Office of the Vice President for Research and Graduate Studies has announced the electronic research administration project at Temple, eRA@TU, has reached it's first major milestone with the deployment of the Proposal Tracking module. This new software application will allow OVPR staff to record, track, and report on research in a manner that reflects how research is actually conducted at a major R1 institution.

Proposal Tracking will replace legacy systems and allow tracking of entire projects instead of individual funding increments. This will give the big picture of a project and allow management to review projects in their entirety rather than just the individual pieces.

The eRA project team has converted the last 3 years of data for the new system. Older data will be archived and used for some reporting when needed. The staff of the OVPR will be using a new web application that interfaces with other University systems of record such as HR and FMS and will track much more relevant data about a project. Documents relating to a proposal such as protocols, contracts, abstracts and electronic versions of submissions will also be stored with the proposal record.

Initially, faculty will see little change in their processes, however enhancements and changes impacting faculty will begin immediately after implementation. One of the first to be scheduled will be automatic email notifications of coming project milestones such as notice of award letters, protocols that are about to expire or reminders of upcoming award closeouts.

Phase I also brings a new funding opportunity database, SPIN, to Temple. SPIN works in conjunction with GENIUS, the faculty CV database and SMARTS which matches faculty interests with funding opportunities. Training opportunities will be announced for these new research tools.

Protocol Status on the Web (PSotW)
The Office of the Vice President for Research is pleased to announce that beginning in March, faculty and students will be able to check the status of their Committee A (Medical Intervention) or Committee B (Social & Behavior Sciences) protocols using a secure connection to the new Temple Protocol Status on the Web application. This new application, is part of the electronic research initiative and the eRA@TU suite of applications. By simply logging in through the new OVPR Research Portal with their AccessNetID, the users will be able to check the protocol status, review committee, approval date, expiration date, issue date, sponsor and other protocol related information. The protocols will be viewable by the PI named on the protocol only. Using the University LDAP compliant logon modules, faculty and students will have a safe and secure method to check their protocols. Protocol data will be classified by review committee and the current standing of the protocol, open or closed. Look for announcements of availability in the Temple Research Flash and the OVPR Home Page

eRA@TU Vendor Selected and Contract Signed
The Office of the Vice President for Research & Graduate Studies has signed a contract with InfoEd International to provide the University with software and services in support of the electronic research administration project; eRA@TU. InfoEd was selected from a pool of 4 finalists, as the vendor of choice after several months of demo’s and negotiations.

Over the past 3 months the eRA@TU team has been working on ‘cleaning’ and converting legacy data in preparation for Phase I of the implementation. During the first phase of the project, legacy back office applications will be replaced with web based software to better track proposals and protocols. In addition, SPIN, the InfoEd funding opportunities database and GENIUS the expertise database will be available to the Temple research community.

Faculty and research investigators will see residual improvements in the first months of the implementation but in the latter phases, software will be rolled out that will allow faculty to develop protocols and proposals online, electronically route them for approval within their departments and schools as well as any regulatory offices, and final submission to the Vice Provosts Office for review and approval. In time, working with the Federal government, Temple faculty will be able to submit the entire proposal electronically to their Federal sponsors.

eRA@TU implementation phases:
Phase I – Protocol tracking (human subjects and lab animals), SPIN/GENIUS
Phase II – Proposal development and protocol development
Phase III – Clinical trials and animal facilities management
Phase IV – Hazardous materials protocol development
Phase V – Integration with financial systems of record

Temple Adverse Events Reporting System (TAERS)
Several other initiatives have been undertaken as part of the larger eRA@TU project. One of these projects is the Temple Adverse Events Reporting System. The TAERS system will be in pilot in the spring of 2004 for clinicians and key personnel who have registered and completed training on website assisted reporting of Serious Adverse Events. The Institutional Review Board/Office of the Associate Vice President for Research will provide required user training of this on-line system. Principal Investigators, clinical coordinators and other authorized staff will access the system via an IRB Protocol Number and their AccessNet user-id. The system is constructed to allow for both Temple and Non-temple Serious Adverse Events to be reported and updated within a searchable database. The systems expanded reporting capabilities will allow administrative users to track trends and identify potential links between seemingly unrelated events. This project has been funded by a grant from the NIH and was demonstrated during the grant-reporting meeting in March. The Adverse Events website utilizes the industry standard Secured Sockets Layer protocol (SSL) for all data transmissions in an encrypted format to ensure privacy of sensitive Information. Although the document of record will initially be a signed adverse event form delivered to the IRB, this is an important first step in electronic research administration at Temple University. Watch for the training schedule to be posted on the IRB website.

Electronic Research Administration Project Memorandum by Dr.Kenneth J. Soprano

Electronic Research Administration Project Planning Overview