Research Administration final - University of · PDF fileAppendix 15: Research Administration...

Appendix 15: Research Administration Project 1

Research Administration: An Integrated Digital System to Facilitate Research and

Manage Research Information Project Leaders • Daniel E. Albrinck, JD, CPA, Associate Senior Vice President, Medical Center, Associate Dean,

Management & Finance, College of Medicine • J. Roger Guard, MLS, Assistant Senior Vice President, Medical Center Academic Information

Technology and Libraries, and CIO, College of Medicine • Robert F. Highsmith, PhD, Associate Dean & Director, Office of Research and Graduate

Education, and Professor of Molecular Physiology, College of Medicine Project Team • Mary Belskis, MBA, Director, Institutional Research and Compliance Services, UC • Ralph F. Brueggemann, MBA, Director, Systems Development and Maintenance, Medical Center

Academic Information Technology and Libraries (AIT&L) • Gregory A. Fish, MS, Technology Manager, Data Center, Servers, and Security, AIT&L • William Gordon, PhD, Applications Analyst, Systems Development and Maintenance, AIT&L • Li Huang, MD, MS, Applications Analyst, Web Development, AIT&L • Richard Kordal, PhD, Director, Intellectual Property Office and University Patent Officer • Robert Kraft, BS, Applications Analyst, Systems Development and Maintenance, AIT&L • Stephen Marine, MLS, MA, Director, Outreach, AIT&L • Bruce Merz, BA, Applications Analyst, Systems Development and Maintenance, AIT&L • John Michnowicz, BS, Director, Sponsored Programs, Medical Center Management, Finance, and

Support Services • Delores Mincarelli, BS, Research Associate, Systems Development and Maintenance, AIT&L • Vicki Morris, MS, CHP, Radiation Safety Officer • Josette Riep, Technology Manager, Web Development, AIT&L • Sandra Sanders, Applications Analyst, Systems Development and Maintenance, AIT&L • Anshul Sharma, BTech, Applications Analyst, Web Development, AIT&L Oversight Committee • J. Roger Guard, MLS (Chair) • Daniel E. Albrinck, JD • Mary Belskis, MBA • Gary Gudelsky, PhD, Professor of Pharmaceutical Sciences, and Director, Graduate Program,

College of Pharmacy • Gilbert R. Hageman, PhD, Professor of Rehabilitation Sciences and Associate Dean, College of

Allied Health Sciences • Linda Harpster, JD, Associate General Counsel, Office of the Senior Vice President and Provost

for Health Affairs, University of Cincinnati • Robert F. Highsmith, PhD • Marilyn Sommers, PhD, RN, Professor and Director of Institute for Nursing Research, College of

Nursing, University of Cincinnati


Existing Programs/Organizations Involved • College of Medicine • College of Nursing • College of Pharmacy • College of Allied Health Sciences • Academic Information Technology & Libraries, UC Medical Center • Office of Compliance • Institutional Animal Care and Use Committee • Institutional Review Board • Office of Intellectual Property • Office of Management, Financial and Support Services, UC Medical Center • Office of Radiation Safety • Office of Research and Graduate Studies, UC College of Medicine • Office of the Vice President for Research and University Dean for Advanced Studies • Office of Sponsored Programs, UC Medical Center Objectives/Needs By adding business intelligence and increased integration to existing research administration and compliance systems, and adding functionality specifically related to research activities, we will simplify and enhance the computer environment for researchers at the Medical Center. In the new environment, customers will receive exactly the material they need for their research activities. As a result, this project will: 1. Facilitate the research process and enhance research productivity. 2. Integrate digital systems for research administration across various offices and units in the

university, and thereby simplify the research administration processes. 3. Improve efficiency and effectiveness and reduce the potential for error. 4. Ensure compliance with federal and state regulations. Background/Local Context Over the past ten years the University of Cincinnati Medical Center has become a major research institution, now ranking in the upper 25% of all public medical schools with over $180 million last year in sponsored program awards. This dramatic growth has been greatly facilitated by the application of information technology in eight offices or major units whose activities impact the research enterprise at the University of Cincinnati. These activities focus on both the pre- and post-award phases of grant administration. Pre-award activities include funding opportunity information, grant and contract proposal development, fundraising, expertise databases, web sites, space planning, and sponsored research administration. Post-award activities include Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), grant and contract administration, accounting, the commercialization of intellectual property, publication assistance, core facilities, institutional reports, and compliance


(radiation safety, bio-safety, web-based training modules, etc.) All activities are based in offices that are linked with the university’s financial system (CUFS) and human resources system (HRMS). Several applications currently exist that support services in each phase of the Research Administration lifecycle. The challenge is to build a tightly integrated Research Administration System that expands upon blocks that have already been established. Full digital integration of the research administration enterprise will include the following extant systems: System*

Pre Award Post-Award Compliance

Research Expertise Research Center (Web Site) Grants Online (eGrants) IACUC (SIRIUS) IRB Research Training Sponsored Programs Online Tracking System (SPOTS)

Contract Approvals (eContracts) Radiation Safety System Laboratory Animal Medicine System (SIRIUS)

Personnel Action Form (ePAF) Medical Center Administration Center (Web Site) including Sponsored Programs

Human Resources Management System Space Planning (Facility Center) College and University Financial System (CUFS)

Electronic Journals and Resources Database

*See the Applications section for descriptions of each of these systems. The University of Cincinnati Medical Center Integrated Database (see Appendix 1, Plan for IAIMS, “Information Technology and Resources Self-Study” Appendix, “Database” section for a full description of the Integrated Database) with its security component is the unifying core of the planned Research Administration System. Three Medical Center digital systems (the Electronic Personnel Action Form (ePAF) the eContracts Routing System, and Ask an Expert) will provide reusable components and “software integration glue” for the Research Administration System. The ePAF system uses web forms, a robust middleware environment, a media repository, and relational database technology to replace paper for one of UC’s most heavily used systems. The ePAF system pulls information from the University’s HRMS system and uses workflow software to perform complex routing and approval before sending the information back to Human Resources. The eContracts Routing System utilizes workflow software to perform complex routing, review and approval (via digital signature) throughout the University. The eContracts Routing System also facilitates a more efficient method for generating management reports and compliance reports. Ask an Expert provides


guidance to faculty who wish to use the various systems and to define various aspects about themselves. This information in the Ask an Expert module can be used to generate curricula vitae as well as link researchers who have specific interests to one another. National Context Massachusetts Institute of Technology (MIT) has been working for several years on a system for tracking sponsored programs (Coeus) and on an Electronic Research Administration (ERA) system. Although MIT's systems have stirred interest within the academic community (Coeus and ERA are installed at about 50 universities) and at NSF and NIH, progress has been slow over the last 3 years pending decisions by the federal government on forms standardization. Both the Coeus and ERA systems are client/server systems, developed using PowerBuilder, with the attendant limitations of access and flexibility. Vanderbilt University Medical Center is currently implementing an electronic system designed to make their medical enterprise paperless. The strategy at Vanderbilt was not one "mega" system. Instead, Vanderbilt created a user-friendly front end that integrates multiple information systems in a seamless manner for clinical provider use and coupled this with an organization change process. This strategy has proven very successful. We use a due diligence process to periodically evaluate commercial systems using a set of criteria that includes functionality, price, and availability. In 2000 and again in 2002, we conducted this process to assess whether we should buy or continue to build new research administration applications. In this process we reviewed the InfoEd International product suite and found that they were developing a set of independent research administration subsystems using Visual FoxPro. Visual FoxPro does not match our criteria requiring the use of a high volume relational database product, such as Microsoft SQL Server or Oracle. We will continue to monitor InfoEd progress and consider them for future projects, especially if they evolve to an integrated relational database environment. Note that we violated our own policy when we purchased Sirius in 2001. Sirius is a content-rich solution for managing Lab Animal Medicine (LAMS) and Institutional Animal Care and Use Committee (IACUC) data that was urged on us by a key customer. Sirius is written in Fox Pro and is the sole product of a very small vendor (NTM Consulting Services, Inc.). Sirius has proved to be extremely difficult to customize and has yet to be integrated into our database petal model because it requires a warehouse solution to make it SQL-compliant. This is a lesson learned that we knowingly did to ourselves. In retrospect, we probably would have been better off building the LAMS and IACUC application from scratch. The efforts at other research institutions, as well as our own experience, highlight the critical need to streamline the administrative components of academic research. The current paper and people-based systems at the University of Cincinnati add weeks of personnel time and endless potential errors and bottlenecks to the processing of a single grant application. The automation of grants administration has become an essential element for grant submission and monitoring. The solution to this problem is a combination of appropriate application of information technology and the education of personnel who will use it.


Description This project encompasses many tasks, which fall into 3 major categories: 1. Integration of Existing Research Administration Systems: To accomplish this category of tasks, we will start by making changes to many of the systems listed in the table above, so these systems can easily exchange information with each other as appropriate. Each of these systems manages a collection of objects, e.g. a research protocol or research training requirement. The first stage of integration is to ensure that each existing system links the objects it manages with individuals at the Medical Center via references to the Person Core of the integrated database. The second stage of integration is to add “business intelligence” to the systems, so that a change made in one system is automatically propagated to other systems as appropriate. For example, if the IRB office starts to process a new proposal, the system’s business intelligence will ensure that “Human Subjects Training” requirement is applied to each Investigator on the proposal. 2. Research Expertise Information: Researchers can provide descriptive material about their research interests and areas of expertise. This information allows them to be notified of appropriate funding opportunities, find collaborators for research, and make expertise available to others in the Medical Center research community. 3. Process Automation and Streamlining: Implementing systems to automatically process university and external forms, manage routing of applications and proposals to the correct offices and people in sequence, and provide in-process electronic validation during data entry, will reduce the amount of effort researchers need to spend on administrative tasks. The overall goal is to provide a seamless integration of core administrative research information systems across the university. Tremendous value will accrue in several ways: • Preparation of research proposals will be streamlined. • Administrative processes will be simplified, leading to less clerical work by researchers. • There will be a marked reduction in the amount of paper required for administrative purposes. • Professional training requirements and certification for researchers will be monitored to ensure

compliance and provide a method for demonstrating compliance. • The model of a flexible Research Administration system will be shared with others. We will achieve this goal by creating a web-based Research Administration System that will encompass Pre-award services; Post-award services; and Compliance.


Logical View

Researcher

IRB ServicesResearch Training

Research Center (Web site)Administrative Services Center

Human Resources SystemePAF

eContractsIACUC (Animal System)

SPOTSElectronic Journals

Radiation Safety

Post-AwardResearch Expertise

Institutional Review Board SystemResearch Training

Research Center (Web site)Medical Center Administration

CenterHuman Resources System

IACUC (Animal System)eGrants

Electronic Journals

Pre-Award

Research Center (Website)

Research TrainingRadiation Safety

Institutional Review Board SystemIACUC (Animal System)

Compliance

Research Administration System

Future State


System View


Pre-Award The primary goal of pre-award services will be to assist faculty, staff, and trainees in the formulation of ideas worthy of their research, to match their research expertise with potential collaborators and foster such interactions, to provide information about funding opportunities that parallels their research ideas and expertise, to supply core research infrastructure to carryout cutting edge research, and to provide knowledge of the peer review process and assistance in effective grant writing. Faculty and trainees using this module of the Research Administration System will thus be able to search for ideas, expertise and collaboration, find appropriate core facilities (animal models, multiple-user equipment, genome information, computational analyses, etc) and sources of funding, obtain assistance in proposal development, and have a work area that guides them through the grant submission process via an integrated web based enterprise system. Faculty will be able complete university forms, gather salary/benefit information, and complete other administrative steps necessary to gain approval for grant submission. Currently that process involves over a dozen forms and pieces of paper that must be completed and walked from office to office. Post-Award Several Offices within the University provide post-award services such as accounting, grants and contracts administration and fund transfers. Post-Award services will provide online availability of electronic contract approvals (eContracts), grant award information, grant budget information as it is established in CUFS, all forms to establish and maintain protocols, compliance regulations, and compliance training courses. These services will streamline the process for submitting budget reports, effort reports, and grant audits. Post-Award will also focus on areas dealing directly with researcher productivity: publication assistance, management of intellectual property, and entrepreneurship. Compliance The number of mandatory compliance/regulatory procedures from federal and non-federal granting agencies has greatly escalated in the last few years. Acceptance of sponsored funding from most agencies is contingent on grantee institutions demonstrating compliance with these regulations. The regulatory policies govern many areas of experimentation including that performed on human (IRB) and animal (IACUC) subjects. Precautions must be taken and investigators trained when there is potential exposure to hazardous chemicals, environmental toxins, infectious agents, and blood-borne pathogens. Overall, the compliance module of the Research Administration System will alert researchers to required training, will provide that training, and will maintain all necessary records related to research environment regulations. Program Uniqueness/Benefits The Medical Center’s Research Administration project is among the first to propose to integrate and fully automate academic health center research administration. We believe that the Research Administration System will have many benefits including the ones listed below.


• It is much broader in scope than MIT’s Coeus. Our plan extends the Coeus model to include full integration between the Pre-Award, Post-Award, and Compliance phases.

• Though InfoEd International is developing independent research administration subsystems, our application will be built using a proven integrated database. This integrated database is based on a personnel core that is automatically updated for currency from our university personnel and student systems.

• Because of its web-based design, the Medical Center Research Administration System can be easily expanded to provide direct access to researchers.

• The Research Administration System puts a strong focus on streamlining by providing access to information already available in other sources and hence reducing duplication of information.

• The Research Administration System will provide web portals and a robust content management system so that researchers can receive information tailored to their needs (i.e. funding notices, journals and other information in their areas of interest).

• The Research Administration System is similar to clinical systems such as Vanderbilt’s in the sense that it is to be a paperless, web accessible system.

Management During the last six years the Medical Center research, administration, planning, and information technology teams developed a research and customer vision, trust, commitment, and tools for an integrated research information system. This vision is based on our internal organizations sharing data and integrating their systems. They agreed to use relational database technology and web tools. An IAIMS operations grant will accelerate the advance of our research enterprise both technically and culturally. The Research Administration Oversight Committee, chaired by Mr. Guard, will meet regularly to determine the strategic direction, to ensure coordination of research administration processes throughout the Medical Center, and to monitor the progress of the development of the integrated research administration system. In addition to Mr. Guard, who represents information technology and libraries, the Committee consists of the associate deans for research of the four colleges, the senior Medical Center business and finance administrator, legal and compliance officer, and Institutional Review Board director. The committee will report to the Senior Vice President and Provost for Health Affairs, who chairs the IAIMS Steering Committee. The research administration project team, led by Mr. Albrinck, Mr. Guard, and Dr. Highsmith will be responsible for the development and deployment of the project. The project team will meet regularly to assess progress, solve problems, and redirect activities as required. They will receive direction from the Oversight Committee and will make adjustments throughout the course of the grant funded program based on data provided by the formal process of evaluation. For the past several years, AIT&L has used the Unified Method of software development, and especially Use Cases, to determine and refine customer needs and develop software that addresses these needs. This method encourages customer participation in the development phase and gives people a sense of “ownership” of the resulting products, while providing ample opportunities for “tuning” the software during the development stages to ensure that needs are fully addressed.


Technical Description The entire Research Administration project is based on a multi-tiered architecture where applications share information across a database, and the database provides different views of the data to different users, based on their needs and position at the university. Where external sources of data are needed integration at the database level or web application layer level will be implemented. The database underlying the system will be a relational database, currently based on the SQL Server 2000 platform. Because data stored in the database will be central to all applications, we will be using Windows 2000 clustering and/or load balancing to provide maximum availability and performance. The web architecture will be primarily developed using Cold Fusion, Microsoft .NET framework, Macromedia products, and other programming environments as defined by specific needs. A complete list of environments, languages, and protocols is available in the technical specification. Because the application layer is key in integrating all of the services together, we will be using a combination of hardware and software-based load-balancing to provide maximum availability and performance. To ensure system security, we will use multiple firewalls, intrusion detection software, anti-virus software, digital signatures, encryption and other components. Typically, there will be multiple levels of firewalls, with the web servers protected, but quite accessible, the database servers protected behind additional levels of firewall for greater security, and additional security measures applied to certain workstations. Scope Definition The overarching goal is to provide seamless integration of all core administrative research information systems across the university. The completion of this administrative research information system will both enhance the administrative support of researchers through research-friendly systems and allow the hypothesis-driven researchers more time to focus on their work. The Research Administration System will be built as a set of web middleware services that use a strongly integrated database backend to provide resources and information based on expertise, need and interest. All services within the Research Administration System use a security component to control authorization and level of access. The AIT&L Training Center will develop a series of short training experiences to help faculty and staff become familiar with the middleware applications. Additionally, "help" modules will be available online for system users. General System Details: Hardware:

2 Dell Clustered Database Servers (to provide redundancy and scalability) 2 Software Clustered Web Application Servers Media Server(s) or a Storage Area Network (SAN)

Server Software:


Windows 2000 Data Center Server SQL 2000 Enterprise (Clustering version) JRUN (supports J2EE) Cold Fusion Enterprise MX (supports clustering, advanced security, robust development,

multimedia integration) .NET environment Secure Server w/Encryption using PGP and Secure Socket Layers.

Development Tools:

JRUN Ultra Dev Cold Fusion Studio Visual Studio (.Net)

Programming Language:

JSP, CFML, JavaScript, VB.NET, C#, and JScript.NET Specialized Tools:

Web based Testing Tool: Tool to test Interface (browser testing) / Usability / Error / Load / DB Verification.

Database Migration Tool: Tool to manage migration between Development, System Test, User Test, and Production database Environments.

Macromedia Code Testing Tool: Tool to test interpreted and compiled code for JSP, CFML, and ASP applications.

Processing Requirements (including Availability, Backup/Recovery, Staffing):

Availability: 24/7 Fault Tolerance/ load balancing: Microsoft Clustering Technology and Macromedia middleware

clustering technology. Backup/Recovery: Nightly backups performed based on Server Team Specifications

Functional Specifications The Research Administration system will provide the following web services or application components. Functional specifications for each component follow the lists below. Pre-Award Services

• Research Expertise Pre-Award Services • The Research Center (Website) Pre-Award Services • eGrants • Institutional Animal Care and Use Committee (IACUC) Pre-Award Services • Institutional Review Board (IRB) Pre-Award Services • Research Training Pre-Award Services


• Sponsored Programs Online Tracking System Pre-Award Services (SPOTS) Post-Award Services

• The Research Center (Website) Post-Award Services • IACUC Post-Award Services • IRB Post-Award Services • Research Training Post-Award Services • SPOTS Post-Award Services • eContracts • Radiation Safety Post-Award Services • Laboratory Animal Medicine Services (LAMS) Post-Award

Compliance

• IACUC Compliance Services • IRB Compliance Services • Research Training Compliance Services • Radiation Safety Compliance Services • Research Center (Website) Compliance Services

Research Expertise Pre-Award Services Research Expertise Pre-Award Services will provide a means for researchers to let others know of their areas of interest and expertise and their specific research activities. A faculty member seeking collaborators on a project will be able to use this site to find colleagues with appropriate research interests and expertise. The Office of Research will be able to use the information in the Expertise system to target information about funding opportunities to the appropriate researchers. CV Management, a feature included in the Expertise System, will reduce the amount of researcher time needed to maintain NIH Bio-Sketches.

• Research Identification Service • Research Collaborators Search Service • Research Notification Service

Research Identification Service

1. The researcher goes to the research identification component from which they can add or modify one or more Preferred Areas of Activity from a list, which includes items like “Basic Science”, “Clinical Practice”, “Entrepreneurial Activity”, and “Education & Training.”

2. The researcher marks one of these as their Primary Interest. 3. The researcher selects one or more Research Subject Areas from a second list, which

includes items like “Endocrinology” and “Molecular Genetics.” 4. The researcher marks one of the areas as the Primary Subject Area. 5. He/she may enter a comment describing his or her particular sub-areas of interest in this

subject area. 6. Next, he/she selects one or more specific research sub-areas, if appropriate, from a third list. 7. Finally, the researcher enters a self-description about his or her overall research interests and

activities; and specifies keywords of interest and his/her Medline name.


8. If the person has already used the system, he or she can log onto the research identification component to change any of the information already listed.

Diagram of Research Identification Flow

Platform Selection Description Client Configuration System that supports basic Internet Access via a 4th

generation or higher browser Database New Petal of the Integrated Database (Research

Expertise). Will also integrate with the Research Information Award Services section of the Integrated Database.

Applications This Service Spans: Research Expertise, eGrants, IRB, IACUC Capacity Planning

Unit Development Beta Production # Users 10 15 Data Storage (Mb or GB)

50 MB 100 MB 150 MB

Software/Program/Storage (MB or GB)

10 MB 25 MB 50 MB

Peak Usage Periods

It is expected that this service will be available to researchers at any time. Based on log analysis of hits on the Office of Research site, highest use of this application by researchers is anticipated to be in between 11:30 am and 8:00 pm. The highest volume of system processing (i.e. dissemination of expertise alerts, etc.) will be scheduled to take place at off


peak hours (i.e. 3:00 am – 5:00 am).

Interfaces

Description 1.0 Research Identification: Application screens that will enable the researcher to manage their expertise information.

1.1 Research Expertise Main Screen 1.2 Select Areas of Activity Screen 1.3 Select Research Subject Areas Screen 1.4 Select Primary Research Subject Area Screen 1.5 Select Sub Areas Screen 1.6 Enter Self Description and Keywords

Estimated Resources

Stage

Person Days

Roles

Project Management 12 Project planning, scheduling, and monitoring Requirements 31 Customer needs collection and define workflow Analysis 33 System Analysis and Preparation of Specifications Design 47 Database and web interface design Implementation 41 Database Development / Middleware Development /

Interface Development Quality Assurance 21 Interface (browser testing) / Usability / Error / Load /

DB Verification. Evaluation 1 Evaluate Project Maintenance 2 Ongoing maintenance – 5 hours per week.

Research Collaborators Search Service This service will enable researchers to view ongoing research activities at the University. The information that will be viewed and searched will be derived from information in the expertise section of the database as entered by individual researchers. Grant and contract information will also be available from the Sponsored Programs Online Tracking System.

1. The Researcher can select from: View By Institution, View by Name, View by Research Interest, Global search, or Advanced search.

2. If “View by Institution” is selected the researcher can pick the college, department or division. Once selected, research information for that given institution will be viewable.

3. If “View by Name” is selected the researcher can enter the last name of the researcher they want to view. Every researcher that matches the last name entered will be listed with an option to view.

4. If View by Research Interest is selected, a dropdown list of areas will be available. Once an area is selected, researchers that meet the criteria will be listed.


5. If the Global search option is selected, the researcher can enter free form text. The entry of this free form text will initiate a keyword search on an inverted database (the inverted database will be based on queries run to gather information from the integrated database on a nightly basis). Researchers that meet the search criteria will be listed in order of relevance.

6. If Advanced search is selected, researchers will be able to limit their search by institution, expertise, etc.

• People looking for collaborators will only be able to see information that researchers have marked

as viewable via the research identification service. Diagram of Research Collaborators Search Service Flow


generation or higher browser Database Integrated Database with concentration on the

Research Expertise Petal. Applications This Service Spans: Research Expertise


Capacity Planning Unit Development Beta Production

# Users 10 25 Data Storage (Mb or GB)

50 MB 150 MB 200 MB

Software/Program/Storage (MB or GB) -excluding middleware and OS level software.

25 MB 75 MB 100 MB

Peak Usage Periods

It is expected that this service will be available to researchers at any time. Based on log analysis of hits on the Office of Research site, highest use of this application by researchers is anticipated to be in between 11:30 am and 8:00 pm.

Interfaces

Description 2.0 Research Collaborators Service

2.1 View by Institution 2.1.1 Display college, department or division screen 2.1.2 List of Researchers screen 2.1.3 Researcher detail screen

2.2 View by Name 2.2.1 Enter Last Name 2.1.2 List Researchers 2.1.3 Researcher detail screen

2.3 View by Research Interest 2.3.1 Display research interests screen 2.1.2 List of Researchers screen 2.1.3 Researcher detail screen

2.4 Search 2.4.1 Basic search screen (keyword only) 2.4.2 Advanced search screen 2.1.2 List of Researchers screen 2.1.3 Researcher detail screen

Estimated Resources

Stage

Person Days

Roles


Interface Development


Quality Assurance 21 Interface (browser testing) / Usability / Error / Load / DB Verification.

Evaluation 1 Evaluate Project Maintenance 2 Ongoing maintenance – 5 hours per week.

Research Notification Service System Flow The Office of Research and Development will be able to use a researcher’s interest as defined by the Research Identification Service to alert them to appropriate funding activities. (A researcher can specify on the My Preferences page that he will or will not receive such notifications.) Expertise Query:

1. A “scheduler” initiates an event each night that will match expertise with available funding options.

2. Email alerts will be sent based on query results from step 1.

Research Training Query:

1. A “scheduler” initiates an event each night that will check training requirements against a researcher’s Research Training profile, expertise interests, and activity within related systems such as IRB and IACUC.

2. Email alerts will be sent based on query results from step 1. Administration Query:

1. The office of research or other designated administrative groups will have an administrative interface from which they can query for researchers that fit certain research interest.

2. Once that list is generated, the office of research can select a button that will send an email alert to the generated list.

3. The office of research can also enter funding notices or activities that will be picked up by the scheduled event each night.

Researcher Query:

1. The researcher selects the preferences screen option from the notification section. 2. The researcher can modify notification preferences (i.e. notification times, secondary email). 3. Direct access to the Research Identification or research training services will be available. 4. The researcher will also have the option of adding notification from a list of national funding

notice systems.


Diagram of Notification System Service Flow Expertise Query:

Email reseacherregarding f unding

notices that match hisor her expertiseStart Select Researcher

Query to selectexpertise matches

with fundingopportunities f or each

researcher.

End ofResearchers?

No

End

ScheduledEvent

Research Training Query:

Email reseacherregarding training

requirments and/oropportunitiesStart Select Researcher

Query to match trainingrequriments agains profile

and expertise.

End ofResearchers?

No

End

ScheduledEvent

Administration Query:

Start

Manage FundingNotice Information

Manage Research/Funding Notice

Association

Add Funding Notice

Modify/Delete Funding Notice

Select Researcher Associate with afunding notice

Send immediatefunding alert

Group funding noticewith research area(s)


Researcher Query:

Start

View Preferences Edit Preferences

View TrainingRequirments

Direct access toResearch Training

System

Direct access toexpertise orResearch

Identification Service



Research Expertise and Training Tracking Petals. Applications This Service Spans: Research Training, Research Expertise, IRB, IACUC

Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB

Peak Usage Periods


Interfaces

Description 3.0 Research Notification Service

3.1 Manage Funding Information 3.1.1 Add new Funding Notice 3.1.2 Edit Existing Funding Notice


3.1.3 Associate Funding Notice with research area(s) 3.2 Manage Research / Funding Notice Association

3.2.1 Enter Last Name 3.2.2 List Researchers and Select 3.2.3 Researcher Detail Screen 3.2.3 Associate Researcher with notices or groups of notices.

3.3 Manage My Preferences 3.3.1 View Preferences 3.1.2 Edit Preferences 3.1.3 View Training Requirements

Estimated Resources

Stage

Person Days

Roles




The Research Center (Website) Pre-Award, Post-Award, and Compliance Services The Research Center (Web Site) Services will streamline the process of providing useful information to potential researchers. Various offices, including the Institutional Review Board (IRB), the Institutional Animal Care and Usage Committee (IACUC), Medical Center Management Finance and Support Services/Sponsored Programs, College of Medicine Office of Research, and Academic Information Technology & Libraries currently have web sites from which researchers can retrieve materials that include everything from proposal preparation guidelines, proposal templates, and descriptions of standard procedures to online journal access. These web sites also include links to the relevant regulations, summaries of professional training requirements, and other pertinent information. These sites were built and modified to meet researcher-defined needs. Currently these sites are separate and researchers need to wade through a myriad of information to get to their items of interest. Under the Research Information Center, these sites will be transformed into an integrated content management system through which researchers can automatically receive data specific to their research interests as defined in the expertise services component. Researchers will also have the ability to traverse the center. These services will rely heavily on the Media Repository that will enhance existing websites by transforming them into integrated bits of information made available through a robust content management system.


Though not currently integrated, all web sites in the Pre-Award phase from which researchers can retrieve materials also serve to provide Post-Award information to researchers and administrators. For example, publication assistance will be provided by the Office of Research in the form of online manuscript review and feedback from a panel of internal reviewers with matching expertise obtained from the expertise database currently being developed. AIT&L will continue to provide full access to electronic journals. Entrepreneurial activity will be fostered by web links to the Office of Intellectual Property and the new Resource Center for Entrepreneurial Initiatives. Media Repository Technical Overview: The database design includes 5 major parts: Media Topics Descriptors Objects Control

These 5 items will allow us to index and group our information in various fashions: Media: Any piece of media can be defined by the following criteria: Title Keywords Description Creation date Revision date Descriptors (i.e. gender, age, etc.) Objects (layout control i.e. header, footer)

Topics: Any topic or sub topic will be entered into the topics table. Any topic can have the following: Title Keywords Description Creation date Revision date Descriptors (i.e. gender, age, etc.) Objects (layout control i.e. header, footer)

Descriptors: Any item used to describe the information. This information can be used for funneling a user to specific information based on any given criteria such as gender or age. Each descriptor can be assigned to any topic or media associated with the Integrated Database.


Objects: Objects actually define the layout information for any given media or topic. Header, footer, and other layout information can be defined in this area. Each object can be assigned to any topic or media associated with the Integrated Database. Control: Control of the viewed information will be handled using the security model in the Integrated Database along with expertise criteria listed within the expertise component of the database.

Users Groups Roles

In this way we can control access to Pre–Award information. Researcher access would be issued through their account, which is part of a group called “UC Researchers” who have certain permissions based on their defined role within the application. Consequently administrators would belong to a different group that has a different privilege set based on their role. For example, they would see all research related documents and define their criteria. Diagram of Media Repository Flow

Items used to add descriptive information to topicsand media within the integrated database.

Descriptors such as DNA Sequencing, HumanGenome, Research Interest, NIH Resources, etc

will be included in this section. Entries within thisarea will be dynamic.

Information regarding the "type" of media or topic.For example, a topic such as core facilities may be

structured in a certain way as to provide a"template" of information for each facility. This list

will be dynamic.

Topic information. Info such as topic name, description, keywords, etc. will be included. Topics can also link to other topics thus creating sub or

met topics this list will be dynamic.

Container/Pointer for all media on NetWellness.Media should include all documents, audio, videoand other multimedia based materials. This list will

be dynamic.

Descriptors

Media

Objects

Topic

Topic_Descriptors Media Descriptors

Topic_Media

Topic_Objects Media_Objects




Research Expertise and Media Repository Petals. Applications This Service Spans: IDB Content Management System, Research

Expertise Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB

Peak Usage Periods


Interfaces

Description 4.0 Research Information Award Services - Administration

4.1 Manage Descriptors 4.1.1 Add Descriptors

4.1.2 Modify / Delete Descriptors 4.2 Manage Topics

4.2.1 Add Topics 4.2.2 Modify / Delete Topics

4.3 Manage Objects 4.3.1 Add Objects

4.3.2 Modify / Delete Objects 4.4 Manage Media

4.4.1 Add Media 4.4.2 Modify / Delete Media

4.5 Associate Media 4.5.1 Associate Media with descriptors/objects/topics 4.5.2 Associate Topics with objects/descriptors/sub topics


Estimated Resources

Stage Person Days

Roles




eGrants Pre-Award Services Grant Application Pre-Award services will streamline the grant submission process by providing an online grants management center or “eGrants” where researchers and administrators can be guided step by step through an online submission process. Current prototypes of this system support some level of integration with the Integrated Database so that various sections can be automatically filled with demographic from Human Resources Management System (HRMS), space information from Facility Center, and other information. The overall goal is to continue the development and integration of this system with other existing services such as those of the Institutional Review Board, the Sponsored Programs Office, and the Institutional Animal Care and Usage Committee. The proposal information generated in Grants Online will populate the Sponsored Programs Online Tracking System (SPOTS) electronically. Details that are normally completed and verified manually can be done automatically from one central location. Researchers and administrators will also have access to an online archive of information that will be available from anywhere, given the proper level of access and authentication. eGrants Pre-Award Process Flow

1. Researcher logs on to the system.

2. The researcher or grant writer/administrator goes to the site to log in and grabs new grant submission form.

3. In the case of a researcher the departmental business office is alerted. The researcher is also alerted about information they should have ready and available (budget info, etc)

4. The researcher or department then has the ability to fill out various sections of information: Budget, Extramural Support Proposal Review "Gold" Form, Face Page, Abstract Page, Table of Contents, Detailed Budget, Proposed Project Period, Bio, Resources, Personal Data, Personnel Report, Grant Checklist


5. If “Budget” is selected, the researcher or department administrator uploads the completed budget template to the system. Information from the Excel template will be automatically loaded into the grants database. The researcher or department administrator can replace the budget grid at any time. This will automatically update corresponding information.

6. If the “Gold Form" option is selected, the researcher or department administrator fills out gold form – funding info should be pulled from budget. If the budget has not been completed the user will receive an alert.

7. If the “Face Page” is selected, the researcher fills out face page.

8. If the “Abstract Page” is selected, the researcher fills out abstract page.

9. If the “Table of Contents” is selected, the researcher or administrator fills out table of contents. 10. If “Detailed Budget” is selected, the system will check for information that should have been

retrieved from the budget template. If the information is there, it will be filled in automatically. If it is not there, an alert will be given and the corresponding fields will remain empty until the information is available.

11. If “entire proposed project period” is selected, this information can be completed. 12. If “Bio” is selected, the researcher can upload an existing bio or fill out information online that

will generate their bio. This section will eventually interface with research expertise system. There are 3 types of bios (corporate, NIH, NSF).

13. If “Resources” is selected, the resources section will be presented. 14. If “Grant Checklist” is selected, the researcher or department can complete the form. 15. If “Personal data” is selected, the researcher or department can complete this information.

Much of the information in this section will be automatically populated. 16. If “Personnel Report” is selected:

The user can complete information in this section. Personnel should be available from a dropdown list. Once selected, many fields of information will automatically be populated.

17. Submit all:

Once the researcher and department administrator are ready to send their information to OSP, the Submit All button can be selected. This will immediately initiate a validation procedure. The validation procedure will check all requirements and either pass it on for submission or present a list back to the researcher/department administrator stating why it cannot be submitted.

18. If approved, an email alert is sent to all OSP for the submitted application. The OSP office

reviews (should have the ability to cross check against training requirements).


19. OSP manages Salary information – Pull from HRMS – 5% leeway:

As the university negotiates future salary increases for faculty and staff these figures are available to OSP. They, in turn, publish this information to grant faculty and administrators. The salary/benefit increase information is automatically calculated into calculations for multi-year budgets.

20. OSP reviews Checklist 21. Notice sent to Department (Ready for submission or returned for more work) – either approved

with request for minor changes or not approved until changes are made. Diagram of eGrants Flow

Researcher/Administrat or Logs on

to t he syst em.

Authenticat ionRoutine Authenticat ed? New

Submission?

No

Generat e Screen toSelect Act ive Grants

Grant Initializat ionRoutine

View Grant Workspace

Workspace

Select WorkspaceOption

Budget Gold Form Face Abstract TOC D. Budget P.Period Bio Resources Checklist P Data P Report

AutoF ill

AutoFill

Aut oFill

AutoFill

AutoFill

Aut oFill

AutoFill

AutoFill

Aut oFill

AutoFill

AutoFill

Aut oF ill

EditInfo

EditInf o

EditI nfo

EditInfo

EditInf o

EditI nfo

EditInfo

EditInf o

EditI nfo

EditInfo

EditInf o

EditI nfo

Save Save S ave S ave S ave S a ve Save Save Save Save Save Save

Submit Grant Validat e

Valid?

End

No

Workstat ions


generation or higher browser Database Integrated Database, New Pedal to support grant info,

HRMS Applications This Service Spans: SPOTS, eContracts

Capacity Planning

Unit Development Beta Production # Users 10 15


Data Storage (Mb or GB)

50 MB 200 MB 350 MB

Software/Program/Storage (MB or GB)

10 MB 25 MB 50 MB

Peak Usage Periods

It is expected that this service will be available to researchers at any time. Based on log analysis of hits on the Office of Research site, highest use of this application by researchers is anticipated to be in between 11:30 am and 8:00 pm. The highest volume of system processing (i.e. dissemination of expertise alerts, etc.) will be scheduled to take place at off peak hours (i.e. 3:00 am – 5:00 am).

Interfaces

Description 5.0 eGrants Services 5.1 Add New proposal 5.1.1 Route for review and approval 5.1.2 Store in SPOTS for base for award information

Estimated Resources

Stage

Person Days

Roles




Institutional Animal Care and Use Committee (IACUC) Pre-Award Services Institutional Animal Care and Usage Committee (IACUC) Pre-Award Services are used to initiate the protocol submission process for grants involving animal subjects. Principal Investigators complete a protocol submission either before or after the grant application is submitted during the Pre-Award phase. Templates will also be available to researchers to support them during the protocol submission process. Protocol information entered through these services will be readily available to other services in the Research Administration System.


A robust web based system will enable researchers to authenticate and manage new protocol submissions. Institutional Animal Care and Use Committee (IACUC) Pre-Award Services System Flow

1. Investigator (after being logged into the RAS) selects either to submit a new protocol or edit an existing protocol submission under development.

2. The investigator is prompted with any information regarding training requirements that need to

be met in order to meet compliance regulations. 3. The investigator completes the information online. 4. The IACUC office will receive an email alert once the submission is completed. A member of

the IACUC office will conduct a preliminary review of the protocol, ensuring all questions have been adequately addressed. If the protocol needs to be revised prior to IACUC review, the PI will be informed of necessary revisions. Once the final revision is received, the protocol will then be submitted for veterinary review. They will be prompted with an email notification as well.

5. Protocols involving radiation or radioactive materials, biosafety hazards, or environmental or

personnel hazards must be approved by the appropriate committee before final IACUC approval may be granted. The Radiation Safety Committee (RSC) must approve protocols involving radiation or radioactive materials. The Institutional Biosafety Committee (IBC) must approve protocols involving biological agents (i.e. infectious agents or recombinant DNA). Environmental Health & Safety (EH&S) must approve protocols involving environmental or personnel hazards (i.e. chemicals and personnel health). Final IACUC approval is contingent on any outside safety committee approval.

6. The protocol will be sent to a LAMS (Laboratory and Animal Medicine Services) veterinarian.

The veterinarian will review the protocol and sign the endorsement page. The digitally signed protocol & veterinary comments (if any) will be submitted and the IACUC office will receive an alert.

7. The signed protocol & veterinary comments (if any) are then forwarded to members of the

IACUC for review. IACUC members are allotted 2 weeks for protocol review. 8. The IACUC has predetermined requirements for full committee review:

• Category E Protocols: Multiple Major Survival Surgeries, Food and/or Water Deprivation, Burn Studies, Major Survival Surgery for Non-rodent Species, Use of Non Human Primates, The Production of Monoclonal Antibodies in Ascites .

• If a protocol meets any of the above-mentioned criteria, all IACUC members must

review the protocol. Protocols requiring full review may only be approved by a quorum


of the IACUC at a convened meeting. IACUC meetings are held on the second Thursday of every month.

9. Protocols that do no meet any of the full review criteria will undergo designated review.

Designated review consists of a review by a LAMS veterinarian and 2 IACUC members as opposed to review by the entire IACUC. Protocols undergoing designated review can be approved outside of a convened IACUC meeting; therefore, IACUC meeting dates may be irrelevant to the final approval date.

Diagram of Institutional Animal Care and Use Committee (IACUC) Pre-Award Services Flow

Notification :Veterinarian

Radiation SafetyBiohazardsEnv. Health

Email Alert Sent toIACUCStart Protocol Status

New

Existing

InvestigatorCompletes new

form. Someinformation will be

automaticallyposted from the

database

Query to getPI Information

InvestigatorSubmits data andvalidation is doneto ensure integrityof data entered.

Validated? Yes

InvestigatorCompletes new

form. Someinformation will be

automaticallyposted from the

database

No on New Submission

No on Edited Sumission

PreliminaryReview of

Information doneonline by theIACUC office.

Review OK?

NO: sent back to the investigator

Veterianry andother Reviews

conductedReview OK?

No

End

Researcherreceives alert

regarding trainingrequirements


generation or higher version of Internet Explorer. FoxPro Executable.

Database Integrated Database (concentration on Data Warehouse for IACUC), Sirius (Fox Pro Database), Research Training

Applications This Service Spans: Sirius, Research Training, Research Expertise, IACUC Online Protocol Submission, eGrants.


Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB

Peak Usage Periods

It is expected that this service will be available to researchers at any time. Highest use of this application by researchers is anticipated to be in between 8:30 am and 4:30 pm.

Interfaces

Description 6.0 Institutional Animal Care and Use Committee (IACUC) Pre-Award Services

6.1 Add a New protocol 6.1.1 View Compliance information

6.2 Edit an existing protocol 6.2.1 Protocols in progress 6.2.2 View Protocol Detail 6.2.3 Edit Protocol Detail 6.2.4 Validation/Verification

6.3 IACUC Office, Veterinarian, Radiation Safety, Biohazards, Environmental Health

6.3.1 List of Protocols (all statuses) 6.3.2 View Protocol Detail 6.3.3 View Compliance Details 6.3.4 Edit Protocol Detail

Estimated Resources

Stage

Person Days

Roles





Institutional Review Board (IRB) Pre-Award Services Institutional Review Board (IRB) Pre-Award Services are used to initiate the protocol submission process for grants involving human subjects. Principal Investigators complete a protocol submission either before or after the grant application is submitted during the Pre-Award phase. Protocol information entered through these services will be available to other services in the Research Administration System. Institutional Review Board (IRB) Pre-award Services System Flow

1. Investigator (after being logged into the RAS) selects either to submit a new protocol or edit an existing protocol submission under development.

2. The investigator completes the information online. The investigator will be entering information such as the title, purpose, Co-Principal Investigator, co-Investigators, department, sponsor, drugs, keywords, modalities, protocol type and comments.

3. The IRB office will receive an email alert once the submission is completed. A member of the

IRB office will conduct a preliminary review of the protocol, ensuring all questions have been adequately addressed. If the protocol needs to be revised prior to review by an IRB Chair, the PI will be informed of necessary revisions. Once the final revision is received, the protocol will be sent to the IRB Chair for review. The Chair will be prompted with an email notification as well.

4. The IRB Chair reviews the protocol and determines whether it should be Exempt, Expedited,

Executive Expedited, or Full Board Reviewed. 5. A protocol that is marked for Full Board Review will have a primary (and possibly secondary

and tertiary) reviewer selected. The protocol is put on the agenda for one of three committees to review.

6. A protocol that is marked as Expedited (includes a consent form), can be approved by the IRB

Chair person after review by three other reviewers without a board review. 7. A protocol that is marked as Executive Expedited (involves chart review without a consent

form), can be approved by the IRB chairperson. 8. A protocol that is marked as Exempt has been identified as not needing a review by the IRB

chairperson. 9. Protocols involving radiation or radioactive materials, biosafety hazards, or environmental or

personnel hazards must be approved by the appropriate committee before final IRB approval may be granted. The Radiation Safety Committee (RSC) must approve protocols involving radiation or radioactive materials. The Institutional Biosafety Committee (IBC) must approve protocols involving biological agents (i.e. infectious agents or recombinant DNA).


Environmental Health & Safety (EH&S) must approve protocols involving environmental or personnel hazards (i.e. chemicals and personnel health).

10. Protocols that have been approved under Full Board, Expedited, or Executive Expedited

review, will be given an approval date that is in effect for one year. Diagram of Institutional Review Board (IRB) Pre-Award Services Flow

New

Existing


generation or higher version of Internet Explorer. Database Integrated Database with concentration on the IRB

Petal Applications This Service Spans: Research Training, Research Expertise, eGrants

Capacity Planning

Unit Development Beta Production # Users 10 25 250 Data Storage (Mb or GB)

50 MB 150 MB 200 MB



25 MB 75 MB 100 MB

Peak Usage Periods


Interfaces

Description 7.0 Institutional Review Board (IRB) Pre-Award Services



7.3 IRB, Radiation Safety, Biohazards, Environmental Health 7.3.1 List of Protocols (all statuses) 7.3.2 View Protocol Detail 7.3.3 View Compliance Details 7.3.4 Edit Protocol Detail

Estimated Resources

Stage

Person Days

Roles





Research Training Pre-Award, Post-Award Services Research Training Pre-Award, Post-Award Services enable researchers and administrators to manage compliance information. Researchers can be alerted to compliance requirements based on grant proposal submission and/or protocol submission information. The Research Training System is built as a part of the Integrated Database that enables demographic and security information to span across multiple applications. However stronger integration between Research Training, IACUC, and IRB needs to be established. Integration within the Research Administration System will enable researchers to ensure their compliance with federal regulations. The Research Training system will continue to be enhanced. Currently the system is designed to select training requirements based on roles as defined in the Integrated Database. For example, a Principal Investigator on a Human Subjects protocol is required to have met certain training requirements. There is also an administrative component that enables the Legal Department to define requirements for individuals. Tighter integration with IRB, IACUC, and other systems will permit more detailed definition of training requirements for each individual investigator. Enhancements to this system will also give more control to departmental administrators so that management of training requirements for the University is spread across several groups and is therefore not limited by lack of administrative resources. In addition, training modules (short, interactive focused instructional information) can be developed using web technology and made available as a resource. A combination of Research Training and web based course materials enable researchers and administrators to manage and update their compliance with rules of regulatory bodies. The Research Training System will make it easier for researchers and staff at the medical center to maintain their required certifications. Individuals will log onto the system to review their current professional training requirements and compliance status, and from this site they will complete a self-assessment questionnaire to identify any changes in their requirements based on changes in their research and professional activities. The system will automatically notify researchers in advance of the expiration of any required certifications. As stated above, integration of Research Administration offices with this system will reduce the need for researchers to document their current compliance status. Online compliance verification allows the Research Administration offices, like Radiation Safety, IACUC, and IRB, to call up a researcher’s compliance record. As a result, researchers are no longer required to submit compliance certificates to the research administrative offices, and the offices can easily verify the compliance status of anyone proposing or engaged in funded research. Research Training Pre-Award, Post-Award Services System Flow

1. The service can be invoked in several ways:

a. An Investigator tries to submit a new protocol via the IRB system.


b. An Investigator tries to submit a new protocol via the IACUC system. c. An IRB administrator chooses to verify the investigators training their requirements and

status. d. An IACUC administrator chooses to verify the investigator’s training their requirements

and status. e. A researcher tries to submit a new grant via the eGrant system. f. A Grants Online administrator chooses to verify a researchers training requirements and

status. g. A person logs into the Research Training system to view their requirements and status.

2. Once invoked, the service will query for the investigator(s) training requirements and status. 3. The individual’s requirements and status will be compared to overall requirements for the type

of submission in question. 4. The results will then be passed back to the system that invoked the service for compliance

processing (see compliance section). Diagram of Research Training Pre-Award, Post-Award Services System Flow



generation or higher version of Internet Explorer. Database Integrated Database with a focus on the Research

Training Petal. Applications This Service Spans: IRB, IACUC, Radiation Safety, eGrants

Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB

Peak Usage Periods


Interfaces

Description 8.0 Research Training Pre-Award, Post-Award Services 8.1 View persons training record

8.1.1 View Compliance information Estimated Resources

Stage

Person Days

Roles





Sponsored Programs On-line Tracking System (SPOTS) Pre-Award Services The SPOTS system will be populated with data from the Grants On-line System (eGrants). That information will be available to the Office of Sponsored Programs (OSP) as well as various departments. This will be the “pending” information that can be used for either monitoring the grant application or for reporting purposes. SPOTS Services Pre-Award Flow

1. Office of Sponsored Programs receives a grant application for review through the Grants On-line System.

2. The OSP approves the application electronically when the review is complete. 3. The approval action causes a new record to be established in the SPOTS system for this

application. 4. Authorized users can now see the record in SPOTS as a pending grant and use this record as

the base for the award when it comes. Diagram of SPOTS Services Pre-Award Flow


generation or higher version of Internet Explorer. Database Integrated Database with a focus on the Research

Training Petal. Applications This Service Spans: Research Training, IRB, IACUC, eGrants


Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB

Peak Usage Periods


Interfaces

Description 9.0 SPOTS Pre-Award Services 9.1 View pending proposals

Estimated Resources

Stage

Person Days

Roles




IACUC Post-Award Services IACUC Post-Award Services are used to manage and monitor protocols after the grant has been awarded. Principal Investigators complete a protocol submission either before or after the grant application is submitted during the Pre-Award phase. Templates will also be available to researchers to support them during the protocol submission process. Protocol information entered through these services will be readily available to other services in the Research Administration System.


Institutional Animal Care and Use Committee (IACUC) Post-Award Services System Flow

1. Investigator (after being logged into the RAS) selects either to submit a new progress report. 2. Investigator is prompted with any information regarding training requirements that need to be

met in order to meet compliance regulations.

3. The investigator completes the information online. 4. The IACUC office will receive an email alert once the submission is completed. A member of

the IACUC office will conduct a preliminary review of the progress report, ensuring all questions have been adequately addressed.

5. Review for a progress report consists of a review and sign-off by a LAMS veterinarian and the

Chair as opposed to review by the entire IACUC. Progress reports can be approved outside of a convened IACUC meeting.

Diagram of Institutional Animal Care and Use Committee (IACUC) Post-Award Services Flow

Notification :Veterinarian

Radiation SafetyBiohazardsEnv. Health

Email Alert Sent toIACUCStart

InvestigatorCompletes

progress reportform. Some

information will beautomatically

posted from thedatabase

Query to getPI Information

InvestigatorSubmits data andvalidation is doneto ensure integrityof data entered.

Validated? Yes

PreliminaryReview of

Information doneonline by theIACUC office.

Review OK?

NO: sent back to the investigator

Veterinary andChair Reviews

conductedReview OK?

No

End

Researcherreceives alert

regarding trainingrequirements

• All reviewers will have access to the researcher’s training compliance information. Platform Selection Description Client Configuration System that supports basic Internet Access via a 4th


generation or higher version of Internet Explorer. FoxPro Executable.

Database Integrated Database (concentration on Data Warehouse for IACUC), Sirius (Fox Pro Database), Research Training

Applications This Service Spans: Sirius, Research Training, Research Expertise, IACUC Online Protocol Submission, SPOTS.

Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB

Peak Usage Periods


Interfaces

Description 10.0 Institutional Animal Care and Use Committee (IACUC) Post-Award Services



10.3 IACUC Office, Veterinarian, Radiation Safety, Biohazards, Environmental Health, Sponsored Programs

10.3.1 List of Protocols (all statuses) 10.3.2 View Protocol Detail 10.3.3 View Compliance Details

Estimated Resources

Stage

Person Days

Roles

Project Management 12 Project planning, scheduling, and monitoring Requirements 32 Customer needs collection and define workflow Analysis 33 System Analysis and Preparation of Specifications Design 71 Database and web interface design


Implementation 54 Database Development / Middleware Development / Interface Development

Quality Assurance 26 Interface (browser testing) / Usability / Error / Load / DB Verification.

Evaluation 1 Evaluate Project Maintenance 2 Ongoing maintenance – 5 hours per week.

Institutional Review Board (IRB) Post-Award Services IRB Post-award Services are used to maintain the protocol in good standing after it has been initially approved. Principal Investigators will file annual progress reports, modifications, or adverse events as appropriate during the life of the protocol. Protocol information entered through these services will be readily available to other services in the Research Administration System. IRB Post-Award Services are used to manage and monitor protocols after the grant has been awarded. The IRB office has the ability to monitor protocol submissions, changes in protocol status, adverse events and other information (such as identity of the Principal Investigator) via the IRB system. The current version of this system is web based and runs on top of the Integrated Database. Use is primarily restricted to the IRB office and department administrators. Integration within the Research Administration System would enable researchers to access and update the IRB system. IRB Progress Report Services Flow

1. IRB Office will notify the investigator electronically that there is a progress report due. This report notice will include an itemized list of adverse events that have occurred since the initial approval or last progress report, whichever is latest. It will also notify the researcher about the compliance training status of those listed on the protocol.

2. The investigator (after being logged into the RAS) selects the protocol progress report form to

fill out on-line and submit electronically. 3. When the investigator enters the IRB protocol number, the system automatically populates

several fields in the progress report from the database. The fields include PI name, Co-PI name, Co-investigators, PI department, title, sponsor, initial approval date, last approval date.

4. The investigator completes the additional information that is required for this period and clicks

on the submit button. 5. The IRB office will receive an email alert once the submission is completed. A member of the

IRB office will conduct a preliminary review of the protocol progress report, ensuring that all questions have been adequately addressed. If the report needs to be revised prior to review by an IRB Chair, the PI will be informed of necessary revisions. Once the final revision is received, the protocol progress report will be sent to the IRB Chair for review. The Chair will be prompted with an email notification as well.


6. The IRB Office then decides what type of review the report will have. If the original protocol had full board review, then the report will unless it is doing final patient follow-up. If it had expedited review, then the report will unless it has had any adverse events during the reporting period.

7. Protocol progress reports that have been approved under Full Board, Expedited, or Executive

Expedited review, will be given an approval date that is in effect for one year. Diagram of Institutional Review Board (IRB) Post-award Progress Report Services Flow

New

Existing



Petal Applications This Service Spans: Research Training, SPOTS

Capacity Planning


50 MB 150 MB 200 MB



25 MB 75 MB 100 MB

Peak Usage Periods


Interfaces

Description 11.0 Institutional Review Board (IRB) Post-Award Progress Report Services

11.1 Add a new progress report 6.1.1 View Compliance information


11.3 IRB Office, Radiation Safety, Biohazards, Environmental Health, Sponsored Programs

11.3.1 List of Protocols (all statuses) 11.3.2 View Protocol Detail 11.3.3 View Compliance Details

Estimated Resources

Stage

Person Days

Roles




Protocol Modification Forms Flow

1. Between progress reports, the researcher will be able to make changes to a protocol by filling out an online modification form.


2. When the PI brings up the modification form and enters the IRB protocol number, the system will populate certain fields in the same way that it did in the progress report form. The fields include PI name, Co-PI name, Co-investigators, PI department, title, sponsor, initial approval date, last approval date.

3. The investigator will fill in the remaining information that describes the modification. 4. This form will be submitted electronically and numbered electronically for the specific protocol. 5. The IRB office will receive an email alert once the submission is completed. The IRB Office will

review the modification, ask for further information if necessary, and then approve the form. Diagram of IRB Protocol Modification Services Flow




Capacity Planning


50 MB 150 MB 200 MB



25 MB 75 MB 100 MB

Peak Usage Periods


Interfaces

Description 12.0 Institutional Review Board (IRB) Post-Award Modification Services

12.1 Add a new modification form 12.2 Edit an existing protocol

12.2.1 Modifications in progress 12.2.2 View Modification Detail 12.2.3 Edit Modification Detail 12.2.4 Validation/Verification


12.3.1 List of Protocols (all statuses) 12.3.2 View Protocol Detail

Estimated Resources

Stage

Person Days

Roles




IRB Adverse Events Services Flow

1. The investigator will fill out an adverse event form on-line for each event on a protocol. 2. The investigator will click on the adverse event form, fill in the IRB protocol number, and the

system will fill in the standard information from the protocol The fields include PI name, Co-PI name, Co-investigators, PI department, title, sponsor, initial approval date, last approval date.


3. When the investigator completes the adverse event form and clicks on submit to send it electronically, the system will assign the next available number for an adverse event on the appropriate protocol.

4. The IRB office will receive an email alert once the submission is completed. The IRB Office will review the form for completeness and accept it.

5. An electronic acknowledgement notice will go back to the investigator. Diagram IRB Adverse Events Services Flow




Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB

Peak Usage Periods

It is expected that this service will be available to researchers at any time. Highest use of this application by researchers is


anticipated to be in between 8:30 am and 4:30 pm. Interfaces

Description 13.0 Institutional Review Board (IRB) Post-Award Adverse Events Services

13.1 Add a new adverse event form 13.2 Edit an existing adverse event

13.2.1 Adverse Events in progress 13.2.2 View Adverse Event Detail 13.2.3 Edit Protocol Adverse Event Detail 13.2.4 Validation/Verification


13.3.1 List of Protocols (all statuses) 13.3.2 View Protocol Detail 13.3.3 List of Adverse Events

Estimated Resources

Stage

Person Days

Roles




Sponsored Programs Online Tracking System (SPOTS) Post-Award Services Sponsored Programs Online Tracking Services will be enhanced. We propose to extend the capability of (SPOTS) by converting it to a web application that is totally integrated into the medical center Integrated Database architecture. This would enable integration with other applications or services such as Grants On-line, IRB, IACUC, Radiation Safety, Facility Center, and Contract Approvals. We would incorporate new information capabilities in the enhanced services that will contain aggregate summary data that can be used to report research outcomes to various groups (annual State of the Medical Center address, Ohio Board of Regents reports, and accreditation/licensure renewals).


SPOTS Services Post-Award Flow

1. Grant proposal information is already in SPOTS from the time it was approved in the Grants On-line System.

2. When the sponsor’s award letter is received in the Office of Sponsored Programs, the award

information will be entered into SPOTS in the existing pending record. 3. A notification will then be sent to the department with a request to complete an A-323 form to

create an account in the CUFS system. Diagram of SPOTS Services Post-Award Flow


generation or higher version of Internet Explorer. Database Integrated Database Applications This Service Spans: Research Training, IRB, IACUC, eGrants

Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB

Peak Usage Periods

It is expected that this service will be available to researchers


at any time. Highest use of this application by researchers is anticipated to be in between 8:30 am and 4:30 pm.

Interfaces

Description 14.0 SPOTS Post-Award Services

14.2 Edit an existing pending proposal 14.2.1 Update status to awarded 14.2.2 View grant detail 14.2.3 Edit grant details 14.2.4 Validation/Verification


14.3.1 List of Grants (all statuses) 14.3.2 View grant Detail

Estimated Resources

Stage

Person Days

Roles




eContracts Administration Post-Award Services Contract Administration Services will continue to be expanded. Currently the eContracts Approval System enables departmental administrators, Purchasing Department, the Office of Sponsored Programs, Contract Administrators, and the Legal Affairs Department to electronically, route, edit, and approve contracts via a secured web-based interface. Forms and documentation required for the contract review process are completed online and stored in the Integrated Database. The current system is limited by the fact that it does not integrate with other applications such as IRB, IACUC, SPOTS, CUFS, and HRMS. Certain information that must be completed is already available in these systems, but is duplicated via entry forms. This introduces much overhead and can increase the error rate. Conversely, information gathered in the eContracts Approvals system is needed in other services such as SPOTS. A strong integration between these systems will make this information seamlessly available.


eContracts Approvals Post-Award Services Flow

1. A designated department administrator will be responsible for initiating the electronic process.

The system should remind the department initiator to check that the proper intradepartmental authorizations have been obtained. If hard copy documents need to be included, the department initiator will scan the needed documents and submit them through the eContracts Approvals System.

2. Once the authorized department initiator approves the contract, it will be sent to the Office of

Sponsored Programs for an initial review. 3. The contract will then be sent to the contracts administrator to review the contract and make

any changes, if needed, and then route to appropriate reviewers. The contracts administrator will define the workflow for the contract by checking appropriate boxes as defined by the checklist.

4. Each reviewer will be able to approve the contract using an electronic signature. The reviewer

will also be able to disapprove a contract and add comments if needed. If a contract is disapproved, it will return to the previous step in the process for further editing, etc.

5. The contract is then sent to the next person on the checklist if OK, or back to Diane if changes

are needed 6. The contract will then be sent back to the contracts administrator to review the contract and

make any changes if needed.

7. Once the contracts administrator signs the contract and the contract approval sheet, the documents will be sent to Linda Harpster for review. An email alert regarding the contracts status should also be sent to the originating department. In some cases hard copies of the contracts will need to be given to Linda Harpster for signing. This will be available from the eContracts Approval System.

8. Contract Officer reviews and applies the official UC signature (either electronically or

manually).


Diagram of eContracts Approvals Post-Award Services Flow


generation or higher version of Internet Explorer. Database Integrated Database Applications This Service Spans: Research Training, SPOTS

Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB

Peak Usage Periods



Interfaces

Description 15.0 Contract Approval Services

15.1 Add a new contract 15.1.1 Review contract 15.1.2 Revise contract 15.13 Route contract for signature

Estimated Resources

Stage

Person Days

Roles




Radiation Safety Post-Award Services The Radiation Safety system will continue to be enhanced. This system currently monitors the use and purchase of radioisotopes, the disposal of waste, and the training for users of radioactive materials. The system serves the Medical Center and three affiliated hospitals: University Hospital, Cincinnati Veterans Affairs Medical Center, and Cincinnati Shriners Hospital. Currently this system is not integrated with any other applications. Therefore, duplication of demographic information is common and may introduce errors. By integrating this with other applications, we decrease duplication as well as have the ability to track training requirements and monitor compliance globally across all systems. Radiation Safety Isotope Purchase Services Flow

1. The department (after being logged into the RAS) selects the request to purchase radioisotopes form to fill out on-line and submit electronically.

2. When the department enters the authorized user’s badge number, the system automatically

populates several fields in the form from the database. 3. The department selects the name of the cognizant authorized user from a dropdown list and

clicks on the submit button to send the form electronically.


4. The Radiation Safety Office will receive an e-mail alert once the submission is completed. A member of the office will review the form to verify the quantity of the request against what is allowed by the license.

5. After the review is complete, the Radiation Safety Office will simultaneously send the request

to purchasing and send an electronic notification to the department to confirm the placement of the order.

Diagram of Radiation Safety Isotope Purchase Services Flow



Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB


Peak Usage Periods


Interfaces

Description 16.0 Radiation Safety Isotope Purchases Services

16.1 Add a new purchase request 16.11 Review purchase request against license

Estimated Resources

Stage

Person Days

Roles




Laboratory Animal Medicine Services (LAMS) Post-Award Services LAMS will be accessible through a web form where researchers can place their animal orders electronically. Laboratory Animal Medicine Services (LAMS) Post-award Order Services Flow

1. The department (after being logged into the RAS) selects the request to order animals form to fill out on-line and submit electronically.

2. When the department enters the IACUC protocol number, the system automatically populates

several fields in the form from the database. 3. The department selects the animals from a dropdown list and clicks on the submit button to

send the form electronically. 4. The LAMS Office will receive an e-mail alert once the submission is completed. A member of

the office will review the form to verify the quantity of the request against what is allowed by the protocol.


5. After the review is complete, the LAMS Office will simultaneously place the order and send an electronic notification to the department to confirm the placement of the order.

Diagram of Laboratory Animal Medicine Services (LAMS) Post-Award Services Flow


generation or higher version of Internet Explorer. Database Integrated Database with concentration on IACUC Applications This Service Spans: Research Training, IACUC, SPOTS, CUFS

Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB

Peak Usage Periods


Interfaces

Description 17.0 LAMS Animal Ordering Services


17.1 Add a new animal order 17.11 Review order against protocol

Estimated Resources

Stage

Person Days

Roles




Institutional Animal Care and Use Committee (IACUC) Compliance Services Compliance for participation in an IRB protocol can be validated in a number of ways. It can be reviewed on-line by the investigator, the researcher's academic department, or the IRB Office at anytime. IACUC Compliance Services System Flow Protocol/Progress Report Submission:

1. The investigator (after being logged into the RAS) selects the appropriate form to fill out on-line and submit electronically.

2. When the investigator enters their Social Security number or the IACUC protocol number

depending on the form, the system automatically populates several fields in the protocol form from the database. The fields can include PI name, Co-PI name, Co-investigators, PI department, title, sponsor, initial approval date, last approval date.

3. The system checks the social security numbers of each researcher on the protocol and returns

compliance information to the protocol form. 4. The investigator completes the additional information that is required for this period and clicks

on the submit button. 5. The IACUC Office will receive an email alert once the submission is completed. Part of the

review process for the form is to check the compliance status of the protocol researchers. The information showing in the protocol will give them the current status. If more information is needed, they can go on-line for additional training information.


6. If the compliance status of everyone on the form is in good standing, the document is

approved. Diagram of IACUC Protocol/Progress Report Submission Compliance Services Flow



Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB

Peak Usage Periods



Interfaces Description

18.0 Institutional Animal and Use Committee (IACUC) Protocol/Progress Report Compliance Services

18.1 Add a new progress report 18.1.1 View Compliance information

Estimated Resources

Stage

Person Days

Roles




Institutional Review Board (IRB) Compliance Services Compliance for participation in an IRB protocol can be validated in a number of ways. It can be reviewed on-line by the investigator, the researcher’s academic department, or the IRB Office at anytime. IRB Compliance Services System Flow Protocol/Progress Report Submission

1. The investigator (after being logged into the RAS) selects the appropriate form to fill out on-line and submit electronically.

2. When the investigator enters their Social Security number or the IRB protocol number

depending on the form, the system automatically populates several fields in the protocol form from the database. The fields can include PI name, Co-PI name, Co-investigators, PI department, title, sponsor, initial approval date, last approval date.

3. The system checks the social security numbers of each researcher on the protocol and returns

compliance information to the protocol form. 4. The investigator completes the additional information that is required for this period and clicks

on the submit button.


5. The IRB office will receive an email alert once the submission is completed. Part of the review process for the form is to check the compliance status of the protocol researchers. The information showing in the protocol will give them the current status. If more information is needed, they can go on-line for additional training information.

6. If the compliance status of everyone on the form is in good standing, the protocol is approved.

Diagram of IRB Protocol/Progress Report Submission Compliance Services Flow




Capacity Planning


50 MB 150 MB 200 MB


25 MB 75 MB 100 MB

Peak Usage Periods

It is expected that this service will be available to researchers


at any time. Highest use of this application by researchers is anticipated to be in between 8:30 am and 4:30 pm.

Interfaces

Description 19.0 Institutional Review Board (IRB) Protocol/Progress Report Compliance Services

19.1 Add a new protocol or progress report 19.1.1 View Compliance information

Estimated Resources

Stage

Person Days

Roles




Research Training Compliance Services Research training compliance is critical in several medical and scientific areas of the Medical Center. There are training requirements for workers in human research, animal research, clinical work with patients, and researchers and clinicians who work with radioisotopes and radiation. These requirements also affect the approval of protocols and grants. The actual compliance for individuals can be monitored on-line by the Compliance Officer, IRB, IACUC, Radiation Safety, Office of Sponsored Programs, and the departments where the individuals are employed. Radiation Safety Compliance Services The Radiation Safety Office is charged with maintaining compliance for the University of Cincinnati and certain affiliated institutions in the use and handling of radioisotopes. This responsibility includes authorizing and training radiation workers, and purchasing, storing, and disposing of radioisotopes and their waste. Radiation Safety Services Compliance Flow Authorizing Users

1. The department (after being logged into the RAS) selects the new radiation worker form to fill out on-line and submit electronically.


2. When the department enters the worker’s social security number, the system

automatically populates several fields in the form from the database. The fields include worker’s name, date of birth, age, work phone, work fax, title, gender, mail location, and test status.

3. The department selects the name of the cognizant authorized user and clicks on the

submit button to send the form electronically.

4. The Radiation Safety Office (after being logged into the RAS) will receive an email alert once the submission is completed. A member of the office will review the form on-line to verify the training status of both the worker and the authorized user.

5. After the review is complete, the Radiation Safety will send electronic notification to the

department to confirm the approval of the worker. Diagram of Radiation Safety Compliance Services Flow



Capacity Planning

Unit Development Beta Production # Users 10 25 250 Data Storage (Mb or 50 MB 150 MB 200 MB


GB) Software/Program/Storage (MB or GB) -excluding middleware and OS level software.

25 MB 75 MB 100 MB

Peak Usage Periods


Interfaces

Description 20.0 Radiation Safety Compliance Services

20.1 Add new radiation worker 20.1.1 View training status

Estimated Resources

Stage

Person Days

Roles




Resources Required This project will require 4.31 full-time equivalent staff for each of four years to complete. These personnel will fall into the following categories: Faculty/content experts .65 FTE Technology specialists 3.56 FTE Administrators .10 FTE Evaluation This project has two major objectives. The first objective is to create an electronic grants/research administration system at the University of Cincinnati Medical Center. The second objective is to increase the efficiency by which users (researchers and administrators) apply for, conduct, and report on grants and research.


The first objective focuses heavily on the development and integration of automated systems for gathering, organizing, and reporting data from throughout the research enterprise. The evaluation of this objective will rely on monitoring these systems and comparing them to the product/outcome specifications that have been developed. Evaluation systems are built into the automated systems in the form of various reports and statistics. The evaluation strategy for this objective will be almost exclusively summative in nature. The second objective is centered on users' (researchers and administrators) ability to use automated research administration services to assist them with grant submission and administration. The important evaluation questions for this objective are related to the user interfaces of the automated resources and the match between user needs and IT applications. Changes in user behavior and levels of satisfaction will be key measures in the evaluation of this objective. The tables below identify several major milestones for the two project objectives. For each milestone there are several evaluation measures and uses for the data. Evaluation data will be collected as an integral part of the ongoing project. The reports from these data will be continuously fed back to the Project Team and key administrators. In the spirit of continuous quality improvement (CQI) the data will be compared with baseline data and project benchmarks in order to help the Project Team reach its overall goals. 1. Creation of an electronic grants/research administration system.

Milestones Evaluation Measures Feedback

Development of a common data dictionary

Level of agreement among university administrators on common variable specifications

Listing of incompatible data field across data forms and reports

Satisfaction by users that common variable list meets needs

Weekly reports to Project Team for first six months. Reports at least monthly thereafter. Satisfaction survey reports biennially reported to Project Team

Integration of existing electronic systems

Amount of lost or incorrect data Number of independent systems integrated Amount of time/effort required to integrate

independent systems into central database

Weekly reports to Project Team for first six months. Reports at least monthly thereafter. Cost analysis for integration presented biennially to Project Team

Web interface for data input and reporting

Number of web access problems Number and type of SQL interface problems

Weekly reports to Project Team for first six months. Reports at least monthly thereafter.

Automatic data transfer among different administrative

Number of data failures Time required to find and fix problems System downtime Existence, and use of, parallel paper systems

Weekly reports to Project Team for first six months. Reports at least monthly thereafter.


Milestones Evaluation Measures Feedback systems Quarterly tracking of

parallel paper systems and their use

2. Increase the efficiency by which users (researchers and administrators) apply for, conduct,

and report on grants and research.

Milestones Evaluation Measures Feedback Provide grant information that meets users needs

Number/type of "pushed" information to users Match between "pushed" information and

users needs User satisfaction with "pushed" information

(survey)

Reports on information alerts reviewed monthly by Project Team "Match" audits conducted randomly and reported quarterly to Project Team User survey reported biennially to Project Team

Streamline grant submission process

Time to complete grant form submission (compared to "paper" baseline)

User complaints regarding automated forms User/data errors in electronic forms

submission Number of missed grant submission deadlines

Time studies conducted randomly and reported quarterly to Project Team Error reports reviewed monthly by Project Team

Streamline compliance training/reporting

Number of incomplete compliance reports Time to complete compliance training

compared with baseline Usefulness of administrative reports (survey)

Regular meetings between IUCUC and IRB administrators to review data reports with Project Team

Streamline grant budgeting, accounting, and reporting process

Time to process grant budget forms Number, and type, of administrative reports

generated for research grants Number of report errors, lost data, incorrect

information Time to reconcile data errors User satisfaction survey

Report statistics reviewed with Project Team monthly User satisfaction survey conducted biennially for first two years and annually thereafter


Bibliography 1. InfoEd International, Inc., (No date), [Online] Available: http://www.infoed.org/. Accessed May 30,

2002. 2. MIT Office of Sponsored Programs: Coeus, (No date), [Online]. Available:

http://web.mit.edu/osp/www/coeus/. Accessed May 30, 2002. 3. Vanderbilt University Medical Center Reporter, (January 11, 2002), [Online]. Available:

http://www.mc.vanderbilt.edu/reporter/index.html?ID=1883. Accessed May 30, 2002.

Timeline The detailed implementation schedule that follows shows a breakdown of tasks needed to complete the project, the time/effort required for each task, and the order in which tasks will be completed.

Research Administration final - University of · PDF fileAppendix 15: Research Administration...

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