Application for 2012 University of California Larry L. Sautter Award for
Innovation in Information Technology
Date:
May 15, 2012
Project Title:
Research Volunteer Registry
University of California Davis Health System
Submitted:
Kent Anderson, M.S., Research Technology Manager; Associate Director, CTSC
Biomedical Informatics
UC Davis Health System IT, Co-Director, Biomedical Informatics
kent.anderson@ucdmc.ucdavis.edu (916) 703-9123
Dan Cotton, Educational Technology & Application Development Manager
UC Davis Health System IT
daniel.cotton@ucdmc.ucdavis.edu (916) 734-2019
Michael Minear
Chief Information Officer; Director, CTSC Biomedical Informatics
michael.minear@ucdmc.ucdavis.edu (916) 734-7131
I. Project Leaders and Team Members
UC Davis strongly promotes a team science approach as a methodology for translational work. One of
the key elements leading to the success of this project was the consistent partnering of individual experts
throughout UC Davis Health System and other institutions to achieve team goals.
Project Leadership
 Daniel Cotton, Educational Technology & Application Development Manager
 Kent Anderson, M.S., Research Technology Manager; Associate Director, CTSC Biomedical
Informatics
Information Technology
 Peter Ruan, Lead Developer
 Ann Mankser, Analyst
 Alesia Minyard, Analyst
Clinical Translation Science Center (CTSC)
 Ayan Patel, Application Programmer, CTSC Biomedical Informatics
 Sam Morley, M.S., Biomedical Informatics Program Manager
M.I.N.D. Institute
 Lou Ann Barnett, Ph.D., PMP, Autism Phenome Project Manager
 Brenda Shelton, Senior Community Health Representative
Executive Sponsors
 Michael Minear, Chief Information Officer, UC Davis Health System; Director, CTSC Biomedical
Informatics
 Robert Hales, M.D., Joe P. Tupin Endowed Chair, Professor of Clinical Psychiatry and Chair
 Narriman Shahrokh, MIND Chief Administrative Officer
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II. Summary
A Research Volunteer Registry has been created by UC Davis Health System in order to support
research subject recruitment across the Health System for all types of research. This application has
allowed the Health System to consolidate multiple registry databases from different departments into a
single, more compliant, feature rich, and efficient tool for both community volunteers and research staff
alike. The application integrates with the Research Electronic Data Capture (REDCap) software system
so that once the study participants have confirmed their participation, they can be seamlessly imported
into REDCap where a study profile has been defined and study data collection can begin. This new
system reduces liability by ensuring access to volunteer data is restricted until the proper consent is
received.
III. Project Description
Background
The UC Davis Health System conducts more than 1,000 studies each year in areas of medical, clinical,
and behavioral intervention and observation involving human volunteers. Multiple databases following
varying recruitment and security methodologies had been used to track research volunteers. In the past,
Excel, Access, and custom built software were common applications used to manage data for tracking
research volunteers. These legacy systems had propagated throughout the research enterprise, making
security and privacy compliance difficult to manage.
The MIND Institute (Medical Investigation of Neurodevelopmental Disorders) was managing volunteer
registry data in a legacy fashion within unsupported application technology lacking desired functionality
and improvements. UCDHS Information Technology (IT) partnered with the MIND research staff and
faculty to build a generic set of software tools and services to incorporate the requested enhancements,
while modernizing the Health System’s approach to volunteer management. The success of the RVR is
due to the collaboration between IT, MIND executives, faculty and staff.
The Research Volunteer Registry created a starting point for UC Davis Health System researchers to
connect with community members interested in volunteering for research. IT was able to address and
improve several problematic areas of research subject recruitment experienced in the past. Three
specific areas of improvement were focused on:
1. Research volunteers become “owners” of their information – In legacy systems tracking
community research volunteers, information was collected once, and rarely updated with any
regularity. In each system volunteer information was static, and rapidly became obsolete as
volunteers moved, changed contact information, or in the case of pediatric subjects, grew older
and became ineligible for pediatric studies. With the Volunteer Registry, UC Davis Health System
IT shifted the data management paradigm to allow research volunteers to directly and easily
manage their own information. The system sends reminder emails annually to encourage
volunteers to update and validate their information and to affirm interest in research participation.
The volunteer is empowered to be selective about their research participation, and can
anonymously decline to participate in any study without obligation.
2. Bridging and protecting the gap between volunteer and research recruitment – This
valuable repository of research volunteers with their demographic and associated disease
information and study preferences requires an interface to navigate and select cohorts for follow
up. In legacy registries, the information obtained about research subjects was often poorly
protected from data loss or theft of personal information, or multiple researchers could have open
access to the entire data set. The UC Davis Research Volunteer Registry was designed to
comply with standard health data security practices (Health Insurance Portability and
Accountability Act, HIPAA) to ensure the privacy of volunteer data, including “blinding”
investigators to personally identifiable information about the volunteers until explicit consent is
obtained. This added layer of sophisticated protection automates even the “honest broker”
approach commonly used to identify research cohorts.
3. Integration with REDCap study data management software – Only once a volunteer has
given explicit consent to participate in a given study is their personal information made available
to the researcher or their staff. As the researcher receives responses to their recruitment efforts
they can click a button to bring the volunteer data over into the REDCap study data management
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system. This not only saves the research staff a lot of time rekeying data, but this greatly limits
the opportunity for a breach of information or loss of sensitive data. The direct integration of the
Volunteer Registry to the REDCap software further enhances security, and encourages best
practices for study data management. This actually simplifies and accelerates the researcher’s
experience in study subject recruitment, which is often the greatest limitation to study progress
and research success
Research Volunteer Registry Overview
The Research Volunteer Registry is one application but has two distinctly different user interfaces and
authentication/authorization mechanisms. One component of this tool includes functionality designed for
volunteer users that will be referred to as the Volunteer Registry (VR). The second module includes an
interface for research users that will be referred to as the Volunteer Registry Search (VRS). A third
module was built to integrate the registry with REDCap.
Volunteer Registry
Volunteer Registry Search
REDCap
1
Volunteer
Volunteer
PI
PI // Delegate
Delegate
2
Volunteer research
profile is created
Study is approved and
created
Study profile is
created
Search for matching
volunteers
Send IRB approved
email to unknown
volunteers to recruit
Respond to request
for participation
Want to
participate?
Yes
Perform 2nd screening
(optional)
3
Import volunteers
into REDCap
Begin collecting study
data
Figure 1 - Depicts the user interaction with each of the modules in the Research Volunteer Registry.
The innovation of the Volunteer Registry, Volunteer Registry Search, and REDCap integration effort is in
streamlining the entire sequence of the events (Figure 1).
1. Creating a starting point for community members interested in volunteering for research.
2. Improving accuracy of research volunteer cohort selection to participation in a research study and
while protecting volunteer confidentiality
3. Automating the handoff from cohort selection to research subject tracking, improving data quality
and reducing level of effort to initiate a study
Volunteer Registry (VR)
The VR has a public user interface where unauthenticated users can access information on the Registry
and such as an overview, privacy details, and information on how to register (Appendix A - Figure 5).
Volunteers can use the VR to then register to receive information on studies that they may want to
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participate in. Joining the registry is easy, private, and leaves the decision to participate in any study in
the volunteer’s hands.
A volunteer can create an account to log in and out of the VR. Once an account has been created,
account holders can create one or more research profiles. The research profiles are created for the
individual as well as family members, and can be completed in three easy steps.
The first step in completing a registry profile is to enter demographic data on the research volunteer. If
the volunteer is not the user, the system prompts the user to answer a set of questions on the relationship
between himself/herself and the family member.
The second step is to enter any medical conditions that the volunteer has been diagnosed with
(Appendix A - Figure 6). It is important for researchers to get accurate medical conditions collected in
order to filter out volunteers who are not a match for their study. The interface was designed so that as a
user enters the first few letters of the medical condition in a text box, a list of suggested conditions appear
that can be selected. The more letters the user types the better the suggestions become.
The list of medical conditions has been imported into the VR database and is coded with Systematized
Nomenclature of Medicine - Clinical Terms (SNOMED-CT). If a user selects a condition that is in the
SNOMED-CT list the medical condition is coded in the database automatically and can be easily queried
by researchers. Volunteers who are unable to find their condition in the list using the terms that they are
familiar with can enter the term they use for the condition in the text field and save it.
An administrator from the CTSC reviews a dashboard report from the VR showing the number of medical
conditions that were not assigned a SNOMED-CT code. They can log into the system and try to reconcile
the data entered with the correct code for the condition which will not overwrite the data that the user
entered to describe their condition.
As administrators reconcile inaccurate medical conditions entered by the volunteers with correct
SNOMED-CT codes, heuristics built into the system will suggest the correct medical conditions to
volunteers based on common data entry errors.
The third step in creating a registry profile is selecting research studies of interest to the subject. The list
of studies is populated from a CTSC database of active studies.
Once a researcher determines that a research profile matches his/her study criteria, they will be able to
use the system to send the volunteer an email with details about the study and a request to participate.
In the body of the email there are two links that can be clicked indicating their preference to participate. If
the user clicks that they are interested in a study they are taken to the VR to further confirm that a
researcher may contact them (Appendix A - Figure 7).
A research volunteer may keep their data up to date by logging into their account at any time, allowing the
user to become the “owner” of their information. They can also set their profile as inactive which will
prohibit researchers from contacting them about future studies.
Volunteer Registry Search (VRS)
The second module of the Research Volunteer Registry is the search functionality built for research
users. This module includes functionality to search the VR for the number of potential volunteers that
meet the specific study criteria, to invite volunteers to participate, and to transfer the data into their study
database.
A researcher begins their work in the VRS by entering an Institutional Review Board (IRB) approved
email into the system. The email template can be edited later as long as no email has been sent. The
content the researcher enters in a template is sandwiched between boiler plate content that will be sent
with all emails from the VR to any research volunteers. The template editor is very simple and does not
allow for the researcher to format the data or include live links. The reason for this design is to avoid the
emails getting caught in the recipient’s spam filters.
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During the analysis stage of implementation, the Health System reviewed the UC Davis Cohort Discovery
Tool1 (powered by i2b2) to determine the optimal search mechanism for research subject populations. It
was determined that the search functionality created for researchers should be similar to the widely used
Cohort Discovery application in order to lower the learning curve and foster early adoption of the new
Volunteer Registry Search software.
Before any email is sent using the template, the research staff must query for volunteers to include in
their recruitment effort. Queries can be built using three types of data; 1) demographic data fields, 2)
medical conditions (by terms entered by volunteer user or by SNOMED), and 3) research studies that the
volunteers have identified interest in. Complex queries can be built in the user interface designed similarly
to the Cohort Discovery query functionality (i2B2) (Appendix B - Figure 8). The criteria in each of the
groups are combined together with ORs and the groups are combined together as the screen shows with
ANDs. More groups can be added allowing for large and complicated searches.
When a researcher has run his/her query and a required number of possible participants were returned,
they can start Recruitment. In this step the user selects the name of a study and the email template they
want to use and the system shows the user a preview of the email. If they are satisfied with the preview
they can send the email and await the responses.
Using the Study Screening Summary section of the application researcher users can review the
responses and the name of volunteers who have consented to being contacted for this study. By clicking
the volunteer’s name a research user can view the details of the volunteer and can contact them as well
as indicate if they are qualified or not after being contacted.
Now the cohorts are ready to be moved into REDCap. Users can click a button to send Cohorts to
REDCap (Appendix B - Figure 9). As more volunteers respond that they would like to participate, these
last few steps can be repeated.
REDCap Integration with Volunteer Registry Data
REDCap is a modern software application for building and managing online clinical research databases.
A growing number of UC Davis researchers and their collaborators are using REDCap to securely
manage research data. The application allows users to build and manage online surveys and databases
quickly and securely, and to link data collected with existing statistical software tools. REDCap is a
valuable tool that is expected to replace all Microsoft Excel spreadsheets and Access databases that
researchers frequently use to collect study data. The application allows users to access and manage the
data from anywhere in the world over a secure web connection with authentication and data logging.
REDCap is fully customizable with advanced features that allow researchers to shape their database or
survey, and incorporate mid-study modifications, auto-validation, calculated fields and branching logic.
Developed by an informatics core at Vanderbilt University with ongoing support from the National Center
for Research Resources and National Institutes of Health grants, REDCap was designed to address the
high cost of commercial research software and the limited informatics and information-technology support
for research at universities and other organizations -- common problems for academic biomedical
researchers hoping to use electronic databases. The software is supported by a consortium of 300+
active academic health institutions worldwide and is currently being used in more than 36,000 studies
with over 50,000 end-users across the consortium.
REDCap supports:
 Rapid creation and design of projects by constructing a “data dictionary” template file in Microsoft
Excel, that is then uploaded into REDCap for execution
 Audit trails for tracking data manipulation and user activity
 Automated export procedures for seamless data downloads to Excel, PDF, and common statistical
packages (Appendix C - Figure 10)
 Built-in project calendar and scheduling capabilities
 Ad hoc reporting tools
 Advanced features, such as branching logic, file uploading, and calculated fields
1
http://www.ucop.edu/irc/itlc/sautter/2010/ucdhs_cohortdiscovery.doc
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UC Davis Health System launched REDCap for general use in October 2011. The application has been
warmly received by the research community and adopted for a growing number of studies (Figure 2), by
a growing number of researchers and their staff (Figure 3).
Figure 2 – UC Davis Research studies created in
REDCap in the past six months
Figure 3 – UC Davis REDCap Active Users
Project Benefits
There are many benefits to this new application for volunteers, research staff, and the Health System as
well. Volunteers can create one account and if their data changes they can easily update their
information. This application provides an account holder the ability to create research profiles for
themselves as well as family members. Volunteers are able to enter information that a researcher may
be looking for such as height and weight, but are also able to indicate the research studies they are
interested in and can see what types of studies are currently being done. The user interface is intuitive
and makes it easy for a volunteer to respond to participation requests. At any time a volunteer can
exclude themselves from receiving new invitations. There is an extensive user guide and FAQ section to
assist users in using the registry.
Researchers have the benefit of creating and managing intricate queries to find matches of research
volunteers for studies. Once a study is IRB approved a researcher can delegate the tasks of recruiting
volunteers to another user in the application. Researchers can also use the system to manage email
templates for recruitment efforts. Less time will be spent by research staff managing different databases
of research subjects.
The queries return only the total number of subject matches, not the individual names of research
volunteers. The researcher can modify the query as much as they need to until they get the number of
participants that they are looking for without being exposed to sensitive personal information about the
volunteers. Researchers can query demographic data, medical conditions coded using International
Classification of Diseases (ICD-9) and SNOMED-CT, and volunteer interest areas to fine-tune their
queries.
As volunteers agree to participate in a study the research staff are notified, and can very easily click a
button that will push all the data over to REDCap where the study data will begin being collected. This
process can occur repeatedly throughout the recruitment process, so studies can begin even before a full
cohort has been identified.
UC Davis Health system will benefit from these new tools as each is HIPAA compliant and reduces
liability to the researcher and the Health System in general. The volunteer data is compartmentalized so
that only authorized users can see the data and only after informed consent has occurred. The new tool
improves operations enterprise wide by having a single system for all of UCDHS to use. Data is stored
centrally and securely, rather than in departmentally shared databases or file systems. Departments can
leverage the data from other department marketing efforts to increase the size of the population within the
registry database.
Relevant URLs
VR - https://vr.ucdmc.ucdavis.edu/vr/home.vhtml
VRS - https://vr.ucdmc.ucdavis.edu/vrs/secure/common/home.iface (UCDHS intranet only)
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IV. Technology Utilized in the Project
The Volunteer Registry application is completely built with Java Enterprise Edition 5 (Java EE 5)
technologies. Java EE provides seamless integration of persistence, controller/service, presentation
layers, security (authentication and authorization) and a Java EE certified application server. The
following Java EE 5 technologies are being utilized: JPA, EJB, JSF/ICEfaces, Security and Glassfish;
each technology corresponds to a layer or a component mentioned above.
Java Persistence API (JPA) provides an object mapping facility that can correlate conceptualized object
models in an enterprise environment and manage relational data in persistence layer.
Enterprise Java Beans (EJB) provides services such as transactions, security, messaging and web
services that encapsulates the business logic of an application.
JavaServer Faces (JSF) is a server-side user interface component framework that provides the wiring of
component-generated events to server-side application code.
Java EE security services provide a robust security mechanism for authentication users and authorizing
access to application functions and associated data.
Glassfish is a Java EE certified application server that “ties” the above technologies together, so that
developers can concentrate on building functions or features that satisfy business requirements.
We use Eclipse as our primary development tool to build the application. Eclipse is a one-stop shop that
provides fluid development experience to implementing enterprise applications.
The database backend is using MySQL 5.1.
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V. UC Davis Health System Research Volunteer Registry Implementation Timeline
May 2010
September 2010
December 2010
February 2011

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





July 2011








October 2011
March 2012
May 2012



March 2011
June 2011
Project kick off held with MIND leadership
Team members defined
Scope defined
Initial Alpha version of registry demonstrated
Project updated and software features presented to MIND faculty
Initial Beta version of registry completed
Efforts on visual usability underway
MIND faculty introduced to registry software and participated in focus group
testing
Suggestions incorporated into software
Initial pilot launched and targeted towards 1000 “active” existing MIND volunteers
Survey conducted on volunteer use of software
Suggestions incorporated into software
Within first month 165 accounts, 212 research profiles created
Added enhancements suggested by volunteers from pilot launch
Pilot volunteer group expand to remaining 6500 existing volunteers
Development underway for Research portion of software to allow for searching
an identifying a cohort
Initial version of Research Search released for internal testing
Software version released that has full integration with REDCap
Full software version released into production
Current state
In the Volunteer Registry there are currently 1,195 active volunteer accounts and 1,561 volunteer
research profiles. In the Volunteer Registry Search there are 262 accounts with studies, and 6798 pilot
users.
Research
Count
Profile
Child
978
Self
557
Sibling
12
Spouse
11
Parent
3
Total
1561
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Figure 4 – Research Volunteer Registry Statistics
Definitions:
 Active Accounts – community members who have registered online creating a username and
password. The account holder may or may not have set up a research profile.
 Child Profile – a research profile that was created by an account holder on behalf of their child.
 Self Profile – a research profile that was created by the account holder.
 Spouse Profile – a research profile that was created by an account holder on behalf of their
spouse.
 Sibling Profile – a research profile that was created by an account holder on behalf of their
sibling.
 Surveys Sent – the number of emails sent to users to recruit for a study.
 Profile w/ Study – a user has saved studies that the volunteer is interested in to their research
profile.
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VI. Objective Customer Satisfaction Data
One measure of customer satisfaction derives from direct user feedback. Usability testing is a technique
often executed in user centered interaction design to evaluate a product or process by testing it with the
current user base. This usability practice gives direct input on how researchers access information within
the UC Davis REDCap system.
The first user group forum was conducted in December of 2011. The feedback session was held on the
UC Davis Health System campus with clinical research staff to determine the usability of the system and
provide feedback to the system creators.
Further Evaluation of Research Volunteer Registry
Customer Satisfaction surveys are planned for the first week of each quarter to gather feedback, update
application requirements and measure the overall satisfaction with the system in use. The first round of
feedback provided twenty-eight suggested improvements to the overall User Interface, of which more
than half were implemented before the final release of the application. Questions included in the survey
focused on the following:
 Feedback on the current user interface for researcher use
 Feedback on the current user interface for volunteer use
 Clarity and simplifying the steps for participation in studies
 Improvement of the summary screen for researchers
 Email recruitment improvements
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Appendix A
Volunteer Registry Screens
Figure 5 – The public interface for information on the Research Volunteer Registry.
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Figure 6 – Research Profile Creation – Medical Conditions
Figure 7 – Volunteer Registry – Recruitment Consent
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Appendix B
Volunteer Registry Search (VRS) Screens
Figure 8 – VRS Query Tool
Figure 9 – The VRS export into REDCap
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Appendix C
REDCap Screens
Figure 10 - REDCap provides automated export procedures for data downloads to Excel, PDF, and common
statistical packages (SPSS, SAS, Stata, R)
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