UCSF Research Participant Management System
2012 Sautter Award Proposal
University of California, San Francisco
Research Participant Management System (RPMS)
May 15, 2012
UCSF Research Participant Management System
2012 Sautter Award Proposal
Project Title
UCSF Research Participant Management System
Submitter
Nariman Nasser, Director
Participant Recruitment Service
Clinical & Translational Science Institute
University of California, San Francisco
415.514.8517 Phone / 415.412.9070 Mobile
nariman.nasser@ucsf.edu
Project Team

Nariman Nasser, Director, Participant Recruitment Service (Project Leader)

Jocel Dumlao, Technical Recruitment Specialist, PRS

Elia Gonzales, Medical/Technical Writer, PRS

David Thompson, SalesForce.com Analyst, ISU

Kimberly Bartlo, Senior Programmer, ISU

Cynthia Piontowski, Web Producer, CTSI
Summary
The Research Participant Management System is a cloud-computing tool that automates a campus-wide
recruitment service, whose aim is to facilitate enrollment of participants into clinical studies at UCSF.
Prospective participants use a public portal to submit an online form that registers them to be contacted
about clinical studies they may be interested in, and the sponsoring department queries the database to
identify recruitment cohorts on behalf of researchers. The HIPAA-compliant and IRB-approved RPMS
stores potential participant data from the Research Participant Registry and integrates participant data
from other sources, tracks marketing and outreach campaigns in support of specific clinical studies, and
provides recruitment metrics by measuring screening and enrollment outcomes.
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Project Description
With more than 5000 actively enrolling studies at UCSF, the Clinical & Translational Science Institute saw
the need to form the Participant Recruitment Service (PRS) and charge it with creating a centralized
technology-based recruitment system to facilitate participant enrollment in clinical trials. PRS set about
to create the Research Participant Management System, and its public component, the Research
Participant Registry to fulfill these two aims: First is to create public awareness of the positive
contributions that volunteer participants make toward their own health, the health of friends and
family, and the well-being of the community. On the investigator side, to support researchers who
request recruitment assistance by providing them with the tools and services needed to identify and
communicate with potential participants for their studies.
Before the PRS, principal investigators depended on do-it-yourself recruitment activities, which included
laborious query-building procedures for data extraction, and paper-based tracking tools or shared Excel
sheets with manual data entry. Without a uniform recruitment process, university administrators were
unable to accurately evaluate a study’s recruitment activities, including marketing costs or enrollment
outcomes.
The solution was to build a Participant Recruitment Management System (PRMS) that integrates a
secure IRB-approved and HIPAA-compliant registry website and database with the PRS recruitment
workflow. With the RPMS, PRS is able to track participant, marketing, and study data to create an
effective campus-wide recruitment service.
Technology
The RPMS is built with commercially available cloud- computing enterprise products from SalesForce:
the Force.com platform, a customer relationship management (CRM) application, and VisualForce. By
customizing the CRM application as a healthcare application, the team was able to build the RPMS with
minimal development time.
Before choosing a cloud-based application for the RPMS, the team evaluated several technology
options, but found them unsuitable:

Inhouse resources did not have the expandability needed for a centralized recruitment workflow.

A dedicated application, due to its costs and uncertainties, was not ideal.
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UCSF Research Participant Management System
2012 Sautter Award Proposal

Many off-the-shelf applications required programming skills and implementation costs that were
beyond PRS expertise or budget.
An enterprise cloud-based product was chosen for these reasons.

Being able to access data from anywhere at anytime was an advantage.

By using vendor servers, PRS would not have the burden of buying and maintaining a database
server.

We also felt that the vendor’s experience in the cloud-computing market meant that the
safeguards they had in place were sufficient to meet federal and local regulations for privacy
protection and data security.

Also, by buying a product license, we could have access to various features that we could
customize as our “business” increased and more investigators requested our services.

Financial impact of building the RPMS was trimmed considerably through a donation of time and
developer skills from a team of SalesForce volunteers and a license discount from the SalesForce
Foundation.
User Access
With the native application’s ability to be partitioned into virtual spaces, the RPMS administrator can set
permissions and data visibility for the two user types: PRS staff (RPMS users) and the public (registry
users).
UCSF Research Participant Registry
Individuals interested in being contacted about specific clinical studies register online by providing
contact and health information. Access to the public portal is through a secure login website built on
the Force.com Customer Portal and Force.com Sites: www.registry.ucsf.edu.
The team created these functions for the interactive registry website, which is linked to the RPMS:

Landing page modeled on UCSF design standards

Email address authentication

Electronic consent process

Online self-registration form

Health survey with branching logic
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Potential Participant Data
Contact Information
The native contact object was used to collect and store participant data. Contact information (i.e.,
name, address, phone, email address) about the potential participant is stored in a native Force.com
object called Contacts. Contact information from participants who enter through the UCSF Registry is
automatically stored in the RPMS database. Contact data for participants identified through other
sources are entered manually by recruitment staff.
Health Information
An online health survey is part of the registration process for the public. Health information from the
online registration form responses lives in multiple custom objects, which can be further customized
based on regular evaluations of the data by PRS.
Registry Call Center
For callers who do not want to self-register online, PRS provides registration assistance on the
telephone. The native activity object is used by recruitment staff to conduct telephone registration
interviews for new registry members or to provide technical support to existing registry members. Staff
enters caller responses into the registration form and health survey, and then submits the participant
data to the RPMS database. Both PRS and external vendors, such as a call center, can track
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communication with potential participants using the Activities function. This function also allows users
to track tasks and followup items.
Cohort Identification
Native report functionality is used to query the registry database and compile a list of potential
participants who match prescreening criteria for a specific UCSF study. Only PRS has IRB approval to
conduct database searches and extract participant data.
Study Marketing
The native marketing module is used to track marketing and outreach campaigns launched in support of
specific studies. Once a list of potentially eligible participants is compiled, PRS can track which
participants have been contacted via mailers through a native Force.com object called Campaigns. This
function can also be used to track the distribution of other PRS recruitment materials such as radio ads,
newsletters, and bus banners. Staff uses the native Leads function to associate registry and nonregistry participants to marketing and outreach efforts (Subcampaigns). The Campaigns function is used
to associate Subcampaigns (e.g., direct mail, print ads) to a specific study.
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Recruitment Tracking
Dashboard widgets to track recruitment performance and custom templates to report recruitment
metrics are part of a custom recruitment object in the RPMS. The PRS Recruitment app gauges the
success of recruitment campaigns for specific studies. PRS is able to track those registrants who were
contacted about a specific study and subsequently pre-screened. The custom recruitment object tracks
the following data:

Contact name

Study name

Enrollment number

Referral for screening visits

Screening date

Screen result

Reason for failure

Study consent
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Cloud Security
The RPMS is hosted on SalesForce.com servers, and the vendor provides these security safeguards:

Secure data centers with continuous security monitoring

Secure transmission and sessions

Network protection

Backups and disaster recovery

Internal and third-party testing and assessments
Communication and Collaboration
The PRS makes ample use of Chatter to communicate and collaborate on projects. The Chatter tool,
which is part of the enterprise application, has some of the features of popular social media and allows
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2012 Sautter Award Proposal
staff to upload files and post messages. By keeping all project details visible and not hampering
ourselves with the additional task of searching and forwarding emails and file attachments, we have
improved staff efficiency.
The native Mail Merge function is used to process direct mail from contact lists created during the
cohort identification process. Another native function, Libraries, is used as a one-level knowledge
management system.
Implementation Timeline
Nov 2010
Mar 2011
Aug-Dec 2011
Feb 2012
Mar 2012
Apr 2012
July 2012
Definition of functional requirements
Build registry website and customize CRM to create RPMS
Fine-tune custom objects and conduct user testing
Receives IRB approval
Soft launch
Over 200 participants registered and recruitment cohorts identified for 5
enrolling studies
Production launch
Customer Satisfaction
The RPMS is accessed and used by PRS staff to provide services to UCSF investigators who request
recruitment assistance. Although investigators and their study teams do not have access to the RPMS,
they do receive indirect benefit from its use as a campus-wide recruitment tool. Investigators are
certainly able to reap the benefits of the registry, an RPMS component:
“As an investigator new to clinical trials, I have found that the most difficult
part of conducting the trial is designing and implementing an effective
recruitment plan. Although I have been on faculty for the last 8 years, I still lack
a comprehensive understanding of potential arenas where patients can be
identified and recruited for clinical studies. As such, providing resources to help
investigators identify and reach out to potential research subjects, and to
better understand how the UCSF research system works, are vital for the
continuing success of our research endeavors. Such a resource would help us
conduct ongoing research projects, and be attractive when preparing grant
applications.”
-- Margaret C. Fang, MD, MPH
Medical Director, UCSF Anticoagulation Clinic
Associate Professor of Medicine
May 15, 2012
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2012 Sautter Award Proposal
“It’s critical that investigators have access to a registry of potential research
subjects that is quick and easy to use and represents the populations needed
for their samples. Much time is lost screening patients who may or may not
meet study inclusion criteria and relying on busy care providers to refer their
own and other patients to studies. Patients may have good intentions about
contacting investigators to learn more about studies but all too often forget to
make the contact. Having a large repository of volunteers who have indicated
a willingness to be contacted for future studies eliminates much of this
inefficient use of time and reduces the burden on busy clinicians to screen and
refer patients;”
-- Claudia M. West, RN, MS
Clinical Professor
Department of Physiological Nursing
May 15, 2012
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