Assessing Clinical Research Infrastructure Needs

May 2013
Authors:
Allison Orechwa, Ph.D.
Melanie Funes, Ph.D.
Susan Autry, MBA
CLINICAL RESEARCH
INFRASTRUCTURE NEEDS
SURVEY RESPONSE REPORT
Responses from
USC Health Sciences
Faculty and Staff

www.sc-ctsi.org | Page 2
3 Executive Summary
4 Introduction
5 Describing the Sample
7 Clinical Data Warehouse for Research
10 Clinical Trials Management System
11 Biorepository
12 Southern California Clinical and Translational Science Institute
14 Perceived Challenges in Conducting Clinical Research
16 Appendix A: Full Survey
22 Appendix B: CDWR – Other Types of Data
23 Appendix C: CDWR – Other Feedback and Concerns
25 Appendix D: CTMS – Other Feedback and Concerns
26 Appendix E: All Perceived Challenges
Table of Contents

Executive Summary
139
volunteers
There is significant interest across the USC enterprise in the development of a clinical data warehouse for re-
search (CDWR) and a clinical trials management system (CTMS). This survey was created to gather input from
potential users in order to inform the development of these new tools. Selected findings include:
The biggest perceived challenges among the clinical
research community are: Administrative hurdles (men-
tioned by 26% of faculty respondents), Funding (24%),
Access to clinical data or specimens (21%), and Clinical
research support staff (21%).
Ninety percent of faculty respondents said that having
access to clinical data from the Keck Medical Center
is important to their research; 57% said access is criti-
cally important.
Eighty-oneofthe126faculty(64%)indicatedthatusing
the CDWR for Historical data extraction for retrospec-
tive studies was critically important to their research.
The next most highly rated purposes were Health out-
comes research (48%) and Identification of potential
participants in on-going or planned clinical trial (42%).
Of the different types of data that could be included in
a CDWR, five were rated as Critically Important by at
least 50% of faculty: Demographics, Diagnoses, Proce-
dures, Laboratory test results, and Outcomes.
The highest-rated capabilities of a CTMS, in terms of
importance to faculty research, were Patient Manage-
ment and Biorepository Management (44% and 40%
of faculty selected Critically Important, respectively).
The top two components according to staff were Pa-
tient Management and Study Management (63% each).
Thirty-five percent of faculty rated a structured biore-
pository as Important to their research, and 38% rated
it as Critically Important.
When asked about resources and services offered by
the Southern California Clinical and Translational
Science Institute, over 50% of faculty rated pilot fund-
ing, informatics consultations, and assistance in the
design, conduct, and management of human studies as
Important or Critically Important to their research.
Seventy percent of respondents (139 individuals) said
they want to be involved at some level (i.e., participat-
ing in working or advisory groups) in the development
of the CDWR or the CTMS.
“Development of a useful and accessible data-
base is critical to my research.”
- USC health sciences faculty member

Introduction
Purpose
There is significant interest across the USC enterprise
in the development of a clinical data warehouse for
research (CDWR) and a clinical trials management
system (CTMS), which are essential to providing clin-
ical trial data management solutions and enhancing
the competitiveness and impact of clinical research
at USC. This survey was created to gather input from
potential users in order to inform the development of
these new tools, including their functionality and in-
tended use. The survey was broadened to also identify
the biggest challenges in conducting clinical research
and assess the importance of existing and potential
clinical and translational research infrastructure.
Survey Development
SC CTSI staff worked with faculty researchers, senior
university leadership, and other representatives of the
clinical and translational science community to de-
velop the survey. The final survey contained questions
pertaining to a CDWR, a CTMS, and general needs
for clinical research infrastructure, with the hope that
a single set of responses would serve multiple efforts.
See Appendix A for the full survey.
Audience
The intended audience for the survey was all faculty
and staff at USC and its partner institutions who
conduct or support clinical and translational research
(staff responses were excluded from the CDWR and
biorepository analyses because those questions per-
tained mostly to faculty). The survey was therefore
distributed via email listservs to the following groups:
faculty and staff in the Schools of Medicine, Dentistry,
Gerontology, Pharmacy, Public Policy, and Social
Work; the Biomedical Engineering department within
the School of Engineering; the USC Norris Compre-
hensive Cancer Center; Children’s Hospital Los Ange-
les. A few key groups were also contacted directly by
SC CTSI’s director, including investigators who were
previously served by SC CTSI.
USC Health Sciences
Medicine
Dentistry
Gerontology
Pharmacy
Public Policy
Social Work
Biomedical Engineering

Describing the Sample
Of the 201 individuals who completed the survey, 127
were faculty, 63 were staff, and 11 were “other” (e.g.,
student, adjunct instructor). When asked to indicate
their role and primary activity, 12% of respondents
selected Basic researcher, 24% selected Clinician
researcher (>15% spent on research), and 11% selected
Translational researcher. Forty of the 63 staff respon-
dents (63%) selected Clinical research support as their
role and primary activity. The majority of respondents
were located on the Health Science Campus and affili-
ated with the School of Medicine.
The sample includes 94faculty who
conduct research at USC.
Role Number of
Respondents
% of Total
Faculty 127 63%
Rank
Assistant Professor 52 26%
Associate Professor 28 14%
Professor 42 21%
Other or No Response 5 2%
Primary Activity
Basic researcher 24 12%
Clinician (0 15% spent on research) 28 14%
Clinician researcher (>15% spent on research) 48 24%
Translational researcher (early stage development) 22 11%
Device development 6 3%
Drug development 5 2%
Staff 63 31%
Primary Activity
Clinical research support 40 20%
Other research support 18 9%
Other 11 5%
Total 201 100%

Describing the Sample (cont’d.)
Number of
Respondents
% of Total
Number of
Respondents
% of Total
Campus
USC Health Sciences Campus 81 40% 53 26%
USC University Park Campus 17 8% 6 3%
CHLA Children's Hospital Los Angeles 25 12% 2 1%
Other or No Response 4 2% 2 1%
School
Dentistry (including Physical and Occupational Therapy) 14 7% 4 2%
Engineering (Biomedical Engineering only) 5 2%
Gerontology 4 2% 3 1%
Medicine 94 47% 38 19%
Pharmacy 5 2% 3 1%
Social Work 5 2% 1 0%
Cancer Center Affiliation
Yes 42 21% 32 16%
No 84 42% 31 15%
Affiliation Faculty Staff

64% of faculty say historical data ex-
traction from a CDWR is critically
important to their research.
Clinical Data Warehouse for Research
CDWR purposes
Following a brief description of a clinical data ware-
house for research (CDWR), respondents were asked,
“For what purpose(s) would you use a clinical data
warehouse?” They were instructed to rate each pur-
pose in terms of its importance to their research
(Would Not Use It for This Purpose, Minimally Im-
portant, Important, or Critically Important/Essential).
Eighty-one of the 126 faculty who responded to the
question (64%) indicated that using the CDWR for
Historical data extraction for retrospective studies was
Critically Important to their research. The next most
highly rated purposes were Health outcomes research
(48%) and Identification of potential participants in
on-going or planned clinical trial (42%). All other
options provided were rated as either Important or
Critically Important by at least 50% of faculty respon-
dents.
A number of respondents added purposes of their
own in an “Other” field, including Decision support;
Education for Keck and informatics students; Initiat-
ing new studies using the same database and speci-
mens if available; IRB; Patient information for labo-
ratory medicine research; Physiology, mechanisms;
Prospective etiologic research; Systematic reviews;
Access to MRI neuroimaging images.
Purpose (Total Responses) Would Not
Use It for This
Purpose
Minimally
Important
Important Critically
Important
8 12 25 81
6% 10% 20% 64%
13 20 33 60
10% 16% 26% 48%
13 23 37 53
10% 18% 29% 42%
30 21 30 42
24% 17% 24% 34%
20 20 44 37
17% 17% 36% 31%
27 25 38 35
22% 20% 30% 28%
28 27 36 34
22% 22% 29% 27%
24 25 44 32
19% 20% 35% 26%
Precision/personalized medicine (125)
Health access disparities research (125)
Historical data extraction for retrospective
studies (126)
Health outcomes research (126)
Identification of potential participants in on
going or planned clinical trial (126)
Quality healthcare research (123)
Health effectiveness research (121)
Health economics/cost effectiveness research
(125)

CDWR types of data
Using the same rating system, survey respondents
were next asked to rate 23 different types of data that
could be included in a CDWR. Five data types were
rated as Critically Important by at least 50% of fac-
ulty: Demographics, Diagnoses, Procedures, Laboratory
test results, and Outcomes. The table below presents
the combined number and percentage of faculty who
rated each data type as either Important or Critically
Important. Appendix B contains all responses to the
open-ended “Other types of data” item.
Type of Data (Total Responses)
Diagnoses (ICD 9/10) (126) 116 92%
Outcomes (124) 114 92%
Demographics (125) 110 88%
Medications (126) 110 87%
Laboratory test results (124) 105 85%
Procedures (CPT) (123) 102 83%
Radiology reports (123) 95 77%
Elements of physical exam other than vital
signs (122)
83 68%
Pathology reports (125) 84 67%
Family history (125) 84 67%
Elements of physical exam vital signs (123) 82 67%
Images (122) 80 66%
Genetic/genomic data (123) 79 64%
Smoking status (125) 77 62%
Physician notes (121) 74 61%
Bio repository data (124) 74 60%
Drug/Alcohol use (123) 73 59%
Stage (for cancer diagnoses) (123) 71 58%
Financial/cost data (122) 70 57%
Review of Systems (120) 68 57%
Other text in medical records (115) 51 44%
Insurance coverage (123) 54 44%
Allergies (125) 44 35%
Important or Critically Important
0% 25% 50% 75% 100%

CDWR sources of data
Respondents were asked to rate the importance of
having access to clinical data from the following
sources: Keck Medical Center of USC, Children’s Hos-
pital Los Angeles (CHLA), Los Angeles County Hos-
pital (LAC+USC), and the Los Angeles County public
health system (DHS). Both Keck Medical Center and
LAC+USC were rated as Critically Important by 57%
of faculty respondents.
When asked, “In addition to hospital electronic medi-
cal records, pharmacy records, lab data, and finan-
cial systems, are there other sources of data that you
would like to see ultimately included in the CDWR,”
the majority of respondents checked Cancer Registry
(63%) and Death Registry(ies) (72%). Other types of
sources provided by the respondents include Dis-
ability and Social Services Registry; Chronic Disease
Registry; Obesity and diabetes registry; Rehabilitation
reports and data; Patient satisfaction data; Brain im-
ages.
Source (Total Responses) Would not
use
Minimally
Important
Important
12 12 29 71
10% 10% 23% 57%
25 15 25 54
21% 13% 21% 45%
10 11 33 71
8% 9% 26% 57%
19 18 33 41
17% 16% 30% 37%
Keck Medical Center (124)
CHLA (119)
LAC+USC (125)
DHS (111)
Registry Type Number of
responses*
% of total
Cancer Registry 55 63%
Cardio Registry 30 34%
Death Registry(ies) 63 72%
* Multiple selections possible

Clinical Trials Management System
CTMS capabilities
The next section of the survey pertained to a clini-
cal trials management system (CTMS). Respondents
were presented with six broad components or capa-
bilities of a CTMS and asked to rate each in terms of
its importance to their research. Patient Management
and Biorepository Management received the highest
ratings from faculty (44% and 40% selected Critically
Important, respectively), whereas the top two compo-
nents according to staff were Patient Management and
Study Management (63% each). Sixty percent of staff
rated a Financial Management component as either
Important or Critically Important .
Capability Respondent Type
(Total Responses)
Would not use Minimally
Important
Important
11 21 43 48
9% 17% 35% 39%
3 5 14 38
5% 8% 23% 63%
28 26 41 28
23% 21% 33% 23%
12 12 10 27
20% 20% 16% 44%
13 20 36 55
10% 16% 29% 44%
2 6 14 38
3% 10% 23% 63%
12 24 39 48
10% 20% 32% 39%
3 3 19 34
5% 5% 32% 58%
22 17 35 50
18% 14% 28% 40%
8 5 22 27
13% 8% 35% 44%
23 19 33 46
19% 16% 27% 38%
7 5 22 25
12% 8% 37% 42%
Study Management (protocol tracking;
enrollment tracking; study calendar)
Faculty (123)
Staff (60)
Financial Management (study budgeting;
Medicare coverage analysis; invoicing)
Faculty (123)
Staff (61)
Patient Management (patient enrollment,
identification, and randomization;
scheduling; eligibility tracking; adverse
event tracking)
Faculty (124)
Staff (60)
Report and Data Management (electronic
case reports; data reporting and export
tools)
Faculty (123)
Staff (59)
Biorepository Management (specimen and
result tracking; inventory management)
Faculty (124)
Staff (62)
Importing current clinical study data from
my existing database(s)
Faculty (121)
Staff (59)

Biorepository
Of the 127 faculty who responded to the item, “Please
rate the importance to your research of having a
structured biorepository,” 19 selected “Would Not
Use,” 16 selected “Minimally Important,” 44 selected
“Important,” and 48 selected “Critically Important.”
85% of faculty said they
would use a biorepository.
Would Not
Use
15%
Minimally
Important
13%
Important
35%
Critically
Important
38%

Southern California Clinical and Translational
Science Institute
SC CTSI resources and services
Respondents were next asked to rate existing and
potential future clinical research infrastructure. The
types of services that received the highest ratings
from faculty were pilot funding; informatics consul-
tations; and assistance in the design, conduct, and
management of human studies. The two “under con-
sideration” resources or services were each rated as
Important or Critically Important by the majority of
respondents (Clinical research coordinator core: 66%;
Participant recruitment service: 71%).
Would not
use
Minimally
Important
Important
6 11 23 76
5% 9% 20% 66%
17 16 30 51
15% 14% 26% 45%
8 11 32 72
7% 9% 26% 59%
9 12 32 70
7% 10% 26% 57%
9 21 45 49
7% 17% 36% 40%
11 24 42 44
9% 20% 35% 36%
17 21 44 41
14% 17% 36% 33%
15 21 49 38
12% 17% 40% 31%
14 23 49 36
11% 19% 40% 30%
17 27 43 36
14% 22% 35% 29%
24 34 41 23
20% 28% 34% 19%
27 33 38 21
23% 28% 32% 18%
22 34 48 18
18% 28% 39% 15%
18 23 36 46
15% 19% 29% 37%
11 24 45 42
9% 20% 37% 34%
RESOURCES & SERVICES (TOTAL RESPONSES)
CURRENTRESOURCES&SERVICES
PILOT FUNDING (116)
CLINICAL RESEARCH SPACE AND SERVICES (114)
CONSULTATIONS
Biostatistics (123)
Statistical analysis (123)
Data management (124)
Study design (121)
Bioinformatics (123)
UNDER
CONSIDERATION
CLINICAL RESEARCH COORDINATOR CORE (123)
PARTICIPANT RECRUITMENT SERVICE (122)
Conducting and managing human studies
(123)
Regulatory knowledge and support (122)
Translation of preclinical discoveries
(123)
Scientific writing (122)
Community engaged research (119)
Research ethics (122)

• A clinical research coordinator core would be extremely helpful for a biological / biomarker study we
are trying to get off the ground. A core - which could charge for their expertise in coordinating such
activities - would be a great help.
• Access to trained clinical coordinators would be extremely helpful.
• Artificial intelligence machine learning big data management
• Data core: Need experience and help from someone working with the data on a daily basis to assist in
producing extracts and analytic data files.
• I don't get out enough - I could use help networking
• I have good coordinators, but it would be a very valuable resource for the institution overall.
• One-stop service to submit request for obtaining clinical data and/or biorepository specimens from
USC study sites (Keck, CHLA, LAC-USC, etc)
• Really need to improve access to bioinformatics experts. This is a major bottleneck for our research.
• Specific consultation and troubleshooting on REDCAP or any improved similar data collection tools;
it beats Qualtrics on most indicators but problematic still
• The importance of having a PARTICIPANT RECRUITMENT SERVICE cannot be over emphasized.
This is the Achilles Heel of many studies.
• Training of graduate and post graduate young investigators in clinical translational research
SC CTSI - Other valuable resources and services
Asking the question, “What other services or resources would be valuable to your work?” elicited a dozen
responses from faculty, including more than one expressed need for trained clinical coordinators. All faculty
responses are shown below.
Southern California Clinical and Translational
Science Institute
“The importance of having a participant recruitment
service cannot be over emphasized. This is the
Achilles Heel of many studies”

Perceived Challenges in Conducting Clinical Research
A qualitative review of the responses to the open-end-
ed question, “What is your biggest challenge in con-
ducting clinical research?” revealed a number of chal-
lenges perceived by the community: Administrative
hurdles (mentioned by 26% of faculty respondents),
Funding (24%), Access to clinical data or specimens
(21%), and Clinical research support staff (21%). Other
frequent responses included Participant recruitment,
Subject-specific expertise/assistance, and Dedicated
time. The table below includes select responses as
examples under each category; for a complete listing
of responses, see Appendix E.
Administrative Hurdles 22 26% 15 52%
Funding 20 24% 4 14%
Access to Clinical Data or Specimens 18 21% 4 14%
Clinical Research Support Staff 18 21% 3 10%
Participant Recruitment 15 18% 7 24%
Participant Recruitment Needs
Cohort recruitment and retention
Recruiting and sustaining non english speaking populations
Obtaining samples relevant to my studies
Getting well characterized and well preserved specimen.
Support Staff Needs
Sufficient number of competent clinical research support staff
Finding experienced research coordinators
Specimen/Sample Access
Compliance officers who don't understand human research
Non integrated Administrative Systems
The existence of so many different entities (CISO, CTSI, HRA, IRB, etc.) that have different requirements for similar things
CRO
Getting the clinical trial budgets, Medicare Coverage Analyses, and Research Order Forms from USC CRO in a timely manner.
Lack of Funding
Getting NIH funding!
Minimal start up funds available for junior faculty.
Data Access
Lack of databases to find patients with specific conditions / diagnoses
Having to review paper medical charts, electronic charts, Affinity, Synapse systems to mine data
Compliance
Faculty
(84 total respondents)
Staff
# of Unique
Mentions
# of Unique
Mentions
% of
Respondents
% of
Respondents
IRB/Regulatory
Disorganized and disconnected systems for regulatory approvals.
IRB delays
Administrative Processing Time/Efficiency
Cumbersome paperwork submission and review processes
Con nued on p. 15

Perceived Challenges in Conducting Clinical Research
Subject Specific Expertise/Assistance 15 18% 4 14%
Dedicated Time 12 14% 1 3%
Communication, Support, and Engagement 6 7%
Facilities and Space 5 6% 2 7%
Working Collaboratively 3 4% 3 10%
Not Categorized 4 5% 1 3%
No institutional resources
Positive outcome of the studies
Team Building/Collaboration
Identifying partners
Differential capabilities and resources in interdisciplinary teams
Keeping Confidentiality in diverse groups
Facilities
Lack of a CTU in a convenient location
Getting quality microarray/Next Generation sequencing data done via a core
Space
People fight over freezer space
Clinical Research Knowledge and Engagement
Difficulties in enrolling patients into clinical trials (parental distrust of research)
Disseminating information about the study to other treating physicians and patients in the community
Departmental Support
Obtaining fresh tumor specimens with Dept. cooperation and flexibility
Securing time and money in the first place
Coordinating dissemination of multiple secondary outcome papers after the funding for the clinical trial has ended and the primary outcomes have
been published
Mentorship
Mentorship
Funding Applications
Assistance with applying for funding
Help with protocol development and study design
Lack of time
Carving time away from my administrative demands
Publication
Biostatistics
Access to clinicians with knowledge of biostatistics and time to help
Data Management
Data management
Translational Value
Evaluating how 'translatable' mouse research is to clinical issues
Study Design
Identifying the appropriate question to be addressed in a clinical study
Faculty
Staff
# of Unique
Mentions
# of Unique
Mentions
% of
Respondents
% of
Respondents

Appendix A: Full Survey
Survey Title
New tools to enable clinical research: Clinical Data Warehouse for Research (CDWR) and Clinical Trials Management
System (CTMS)
Sec on 1 of 5: Par cipant Informa on
1. First & Last Name: [free text]
2. Title: [drop-down]
Professor
Associate Professor
Assistant Professor
Staﬀ
Other (please specify) [free text]
3. Highest Degree: [drop-down]
MD
PhD
PharmD
DDS
DO
MSW
RN
MBA
DOT
DPT
MPH
MS
BS
4. Email address: [free text]
5. Campus where you spend the majority of your me: [drop-down]
University Park Campus
Health Sciences Campus
Children’s Hospital Los Angeles
Both USC and Children’s Hospital Los Angeles
6. School and Department/Division: [drop-down]
Den stry
Biokinesiology and Physical Therapy
Biomedical Sciences
Craniofacial Molecular Biology
Dental Public Health and Pediatric Den stry
Endodon cs, Oral and Maxillofacial Surgery and Orthodon cs
Occupa onal Science and Occupa onal Therapy

Periodontology, Diagnos c Services and Dental Hygiene
Restora ve Sciences
Other
Engineering
Biomedical Engineering
Other
Gerontology
Medicine
Anesthesiology
Biochemistry and Molecular Biology
Cell and Neurobiology
Dermatology
Emergency Medicine
Family Medicine
Medicine
Molecular Microbiology and Immunology
Neurological Surgery
Neurology
Obstetrics/Gynecology
Ophthalmology
Orthopaedic Surgery
Otolaryngology – Head & Neck Surgery
Pathology
Pediatrics
Physiology and Biophysics
Preven ve Medicine
Psychiatry and Behavioral Sciences
Radia on Oncology
Radiology
Surgery
Urology
Other
Pharmacy
Clinical Pharmacy and Pharmaceu cal Economics and Policy
Pharmacology and Pharmaceu cal Sciences
Other
Public Policy
Social Work
7. Are you aﬃliated with the USC Norris Comprehensive Cancer Center? [radio bu ons]
Yes /No
8. What is your role and primary ac vity(ies)?
Faculty
Clinician researcher (>15% spent on research)
Clinical research
Clinical trials
Human mechanis c research (including “-omics”)
Cancer research
Appendix A: Full Survey (cont’d.)

Health outcomes/services
Preven on research
Behavioral research
Epidemiology (including gene cs and epidemiology)
Clinician (0-15% spent on research)
Transla onal researcher (early stage development)
Drug development
Devise development
Other
Basic researcher
Staff
Clinical research support
Study coordinator
Informa on science
Program manager
Finance
Other research support (please specify) [free text]
Sec on 2 of 5: Clinical Data Warehouse for Research (CDWR)
The ques ons in this sec on pertain to the Clinical Data Warehouse for Research (CDWR). There is significant
interest in the crea on of a clinical data warehouse for use by researchers across the USC enterprise. Containing
pa ent data from USC hospitals, Children’s Hospital Los Angeles (CHLA), and ul mately Los Angeles County (LAC),
the warehouse would support the research enterprise by enabling large-scale popula on analysis and aggregate
data output, as well as cohort iden fica on and other efforts.
9. For what purpose(s) would you use a clinical data warehouse?
Please rate each of the following in terms of its importance to your research. [radio bu ons]
0 = Would not use it for this purpose; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al
Iden fica on of poten al par cipants in on-going or planned clinical trial
Historical data extrac on for retrospec ve studies
Health outcomes research
Health access dispari es research
Precision/personalized medicine
Health effec veness research
Health economics/cost effec veness research
Quality healthcare research
10. Listed below are types of data that could be included in a CDWR.
Please rate each of the following in terms of its importance to your research. [matrix]
0 = Would not use it for this purpose; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al

Demographics
Diagnoses (ICD 9/10)
Procedures (CPT)
Medica ons
Laboratory test results
Radiology reports
Stage (for cancer diagnoses)
Pathology reports
Outcomes
Financial/cost data
Insurance coverage
Bio-repository data
Gene c/genomic data
Elements of physical exam – vital signs
Elements of physical exam – other than vital signs
Review of Systems (i.e., a checklist covering the organ systems)
Allergies
Smoking status
Drug/Alcohol use
Family history
Images
Physician notes
Other text in medical records
Other data type (please specify) [free text]
11. In addi on to hospital electronic medical records, pharmacy records, lab data, and ﬁnancial systems, are there
other sources of data that you would like to see ul mately included in the CDWR? (Check all that apply) [check
box]
Cancer Registry
Cardio Registry
Death Registry(ies)
12. Please rate the importance to your research of having access to clinical data from the following loca ons.
[radio bu ons]
0 = Would not use; 1 = Minimally important; 2 = Important; 3 = Cri cally important/essen al
Keck Medical Center of USC
Children’s Hospital Los Angeles
LA County Hospital (LAC+USC)
LA County public health system (DHS)
13. Please rate the importance to your research of having a structured biorepository. [radio bu ons]
14. Please provide any other feedback/concerns you may have related to the CDWR. [free text]

Sec on 3 of 5: Clinical Trials Management System (CTMS)
The following ques ons pertain to the development of a Clinical Trials Management System (CTMS).
15. Please rate each of the following capabili es of a CTMS in terms of its importance to your research. [radio
bu ons]
Study Management (protocol tracking; enrollment tracking; study calendar)
Financial Management (study budge ng; Medicare coverage analysis; invoicing)
Pa ent Management (pa ent enrollment, iden ﬁca on, and randomiza on; scheduling;
eligibility tracking; adverse event tracking)
Report and Data Management (electronic case reports; data repor ng and export tools)
Biorepository Management (specimen and result tracking; inventory management)
Impor ng current clinical study data from my exis ng database(s)
16. Please provide any other feedback/concerns you may have related to the development and implementa on of
a CTMS. [free text]
Sec on 4 of 5: Addi onal par cipa on in planning process
17. We will soon begin selec ng individuals to guide the development of the CDWR. We want broad
representa on of perspec ves and research areas. Would you be interested in par cipa ng in: (check all that
apply) [check box]
a. Quarterly mee ngs intended to update and gather input from a broad range of users on the
development and implementa on of the CDWR?
b. A working group that met more frequently (e.g., monthly) to develop key func onality, policies or
opera onal strategies for the CDWR?
18. We will soon begin selec ng individuals to guide the development of the CTMS. We want broad representa on
of perspec ves and research areas (faculty and staﬀ). Would you be interested in: (check all that apply) [check
box]
a. A ending two CTMS vendor demonstra ons and rate their func onality, ease of use, etc., on the
a ernoons of May 13th
and May 29th
on the HSC campus?
b. Par cipa ng on an advisory commi ee regarding development/implementa on and policy
development for a CTMS (mee ng every 6 to 8 weeks or via email ques ons)?
c. Serving on a working group that meets more frequently (e.g., monthly) to develop opera onal
strategies for the CTMS?
Sec on 5 of 5: Exis ng and poten al clinical and transla onal research infrastructure
The Southern California Clinical and Transla onal Science Ins tute (SC CTSI) is focused on serving researchers and
would like to be er understand your current needs.
19. Please rate the following currently available resources/services, in terms of importance to your research.
[radio bu ons]

Pilot Funding: to support research, career development, innova ve technologies and
methodologies, progression of discoveries and mul disciplinary team forma on
Clinical Research Space and Services: two clinical sites; outpa ent and inpa ent clinical research
space; access to trained clinical research staff; sample procurement; specimen processing and
handling laboratory; neurologic and bionutri on evalua ons; and more
Consulta on Services: Research advice from faculty, senior staff and external consultants
Study Design
Regulatory Knowledge and Support
Research Ethics
Conduc ng and Managing Human Studies
Data Management
Bioinforma cs
Biosta s cs
Sta s cal Analysis
Scien fic Wri ng
Transla on of preclinical discoveries
Community-engaged Research
20. Please rate the following under considera on resources/services. [radio bu ons]
Par cipant Recruitment Service: Exper se, tools and resources to recruit par cipants for
studies
Clinical Research Coordinator Core: Trained coordinators available on an ad hoc recharge basis
21. What other services or resources would be valuable to your work? [free text]
22. What is your biggest challenge(s) in conduc ng clinical research? [free text]

Appendix B: CDWR – Other Types of Data
Faculty responses to “Other data type [that could be included in a CDWR]”:
• adverse events, provider type (dept, service), guideline use
• behavioral health history
• Digital static, dynamic, and video Histopathology and cytopathology whole slide images
• Emergency department visits, Hospitalizations
• followup
• For personalized “omics” and tranlational studies the quality of specimens collected and saved,clincal
stages of the disease and response to thearapy data are critical.
• If waveforms for vital signs and hemodynamic variables were available
• Interventions (intubation, inotropes, CPR, etc.)
• language
• Medical errors, Medical malpractice claims that resulted
• Medical images, surgical history
• medical service use, unit in hospital, advance directive status and content, palliative care consultation
• outside referral records
• Plasma and CSF samples
• pregnancy and birth data
• prescribed and implanted medical devices
• prescriptions; evidence of adherence; recommendations for devices; use of technology; role groups en-
gaged with patient; number of contacts for specified clinical problems; note this list is written for MDs,
we need all disciplines including patients engaged in building such a data warehouse
• Primary care physician
• Rehabilitation utilization and daily documentation
• reproductive history
• samples and data of healthy potential matched controls
• signs and symptoms
• socioeconomic status; marital status; a brief clinical survey about health behaviors (e.g., physical ac-
tivities); residential addresses
• surgical reports, biorepository of cultured organisms
• The kind of data that would be relevant for many rehabilitation trials is not reflected above. This data-
base seems as if it would largely serve the needs of those interested in pharmacological issues.
• tumor biology features (estrogen receptor, progesterone receptor, HER2)
• what treatment they received and for how long

Appendix C: CDWR – Other Feedback and Concerns
Faculty responses to “Please provide any other feedback/concerns you may have related to the development
and implementation of a CDWR”:
• Would be hugely helpful but as a Division Chief for many of my faculty, essential to advancing us as an
academic medical center.
• Data must be stored in an abstract able/searchable format 2. Must be integrated to clinical work-load
so as to prevent duplication 3. Who owns the data?
• Adequate support for the infrastructure is critical. In my experience, it cannot be dependent on indi-
vidual investigator’s grant support/chargebacks. This is a capital investement in our future as a research
institution.
• As near real time as possible
• Need a transdisciplinary focus, engage patients and all providers in building key elements; recall for
pharmacy: too often data bases track what was dispensed or prescribed and no data on patient use of
drugs including nursing notes and data on prescription refills
• Biorepository needs to be clinically annotated. Infrastructure needs to be established for tumor bank-
ing and adequate communication with operating surgeons/research coordinators and pathology. The
department of pathology and department of surgery members who participate in tumor banking
should receive credit as co-authors on manuscripts resulting from their efforts.
• Biorepository should if possible have bloods at various stages of disease for biomarker discovery.
• Development of a useful and accessible database is critical to my research. Difficulty in getting this
information has the primary roadblock in getting research completed.
• I know from experience that absorbing free text could pose HIPAA issues - it is more difficult to mask.
If we had an identifier that lets us track back to MR where necessary, that might help.
• I would be happy to help develop data structure for assessment of family structure and history, and
history of exposure to selected agents
• Key is connecting the LAC+USC patient data & the UH/Norris patient data.
• Please see earlier note. While I’m sure this database will mee the needs of those interested in pharma-
cological and medical interventions, it will may not fully support rehabilitation efforts as currently
designed.
• something that is critically needed, however there are other registries for a variety of specialties, so one
challenge is to integrate the data capture for this database with already exisiting databases.
• We are particularly interested in the sustainability of changes obtained during hospitalization and as
such are interested in follow-up status data.
• Working on clinical samples has been abasic problem because “birepositories” are personal! No shar-
ing unless there is a personal interest.
• would be excellent to link this directly to the EMR and make the EMRs able to communicate across
campuses.

Appendix C: CDWR – Other Feedback and Concerns (cont’d)
• Would be great to have a clinical data warehouse that is linked anonymously to biorepository of pa-
tient specimens
• Would suggest periodic update of the patient information so patient information can be followed lon-
gitudinally

Appendix D: CTMS – Other Feedback and Concerns
Responses to “Please provide any other feedback/concerns you may have related to the development and
implementation of a CTMS”:
Faculty
• Cafe and Redcap are working well
• Need to have it operative at County as well as USC. Also, would be great if it alerted when protocol
patient showed up for a regular health system visit.
• Please arrange focus groups and other feedback opportunities after this survey is completed
• Would like integration of the biorepository clinical data to be linked to clinical trial data so outcomes
can be analyzed based on genomic and other biomarkers
• Would love for this to ultimately communicate with other data repositories and large databases. The
ability to import data from large databases into this would be phenomenal.
• Would need to be able to access from my LAC office computer; archives from paper medical records
Staff and Other
• Better still is if the electronic case reports, data reports can self-populate from the hospital systems
• Concern if the study specific trial has it specific tracking logs then having to enter the same informa-
tion into the CTMS system? Or would the CTMS be used if the trial did not have these systems are in
place.
• Development of the management systems is theoretically a good idea, however, general systems are
often not setup to individual project needs
• Having a fair, easy to use system to access clinical samples (i.e., one PI can’t keep all the samples!)
• It will hopefully be more intuitive and user-friendly than TRUE 2.0.
• The system should ideally accommodate, be useful to, various types of research and disciplines

Appendix E: All Perceived Challenges
All responses to “What is your biggest challenge(s) in conducting clinical research?” by category:
Access to Clinical Data or Specimens
Data Access
Absence of centralized resources, data and procedures, making start-up extremely taxing
Access to affordable blood draws and tissues biopsies in human research
access to data
Access to Electronic Medical Records data for CTMS
Having to review paper medical charts, eletronic charts, Affinity, Synapse systems to mine data
Lack of access to patient clinical data and difficulty in identifying eligible patients for retrospective radiology studies
Lack of data collection
Lack of databases to find patients with specific conditions / diagnoses
lack of infrastructure to access large patient dataset and biospecimens
linking biospecimens to clinical data
No central database
no source of clinical data
the lack of a searchable medical records for study recruitment
We need a database and the associated support to extract information from the existing patients population to form
and test hypothesis, and to develop prospective clinical studies
Specimen/Sample Access
Collection of specimens
Getting well characterized and well preserved specimen. We need a”CORE” for preserving quality contrrolled
specimens that can be used for many different tests in the future. The core should save not only the specimen slides
or paraffin blocks but also RNA, DNA and protein if material is available for future omics studies.If fresh material is
available then tissue should be cultured for short term and preservrd in small aliquots for research
having access to tissue
lack of infrastructure to access large patient dataset and biospecimens
Lack of resources available (no system for creating a tissue repository)-every lab does it differently
Obtaining fresh tumor specimens with Dept. Pathology cooperation and flexibility
obtaining samples relevant to my studies
The Tissue Procurement Core as it is currently being run is my biggest challenge.
Administrative Hurdles
Administrative Processing Time/Efficiency
Cerner
cumbersome paperwork submission and review processes
Efficient start-up including development of the CRFs, database, and recruitment infrastructure
Paperwork

the most challenging issue is the bureaucracy that county has. the lab agreement takes a long too long to approve, then
after that to pull the slides and blocks more and more time. very inefficient, they lead you to despair. I hope there is
another way to cut the time and rush things through
the USC bureaucracy and paperwork, the process needs to be streamlined, and much mor efficient if we are going to
compete for clinical research grants with other established institutions
TIME- Gathering so much info to put a patient on study or waiting for data that you need to enter from and off site
slows down the process and you now have others waiting on you for what your waiting on
Too much administrative paperwork and requirements to be met - EVERYBODY has more and more from C and G to
financial systems, to Research Admin!
working with grants and contracts: now that the system will be changing and will the new staff be able to decrease the
turn around time of executing contracts and assisting with working witht the research team to build and provide a
budget
Compliance
Compliance is not helpful with executing contracts or confidentiality agreements.
Compliance
compliance officers who don’t understand human research
CRO
Also approval from CRO (approx 3-6 months) for a research order form is too long and hinders research. We’ve had
student research delayed because they did not receive necessary approval from CRO, despite frequent follow-up. For
Industry Sponsored clinical trials, the amount of time it takes to negotiate and finalize an agreement has discourage my
faculty from working with industry sponsors
Getting the clinical trial budgets, Medicare Coverage Analyses, and Research Order Forms from USC CRO in a timely
manner.
Getting the MCA, budget & Research Order Form for non-industry sponsored trials
lack of infrastructure for performing clinical trials
Timely sponsor contract negotiation and approval, MCA, and budget negotiation and approval
Unhelpful and procrastinating CRO; ineffective, slow contract negotiation
IRB/Regulatory
Getting anything through the IRB process. It takes FOREVER!
getting studies approved by IRB
Having a structured system and adequate personnel in ensuring that the regulatory group is able to do their tasks
accurately and in a timely manner
Initial regulatory hurdles before a study is opened
IRB delays and inflexibility
Obtaining regulatory approval
Regulatory environment
then all disorganized and disconnected systems for regulatory approvals. We need ONE portal through which
reserachers and thier teams can access all aspects of tools and retulatory applications for clinical research
working through the IRB process
writing IRB
Non-integrated Administrative Systems
A website with guidance (contact info, necessary forms, etc) would be helpful.
Appendix E: All Perceived Challenges (cont’d.)

Coordinating efforts/reports/applications across disciplines and school
the bureaucratic nightmare that is USC. As a coordinator there are over a dozen different USC departments that I
need to go through in order to set up new studies and have proper training/clearance/access to information. This is
especially true with regards to budgeting and contracting
The existence of so many different entities (CISO, CTSI, HRA, IRB, etc.) that have different requirements for similar
things--for example, I had to take 2 HIPAA courses that were almost identical when I first started working here. The
office of compliance didn’t recognize the one that was on the IRB website. The roles (of all of the different departments)
get confusing.
The very limited central infrastructure at USC for research. Unfortunately, what little infrastructure that is available in
our system is set up for departmental research and not programmatic research
then all disorganized and disconnected systems for regulatory approvals. We need ONE portal through which
reserachers and thier teams can access all aspects of tools and retulatory applications for clinical research
too many systems
Working within different departments to coordinate scheduling of patient procedures
Clinical Research Support Staff
A clinical research coordinator core would be exxtremely helpful for a biological / biomarker study we are trying to
get off the ground. Our clinical trials office has indicated they are too busy to obtain consents and accrue samples, but
at the same time it would not be appropriate for lab researchers to obtain consents and samples. A core - which could
charge for their expertise in coordinating such activities - woudl be a great help
Absence of centralized resources, data and procedures, making start-up extremely taxing
Access to resources to perform the research
administer pharmacological manipulations
As Research Administrator, assisting faculty with determining who the appropriate contacts are to have blood work or
radiology work done
available research assistants
coordinating all study personnel, as a Ph. D. researcher this is challenging
Coordinating efforts/reports/applications across disciplines and school
Finding experienced research coordinators
lack of mid-level support so that faculty can concentrate on academic endeavors
lack of support staff
Not having enough regulatory staff to do the work
Overworked research coordinators
person to mine the data
project managers
qualified staff to conduct specific tests within in budget limits, (e.g. treadmill, dexa) management and analysis of blood
assays
scheduling CTU visits
skilled research assistants
Study coordinator or research nurse
sufficient number of competent clinical research support staff
Support staff

Communication, Support, and Engagement
Clinical Research Knowledge and Engagement
difficulties in enrolling patients into clinical trials (parental distrust of research),
Disseminating information about the study to other treating physicians and patients in the community
getting MDs to comprehend clinical studies and getting their approval for pt participation
lack of knowledge on the part of departments when they want to be supportive
Departmental Support
lack of department support
Obtaining fresh tumor specimens with Dept. Pathology cooperation and flexibility
Dedicated Time
Carving time away from my administrative demands
finding adequate time given clinical care obligations
Having dedicated research time away from my clinical duties
protected time
Securing time and funding in the first place
time
time
time away from clinical responsibilities
Time from clinical responsibilities
Time!
Trite but true: time and money
Facilities/Space
Facilities
adequate user and patient friendly facilities
lack of a CTU in a convenient location
we need more clinical research facilities
Sample Processing Core
Getting quality microarray/Next Generation sequencing data done via a core and analyzed via our bioinformatician.
Space
laboratory space
people fight over freezer space
space
Funding
$$$
Access to affordable blood draws and tissues biopsies in human research
adequate funding
Funding

funding, decrease NIH funding
Funding. Much of the funding available through major funding agencies is less likely to be directed towards
rehabilitation clinical trials
funds
Getting NIH funding!
inexperience with defining and framing clinical research questions and how to get pilot funding to pursue
Lack of sufficient funding from federally supported trials
minimal start up funds available for junior faculty.
Obtaining funding
securing funding
Securing time and funding in the first place
Trite but true: time and money
Not Categorized
I currently perform basic with translational outlook research only
Lack of infrastructure support
No institutional resources
Positive out come of the study’s
REDCAP type tools
Participant Recruitment
Acquiring subjects
Cohort recruitment and retention
Efficient start-up including development of the CRFs, database, and recruitment infrastructure
Follow-up attrition
Having access to patients to get clinical samples
inform consent
knowing how to recruit and consent patients
Lack of resources to streamline pre-screening for subjects
participant recruitment
Patient accrual
Patient Recruitment
patients
recruiting and sustaining non-english speaking populations
recruiting subjects
recruitment
Recruitment and retention
recruitment and retention of study participants
Recruitment of Patients
The cancer registry has numerous wrong numbers and unable to locate patients using other resources

The importance of having a PARTICIPANT RECRUITMENT SERVICE cannot be over emphasized. This is the
Achilles Heel of many studies
understaffing for participant recruitment and follow-up
Subject-Specific Expertise/Assistance
Biostatistics
access to clinicians with knowledge of biostatistics and time to help
analysis
As a new researcher, help with protocol development and study design; statistics
Getting quality microarray/Next Generation sequencing data done via a core and analyzed via our bioinformatician.
management and analysis of blood assays - currently using Quest and would like to keep it in-house if cost effective
statistical support
Data Management
data management
Data Management
We need a database and the associated support to extract information from the existing patients population to form
and test hypothesis, and to develop prospective clinical studies
Funding Applications
Initiating Studies
Identifying the appropriate question to be addressed in a clinical study
inexperience with defining and framing clinical research questions and how to get pilot funding to pursue
Mentorship
mentorship
Protocol Development
Publication
Coordinating dissemination of multiple secondary outcome papers after the funding for the clinical trial has ended
and the primary outcomes have been published
Study Design
Translational Value
Evaluating how ‘translatable’ mouse research is to clinical issues
Knowing how to move from a basic discovery to translational study
Working Collaboratively
Matching Service
In my particular case I am in a situation where as an Biomedical Engineer I need to work in conjunction with a
clinician. It would be helpful to have a matching service, where technical experts can work with clinical experts to work
on issues and projects.

Differential capabilities and resources in interdisciplinary teams. Example: citation software saves valuable time, can we
get equal access to EndNote and RefWorks and easy transfer of files? Referencing should not be a burden in building
a grant application given these resources. Make sure that all researchers know of new ORGANIZATION option on
Blackboard for posting materials, sharing announcements, drafts etc. Experts should explore and coach on use of
Discussion board to short circuit asynchronous emails.
facilitating collaboration
forming a multidisciplinary team
Identifying partners
My area of research is based on addiction. We do not have a strong addiction clinical group at USC. Currently
collaborating with UCLA
Keeping Confidentiality in diverse groups

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