“I am grateful for the assistance of the Translational Research Institute, which helped connect me with physicians and clinics internally and externally to recruit subjects for a Phase 2 industry sponsored clinical trial.” Mauricio Garcia Saenz De Sicil, M.D., Principal Investigator, Assistant Professor, UAMS College of Medicine, Department of Internal Medicine.
RESEARCH RECRUITMENT AND RESOURCES eBOOK
INTRODUCTION ………………………………………………………………...........3 DATA SOURCES FOR IDENTIFYING RESEARCH PARTICIPANTS ….......4 ARresearch.org ………………………………………………………........................................................….4 Arkansas Clinical Data Repository (ARCDR)……………...................................................……5 ResearchMatch.org………………………………………………….........................................................….6 Arkansas Children’s Research Institute Registry…….....................................................…….6 Additional Accrual and Recruitment Resources…….....................................................…….6
PARTICIPANT INCENTIVES…………………………………………….............…7 RECRUITMENT ADVERTISING…………………………….…………...........……8 Research Awareness………….………………………………......................................................….….….9
PLAIN LANGUAGE....………………………………………………...........………10 HEALTH LITERACY………………………………………………...........………….10 Retention Strategies………………………………………….......................................................…………11
SERVICES TO FACILITATE RESEARCH.………………………………........….12 Clinical Trials Innovation Unit (CTIU)…………………...................................................………….12 Recruitment and Retention Consultations……………....................................................……..13 Biostatistics Consultations………………………………......................................................………....13 Comprehensive Informatics Resource Center (CIRC)…....................................................14 Data Safety Monitoring Boards (DSMBs)…………....................................................………….15 Community Engagement (CE) Consultations……………..................................................….16 Equipment Library…………………………………………….......................................................…………17
CLASSES AND CONTINUING EDUCATION FOR STUDY TEAMS…........18 Certified Research Specialist (CRS) Program………...................................................………18 Good Clinical Practice Training………………………………....................................................…….18 Responsible Conduct of Research…………………………....................................................…….19 Grants Management Certification Program………………...................................................…19 Graduate Certificate in Regulatory Science…………..................................................……….20 Clinical and Translational Science (CTS) Track…................................................……….……20 TRI Video Library……………………………………………………....................................................…….21
PROFESSIONAL DEVELOPMENT FOR STUDY TEAMS……….............…22 Other Research Resources…………………………………………......................................................22
INTRODUCTION Effective participant recruitment begins with a detailed
Having a detailed strategy for recruiting participants
recruitment plan. Because every study cohort is unique,
early on will speed the pace of accrual and help avoid
researchers must tailor their recruitment strategies to
potential IRB amendments and delays.
achieve their target enrollment goals. The Research
The eBook also includes important tools, tips and
Recruitment and Resources eBook was prepared to
other resources, such as community engagement,
help UAMS researchers know what is available when
biostatistics, continuing education and professional
developing a recruitment plan.
development opportunities.
3
DATA SOURCES FOR IDENTIFYING RESEARCH PARTICIPANTS
ARresearch Participant Registry ARresearch.org is home to a volunteer database
Access to the database requires IRB approval. Your
of more than 3,500 individuals located primarily in
IRB protocol must include your intent to use the
Arkansas who are willing to consider participation in
ARresearch registry for recruitment. You will need to
research studies. It contains demographic data and
inform the IRB how you plan to contact registrants
general disease categories that registrants choose,
(e.g., phone, mail, email). Once you have received IRB
including a “Healthy Volunteer� option. For example,
approval, please submit your request and updated IRB
if your study is related to diabetes, you would learn
approval letter through the TRI Services Portal.
how many registrants have selected the diabetes option, meaning they are willing to be contacted about
For additional information, please browse the
diabetes studies.
Frequently Asked Questions page on the TRI website.
Cost: Free tri.uams.edu/arresearch-3/
Sandra Hatley
(501) 686-5417 HatleySandraE@uams.edu
DID YOU KNOW? Weight Management is the top health interest area among ARresearch registrants. Fifty-two percent of registrants have selected Weight Management, indicating they wish to be contacted by UAMS about studies related to that area.
4
Arkansas Clinical Data Repository (AR-CDR)
AR-CDR is a research data warehouse that provides
To gain access to the UAMS Research Cohort
a single and secure source of data for use in clinical
Estimation tool, you will need to:
and translational research. It houses data that are 1. Complete the brief (10 minute)
extracted from the EPIC health care software system,
online training module.
including patient data (e.g., demographics, admissions,
2. Submit a request for AR-CDR access through
visits, inpatient/outpatient, providers) and clinical data
the TRI Services Portal.
(e.g., diagnoses, immunizations, laboratory results, procedures, medications).
To request identifiable patient data, you will need to:
Access to the UAMS Research Cohort Estimation
1. Submit a request to the UAMS Institutional Review
tool allows investigators to query AR-CDR to obtain
Board (IRB) for approval.
aggregate data (patient counts) according to patient
2. Once IRB approval is obtained, submit a request for
population characteristics.
a limited data set through the TRI Services Portal. Please include your IRB approval letter in your request. 3. The AR-CDR team will work with the honest broker to coordinate and review the data requirements of the limited data request and then deliver the requested data to the investigator in a timely manner. Cost: Free tri.uams.edu/circ/arkansas-clinical-data-repository/
Kim Gates
(501) 686-8419 KDGates@uams.edu
5
ResearchMatch
Arkansas Children’s Research Institute Research Registry
ResearchMatch is a free and secure recruitment tool
Arkansas Children’s offers opportunities to the
that has been adopted by 138 research institutions
community to participate in many studies. To request
across the country. Anyone from the United States
use of this registry, please complete the ACRI Clinical
can join ResearchMatch. All ages and backgrounds
Study Advertising Form.
are included in the registry. It contains both healthy volunteers and those with medical conditions. For
Cost: Free
additional information, please visit the Frequently
secure.archildrens.org/ResearchContacts/
Asked Questions page. You may also register as a
Janet Storment
researcher.
(501) 364-2760 Cost: Free
stormentjs@archildrens.org
www.researchmatch.org/
Pam Christie
(501) 526-0366 PKChristie@uams.edu
Additional Accrual and Recruitment Resources • Trial Innovation Network Toolkit • Clinical Trials Transformation Initiative: Project Recruitment • AccrualNet: Strategies, Tools, and Resources to Support Accrual to Clinical Trials
6
PARTICIPANT INCENTIVES Incentives for participation in research must be IRB
through a petty cash account at the Treasurer’s Office.
approved. Incentives are set up through the study
Guidelines and procedures for establishing, maintaining
team’s department, institute or in collaboration with an
and monitoring petty cash funds can be found in UAMS
industry sponsor. Monetary incentives, such as cash,
Policy 8.7.02. Required forms can he found here.
checks and gift cards, must be set up and processed
7
RECRUITMENT ADVERTISING TRI in partnership with UAMS Communications and Marketing, can help streamline access to free and
of Women g Health Promotin es bi Ba and Future
paid media, both internal and external, to support
erence Make a Diff ts Be Able to ear Resul You May al Pap Sm ve Abnorm If You Ha
recruitment efforts. Assistance includes: PepCan Vaccine Trial
Promoting the Health of Women and Future Babies
• Communications consultations
Benjamin J. Lieblong, Ph.D., Hannah N. Coleman, Mayumi Nakagawa, M.D., Ph.D. Department of Pathology, University of Arkansas for Medical Sciences
-grade d with high diagnose If you were n (HSIL) or helial lesio s intraepit be eligible squamou you may out HSIL”, rule not conducted “can trial being a clinical HPV to enroll in using an treating HSIL for S 0. at UAM Ages 18-5 vaccine. therapeutic
y involves period This stud a 16 month lify 7 visits over 0 if you qua n up to $30 Compensatio ing
• Digital communications
Paid Park For more
nah enro ms.edu to Contact Han dysplasia ineStudy@ua or HPVVacc
HPV is short for Human Papillomavirus, which is known to cause cervical cancer
HPV can lead to low-grade (LSIL), which can progress to highgrade dysplasia (HSIL)
There are over 200 types of HPV, and more are still being discovered
agaw HSIL can be treated with a surgery Mayumi Nak tor: called LEEP, but LEEP can cause Co-Investiga (Ob-Gyn) nfield, MD William Gree pre-term delivery of babies
Principal
PROPHYLACTIC
• Other communications support, including the use
Prophylactic vaccines prevent HPV infection Gardasil® protects against up to 9 types of HPV that can cause cervical cancer and genital warts
of human interest stories, to help raise awareness of your study.
PV? What is H
• Didn’t see your specific recruitment advertising needs listed? We will work with you to develop strategies and tactics tailored to your research project.
Gardasil does not help people that already have HPV, which is why a therapeutic vaccine is needed
THERAPEUTIC Therapeutic vaccines treat HPV infection, dysplasia, and cancer No HPV therapeutic vaccines are currently available A therapeutic HPV vaccine could reduce the risk of premature delivery by avoiding LEEP surgery
had a Pap Have you at wasn’t smear th normal? ink you Do you th ve HPV? might ha
irus papillomav for human Currently Recruiting: Phase II Clinical Trial HPV is short cervix andof PepCan and Candin the in er nc use ca HPV can ca Candin is meant to stimulate the “Pep” stands for 4 “peptides” s ce other pla immune system e of contained that mimic a protein ving any typ from HPV called E6 t HPV by ha PepCan and Candin have been it s You can ge ha shown to be safe Being able to mount an immune meone who sex with so response against E6 has been
out? e study ab What is th dy: out the stu ab ts ¿Qare fac ué me el VP soes Here H? ll a new k at how we
associated with good outcome
“Can” stands for “Candin®,” an extract from the yeast, Candida
PepCan has been shown to reduce HPV 16 virus by 93%
PepCan has been shown to regress HSIL by 45% in 3 months
You could
ake health d babies!
help us m
will loo women an which are also caused by HPV stuHdy ThElisVP es una ma PepCan works better for evi mode us ccine callednera abr vase refVerir HP e squaada al viru rad -g s del gh pap (hi IL ilom a humano st HS ainH agVP El pulesion ns? ) sar cau elial ede cáncer en el ne is epith ve questio ute rino y otras par cci llo vacue hat if 1 I haVaccination 2 Vaccination tes WVaccination w safe the Screening Visit ho 3 Vaccination 4 at ? k loo up o alsede Ust Pregnancy Testn Pregnancy Test Consent Pregnancy Test Pregnancy Test willpu I sig It ed contagiarse con Blood Draw Blood Draw History Blood treat Blood Draw HDrawow doInjection ellpVP tener cualquthi ne may he Injection Injection Injection H,Physical al Exam vacci l pe iers tip ai HPV Testing o de relación ho em We ll or con alguien qu sexual Colposcopy-Guided Biopsy Ca s: e lo tenga en Blood Draw Pap/HPV w HSIL O na EP LE Colpo Shaw ¿En qué coal treatment for HSIL is Blood Draw 7657 re) Is Eligible? e el ceduWho (501) 526- uams.edu The norm nsist estudi l excision pro ica Women ages 18-50 with s@ Women ages 18-50 with abnormal ctr na o? ele w Pap/HPV ha (loop ss Pap smear results: biopsy-proven HSIL: en s ow bie Colpo/4QBx es ba High-Grade Dysplasia (HSIL) CIN 2 or CIN 3 Blood Draw He aquí algun rks, but it also caus “Cannot Rule Out HSIL” (ASC-H) wodatos ace ing Any woman LEEP os foll low rcainde with an eligible diagnosis can early estudio: too rn join, regardless of citizenship or US residency status Este est bo be toud io evaluará la efectividad ancies la nueva gnuna pre vac llamada PepCaPepCde an and HSIL (lesión intr t both n contra ll tes wiitel more aep finIdjoin ial escamfor HSILs This study n I do alto grado) How the study Where ca .ndin® as treatments osa deIs there any compensation ¡Puede ayud Ca atioan? for orrm refer patient? lps info heparticipating? arnos a mejo También eva ich wh t results sa as ap ye luará qu tan /pdiscuss rar la e of If you qualify¿Y to receive the vaccine, Call du us to eligibility: 501-526-7657 lud de muje to s.e m seguratem nd si po ua te vacuna. Candin is a étyp ng ww. w o res y bebés! pr sys es lares youthe can receive up to $300 in eg ne un mu im s? is Email usta at HPVvaccinestudy@uams.edu body’s tem ¿C sys compensation óm ne Esperamosthe o me regist d . The immu quePe an an n est tio pC a ec ro vac Fax Pap smear/biopsy results and contact ? una ayutde hts inf If you travel 50.0+ miles one-way, figal tratamientothe Llame o$40 de of IL. information to 501-526-5812 the body tha you can receive between $100 en-víe partHS un correo a El tratamiento er per visit normal para canc m HSIL esep Sh fro (escisión electr aw V HP na All study procedures are free of Ow P oquirúrg in helps ke LEE en charge (501) 526-76 s: Using Candica con asa) LEEP funciona, 57 and parking is paid ow miongtambién puede ensshawnas forper causar que beb @ ua ms.edu és nazcan ant es de tiempo en fut uros embarazo s. Este estudio Where are study visits evaluará ambas PepCan y conducted? Candin®, com o tratamientos para HSILs. University of Arkansas for Medical Sciences Candin es un ¿Dónde pu tipo de levadu edo encont Winthrop P. Rockefeller ra, la cual ayuda a su sist rar más ema inmune Cancer Institute informació a responder al PepCan. El n? www. 4018 West Capitol Ave. sistema inmune uams.edu/ , es la parte del cue papresults Little Rock, AR 72205 rpo que lucha contra las infecciones y el cáncer. El usar el Cand in evitará que de desarrolle el VPH. Candin has been used to treat warts,
¿Ha tenido usted un Papanic olaou anormal? ¿Piensa ust ed que puede tene r VPH?
“When I needed help with participant recruitment, the Translational Research
Institute’s professional staff assisted with
crafting communications for social media
and has provided platforms to spread the word to our cohort of women.” Barbara Fuhrman, Ph.D.,
Principal Investigator, Assistant Professor, UAMS College of Public Health.
8
leman HannahCo 57 ms.edu 501-526-76 eStudy@ua HPVVaccin
What are HPV vaccines?
leman HannahCo 57 ms.edu 501-526-76 eStudy@ua HPVVaccin
leman HannahCo 57 ms.edu 501-526-76 eStudy@ua HPVVaccin
leman HannahCo 57 ms.edu 501-526-76 eStudy@ua HPVVaccin
leman HannahCo 57 ms.edu 501-526-76 eStudy@ua HPVVaccin
leman HannahCo 57 ms.edu 501-526-76 eStudy@ua HPVVaccin
leman HannahCo 57 ms.edu 501-526-76 eStudy@ua HPVVaccin
campaigns (Facebook, Twitter, Text blasts)
leman HannahCo 57 ms.edu 501-526-76 eStudy@ua HPVVaccin
• Utilizing social media as part of recruitment
: Investigator PhD (Pathology) a, MD,
leman HannahCo 57 ms.edu 501-526-76 eStudy@ua HPVVaccin
• Developing and disseminating recruitment materials
k
tion chec
informa sults .edu/papre at (501) 526-7657 www.uams Coleman ll
What is HPV?
Research Awareness Public awareness of research participation opportunities has been enhanced by ARresearch and TRI’s Community Engagement Program. ARresearch.org is the cornerstone of existing participant recruitment and the focus of a broad media campaign to recruit volunteer participants. Through ARresearch.org, we provide the public with easy access to information about research at UAMS and how to participate.
• Prominent placement of an ARresearch.org
This awareness support includes:
promotional blurb and link on the UAMS My Chart
• The ARresearch.org website, which uses plain
web page.
language to provide the who, where and how to engage in research studies
• Utilization of social media (Facebook, Twitter, Text blasts)
• Use of UAMS patient appointment reminder letters to promote the volunteer registry at
• ARresearch promotional brochures, giveaways, and
ARresearch.org
other materials
The TRI Community Engagement Program has also increased community awareness and involvement through initiatives such as the Community Scientist Academy. These academies teach lay audiences about the research process. The knowledge they gain serves them in future research volunteer roles at UAMS. 2017 Community Scientist Academy Graduates 9
PLAIN LANGUAGE
HEALTH LITERACY
Researchers are not often taught – or encouraged – to
Health literacy is a person’s ability to find, process,
write on an eighth-grade level (U.S. adult average).
and use health information, so they can make
But simply written lay summaries, informed consents,
informed choices. Plain language is one important
and other public-facing materials (such as flyers and
tool to improve health literacy, but it’s not the only
surveys) are important to a study’s success. When
consideration researchers should make when designing
the public understands and appreciates the aims and
recruitment and study materials. Health literacy is
methods of your research, they are more likely to enroll
a complex concept that depends on many factors,
as a subject or support it in other ways.
including the skills and experience of the user and the quality and clarity of the communication.
The UAMS Center for Health Literacy is offering plain
Links to Helpful Health Literacy Resources:
language assessment and editing of lay summaries to UAMS researchers at no charge, as staff workloads
• UAMS Center for Health Literacy
allow. To submit a request or for questions, contact Alison Caballero at BACaballero@uams.edu or (501)
• CDC Health Literacy Resources
686-5463.
• Quick Guide to Health Literacy
Links to Helpful Plain Language Resources
• AHRQ Health Literacy Universal Precautions
• United Healthcare Group- Just Plain Clear: English
Toolkit
and Spanish Glossary
• The Health Literacy Style Manual
• UAMS- Plain Pages
• Simply Put: A Guide for Creating Easy-toUnderstand Materials
• PlainLanguage.gov- Improving Communication from the Federal Government to the Public
• University of Michigan, Library- Plain Language Medical Dictionary PLAIN LANGUAGE MEDICAL DICTIONARY
10
Retention Strategies • Educate participants about their important role in
Retention of research participants is a critical component of recruitment. TRI recognizes that
your study and emphasize the importance of their
identifying and addressing retention issues as part of
continued participation.
the overall recruitment strategy has a direct impact
• Review and address potential barriers to
in maintaining subjects in clinical trials. The following
participation such as work schedule, child care and
pre and post recommendations will help you maximize
transportation.
retention:
• Communicate with participants throughout the study.
11
SERVICES TO FA C I L I TAT E R E S E A R C H
Clinical Trials Innovation Unit (CTIU) Clinical Trials Innovation Unit (CTIU)
ensure efficient processing and implementation of
TRI’s CTIU provides services and support for all
all clinical trials conducted at UAMS. The CTIU also
types of human-based research studies, including
coordinates protocol submissions to central and local
investigator-initiated and industry sponsored studies.
IRBs, providing a single contact point to enhance
CTIU staff will guide investigators throughout the entire
communication and reduce redundancy. Learn more
clinical trial process. The CTIU works collaboratively
at our Frequently Asked Questions page. You can
with other groups on campus, such as contract
request services through the TRI Services Portal.
attorneys and institutional compliance offices, to
Cost: There is no cost for utilizing protocol assistance, budget review, budget development, budget negotiations and Medicare coverage analysis services. Other services are available using a fee-for-service schedule to ensure that UAMS sustains the necessary infrastructure for conducting research. Investigators are encouraged to contact the CTIU at the beginning of grant or protocol development or prior to budget negotiations for industry sponsored research studies.
Jonathan Young (501) 526-7984 jayoung@uams.edu
Despite a fire alarm evacuation, the TRI study team kept research participant Homer Paul’s testing on schedule in UAMS Parking 3. “I started calling them the A-Team,” Paul said.
12
Recruitment and Retention Consultations TRI can help guide researchers on a range of
discussing strategies for recruiting underrepresented
participant recruitment strategies. This assistance
populations. We strongly encourage researchers to
includes accessing volunteer participant registries
contact TRI about their recruitment needs prior to IRB
(ARresearch.org, ResearchMatch, etc.), identifying
submission. You can request services through the TRI
cohorts through electronic health records, consulting
Services Portal.
about communication techniques/modes and Cost: Free
Pam Christie
(501) 526-0366 PKChristie@uams.edu
Biostatistics Consultations TRI offers support in biostatistics and research design
studies. Well-designed studies are not developed in
for both human and animal research projects. The
isolation. As such we recommend that investigators
biostatistics group provides front-end assistance to
include a biostatistician as part of their research team
investigators to ensure the use of statistically sound
as early as possible in the design process. You can
practices, thereby facilitating properly designed and
request services through the TRI Services Portal.
scientifically valid clinical and translational research Cost: There is no fee for the initial consultation. Subsequent assistance requires support, with costs dependent on the scope of the work.
Trey Spencer
(501) 526-6719 spencerhoracej@uams.edu
13
Comprehensive Informatics Resource Center (CIRC) • Research Electronic Data Capture system
TRI is dedicated to advancing the use of cutting-edge informatics, providing researchers with the tools,
(REDCap). A secure, web-based application to
expertise and procedures for clinical and translational
support data capture for research studies.
research. Through a partnership with the Department
• CLinicAl Research Administrator (CLARA). A web-
of Biomedical Informatics at UAMS, the following CIRC
based portal for submission, review, approval and
services and resources are available to researchers. You
tracking of human subjects research.
can request services through the TRI Services Portal.
• Investigator Consultations. CIRC faculty and
• Arkansas Clinical Data Repository (AR-CDR). A
staff provide consultations on data management,
searchable database that compiles patients’ clinical,
bioinformatics analysis and biomedical informatics
laboratory and billing data from their electronic
research approaches.
health records.
• Informatics Education & Training. Graduate
• UAMS Profiles Research Networking Software.
programs in bioinformatics, a clinical informatics
A web-based tool that helps researchers find
board prep course, a seminar series and more.
collaborators at UAMS and worldwide.
• Comprehensive Research Informatics Suite (ARCRIS). A set of open source software tools for the electronic management of research data. Cost: There is no fee for the initial consultation. Subsequent assistance requires support, with costs dependent on the scope of the work. Contact: Please submit all questions and questions directly through the TRI Services Portal.
14
Data Safety Monitoring Boards (DSMBs) Data Safety Monitoring Boards (DSMBs) TRI can assist with the organization and implementation of DSMBs when applicable. DSMBs regularly review accumulating data for ongoing research studies to assess subject safety, scientific validity and efficacy. The Food and Drug Administration (FDA) offers a guidance document that provides recommendations on when a DSMB may be required. Individual funding agencies may also impose additional DSMB requirements. You can request a DSMB through the TRI Services Portal. Useful Links
• NIH Data Safety and Monitoring • NIH DSMP Guidance • NIH DSM Policies and Guidance • NIH Adverse Events Cost: Free
Amy Jo Jenkins
(501) 686-5939 AJJenkins@uams.edu
15
Community Engagement (CE) Consultations To help you more effectively recruit underrepresented populations, TRI provides investigator consultations on the following aspects of community-engaged research. You can request a consultation through the TRI Services Portal.
• Community member introductions • Partnership development • Establishment of study-specific Community Review Boards to advise on research questions, participant recruitment and retention, research implementation, and dissemination of research findings
• CE portions of grant applications • Conceptualizing studies that may benefit from CE • Identifying potential research staff with CE expertise
• Technical assistance for CE strategies • Community input on specific projects, grant applications, manuscripts, etc. Cost: Free
Camille Hart
(501) 454-1467, cnhart@uams.edu 16
Equipment Library TRI has a variety of equipment available for shortterm use to help you recruit in the community. The typical loan period is 14 consecutive days, but other arrangements are possible. Borrowers or their department are responsible for replacement of missing or damaged equipment. Requests for equipment should be made through the TRI Services Portal. This equipment includes items such as iPads, tablets, laptops, portable PA system, LCD projector and screen, tables, display boards, and tents. Cost: Free
Nicki Spencer
(501) 526-6629 ndspencer@uams.edu
17
CLASSES AND CONTINUING E D U C AT I O N F O R S T U D Y T E A M S Certified Research Specialist (CRS) Program
Good Clinical Practice (GCP) Training
Certified Research Specialist (CRS) Program
Good Clinical Practice (GCP) Training
The CRS Program provides essential training in key
The National Institutes of Health (NIH) Policy on GCP
areas of recruitment and working with research
Training became effective Jan. 1, 2017, requiring GCP
subjects. The training program is open to investigators
training for NIH-funded investigators and site staff re-
and research staff. Certified research specialists
sponsible for the conduct, management and oversight
complete 28 hours of coursework and pass a
of NIH-funded clinical trials. UAMS offers several GCP
comprehensive CRS Proficiency Exam. To maintain
training options:
certification, specialists must keep their CITI Human
• CITI program
Subject Protection training up-to-date and complete six CRS contact hours between Jan. 1 and Dec. 31 each
• NIH-developed GCP training
calendar year. You can register here. Education topics include:
• The Good Clinical Practice (GCP) course for Social
Cost: Free
& Behavioral Research is now available through the Collaborative Institutional Training Initiative (CITI
Darri Scalzo
Program)
(501) 686-8062 DLScalzo@uams.edu
• UAMS Graduate School course PGSP6101 Cost: Free, except Graduate School course
Darri Scalzo
(501) 686-8062 DLScalzo@uams.edu
Certified Research Specialist Awardees, 2017
18
Responsible Conduct of Research (RCR)
Grants Management Certification Program
Responsible Conduct of Research (RCR)
Grants Management Certification Program
Federal regulations require all federally funded trainees
The intent of this program is to establish a structured
of specific programs to have at least eight hours of
environment for professional development of the
face-to-face RCR training within one year. Once the
grants manager role. Our mission is to ensure that
training is complete, the training requirement is fulfilled
each and every employee participating in the process
for four years. The Office of Research Compliance and
of grants management has the same opportunity
the College of Medicine have collaborated with the
to become a highly trained and professional grants
Graduate School to meet these federal requirements.
manager.
A scientific communications one-year course is
Cost: $10
offered to all federally funded trainees in order to meet federal requirements. There are five scheduled
Bettie Cook
sessions per semester. Each session is one hour; eight
(501) 320-7045 CookBettieJ@uams.edu
sessions must be completed to comply with the federal regulations. Cost: Free
Darri Scalzo
(501) 686-8062 DLScalzo@uams.edu
19
Graduate Certificate in Regulatory Sciences
Clinical and Translational Science (CTS) Track
Graduate Certificate in Regulatory Sciences
Clinical and Translational Science (CTS) Track
The Regulatory Sciences Certificate program provides
UAMS is working to close the gap between biomedical
insight into the laws, regulations, policies, processes
research and the application of that research by
and application of the underlying scientific knowledge
offering MS, PhD or graduate certificate training in
that goes into FDA decision-making. Students obtain
CTS through the Interdisciplinary Biomedical Sciences
a working knowledge of regulatory science that can
Graduate Program. Students in the CTS track take
foster leadership in industry, government or academia.
coursework designed to build a strong foundation in
Graduates from the program acquire a competitive
clinical and translational sciences including biostatistics,
background for regulatory science-based careers.
epidemiology, data management and analysis, clinical
The program is fully online and accessible to students
research methodology, clinical trials design, drug
worldwide. It can be completed in one year by taking
development, responsible conduct of research, grant
two courses a semester, with flexibility for a two-year
writing and scientific communications. The CTS track
option by taking one course per semester.
is designed for students holding an advanced degree in a biomedical or health sciences field (eg, MD, RN,
Cost: Tuition information
PharmD, MPH, DPH or PhD), but it is also available to others having significant clinical research management
Christopher Fettes
or clinical experience.
(501) 526-4260 cafettes@uams.edu
Cost: Tuition information
Dr. Robert McGehee (501) 603-1998 REM@uams.edu
20
Translational Research Institute’s (TRI) Video Library Translational Research Institute’s (TRI) Video Library Miss a talk or lecture? Many recorded seminars can be found in TRI’s video library. Cost: Free Contact: TRI@uams.edu
21
PROFESSIONAL DEVELOPMENT FO R S T U DY T E A M S • Society of Clinical Research Associates (SoCRA) • UAMS also hosts the local Arkansas
• Public Responsibility in Medicine and Research (PRIM&R)
SoCRA Chapter.
• Association for Clinical and Translational Science
• Association of Clinical Research Professionals
(ACTS)
(ACRP)
OTHER RESEARCH RESOURCES LINKS • Clinical Trials Registration • Core Laboratory Services • Grant Submissions • Institutional Review Board • Office of Sponsored Programs Administrative Network
• Quality Assurance • Regulatory Affairs (FDA) • Research Compliance • Study Monitoring
22