Research Recruitment and Resource eBook

“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 recruitment begins with a detailed

tools, tips and other resources, such as how a

recruitment plan. Because every study cohort is unique,

consultation with the Translational Research Institute

researchers must tailor their recruitment strategies to

will help you navigate UAMS’ research enterprise.

achieve their target enrollment goals.

Having a detailed strategy for recruiting participants

This Recruitment e-Book was prepared to help UAMS

early on will speed the pace of accrual and help avoid

researchers know what questions to consider in

potential IRB amendments and delays.

developing a recruitment plan. It includes important

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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.

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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

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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

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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

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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.

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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.

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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

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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.

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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

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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

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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

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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

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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

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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

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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

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