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Tools and Resources

Platforms & Technologies

Enterprise Data Warehouse (EDW)

  • Maintained by the Center for Biomedical Informatics at UTHSC, with daily feeds of inpatient, outpatient and emergency department data on diagnoses, procedure, demographics, laboratory, pharmacy, vital signs, microbiology, and pathology EMR data from Methodist Le Bonheur Healthcare Systems (Cerner; AllScripts; eClinical). Research specific data sets are linked to patient identifiers via a master patient index. Learn more about the EDW at the CBMI website.

Biorepository

  • The Biorepository for Integrative Genomics (BIG) initiative facilitates highly effective genomics based research at UTHSC and supports future personalized healthcare delivery platforms. Genomic research has played a crucial role in understanding cancer related genomic biology and predicting health outcomes based on genetic interactions. We are establishing a pediatrics-based genomic biorepository to provide genetic material that will link to the Pediatric Research Database allowing both genome and phenome based research. Learn more about the BIG initiative at the Le Bonheur BIG website.

Research Electronic Data Capture (REDCap)

  • REDCap is a secure web platform for building and managing online surveys and databases. REDCap’s stream-lined process for rapidly developing projects offers a vast array of tools that can be tailored to virtually any data collection strategy. 

ResearchMatch

  • ResearchMatch is an free, online recruitment and education platform that securely matches people interested in participating in research with researchers throughout the United States. ResearchMatch has a network of 219 institutions for researchers and volunteers to connect to take part in their health research studies. Researchers have access to thousands of volunteers and are able to message a de-identified cohort of potential participants based on their study’s criteria (i.e., women between the ages of 45 and 80 with heart disease). Investigators must have IRB study approval and permission to use ResearchMatch. Learn more at the ResearchMatch FAQ page.

Classroom & Online Training

CERTIFICATE IN CLINICAL RESEARCH

Offered by the Department of Preventive Medicine, the Certificate in Clinical Research is a 12-credit hour online non-degree program designed to provide initial clinical research skills and training to healthcare professionals, with track options of Health Disparities or Health Behavior Intervention. 

GOOD CLINICAL PRACTICE

The Collaborative Institutional Training Initiative (CITI Program) Good Clinical Practice (GCP) training is comprised of basic and refresher courses that provide essential training for researchers involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies. There is also the NIH GCP course for additional training. 

HUMAN SUBJECTS RESEARCH

The Collaborative Institutional Training Initiative (CITI Program) Human Subjects Research (HSR) training provides foundational training, including the historical development of human subject protections, ethical issues, and current regulatory and guidance information. HSR basic content is organized into two courses: Biomedical (Biomed) and Social-Behavioral-Educational (SBE).  

M.S. IN EPIDEMIOLOGY

Offered through the Department of Preventive Medicine, our Master’s of Science in Epidemiology provides the necessary methodological skills for students to independently pursue epidemiological research in their chosen areas. Three distinct tracks are offered: The Clinical Investigation Track, emphasizing clinical investigation and interdisciplinary translational research; the Data Science Track, emphasizing statistical and analytical skills needed to work with large observational datasets; and the Biostatistics Track, covering theoretical, applied and computing areas of biostatistical science. 

PHD IN DATA SCIENCE & ENGINEERING

In collaboration with Oak Ridge National Laboratory and UT Knoxville, this Doctorate degree in Data Science and Engineering is aimed at providing graduate researchers with some of the most powerful computing and data science platforms available anywhere in the world and the opportunity to collaborate on computational challenges that involve some of the largest and most unique data sources in science, engineering, and health care.  

PHD IN HEALTH OUTCOMES & POLICY RESEARCH

Our doctorate in Health Outcomes and Policy Research, with a concentration in pharmacoeconomics, is designed to develop the knowledge and skills necessary for evaluating the economic, clinical, and humanistic outcomes of treatment. 

Seminars & Workshops

ONGOING

IRB INSIGHTS

Campus training for researchers to learn more about human research protections and how to use the UTHSC IRB electronic system, iMedRIS. 

THIRD THURSDAY

Monthly seminars on clinical and translational research, hosted by the Department of Preventive Medicine. Contact Bill Cushman for more information.

BIOSTATISTICS SEMINAR

Monthly seminars on biostatistics, methods, and skills offered by the BERD Clinic.

RECORDINGS AND POWERPOINTS

RESEARCH 101, 102, & 103

A series of  basic and advanced research training, designed for new investigators, research staff and coordinators, and anyone who wants to learn more about research study conduct.

PRINCIPAL INVESTIGATOR RESEARCH TRAINING

Taught by experienced researchers and experts in their respective fields, this series was designed to meet the needs of PIs across the state.

LIBRARY RESEARCH AND NIH DATA MANAGEMENT PLAN AND SHARING TRAINING FOR CLINICAL RESEARCHERS

A series for students, residents, fellows, staff and faculty, or anyone who wants to learn more about how the library can support clinical researchers.

CERTIFICATION EXAM PREPARATION COURSE

A series to prepare clinical researchers for the SOCRA CCRP (Certified Clinical Research Professional) or the ACRP CCRC (Certified Clinical Research Coordinator) certification exam. This course also serves as an orientation for anyone interested in learning about clinical research.

RECRUITMENT & RETENTION SERIES

A series covering many aspects of recruiting and retaining subjects, including planning and preparing for recruitment, creating an effective advertisement, using social media, recruiting and retaining families, and more.

DEVELOPING A DIVERSE RESEARCH COMMUNITY

Topics include cultural competence, social determinants of health and the relationship to clinical research, health disparities in research and electronic health records, diversifying the scientific workforce, and community-engaged research. 

COLLABORATING WITH A STATISTICIAN 

A series covering the services offered by the Biostats, Epidemiology, and Research Design (BERD) Clinic, along with how to manage and send data, data security and privacy and much more.

REDCAP BASIC AND ADVANCED TRAINING

Series topics include how to develop a research database, how to export for seamless data downloads to Excel and common statistical packages (SPSS, SAS, Stata, R) and advanced features, such as branching logic, file uploading, calculated fields, and e-consenting. 

e-CONSENT

CLINICAL RESEARCH BILLING AND COMPLIANCE 

A 3-part series on clinical research budgeting. Subjects include: determining what makes a study qualifying; identifying routine costs vs. sponsor responsibilities; coverage analysis when doing a budget; and reviewing the use of NCT’s, CPT’s, ICD-10’s

GRANT WRITING SEMINAR SERIES

For faculty, staff, postdocs, and graduate students who want to learn about the steps to produce a NIH grant proposal.

ARCHIVED RESEARCH TRAINING EVENTS

RESEARCH REFLECTIONS

A mini-series for study coordinators and research staff designed to support the conduct of high quality research and develop a robust research workforce.

RESEARCH METHODS FOR CLINICAL INVESTIGATORS

Concentrating on epidemiological and biostatistical research methods, presentations are intended to assist and support clinical researchers in study design and the interpretation of findings. 

Recruitment

IRB Standard Operating Procedure (SOP) for advertising and recruiting for a study

Enterprise Data Warehouse 

Scholars may access the Enterprise Data Warehouse (EDW) with daily feeds of inpatient, outpatient and emergency department data on diagnoses, procedure, demographics, laboratory, pharmacy, vital sign, microbiology, and pathology EMR data from Methodist Le Bonheur Healthcare Systems (Cerner; AllScripts; eClinical). Research specific data sets are linked to patient identifiers via a master patient index. 

ResearchMatch

ResearchMatch.org (RM) is an free, online recruitment and education platform that securely matches people interested in participating in research with Researchers throughout the United States. ResearchMatch aims to help bring together volunteers and Researchers. It is not just one institution, one partner, or one study. ResearchMatch are a nation of many working together to make a change today and in the future. Currently, the network includes 163 institutions and 57 partner organizations.

Researchers on ResearchMatch are able to message a de-identified cohort of potential participants based on their research study’s criteria (i.e. women between the ages of 45 and 80 with heart disease). They are only allowed to contact potential volunteers if their IRB has approved all aspects of the study and given permission to use ResearchMatch as a recruitment tool.

If you’re a UTHSC researcher, it means you will have access to thousands of volunteers who may match with your studies. Volunteers join every day, so your chances of finding matches increase, and the timeline to discovery gets shorter.

 
ResearchMatch- For Researchers

Sign-up to use ResearchMatch through the ‘Researchers’ tab on researchmatch.org.

  • Click ‘Register Now’.
  • Choose your institution from the dropdown list of participating institutions.
  • Enter institutional email address.
  • Review and agree to the site specific instructions and researcher acknowledgment form by typing ACCEPT in all caps.
  • Enter your contact information, create a username and password, and choose your security questions.
  • You will then be directed to your dashboard with Feasibility Access.

Registering a Study on ResearchMatch
UTHSC researchers must have an IRB approved protocol and approved contact message for use on ResearchMatch before registering a study.

To add a new study:

  • Click ‘add new study’ within the researcher dashboard.
    Specify your role on the study. (The PI must approve the researcher to allow them access.)
  • Complete all the requested information about the study and upload IRB approval letter containing the study expiration date. Specify the study contact type – RECRUITMENT vs. SURVEY ONLY. A recruitment study involves an intervention or interaction with participants, while a survey involves the use of a questionnaire.
  • The PI receives an email to allow the proxy researcher access.**Note: This is a two-step process! The PI must click AUTHORIZE ACCESS in the body of the email rather than responding to the email directly.
  • The PI clicks the link within the body of the email, and confirms access for the researcher.
  • The ResearchMatch Liaison will review the request and approve accuracy of information.
  • Upon approval from both the PI and ResearchMatch Liaison, the proxy receives an email from ResearchMatch requesting they ‘Accept access for recruitment’. Once they click ACCEPT, they now have access to RM volunteers and can begin to recruit for their study!

How Researchers Can Add Themselves to an Existing Study
UTHSC researchers can add themselves to an existing study after securing approval from the Principal Investigator.

  • Join ResearchMatch as a ‘Researcher’ and create a username and password.
    From the dashboard, click ‘Add a new study’ and input the requested study information, including uploading the IRB approval letter.
  • ResearchMatch will automatically recognize existing studies, and will send a request to the PI to approve adding the proxy researcher to their study.
  • Once the PI approves, the institution’s ResearchMatch liaison is sent a request to approve the proxy.
    The ResearchMatch liaison will review the request and approve if information is accurate.
  • Upon approval from both the PI and ResearchMatch Liaison, the proxy receives an email from ResearchMatch requesting they ‘Accept access for recruitment’. Once they click ACCEPT, they now have access to RM volunteers and can begin to recruit for their study!

For a list of the most common ResearchMatch Frequently Asked Questions, please visit the ResearchMatch FAQs webpage

ResearchMatch - Participate in a Study
Advancing research is at the core of the UT Health Science Center’s mission. UTHSC investigators are dedicated to paving the way for innovative patient-centered research and development with a clinical and translational focus. By working together, we can transform lives and build healthy communities.

Research affects our everyday lives – ranging from the medicine we take to the health of our families. Becoming a research participant is a gift you give of yourself to benefit your family, your community, and the health of people everywhere.

UTHSC is a member of ResearchMatch.org, a free, secure online tool that brings together potential study participants who are looking for research studies or clinical trials with investigators who are looking for volunteers.

Anyone living in the United States, including Puerto Rico, can join ResearchMatch (RM). People of all ages and backgrounds are welcome. A parent, legal guardian, or caretaker can register a child under 18, or register an adult that may not be able to join on their own.

Many studies need healthy volunteers as well as those with all types of health conditions. It is always your choice to decide what studies may interest you. You are not required to participate in a study if you join ResearchMatch. It is always your choice!

Please visit the ResearchMatch- For Volunteers webpage to view the online registration questions and for more volunteer information. If you are a UTHSC Researcher and would like to register on ResearchMatch, please visit the ResearchMatch- For Researchers webpage for further instructions.

For a list of the most common ResearchMatch volunteers Frequently Asked Questions, please visit the ResearchMatch FAQs webpage.

 
ResearchMatch- For Volunteers

Online Volunteer Registration Process
Thank you for your willingness to volunteer for research on researchmatch.org. It takes between 5-10 minutes to register and anyone residing in the United States can join. In order to better understand the online registration process, we have listed the online questions below. You will first answer some basic information about who you are and then have the option to enter information about your health. Remember, the more information you include the better match you are to researchers.

There is no cost to register as a ResearchMatch Volunteer and all ages and backgrounds are welcome to register. A parent, legal guardian, or caretaker may register someone under the age of 18 or an adult that may not be able to enter in their own information.

When you become a ResearchMatch Volunteer, you join a pool of thousands of other people across the country that are willing to hear about research studies that might be a good fit for them.

The below list of questions are for reference purposes only. To actually register, visit researchmatch.org.

1. Tell us who you are.

First Name, Last Name
Street Address, City, State, Zip Code
Phone, Email Address, Email Address Confirm
To protect your ResearchMatch information, create a username and password that only you know.

Your Username
Password
Select two security questions and type an answer that you will easily remember and be able to provide if you forget your password.

2. Tell us about yourself.

Date of Birth (mm/dd/yyyy)
Height (ft/in), Weight (lbs)
Gender
Race, Ethnicity
Tobacco use
Are you a twin or triplet?
Veteran Status

3. Your Health Conditions.

Please add any health conditions that you would like to include in your ResearchMatch profile.

4. Your Medications

Please add any medications or over-the-counter drugs that you are currently taking that you would like to have as a part of your ResearchMatch profile.

5. Additional Information

In general, how far would you be willing to travel for these types of studies?
Would you like to be contacted about studies related to being a parent?
Additional information you’d like to share
How did you learn about ResearchMatch?
When you get emails from ResearchMatch about research studies, what languages would you like those emails to be in?

What Will Happen When You Join?

After you register, your anonymous (unidentified) ResearchMatch Volunteer profile will become part of a national registry pool. Approved ResearchMatch researchers search the registry by entering in IRB (Institutional Review Board) approved specific study criteria (age, gender, condition of interest, etc.) to find possible matches for their studies. ResearchMatch then sends an email about a researcher’s study to the ResearchMatch Volunteers who appear to be a good fit for their study. While the researcher knows that you may be a good match for their study, they do not know who you are until you allow them to see your contact information. If the study is something that the volunteer wishes to learn more about, the Volunteer (you) allow ResearchMatch to release your contact information to the researcher so you can be directly contact by the researcher about the study. The Volunteer can choose to be part of the study or be removed from a study at any time. The choice is always up to the Volunteer! And that is how the wonderful ResearchMatch “match” is made.

For a list of the most common ResearchMatch Frequently Asked Questions, please visit the ResearchMatch FAQs webpage.

 

CITI Links & Info

Collaborative Institutional Training Initiative (CITI)

UTHSC has selected the CITI training program for clinical researcher training. CITI is a widely utilized web-based training platform that provides a variety of training courses for different aspects of clinical and non-clinical research. Human subject protections and good clinical practice courses are mandatory for clinical researchers; however, there may be additional courses required based on other research activity, e.g., responsible conduct of research, animal welfare, conflicts of interest, bio-safety, etc. These courses may be assigned through an institutional office, department or program.

Mandatory Human Subject Protections (HSP)/Good Clinical Practice (GCP) Training for New Users

UTHSC requires documented coursework for clinical researchers that meets the mandates for human subject protections (HSP) and for good clinical practices (GCP) training established by the DHHS Office of Human Research Protections (OHRP), Food and Drug Administration (FDA) and the National Institutes of Health (NIH). This training must be completed BEFORE engaging in any clinical research activity.

Clinical Research = Human Subject Research

Clinical research can be defined is any systematic investigation conducted through an intervention or interaction with human subjects or on material of human origin such as tissues, specimens and cognitive phenomena. Types of human subject research include:

  1. Patient-oriented research studies:
    • mechanisms of human disease
    • therapeutic interventions
    • clinical trials
    • development of new technologies
  2. Epidemiologic and behavioral studies
  3. Outcomes research and health services research.

A clinical researcher, including students and trainees, is one that engages in clinical research activities.

Clinical Researchers Training Requirements

If you have responsibilities in more than one of these areas, you are required to take the more comprehensive training. For example, if you are a clinical investigator and a member of the IRB committee, take the training for IRB members.`

DEPARTMENT CHAIRS ▪ INVESTIGATORS ▪ KEY STUDY PERSONNEL ▪ STUDENTS INVOLVED WITH A RESEARCH STUDY

Select one of the options below for your basic training:

Option 1: Basic Human Subject Protections + Good Clinical Practice (Basic HSP + GCP) combination course: This hybrid course has 22 modules and covers both subject areas in a concise format. For recertification in three years, you will be required to take the entire course again. However, those familiar with the course content may go directly to the quiz. This course is recommended for both biomedical and social / behavioral clinical research.

OR

Option 2: Take the two standard CITI courses: (1) Human Subjects Training Basic Biomedical (Biomed) course which has 18 modules plus: (2) GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course which has 14 modules.

For recertification in three years, a shortened refresher course for these is available. Biomedical researchers may want to select this option if involved in a multicenter trial and these courses are required by the sponsor.

 
IRB COMMITTEE MEMBERS ▪ IRB OFFICE STAFF ▪ APPROPRIATE INSTITUTIONAL OFFICIALS

Take the Basic Human Subject Protections + Good Clinical Practice (Basic HSP + GCP) IRB combination course.

You must take this course every 3 years for recertification.

 
STUDENTS NOT INVOLVED IN A CLINICAL RESEARCH STUDY

Take the “Initial Student Training: Human Subject Protections Training” to satisfy program requirements.

Please note: There are supplemental modules available to all UTHSC registered users that can provide additional information for specific topics, such as, protections for minors, prisoners, FERPA, etc. These modules are listed as supplemental under the required modules in the basic courses.

 
GENERAL INFORMATION

Username/Password

Retain your CITI username and password for all future access. DO NOT create duplicate accounts. If you have forgotten your user name or password, you may request your login and/or password information by selecting the appropriate link on the CITI login page.

Email

Please use the email address associated with your NetID. This will facilitate identification of your learning records and will allow tracking within the institution.

Passing Score

The minimum passing score has been set at >85% for initial and recertification training. When taking the course, if you desire to improve a quiz score at the end of a module, you may re-examine the course material and repeat the quiz until you are satisfied with your score. When testing out, you must attain a passing score or re-take the course.

Documentation of Training

Once you have successfully completed your training, you are responsible for maintaining a record of completion. A completion report and or/ certificate is available and accessible to you and can be printed at any time from the CITI website.

Log into your CITI account. The report can be printed from your main menu/ view courses page.

Continuing Education

The CITI Program is accredited by the Accreditation Council for Continuing Medical Education (ACGME) to sponsor continuing medical education (CME) activities. There is a handling fee for a CME credit letter. Please see details on the CITI website.

Frequently Asked Questions

How long does it take to complete training?

Each module may take from 10 –20 minutes depending on the knowledge and experience of the learner. The learner may take more than one session to complete the training. The course software will track the participant’s completed modules and save any module completions. (To move forward the quiz must be completed.)

Is there a re-certification requirement for HSP/GCP training?

Yes. UTHSC requires all clinical researchers and staff re-certify every three years for both HSP and GCP training.

What if I have completed the previous courses for HSP (e.g. Groups 1, 3, etc.) and/or GCP?

Group designations are no longer valid. You will be directed to appropriate refresher content based on your initial training.

What should I know about the module quizzes?

Upon completion of each training module within a course, the user will be prompted to complete a short quiz. The software will grade the quiz and collate the scores. You may re-read any module and repeat the exam until you are satisfied with the score. The grade book and the completion report will reflect only your best score. (A few selected modules do not require a quiz.)

How important is the member profile information?

This information is critical to the accuracy and tracking of your training documentation. Your CITI profile information, especially your name and email, is used to link your training record with the tracking database. Inaccurate profile information can slow down and/or halt the submission process for research projects while documentation of training is located. Learners can update Member profile information at any time. Common reasons to update your profile include: name changes, a department change and email address changes.

Are notification sent when it is time to re-certify my training?

Yes, you will receive a notification from CITI 30 days prior to your training expiration. This notification will be sent to the email address you have listed in your CITI member profile. Remember: Use your UT email address for registration of your CITI account. In addition, you may receive additional recertification reminder notices from UTHSC prior to your training expiration.

Registered Users

If you are currently registered in the CITI program, do not proceed. See instructions to affiliate with UTHSC.

Affiliate with UTHSC

Log into the CITI platform at www.citiprogram.org with your current user name and password. You will be directed to a landing page showing a list of your institution affiliation/s.

Select “Would you like to affiliate with another institution?” and check “Add affiliation.”

On the next page, enter your new organization name in the box provided and click “Select.” Confirm you are affiliating with the selected institution and agree to the terms of service.

Click “Continue” and complete your learner profile.

Click “Next” and select the course/s you want to take and “Submit.”

You will be directed to your learner page and you can begin taking your course/s.

Feb 29, 2024