Tools and Resources
Research Resources
Biostats, Epidemiology, and Research Design (BERD) Clinic
Center for Biomedical Informatics (CBMI)
Fundamentals of the NIH Grant Process and Need to Know Resources
NIH Clinical Research Policy Program
NIH Presentations
- Including Diverse Populations in NIH-funded Clinical Research
- An Overview of NIH Policies on Human Subjects
NIH Application Resources
- Application Process
- Biosketch Formatting
- Budget
- Formatting your Application
- Preparation
- Reference Letters
- Submitting the Application
- Writing your application
NIH Clinical Research and Bioethics Training
- https://clinicalcenter.nih.gov/training/index.html
- https://bioethics.nih.gov/courses/ethical-regulatory-aspects.shtml
Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
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
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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)
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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
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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.
QuickLinks
Quicklinks are short, informational documents that provider readers with helpful information about a topic and quickly links them to resources where they can learn more.
QuickLinks GRADUATE CERTIFICATE IN HEALTH CARE QUALITY IMPROVEMENT
QuickLinks PHASES OF CLINICAL & TRANSLATIONAL RESEARCH
Quick Links Planning and Preparing for Recruitment
QuickLinks WRITING AN EFFECTIVE ADVERTISEMENT
QuickLinks WRITING A MANUSCRIPT
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).
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.
Forms & Tools
These are examples of forms/tools needed while conducting research studies. Use them as guides and revise them to fit your particular study needs.
ALCOA-C (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete)
Adverse Events (AE) Forms/Logs
Johns Hopkins Adverse Event log
NIH Adverse Event Form
NIH Serious Adverse Event Form
Concomitant Medication Forms
NIH Concomitant Medication Form
Wisconsin Concomitant Medication Log
Delegation of Authority Log (DOAL)/Forms
NIH Delegation of Responsibilities
NIH Delegation of Authority Log
Inclusion/Exclusion (I/E) Eligibility Document
Informed Consent Process (ICP) Continuation of Participation Documentation Form
Manual of Operations (MOP)
NIH Guide for Developing a MOP
NCCIH Tool Summary Sheet: Investigational Product Accountability Log
NIMH Investigational Product Storage Temperature Log Template
Protocol Amendment Tracking Log
Regulatory Binder/Essential Documents
Regulatory Binder Tabs and Essential Documents
NIH Regulatory Binder Guidance
NIH Standard Operating Procedure
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
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.