What does it take to move an NIH K01 grant through submission and resubmission to finally achieve the coveted “NOGA” (Notice of Grant Award)? Nearly 60 attendees gathered at our annual Mock NIH Study Section Review last week to find out. A real-world K01 grant that initially received a non-fundable impact score of 30, which improved to a fundable score of 12 after the investigator worked with CCTS, served as the focus of the review.
Attendees, including 32 participating virtually from five CCTS Partners (Auburn, PRBC, UA, UAB, and USA), learned about the different sections of an K01 grant and how they are scored for scientific and technical merit. Panelists explained their mock scores regarding the overall impact grant and its strengths and weaknesses for review criteria, including significance, investigators, innovation, approach, and environment. They also discussed important considerations for human subject protections; inclusion of women, minorities, and children; resource sharing plans; and budget. The panelists also described the need to address NIH’s rigor, reproducibility, and transparency requirements, which apply to nearly all NIH grant applications.
Panelists stepped out of their roles to address several areas that can weaken an K01 grant: whether the number of subjects chosen is high enough to produce meaningful results and support a well-conceived power calculation; not providing a clear description of appropriate statistical analyses that will be performed; and failing to thoroughly address human subjects protection. Dr. Chaplin encouraged attendees to reach out to the CCTS for help in appropriately addressing these areas, noting K01 applicants who receive a CCTS panel prior to submission "greatly strengthen their grants and increase their chance of funding as much as three times the NIH baseline."
CCTS is grateful to this year’s panelists including Dr. Karen Cropsey, Associate Professor, UAB Psychiatry and Behavioral Neurobiology, Dr. Karen Gamble, Assistant Professor, UAB Psychiatry and Behavioral Neurobiology, and CCTS Training Academy CoDirector Dr. David Chaplin, Professor, UAB Microbiology. A special thank you to Dr. Ceren Yarar-Fisher, whose K01 grant, “Targeting Skeletal Muscle to Improve Metabolic Health in Individuals with Spinal Cord Injury,” served as the before and after model in the mock review.
The Mock NIH Study Section Review traditionally marks the end of our Clinical and Translational Science Training Program (CTSTP). From January to June, our 2018 CTSTP trainees received more than 50 hours of didactic instruction in research project development, ethics, clinical trials, epidemiology, biostatistics. They gained exposure to many types of clinical and translational research, including health services, genomics/informatics, behavioral, and community-based participatory research. The Mock NIH Study Section Review is a highlight for many trainees, especially those who plan to pursue a career in research.
Interested in becoming a CTSTP trainee? Email your interest and/or questions to
Four K-funded investigators shared the aims they are developing for their first independent NIH Research Project Grant (R01)at our inaugural K2R Specific Aims Workshop, held at Edge of Chaos on Thursday, June 21. We highlight their projects below.
The specific aims workshop was divided into two sections. First, each of the K2R scholars briefly presented their aims to a group of established investigators and CCTS team members from Research Commons, our Biostatistics, Epidemiology, and Research Design (BERD) unit, and our Clinical Research Support Progam (CRSP), who provided “big picture” suggestions.
Next, each of the scholars had a break-out “huddle” session with small groups of interdisciplinary scientists, each of which included scientific content and methodology experts who provided more in-depth feedback.
As a next step, each scholar will meet again with their “huddle” team to further develop their study designs, sampling methods, and data analysis plans, with a special focus on sample size and power. The scholars will also continue meeting weekly to draft the Significance and Innovation sections of their applications.
CCTS Training CoDirector Dr. Michael Mugavero said, “The opportunity to receive constructive critiques from such an experienced group of interdisciplinary CCTS experts was invaluable to our K scholars. The level of engagement and collaboration exceeded my expectations and was instrumental to the success of this inaugural Specific Aims Workshop.”
Tiffany L. Carson, PhD, MPH
Assistant Professor of Medicine, Division of Preventive Medicine
UAB School of Medicine
A longitudinal, bi-directional assessment of the relationship between the gut microbiota and cancer therapies among colorectal cancer patients
Bertha Hidalgo, MPH, PhD
Assistant Professor of Epidemiology
UAB School of Health Professions
Epigenetic markers in women with gestational diabetes mellitus
Crystal Chapman Lambert, PhD, CRNP, FNP-BC, ACRN, AAHIVS
Assistant Professor
UAB School of Nursing
Improving health outcomes for minority women living with HIV
Christina Muzny, MD
Associate Professor of Medicine, Division of Infectious Diseases
UAB School of Medicine
Exploring the pathogenesis of bacterial vaginosis (BV) and the temporal relationship between P. bivia and G. vaginalis leading up to incident BV in heterosexual African American women
Congrats to our first K2R cohort on their outstanding presentations, and many thanks to all of the CCTS investigators and staff who participated to further refine our scholars’ applications.
The K2R is currently in pilot mode, according to CCTS Training Academy Administrative Director Becky Reamey, PhD, who also serves as the Program Director for the UAB Scientific Community Outcomes Researchers (SCOR) group, but will likely launch in earnest early in 2019. K scholars who are interested in participating should email
What happens when smart people use the right tool to ask the right questions of Big Clinical Data? Attendees at our April Forum found out when three research teams presented the findings from i2b2-enabled searches of the clinical data in UAB’s electronic health record. CCTS Co-Director and UAB Informatics Institute Director Dr. James J. Cimino gave a brief overview of i2b2 then introduced the three research teams, all of which participated in the Inaugural i2b2 Abstract Contest in 2017.
Abdullah M. Alanazi, MSc, RRT-NPS, Rehabilitation Science Program, UAB School of Health Professions, presented the findings from his cross-sectional study with Eric W. Ford, PhD, MPH, on “Substance Abuse and Smoking Choices: A Comparison between Electronic-Cigarette Users and Tobacco Smokers.” The team used i2b2 to generate smoking, electronic nicotine delivery systems (ENDS), current substance abuse, and former substance abuse data to determine if the two different smoking populations differ in terms of substance abuse. They found higher rates of past, current, and any substance abuse for ENDS users than for tobacco smokers. Future research, Alanazi said, will look at the temporal initiation and cessation patterns to help determine if ENDS is being used as a cessation tool or a “gateway” drug, which will inform the design of an effective intervention.
(See UAB News, "Does vaping lead to abuse of illicit substances? Rehab scientists use i2b2 to find answers," to learn more).
Dr. Wolfgang Muhlhofer, Assistant Professor, UAB Dept. of Neurology and Epilepsy Center, presented the methodology, analyses, and findings from his retrospective observational cohort study on “Duration of Therapeutic Coma and Outcome of Refractory Status Epilepticus (RSE).” Muhlhofer began with i2b2-generated data before requesting individual data via CCTS Data Warehouse analysts to take a closer look at the associations he found.
Muhlhofer’s results suggest the use of a therapeutic coma, an effective but risky treatment for RSE, should be started earlier and ended sooner than currently recommended. It also provided additional evidence as to windows at which certain negative outcomes, such as seizure reoccurrence and mortality, are more likely to occur.
Cimino suggested Muhlhofer might increase the power of a follow-up study, a possible randomized controlled trial, by searching the i2b2 databases of the Southeast SHRINE Consortium, a collaboration between CCTS and other CTSA Hubs (Emory, University of Arkansas, University of Kentucky, and Medical University of South Carolina).
(See UAB News, "Study using i2b2 could help standardize use of therapeutic comas for epileptic patients," to learn more).
Morgan Dew, RN, BSN, Nurse Clinician in Pediatric Neurosurgery and Children’s of Alabama, presented the early results of a prospective qualitative study on “Pregnancies in Women with Spina Bifida.” The single institution overview, conducted by Betsy Hopson, MSHA, UAB Dept. of Neurosurgery, and Anastasia Arynchyna, MPH, Children’s of Alabama, supplemented an i2b2 search for potential patients who fit the study criteria with a retrospective chart review. Thus far, they have enrolled 6 women with spina bifida in pregnancy to study trends in mobility and continence both during and after pregnancy.
Dew walked attendees through the steps the team took with i2b2. Her slides familiarized the audience with the i2b2 user interface. She praised i2b2 for replacing a slow, tedious manual search process with a fast, automated approach that also made requesting IRB approval for a patient list for recruitment much easier and faster as well. Other benefits of using i2b2 included querying with AND, not just OR, which provides more specific results; being able to review and run a query from a previous session; and the potential for collaboration with researchers at other institutions with an i2b2 database.
(See UAB News, "i2b2 Helps Answer Questions about Spina Bifida and Reproduction," to learn more)
Cimino encouraged attendees to sign up for the CCTS hands-on i2b2 training, if they had not already taken it. "The one-time course is only a couple of hours long," he said. CCTS Director of Clinical Research Informatics Matt Wyatt then discussed another way to get informatics support for a research project--the Informatics Gateway, a collaboration between CCTS and the UAB Informatics Institute that can "scale up or down" to meet the needs of the researcher. The Gateway spans a wide variety of activities, he explained, including data analysis, genomics, bioinformatics, secondary analysis of EHR data, and even help with study design and methodology. Gateway participants often go on to receive a CCTS Nascent Projects Panel, which provides next-level scientific review. You can request an Informatics Gateway here.
We thank our April Forum speakers for their time. Join us in congratulating all of our i2b2 Abstract Contest teams, whose inspiring results underscore the promise of translational research conducted with i2b2: to more quickly and easily open up new avenues of inquiry that will improve care for at-risk populations.
In case you missed it, the April Forum video will soon be posted on our CCTS YouTube channel. Mark your calendar for our next CCTS Monthly Forum on Wednesday, May 2, when we will explore “The Changing Policy Landscape for Clinical Trials.”
1. Who is eligible to use the CRU resources?
CRU resources are available to University of Alabama at Birmingham faculty and students for human subject studies that have current IRB approval.
2. What CRU resources are available?
Free or low-cost services are available for researchers, including inpatient beds on a limited basis, nursing, bionutrition services, and sample processing.
3. What kind of research can be done on the CRU?
The CRU supports human-based translational research. Studies may involve either healthy volunteers or participants with specific diagnoses. Research is facilitated in a broad area of medical disciplines, including general internal medicine, internal medicine subspecialties, radiology, nutrition, surgery, epidemiology, obstetrics, psychiatry, pediatrics and nursing.
4. Are non-MDs allowed to conduct studies in the CRU?
Yes. However, all non-MD investigators such as PharmDs and PhDs must have an MD or nurse practitioner collaborator who will assume medical responsibility for the research participants.
5. What if there are revisions to the original approved protocol or consent?
All protocol modifications and renewals must be submitted to the IRB and copied to the CRU for review. If a protocol undergoes a major modification that includes changes to the CRU resource utilization, a second presentation to the CRU Protocol Review Committee may be required.
6. Who obtains informed consent of the research participant?
It is the responsibility of the principal investigator or appropriate designee to obtain informed consent from the research participant prior to the commencement of a study.
7. How is medical care provided on the CRU?
The physician investigator, or physician for the study, is responsible for the medical care of research participants. Arrangements for emergency care must be formalized before study implementation.
8. Does the CRU have funds for ancillary testing?
No. The CRU does not have funds to cover ancillary testing performed in departments such as clinical laboratory testing or radiology.
9. Can I conduct an industry-supported study on the CRU?
Yes. Industry pays for the use of the CRU facilities and staff. Investigators who need skilled nursing, bionutrition, or other support are encouraged to contact
Clinical trials from the final UAB Dept. of Medicine (DOM) divisions, listed below, went live in OnCore this week, marking the successful completion of another major phase of the implementation plan. Three other DOM divisions—Endocrinology, Cardiology, and Infectious Diseases—joined CCTS and the UAB Comprehensive Cancer Center as users of the OnCore clinical trials management system (CTMS) in Dec. 2017. OnCore is replacing the older, and no longer supported, SiteMinder system.
DOM Implementation Wave 1b
Gastroenterology/Hepatology
General Internal Medicine
Gerontology, Geriatrics & Palliative Care
Hematology/Oncology
Nephrology
Preventive Medicine
Pulmonology
Rheumatology/Immunology
Training and Team Work
Training for the first "wave" of end users began October 18 and ran through December 15, 2017. OnCore training resumed on January 2, 2018. More than 235 attendees have participated in the OnCore trainings, including focused sessions on its protocol, calendar, and subject management features. For information on how to register for upcoming OnCore classes, contact
Join the CCTS in congratulating the OnCore team, including Naseem Anjum, Emily Bruer, Amy Cleverdon, Meredith Fitz-Gerald, Geoff Gordon, Deanne Guthrie, Shelly Hall, Trafina Jhadav, Dr. Cindy Joiner, Courtney Jordan, Mikela Knox, Steve Lloyd, Mark Marchant, Dawn Matthews, Michael McEwan, John Sandefur, Ashley Specht, Amanda Unrue, Nicky Welch, and Lisa Williams for another masterful launch that is the result of superb collaboration. We are proud of the hard work and dedication of the OnCore implementation team. Embracing this next-generation CTMS will enable us to improve the efficiency, compliance, and cost-effectiveness of our clinical trials.
To learn more about the OnCore implementation, see “Encore OnCore! Nov. Forum Celebrates Enterprise-wide Rollout of Powerful Clinical Trials Management System,” which includes a link to our OnCore Frequently Asked Questions. To learn more about OnCore’s many benefits and how it will integrate with PowerTrials, see UAB Medicine’s OnCore page.