Strengthening Translational Research in Diverse Enrollment (STRIDE), a collaborative project among three CTSA Hubs (UAB, UMass, and Vanderbilt University) that seeks to develop and test innovations to increase participation of under-represented groups in clinical trials and other research, received a shout out from NCATS Director Dr. Chris Austin in his Jan. 2, 2018, Director’s Corner message. "Im excited about the STRIDE initiative," he said, adding that the tools, once shown effective, will help accelerate translation, "ensuring its benefits will reach all who need them."
STRIDE’s personalized informed consent intervention (aka eConsent), featured in a Trial Innovation Network (TIN) webinar on Dec. 14, 2017, is just one of the novel methods under development. Others include the use of storytelling to introduce potential participants to the research process and simulation-based research assistant (RA) training to help build relational skills, such as rapport and understanding, that are critical when discussing clinical trials with potential participants.
The REDCap-based eConsent platform includes avatars, videos, and hover-over features to increase both trust and interest in clinical trial participation. The brief videos feature real participants from clinical trials sharing their personal experiences with research. The eConsent features were reviewed via a Community Engagement Studio, where stakeholders provided feedback to increase their usefulness. The STRIDE team is currently evaluating its multi-modal intervention. As noted by Dr. Austin, once the methods are shown to be effective, STRIDE investigators will disseminate them broadly to help increase participation in research throughout the CTSA network.
Slides from the STRIDE webinar are available here.
Sample storytelling videos are available here.
OnCore is a Clinical Trial Management System (CTMS) that tracks protocols and participants through the life cycle of the protocol. Study calendars are built to track the progress of participants and data from the calendars is passed to the UAB billing units after study visits. OnCore offers financial management including coverage analysis, budgeting, tracking protocol milestones, invoicing, and the recording of sponsor payments. OnCore also has extensive built-in reporting features as well as custom reporting capabilities.
Which Protocols Require Study Team Management in OnCore?
- All industry-sponsored clinical trials
- All protocols that use the following CCTS Services: Clinical Research Unit (CRU) or Bionutrition
- All protocols with UAB Health System clinical billable procedures
- Protocols that do not meet criteria 1-3 may be entered at the discretion of the Principal Investigator (may be beneficial to study teams to enter some studies into OnCore).
Why do we want all this in OnCore?
- OnCore is integrated with the UAB research billing system and the coverage analysis provided by the Clinical Billing Review (CBR) team.
- OnCore is an important safeguard for billing compliance
- OnCore is critical for reporting data on accruals, protocols and is necessary for other reporting such as CCTS annual reporting and NCI reporting.
- OnCore data regarding protocols and subjects is sent to IMPACT and is an important patient safety component. PowerTrials and PowerPlans also depend on this data to function properly.
- OnCore data is critical for tracking internal study and research services.
- For units who use OnCore financial functionality, OnCore is necessary for complete and accurate billing to sponsors.
Data Integration Empowers Research
OnCore sends protocol and participant information to the UAB electronic health record (Cerner’s IMPACT) through PowerTrials. When a new participant is registered to a clinical trial in OnCore, their medical record in IMPACT is associated with the protocol and an indicator that the participant is on a study is displayed in the banner bar of their chart. Clinicians are now able to click on this link to view study information and relevant contact information for the principal investigator and study coordinator for the trial in the Research Summary.
Research summaries contain key information that is useful at the point of care and for clinical care providers who are treating participants enrolled in clinical trials. More than 470 protocols and their associated participants have been sent from OnCore to Cerner, and order sets (aka PowerPlans) to support study implementation are continually being built.
Please see the support page for contact information.
(Updated October 2021)
The CCTS Clinical and Translational Science Training Program (CTSTP) kicked off last week with a record-breaking number of participants. Not only is this the largest cohort in the CTSTP’s history, but it also includes the highest number of virtual trainees (17) from Partner institutions (Auburn, PBRC, UA, USA). A record number of disciplines are likewise represented, including Nursing, OB/Gyn, Pediatrics, Hematology/Oncology, Psychiatry, Dentistry, Neurology, Radiation Oncology, Biomedical Sciences, Pharmacy, Nutrition Sciences, Neurosurgery, Physical Activity/Epidemiology, Community Mental Health, Cardiovascular Disease, Kinesiology, Veterinary Medicine, Surgical Oncology, Immunology/Rheumatology, Infectious Diseases, Urogynecology & Pelvic Reconstruction Surgery, and Transplantation.
Our annual career-changing training opportunity provides trainees with more than 50 hours of didactic and interactive instruction in clinical and translational science competencies. Sessions take place at 8am-10am on Wednesdays from January to June and feature experienced clinical and translational researchers as well as individuals with special expertise in areas such as grant writing and clinical trial regulations.
2018 CTSTP Trainees
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Click here to learn more about the Clinical and Translational Science Training Program.
The CCTS Clinical Research Support Program updated a lunchtime crowd on the recent revision of the ClinicalTrials.gov website, which went live June 29, 2017, and how these changes are affecting investigators. An even newer version of the site went live Mon., Sept. 25, 2017, to improve usability based on research with end-users representing various stakeholder groups.
Below we highlight the key messages of the update:
- For studies that meet the definition of an Applicable Clinical Trial with a completion date of Jan. 18, 2017 or later, investigators must upload the full study protocol and statistical analysis plan as part of the submission of their results data. Full study protocol is defined as “including all amendments.” Results, protocol, and statistics analysis plan are all due within 1 year after primary completion of the study. [Editor's note: Bring your laptop and join us for one of our weekly Biostatistics, Epidemiology, and Research Design (BERD) Drop-in Clinics, if you need assistance developing a statistical analysis plan.]
- The Outcome Measure Section is “the biggest challenge for most, as it is very specific.” All major issues must be addressed and all records must be free of error messages in order to be released.
- A new checklist is available, but “there are many caveats—it is not exhaustive, is very FDA focused, and doesn’t address issues such as what if you want to publish?” It does help, however, in determining if your study qualifies as an applicable clinical trial according to the NIH definition (for more on the NIH effort to clarify this definition, see the Sept. 8 Open Mike post on the topic.
Future initiatives are aimed at increasing trust in potential participants of clinical trial as well as increase the transparency of individual data sharing.
- As of July 1, 2018, manuscripts submitted to journals following recommendations set forth by the International Committee of Medical Journal Editors (ICMJE) that report the results of clinical trials must contain a data sharing statement. Trials that begin enrolling on or after Jan. 1, 2019, must include a data sharing plan in the trial’s registration. McKenzie shared the experience of an investigator who failed to register before beginning recruitment, which led to the rejection of the manuscript submitted to an ICMJE journal.
- Other initiatives will focus on making informed consent and summaries of findings more plain language and increasing the integrity of study design. Currently, it is estimated that 31% or more studies switch outcomes when reporting, rather than report the findings associated with the original hypothesis of the study when registered.
For help in meeting the NIH requirements for clinical trial registration and reporting, email
CCTS is working hard behind the scenes to support the DOM-led transition to OnCore, UAB’s new clinical trials management software (CTMS). Our Center for Research Support Program (CRSP) team has trained 18 OnCore “superusers” who, in addition to serving as resident experts within their units, will also help build the infrastructure to house the data from approximately 100 clinical trials. Other CCTS staff are building study calendars and budgets and testing new components and data migration scripts as they are developed. We applaud their team spirit and unflagging dedication.
In addition to streamlined workflows for CTMS functions such as managing patient appointments and communicating payer designations to billing entities, OnCore will offer expansive new functionalities, including centralizing and tracking protocol activity from startup to closeout, enabling electronic ordering of clinical services, simplifying regulatory compliance, and allowing the transmission of study and patient data to UAB’s electronic medical record.
“We have an opportunity to use OnCore as a catalyst for transformational change in the clinical trials process at UAB,” said Robert P. Kimberly, MD, CCTS director and senior associate dean for Clinical and Translational Research in the UAB School of Medicine. “With the integration of PowerTrials and OnCore, the impact on UAB and patient care will be huge.”
As OnCore is implemented within each research area, the current system, SiteMinder, will be phased out. The first wave of implementation is scheduled for November 2017.
To learn more, visit the OnCore page on the UAB Medicine website. [Editor’s note: the original list of 18 superusers appeared in the Sept. 8 issue of DOM’s Good News e-newsletter, produced by Carolyn Walsh.]
OnCore SuperUsers and Support Team
- Thyrza Johnson-Pulmonary
- Stephanie Biggers-Rheumatology
- Pamela Cunningham-ID
- Mary Dougherty-Bergeron-ID
- Lou Ann Faulkner-ID
- Tomeka Wilson-ID
- Jena Reeves-Rheumatology
- Steven Marchman-Rheumatology
- Rachel McMullen-ID
- Stephanie Ledbetter-Rheumatology
- Leigh Powell-CVD
- Patrick Frazier-CVD
- Lisa Williams-GI
- Rakesha Garner-GI
- Tiffany Grimes-Endocrinology
- Kentress Davison-Endocrinology
- Aras Acemgil-Preventive Medicine
- Michelle East-Preventive Medicine
- Courtney Jordan-CCTS
- Penny Jester-CCTS CRSP
- Meredith Fitz-Gerald-CCTS CRSP
- Dawn Bryant Matthews-CTAO