On October 25, the CCTS introduced a Clinical Trials Lunch & Learn (CTL&L), the first since the Clinical Trials Office hosted its final L&L over a year ago. More than 180 clinical trial investigators, coordinators, and staff gathered in Margaret Spain Auditorium for a “meaty” presentation that covered nine topics in roughly 75 minutes. A sampling (dare we say “tasting menu”?) of what was covered is below. For those who missed it, the entire presentation is available online.
Mark your calendar for the next CCTS Clinical Trials Lunch & Learn (which take place on a quarterly basis), scheduled for Tuesday, February 21, 2017.
Clinical Trials Administrative Office (CTAO)
Mark Marchant, administrative director of the CTAO, provided information on the mission and structure of this new office. He described its main charges—to ensure appropriate 3rd party billing, and so enhance financial management processes that improve internal controls in research-related activities, and to support an integrated approach to capturing research data throughout UAB via enhanced use of clinical research management systems.
PowerTrials and OnCore
Lisa Williams, OnCore Enterprise administrator, discussed the upcoming rollout of PowerTrials and OnCore, which stands for Online Collaborative Research Environment. She described how, as a clinical trials management system, OnCore provides support throughout the protocol lifecycle, from trial activation to study closure. She explained how it will communicate with PowerTrials, a new set of features in UAB’s electronic health record IMPACT, to link protocol and subject information, simplify ordering of clinical services, and improve patient safety. OnCore has replaced SiteMinder, which has limited functionality and is no longer supported by the vendor.
Clinical Billing Review
Dawn Matthews, manager of the Office of Clinical Billing Review (CBR) provided updates on new issues and personnel. She announced that CBR will soon have a new campus-wide financial approval process (FAP) that includes using a FAP Submission Workbook. A meeting to discuss the FAP submission changes is being planned for November.
IRAP
Assistant Vice President for Research Administration, Operations, and Systems Jonathan Miller described the progress and status of the Integrated Research Administration Portal (IRAP) and the development of an electronic IRB submission process. More than 14,000 protocols have already been loaded via the new eForm. Other modules marked for future support include submission of IDPs, IP management, and the Occupational Health & Safety committees.
Single IRB
Leslie Cooper, interim IRB director at UAB, gave status on the implementation of a single IRB, as well as changes to human subjects and consents forms. The goals of a single IRB, she said, are to streamline the IRB review process, improve review efficiency and consistency, and reduce administrative burdens. She reviewed the federal policies underlying the move to a single IRB and outstanding issues that need to be resolved before full implementation can take place.
i2b2
Matt Wyatt, assistant director for Biomedical Informatics at CCTS and the UAB Informatics Institute, discussed ib2b, a powerful research tool available to investigators at UAB. He reviewed when to use i2b2, what to do if i2b2 isn’t sufficient, and resources online to learn more and self-train on i2b2.
Effort Reporting
Jereme Logan, research compliance specialist, described new standards and requirements for effort reporting. He urged attendees to subscribe to the University Compliance Office’s “Compliance 411” newsletter to increase their awareness of important changes in requirements for effort reporting.
RPL Management
Brenda Cox, associate director of the Office of Conflict of Interest, discussed reminders about responsible personnel list (RPL) management and announced a new 4th year refresher course on financial conflict of interest in research that will be required for all RPL.
GCP Training Requirement
Penny Jester, director of the CCTS Clinical Research Support Program, closed the meeting with a brief presentation about the new NIH requirement for GCP training. She announced CCTS is developing new enhanced courses to fulfill this requirement.