CLIC Resource Center

The CLIC Resource Center is a place for CTSA Program members to share relevant and useful guides, manuals and other tools with the full consortium. This page aims to encourage collaboration and resource-sharing so that hubs across the program don’t need to ‘recreate the wheel’ every time they’re faced with a challenge or question.

These resources may be related to administration, informatics, team science or communication, among other subject matters. Similar to our Events and News pages, all CLIC website users are invited to submit resources, but must be logged into the site to access the submission form.

ReGARDD.org
Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)

University of North Carolina at Chapel Hill Translational & Clinical Science Institute

ReGARDD provides academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics and medical devices. 

The ReGARDD affiliates are comprised of regulatory affairs specialists and experts from North Carolina Institutions that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program. Currently these institutions are the University of North Carolina at Chapel HillDuke UniversityWake Forest School of Medicine, and RTI International.

Combining the regulatory talents from the North Carolina CTSAs and the research triangle park (RTP) area enables sharing of ideas, lessons learned, historical information, and the development of successful strategies to assist the academic researcher in navigating an increasingly complex regulatory environment. 

 

DSMB manual Getty Images
Data and Safety Monitoring Board Training Manual

Tufts Clinical and Translational Science Institute

The CTSA Program Collaborative Data and Safety Monitoring Board (DSMB) Workgroup identified a need to provide guidance, training and resources in DSMB practices for investigator-initiated research studies. To promote clinical and translational research, the CTSA Program Collaborative DSMB Workgroup, supported by NCATS, produced an online DSMB Training Manual with a focus on investigator-initiated studies. This manual provides information and training for Principal Investigators, DSMB members, IRB members, biostatisticians, and research staff on how to work effectively with DSMBs.

REP logo REP
The Rochester Epidemiology Project (REP) Portal

Mayo Clinic

The Rochester Epidemiology Project (REP) is a collaboration between health care providers in Minnesota and Wisconsin. This collaboration allows researchers to study health and illnesses in the people living in this community. As a way to share REP data with researchers, clinicians, and the general public, we have developed an online portal for exploring relationships between various characteristics. The portal allows users to choose two characteristics, to summarize the prevalence of each separately by age and sex, and to explore the co-occurrence of the two characteristics. In addition, users are presented with shaded maps to help visualize the prevalence and co-occurrence of the two selected characteristics across the REP region.

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