The Research Design, Compliance, and Data Management (RDCD) Core provides consults and trainings to support Rhode Island researchers in designing rigorous studies, utilizing qualitative and quantitative methodologies, managing complex data, navigating regulatory requirements, and translating discoveries into practice through the application of implementation science. 

Aim 1. Build capacity for CTR by providing content expertise, infrastructure support, and effective workflows. This enhancement of capacity of the Advance RI-CTR will allow investigators to rigorously design, analyze, interpret, and disseminate impactful studies.

Aim 2. Enhance networking for CTR by leveraging and growing partnerships throughout RI and additionally partnering with local and national IDeA programs. This networking will enable us to disseminate innovative methods for study design and analysis that strengthen the capability to perform impactful CTR. 

Aim 3.  Develop the workforce for CTR by providing education and training. In collaboration with the Advance RI-CTR Professional Development (PD) Core, we will provide education and training in regulatory standards, study design, health informatics, epidemiology, qualitative and quantitative methods, and implementation science.

The Research Design, Compliance, and Data Management (RDCD) Core is organized into four specialized Sub-Cores, and includes a Regulatory Advising Unit housed within the Brown University Division of Research.

The Health Informatics Sub Core works closely with the Brown Center for Biomedical Informatics (BCBI) and offers expert guidance and consultations on electronic health record data acquisition and use, data standardization and harmonization (e.g., using the OMOP Common Data Model), privacy-preserving federated analytics, and the development and evaluation of artificial intelligence algorithms and tools to support clinical research. 

The Quantitative Science Sub Core works closely with the Survey, Qualitative and Applied Data Research core, also known as SQuAD, and offers consultations in quantitative research approaches, including best practices for designing observational studies and randomized trials, and in areas such as study design, survey design expertise, quantitative analysis, power calculations, and REDCap use.

The Qualitative Science Sub Core offers consultations that include tailored guidance on qualitative data collection approaches such as semi-structured interview guide creation, focus group design, cognitive interviewing, and qualitative analysis approaches like grounded theory, framework matrix analysis, and mixed methods as well as assistance with NVivo software.

The Implementation Science Sub Core, offers consultations that include guidance about designing an implementation science project, including how to select and use strategies and frameworks—such as EPIS and RE-AIM—to promote the translation, spread, and sustainable scale-up of evidence-based interventions in clinical and community settings.

The Regulatory Advising Unit, a part of the Human Research Protection Program (HRPP), provides expertise in pre-IRB submission guidance, human subjects protections, risk assessment, FDA and NIH policies and regulations, multi-institutional reliance agreements, and ClinicalTrials.gov protocol registration and updates.