Clinical and Translational Science Consultations

IRB and Human Subjects Research Support: Assistance with Institutional Review Board (IRB) submissions, approvals, and ongoing compliance for studies involving human participants. 

FDA Regulatory Guidance: Support for researchers conducting studies involving Investigational New Drugs (IND) or Investigational Device Exemptions (IDE), ensuring adherence to FDA regulations. 

Clinical Trials Support: Guidance on study design, protocol development, and compliance with Good Clinical Practice (GCP). 

ReCODE Health: Provides expertise on ethical considerations in research, particularly related to participant safety, informed consent, and data privacy. 

Bioethics Guidance: Offers researchers advice on handling complex ethical dilemmas in their studies. 

CARE-Q: Introduced at PRIM&R 2023, this initiative focuses on improving research quality and ethics through structured consultations on best practices. 

Monitoring and Auditing Support: Help with internal audits or preparing for external audits to ensure research integrity and compliance. 

The Biostatistics, Epidemiology, and Research Design (BERD) Unit provides expert consultation and collaboration for ACTRI researchers in biostatistics, bioinformatics, and epidemiology. Our faculty and staff specialize in statistical methodologies, reproducible research reporting, R Bioconductor, and high-performance computing. 

Supported by a team of five full- and part-time statisticians, the BERD Unit has extensive experience across various research settings, including clinical trials, longitudinal data, survival analysis, observational studies, and high-dimensional data. 

 
Requesting BERD Services 

All consultation requests must be submitted using the "Request BERD Services" link. ACTRI membership is required, and members receive up to four hours of grant preparation assistance at no charge. Beyond four hours, the standard hourly rate applies. Investigators receiving BERD support for grant preparation must include BERD costs in their grant budgets, a practice that often strengthens applications. 

Timelines 

To ensure efficient collaboration, we recommend submitting requests at least six weeks in advance. If your deadline is shorter, please contact the ACTRI BERD team before submitting a request. 

• Grant submissions (no preliminary data analysis): At least one month advance notice required. 

• Grant submissions with preliminary data analysis or abstract submissions: At least two months advance notice required. 

• A statistical analysis plan must be approved by ACTRI co-investigators before data analysis begins. 

Walk-In Consultation 

ACTRI members can access free walk-in BERD consultations every Wednesday from 3 P.M. to 5 P.M. via Zoom. To join, submit a request using this form during walk-in hours. Once your request is received, we will add you to the list and send a Zoom invite when it’s your turn. 

Grant Writing Support 

The ORS Grant Management unit offers comprehensive grant writing support to help researchers develop competitive proposals. Our services include reviewing grant requirements, crafting proposals, defining project goals, and assisting with budget development. 

Services Offered: 

• Proposal creation and editing 

• Work plan development 

• Budget planning and refinement 

Our team works closely with researchers to ensure proposals meet specific funding criteria and institutional objectives, increasing the chances of success. 

The UCSD ACTRI Dissemination and Implementation Science Center offers personalized consultations to help you navigate Dissemination & Implementation models, measures, and study designs grounded in community engagement methods. The DISC provides tailored resources, expert recommendations, and connections to content-specific specialists. Our services are open to everyone, regardless of field or experience level. If you are interested in this consultation service, please submit a DISC consultation request below.  

DISC Consultation Request Form: https://ucsd-actri.jotform.com/jfcrsi05/disc-consultation-service-request-d