The focus of the Research Methods Core is two-fold: a) to support high quality CTR from study inception to dissemination via combined study design and analysis, as well as regulatory guidance; b) to develop innovative, pragmatic and generalizable methodological solutions in the areas of design, analysis and regulatory support for CTR challenges.
The central theme of CTSI-CN v2.0 is child health CTR and rare genetic disease research. Therefore, the interrelationship between design and regulatory considerations is extremely important. In order to be approved by the IRB, studies must not only meet ethical and regulatory standards but also requirements for statistical inference about a given research question. The Biostatistics, Epidemiology and Research Design (BERD) module will guide the study design, taking into account unique pediatric considerations. The Regulatory Knowledge and Support (RKS) module will ensure that the study design is safe from a risk perspective, recognizing that the risk-benefit ratio is defined differently in pediatric research versus adult research.
The CTSI-CN includes a diverse range of CTR investigators across the spectrum of translational research (T1 to T4), the ages studied (from fetal life through young adulthood), and the level of investigator expertise in terms of both BERD-related and regulatory competencies. The aims of both modules provide flexible structures to meet the special needs of child-health investigators.
BIOSTATISTICS, EPIDEMIOLOGY, & RESEARCH DESIGN
The CTSI-CN's Biostatistics, Epidemiology, and Research Design (BERD) module provides funds to support statistical consultation, analysis, and proposal development. The CTSI-CN Biostatistics, Epidemiology, and Research Design (BERD) module includes the Children's National Health System Division of Biostatistics and Study Methodology (DBSM) and The George Washington University Biostatistics and Epidemiology Consulting Service (BECS). The team of faculty and staff also support the education component of BERD through courses, seminars and online presentations. The Co-Directors of BERD are James Bost, PhD, Division Chief of DBSM, and Sam Simmens, PhD, Director of BECS.
To learn more about specific service options please visit the following:
BERD Service Options
Please Note: All requests for services need to be submitted through the SPARC request portal. The link is provided below and details on how to submit a request can be found on the DBSM website.
WHO CAN USE THIS RESOURCE?
All Children’s National Health System and The George Washington University research faculty and staff can utilize the Biostatistics, Epidemiology, and Research Design module services.
HOW MUCH DOES ACCESS TO THIS RESOURCE COST?
Usage of the services offered by the Biostatistics, Epidemiology, and Research Design module is offered at reasonable cost.
To learn more about specific service options, please visit: BERD Service Options
As part of our BERD funded efforts, all requestors can be provided with up to four hours of free support. Additional free support can be provided on a case-by-case basis especially for proposal development or for K-awardees. See the DBSM home page for additional pricing options.
HOW DO I ACCESS THIS RESOURCE?
To request Biostatistics, Epidemiology, and Research Design module services, please arrange for a consultation meeting via the SPARC Request portal.
WHO SHOULD I CONTACT FOR MORE INFORMATION?
For more information, please also visit the CTSI-CN Faculty and Staff Directory and select the "Biostatistics, Epidemiology, and Research Design" service area to find the person(s) responsible for this resource.
Regulatory knowledge & Support
The Regulatory Knowledge and Support (RKS) module facilitates the conduct of clinical and translational research from the regulatory perspective, improving compliance and efficiency. RKS provides regulatory support to CTSI-CN investigators, spanning the regulatory process involved in the pre-study stage, active-study stage, and post-study stage. The RKS team has extensive regulatory experience, including FDA submissions, preparation of IRB applications, maintenance of approvals, adverse event reporting, protocol amendments and required annual renewals.
- Sponsor and FDA required regulatory submissions
- Preparation of IRB applications, using the IRBear system
- Participant Advocacy program
- Consultation for regulatory issues
- Human Subject Protection training
To request support, click here.
HIPAA FAQs 2015 (pdf)
Please visit the Faculty and Staff Directory to find the faculty/staff member(s) responsible for these resources.