Office of the Director
The Office of the Director provides scientific and administrative leadership for the Institute, including policy guidance, strategic program development and evaluation, and overall operational and administrative coordination.
- Meet the Director – Dr. Rodgers’ and Dr. Germino’s biographies, Dr. Rodgers’ vision statement, the NIDDK annual budget and report, and the Director’s Update newsletter
- Office of the Director staff and contact information
The Office of the Director also manages the following research support programs.
Office of Clinical Research Support
The NIDDK Office of Clinical Research Support is responsible for overseeing and coordinating the development of policies and procedures to guide extramural NIDDK-funded clinical studies and clinical trials, to ensure that such research is compliant with all NIH and HHS human subjects research policies, and that planning for and management of clinical research is consistent, effective and efficient across all divisions. The Office includes specialists in Biostatistics, Regulatory Affairs, Clinical Trial support, Data and Biospecimen Repositories, and Technology Transfer.
The Biostatistics Program provides advice to extramural and intramural NIDDK staff on the design and feasibility of proposed research studies and the conduct of ongoing studies. Staff in the program:
- perform research on statistical methods,
- conduct educational seminars,
- attend Data and Safety Monitoring Board meetings for extramural project, and
- provide analytical services for intramural research projects.
Regulatory Support Program
The NIDDK Regulatory Support Program provides regulatory support for all NIDDK-sponsored trials that require a U.S. or Canadian regulatory application for the use of an investigational drug or device in a clinical trial. Specifically, regulatory consultation is provided to aid in the determination of the need for a regulatory application, protocol development, study drug issues, and other regulatory matters. Regulatory support staff work with the program officials and data coordinating centers (or intramural investigator) to
- initiate regulatory applications,
- maintain applications (e.g., annual reports, protocol amendments),
- assist with safety reporting to FDA and Health Canada, and
- ensure that the Institute is in compliance with any existing or new regulatory requirements.
NIDDK Central Repository
The NIDDK Central Repository makes data and biospecimens from current and previously-funded NIDDK studies available to the broader scientific community. The Repository enables scientists not involved in the original study to test new hypotheses without any new data or biospecimen collection, and provides the opportunity to pool data across several studies to increase the power of statistical analyses. The NIDDK Central Repository has four major components.
- an archive of clinical data and documentation from NIDDK-sponsored studies
- a collection of biospecimens and an associated database that identifies specimens collected from ongoing and completed studies funded by NIDDK and links them to the associated phenotypic data
- a web portal that contains study-specific information within the Repository and accepts electronic requests for biospecimens and data
- a collection of genotyping data from GWAS and sequencing studies housed at the National Center for Biotechnology Information's (NCBI) database of Genotypes and Phenotypes (dbGaP)