|
Study Safety
|
|
The TODAY study has been developed by a team of endocrinologists,
pediatricians, statisticians, psychologists and dietitians.
It has been thoroughly reviewed by
the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK),
the Food and Drug
Administration, and Institutional Review Boards at
the 12 study sites. Each reviewing institution is independent
of the TODAY staff and the studys participating pharmaceutical
companies.
In addition, a Data Safety Monitoring Board, consisting of
independent investigators appointed by NIDDK, oversees the
progress and safety of TODAY throughout the entire study period.
The Board includes experts in endocrinology, pediatrics,
statistics, and clinical trials. Its purpose is to assure
independent review in order to properly assess whether study
patients are exposed to unreasonable risk due to their study
participation. It will also monitor the studys progress and
integrity.
|
|