 |
 |
|
| No reports are made to employers, schools or
to insurance companies. CCT must follow California medical regulations, as well as,
federal guidelines for clinical research concerning your medical and study records.
Information obtained during the course of the study will be retained in confidential
files at CCT; however, data which contains your identity will be subject to disclosure
in certain circumstances. The Sponsor may use the data to seek approval from the Food
and Drug Administration. At any time during or after the study, representatives of the
Food and Drug Administration, members of the institutional review board, or the Sponsor
may inspect the files and your medical records. On rare occasions, the law may also
require disclosure to regulatory bodies or other third parties. All groups that may
have access to the data will be explained to you before the study starts in an informed consent. |
|
|
|
