About FDA
Federal Regulatory Compliance
Description: Provide standardized records keeping program (in accordance with HHS, FDA, and NARA standards).
Accomplishment: During FY 2011, the Records Staff organized the general records within the NCTR records repository by NCTR division and owner. Records were inventoried and categorized according to the record label and placed on a quarterly review cycle. Records meeting their designated cut-off retention timeframes were removed and destroyed according to regulation. Non-sensitive records were recycled directly into the recycle bin while sensitive records were shredded. As a result of this project, NCTR has maintained its compliance with HHS, FDA, and NARA standards.
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
1. Establish records management system |
12/31/2009 |
Completed | 7/1/2009 |
|
2. Develop and present Records Management Training for all NCTR Staff |
7/1/2010 |
Completed | 7/1/2010 |
|
a. Complete training for all Administrative Staff |
3/1/2010 |
Completed | 3/1/2010 |
|
b. Complete training for all Scientific Staff |
7/1/2010 |
Completed | 7/1/2010 |
|
3. Catalog/index all records within NCTR Archives |
10/1/2010 |
Completed | 12/1/2010 |
|
a. Complete catalog/indexing of GLP study records |
3/1/2010 |
Completed | 3/1/2010 |
|
b. Complete catalog/indexing of all subjects study records |
7/1/2010 |
Completed | 7/1/2010 |
|
c. Complete catalog/indexing of all general records |
10/1/2010 |
Completed | 12/1/2010 |
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |
Glossary
HHS
Department of Health and Human Services
NARA
National Archives and Records Administration
GLP
Good Laboratory Practices
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.
