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U.S. Department of Health and Human Services

About FDA

Development of XML Files for Releasable CVM ADE Data

Description: Provide public access to current CVM ADE data in a harmonized format accessible for data mining technologies. This objective will be supported on an ongoing basis with quarterly updates. Non-public data will not be included in the release.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Submit Configuration Change Request (CCR) for creation of XML files

8/1/2011

Completed 7/13/2011

2. Create XML and ReadMe Text Files

12/1/2012

(12/1/2013)

(12/1/2014)

On Track

a. Implement pre-existing CCR for data migration of all historical Submission Tracking and Reporting System (STARS) data into the PV Works database. This is CRITICAL to success as the data migration includes mapping of non-harmonized medical coding to harmonized Veterinary Medicinal Dictionary for Drug Regulatory Authorities (VedDRA) coding. VedDRA coding is only supported in the PV Works database. A continuation of this CCR to include a quarterly data migration will be necessary as data entry of ADE reports received on paper continues in the STARS system.

12/1/2012

(12/1/2013)

(12/30/2014)

On Track

b. Create XML files from PV Works database with IT support and development and clearance of an accompanying ReadMe text file for initial release of cumulative ADE data, to be followed by quarterly updates (may need “continuing CCR”)

12/1/2012

(12/1/2013)

(12/1/2014)

On Track

3. Website Development:

 

a. Develop Format and Content of the Hosting Web Page

4/1/2013

(4/1/2014)

(6/1/2015)

Not Yet Started

b. Complete clearance process for Web Page Content

4/1/2013

(4/1/2014)

(6/1/2015)

Not Yet Started

c. Develop CVM update announcing project with Communications Staff

4/1/2013

(4/1/2014)

(6/1/2015)

Not Yet Started

4. Launch CVM website access to the public

6/1/2013

(6/1/2014)

(8/1/2015)

Not Yet Started

a. Release CVM update

6/1/2013

(6/1/2014)

(8/1/2015)

Not Yet Started

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

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.