FDA OC Safety Reporting Portal (SRP)
Investment ID: 009-000261566
Overview
Program Title
FDA OC Safety Reporting Portal (SRP)
Description
SRP is a new Web site launched by NIH and FDA for industry to report food safety problems or adverse events involving FDA-regulated foods and animal feeds, pet foods and pet treats, animal drugs, human gene transfer research and tobacco products.
Type of Program
Non-major IT Investments
Multi-Agency Category
Not Applicable
Associated Websites
https://www.safetyreporting.hhs.gov
Investment Detail
SRP meets the specific center identified business needs:
- CTP created the new Tobacco Investigator Report (TIRv1) RQ to allow investigators to report adverse events occurring in the context of a clinical study and enhanced the Tobacco Product Report (TPRv2) RQ to support multiple roles, adding questions specific to Manufacturer. Proxy-Users, allowing FDA Personnel to submit on behalf of others, and Group Access were implemented for both RQs.
- Enhancements to CFSAN RQ's an implementation of the Group Access feature has improved their Advent Event reporting system by replacing long checkbox list with multiple select option, adding new data elements and business rules, and adding Group Access.
- Enhanced CDER's SPHR RQ enabling industry users to add verbatim information collected from reporter.
- The Group Access Feature allows for multiple users to track their group's submissions.
- CTP created the new Tobacco Investigator Report (TIRv1) RQ to allow investigators to report adverse events occurring in the context of a clinical study and enhanced the Tobacco Product Report (TPRv2) RQ to support multiple roles, adding questions specific to Manufacturer. Proxy-Users, allowing FDA Personnel to submit on behalf of others, and Group Access were implemented for both RQs.
- Enhancements to CFSAN RQ's an implementation of the Group Access feature has improved their Advent Event reporting system by replacing long checkbox list with multiple select option, adding new data elements and business rules, and adding Group Access.
- Enhanced CDER's SPHR RQ enabling industry users to add verbatim information collected from reporter.
- The Group Access Feature allows for multiple users to track their group's submissions.