Notice ID: 75F40123R00015
Related Notice: DAO6152201
Description
The contractor shall perform these functional DMP services as follows:
- Performing services within the FDA Standard Operating Procedures (SOP) requirements.
- Development and enhancement of SOPs.
- Program management services for the oversight of data management operations, contractor staff training, records management, courier services and regular metrics reports.
- Receiving data in a variety of physical and electronic formats.
- Scanning physical documents into electronic formats, reviewing electronic submissions, and making the required corrections.
- Entering, registering, and processing data into the FDA computer system.
6.0 DMP Task Areas The contractor shall meet the following performance-based objectives within each of these functional task areas and further described below.
- Task Area 1: Case Processing Services Following the Standard Operating Procedures (SOP)
- Task Area 2: Management of the SOPs
- Task Area 3: Case Processing Management
- Task Area 4: Systems & Management Support
- Task Area 5: Document Delivery (Local Courier Services)
- Task Area 6: Program Management Services
- Task Area 7: Data Quality Assurance and Training
- Task Area 8: Support of FAERS DMP Program Enhancements and Efficiencies