Notice ID: RFQ75N980Q6735423
Description
The National Ophthalmic Disease Genotyping and Phenotyping Network (eyeGENE®) is a research venture created by the National Eye Institute (NEI), part of the National Institutes of Health (NIH). eyeGENE® aims to advance studies of eye diseases and their genetic causes by giving researchers access to DNA samples, clinical information, and patients looking to participate in research studies and clinical trials.
Statement of Work (SOW) covers the implementation of an e-consent software solution. A web application is needed to provide participants the ability to review elements of the consent document(s), test participant consent comprehension and allows for electronic signature and the storage of consent records.
Tasks
Task 1. Platform hosting and maintenance – The platform license is inclusive of platform hosting and maintenance as follows:
- High availability cloud hosting environment managed and monitored by Company
- Management of the solution, to include all necessary software and hardware maintenance
- Compliance with applicable standards, regulations and guidelines including those applicable to the federal government
- System training and platform user guides
End user, site, and administer support
Task 2. Professional Service – Professional services in support of platform management, eConsent processing, distribution and management, content management and reporting. Professional Service are to be billed as time and materials. Platform Support Package includes:
- Copyright and Creative Support
- Language translations
- Managed Services
- Solution Enhancements
- Training
Task 3. System Requirements – The list of requirements for the application functionality are as follows:
- 21 CFR Part 11 compliance
- WCAG 2/508 compliance…
