Specifications include, but are not limited to: The overall objective of this RFP is to select a primary supplier to assist UC San Diego in establishing a cost-effective and efficient program to reduce administrative burden and streamline regulatory activities for the campus-wide research community conducting clinical trials. Such solution will store all regulatory documentation, in accordance guidelines for adherence to good clinical practice (GCP), relating to UCSD’s research site. The solution must also support secure workflows and interoperability for exchanging regulated research documents between research stakeholders and related research management and electronic health records systems. Proposed solutions should support efficient organizationally established templates, access roles security, and standards protocols for cross-platform systems integration functionality. UC San Diego plans to implement a system for electronic filing, management and archival of all clinical trial essential documents to be included in the electronic regulatory binder (eRegulatory) services for research. Such services will create a secure longitudinal record keeping system for research studies, to maintain regulatory compliance and promote essential secure data exchanges with stakeholders for transparency and accountability. eRegulatory platform needs to support multi-site trials.
