Electronic Investigator Site File system (eISF) - Medical Research

Concepts

• electronic investigator site file system
• newcastle upon tyne
• software package
• uk hospital
• medical research
• information systems
• digital site file
• approval of research documentation
• eisf
• digitisation

Location

Northumberland and Tyne and Wear:

Description

The requirement is to provide an electronic Investigator Site File system (eISF) for the digitisation, administration, storage, management and approval of research documentation. The solution will require access for around 600-1000 end users, this isn't expected to be concurrent.

Total Quantity or Scope

To procure a digital site file for medical research carried out at a UK Hospital for the digitisation, administration, storage, management and approval of research documentation.

CPV Codes

• 48000000 - Software package and information systems

Other Information

** PREVIEW NOTICE, please check Find a Tender for full details. ** To procure a digital site file for medical research carried out at a UK Hospital for the digitisation, administration, storage, management, and approval of research documentation.Additional informationThe Hospital maintains vast numbers of paper site files relating to study governance. Each site file contains documents such as study protocols, ethics regulatory approvals, delegation logs, training logs, consent forms and email correspondence. Each study will have between three and ten large lever arch site files and there are currently 1,400 studies in progress. Many of the above documents are dynamic and version-controlled and paper copies of all changes must be retained for audit purposes. After study closure the files are sent to an off-site storage facility for periods ranging from five to 25 years depending on the nature of the study.The Hospital wishes to implement a fully electronic site file for each study that eliminates the use of paper documents, reduces the amount of staff time spent on printing and saves the cost of using an off-site storage facility to archive the documents of studies that have closed. The system must be an off the shelf software package provided as a cloud-based service that is already in use in a research environment and comply with FDA Part 11 requirements for electronic signatures. All data must be held in either the UK or the European Economic Area.Requirements from SupplierConfirm with the authority of their interest in the contract by the 14th of July 2023.It is envisaged that a restricted tender process will be undertaken. This likely to take place during the months of August through to October. Suppliers will be requested to respond to a specification as part of the tendering process.