Electronic Trial Master File (inc. Electronic Archiving)

Concepts

• southampton
• medical information systems
• trial master file
• investigator site file
• trial
• electronic
• file
• master
• archiving
• trials

Location

Description

The Southampton Clinical Trials Unit (SCTU) requires an electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) and eArchiving solution that meets regulatory requirements (including Eudralex Vol4 annex 11 for computerised systems). These solutions should follow the ALCOA+ principles (Attributable, legible, contemporaneously recorded, original or a true copy, accurate, complete, consistent, enduring, and available). Documents should be able to be approved with fully regulatory compliant e-signatures. The University requires data to be retrievable, along with all metadata, for up to 30 years. The SCTU expects 4-6 new trials a year, and 25 trials recruiting at any one time.

Award Detail

CPV Codes

• 48814000 - Medical information systems

Indicators

• Contract is suitable for SMEs.
• Contract is suitable for VCOs.