Electronic Trial Master File (Inc. Electronic Archiving)

  Address - United Kingdom

  Contact details - 565656565

  Tender notice no. - 76454545

  GT Ref Id - 82311860

  Document Type - Tender Notices

Description - 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 comput erized 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

Gt Ref Id - 82311860

Deadline - Jun 28, 2024