The Document in eISF

eISF also collects and stores documents like the eTMF; however, the documents in eISF are related to a specific site only. The document types eISF can store are as follows-

  • Essential Study Documents – Investigators documents, protocols, protocol amendments, procedures, manuals, visit guidance, etc.
  • Safety Documentation such as safety letters.
  • Site Specific Documents- Site SOPs, Training Documents, Site CVs, etc.
  • Audit documents and Audit findings.
  • Financial Information such as Budgets, Contracts, etc.