Veeva eISF Reference Model

Resource ThumbnailIn response to growing clinical study complexity and documentation requirements, clinical research sites are looking to standardize filing structures within their electronic investigator site file (eISF) or electronic regulatory (eRegulatory) binders.

The eISF Reference Model defines standard record names, attributes, and structure to electronically manage clinical trial records at research sites. This model is actively being used by thousands of sites around the world, and continues to evolve based on input from customers and stakeholders.

Related: eISF Reference Model: The Case for Standardization

The Veeva eISF Reference Model includes:

  • Standard filing expectations for documents, including those not listed on ICH GCP’s minimum required document list
  • Suggested naming conventions to ensure consistent record-keeping procedures
  • TMF and ICH GCP mapping for document exchange between sites and sponsors
  • Clear signature and certified copy requirements

Access the Veeva eISF Reference Model >

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