In 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. Veeva has released its eISF reference model for further input.
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 eliminate confusion about a document’s contents and enable study stakeholders to speak the same language.
- TMF and ICH GCP mapping to help monitors more easily transition between sites and lay the foundation for document exchange between sites and sponsors.
- Clear signature and certified copy requirements to save time and reduce stakeholder stress.
Download the Veeva eISF Reference Model >
This model is a starting point, but it can’t reach its full potential without you. We need your insight on whether it reflects your site’s regulatory document handling needs. To share your feedback, email us at SiteVault-eISF@veeva.com.