Template SOPs

Veeva’s Standard Operating Procedure (SOP) templates were developed in response to customer requests and are available to sites to download, modify with site-specific information, and adopt into your existing standard operating procedure format. The SOP templates cover core areas of GCP compliance when instituting an electronic Investigator Site File. You can use the SOP Needs Assessment Checklist to help you determine which SOPs you need to create or modify when implementing SiteVault at your site.

Select a card below to view or download the SOP template.

Source/Remote Monitoring

To establish standard processes and procedures for conducting on-site and remote monitoring visits, and to describe the site and study-specific methods for generating source documents and the procedures for reviewing source documents.

Use of eDOA

To document standard processes and procedures for the electronic assignment, management, and acknowledgment of delegated trial-related duties.

Use of an Electronic Investigator Site File

To establish standard processes and procedures for the use of the electronic Investigator Site File (eISF) for the conduct of research.

Use of Certified Copy

To establish standard processes and procedures for the use of certified copy.

Use of eConsent

To establish standard processes and procedures for the use of Veeva eConsent. To describe the methods to create, modify, maintain, transmit, sign, and store electronic informed consent forms.

Use of Electronic Signature

To document standard processes and procedures for use of 21 CFR Part 11-compliant electronic signatures in research.

User Account Management and Training

This procedure describes the process of requesting and managing user accounts and user security. This procedure outlines actions relating to requesting, establishing, issuing, and suspending user accounts.

Additional template SOPs are planned for the future as new features are released. Your feedback on SOPs is welcome.

These resources serve as reference tools only and were prepared based on the current opinions and advice from Veeva personnel with clinical research site experience. Laws, rules, and regulations vary by country and jurisdiction, and Veeva cannot provide you legal advice regarding your legal or regulatory obligations.You should confirm any changes to your practices, policies, and procedures with your own legal, privacy, and compliance resources. The information contained within these documents, outside of cited external references, has not been reviewed or approved by any regulatory agencies. If you choose to implement any of the practices, policies, or procedures referenced within this document, you do so at your own risk.

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