Veeva’s Standard Operating Procedure 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.
- Use of an Electronic Investigator Site File
- Use of Certified Copy
- Use of Electronic Signature
- User Account Management and Training
- Source/Remote monitoring
Additional Template SOPs are planned for the future as new features are released. Your feedback on SOPs is welcome. Contact us via email SiteVault-eISF@veeva.com.
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.