Digital SOP Help Center
Learn how to develop, implement, and maintain Standard Operating Procedures (SOPs) related to instituting an electronic Investigator Site File (eISF).
Why Do You Need SOPs
SOPs are a valuable resource to have to demonstrate that clinical trials are being completed in accordance with regulations and best practices. This resource can be used as a guide for both new and experienced study staff to ensure quality and compliance is maintained.
What to Include in an SOP
At a minimum, the key elements of an SOP should include the six sections below.
Identify Your SiteVault Goals
Identifying which SiteVault features you are using will help you determine which SOPs you will need to revise or implement.
Things to Keep In Mind
As you are developing new SOPs for your site’s use of SiteVault, here are suggested questions to keep in mind:
Break Down the Process
Don’t know where to start in writing SOPs? Start by writing work instructions to clearly explain how to execute all the steps involved in the task. From there, you can create a more generalized version, which will serve as your SOP.
Initially, you may need to review your SOPs more frequently to make refinements as you gain familiarity with SiteVault. Once you feel like your SOPs effectively capture your current processes, you can move to reviewing SOPs according to your internal policies.
Tips for Developing SOPs
As your digital processes change over time, remember to inform and train your team on your updated SOPs to ensure they are still effective and compliant.
SOP Needs Assessment Checklist
You can download the SOP Needs Assessment Checklist to help you determine what SOPs you may need to modify or create when implementing SiteVault.
Veeva’s SOP templates were developed in response to customer requests and are available for sites to download, modify with site-specific information, and adopt into your existing standard operating procedure format. These digital SOP templates cover core areas of GCP compliance when instituting an electronic Investigator Site File.
Select a card below to view or download the SOP template.
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.
What SOPs should my site have if we're using SiteVault?
Some examples include the following SOPs:
- Source/remote monitoring
- Use of eDOA
- Use of an electronic investigator site file
- Use of certified copy
- Use of electronic signature
- Use of account management and training
- Use of eConsent
Veeva digital SOP templates are available for download to modify with site-specific information and align with your site’s existing SOP format.
How do I decide whether an SOP is needed?
To help decide whether an SOP is needed, you may want to consider the following:
- Are there any current issues with lack of training, errors, or lack of consistency?
- Has an auditor or monitor asked for documentation of a process that the site does not have?
- Are organizational changes occurring that impact a current process or way of doing something?
Additionally, you may want to complete an inventory check:
- Review existing SOPs
- Determine what new SOPs are required
- Identify existing SOPs that need revision
- Identify which SOPs are no longer needed
Why do I need to have SOPs?
SOPs are a valuable resource to demonstrate that clinical trials are being completed in accordance with regulations and best practices.
I'm new to creating SOPs for an eISF. Can you help our site create our SOPs?
Yes, our Site Success team can offer advice on best practices regarding what to keep in mind while developing your SiteVault-specific SOPs.
Not all studies at my site will move to digital. What should I do?
Your site can take a hybrid approach to using a paper and digital process. You want to consider which studies will stay on paper, which will move to SiteVault, and which will start on SiteVault. This will help inform which SOPs you might have to revise and which new SOPs you will need to create.