Enable Digital Delegation and Create Study Responsibilities

This video provides a concise, procedural guide on activating and customizing the Digital Delegation feature within Veeva SiteVault, Veeva's eRegulatory/eISF system designed for clinical research sites. The primary objective is to detail the necessary steps for site administrators to enable the digital delegation log for specific studies and subsequently tailor the associated study responsibilities to align precisely with the requirements of the study protocol. This functionality is crucial for maintaining accurate, auditable records of delegated tasks, which is a fundamental requirement for GxP compliance and adherence to 21 CFR Part 11 requirements in clinical trials.

The process begins by emphasizing a key administrative requirement: the Digital Delegation feature is not automatically enabled across an organization's portfolio of studies; it requires manual activation by a Site Administrator for each individual study intending to use the digital delegation log. The administrator must navigate to the study's details section and explicitly select the option to enable digital delegation. This step is a prerequisite for utilizing the system’s automated delegation tracking capabilities.

Upon activation, the system automatically populates the study responsibilities section with a default list of responsibilities that have been pre-defined at the research organization and site level. The core of the video focuses on the customization phase, instructing users to enter the responsibilities section to refine this default list to match the specific protocol requirements. Customization involves two main actions: creating brand new study-specific responsibilities and deleting non-applicable default responsibilities. To create a new responsibility, the user must define both a descriptive name and an appropriate category before saving the entry. Conversely, responsibilities that do not apply to the current protocol can be easily deleted via a menu option, ensuring the final delegation log is clean, relevant, and compliant with the study’s specific needs. The process must be continued until the list of responsibilities perfectly aligns with the protocol, ensuring accurate delegation tracking throughout the trial.

Key Takeaways: • Digital Delegation is Study-Specific and Manual: The digital delegation log feature in Veeva SiteVault is not a global setting; it must be manually enabled by a Site Administrator for each individual study where the functionality is required, highlighting the need for careful study setup procedures. • Administrative Privilege Requirement: Only users designated as Site Administrators possess the necessary permissions to enable the digital delegation feature, underscoring the importance of controlled access for critical regulatory functions. • Enabling Process: The activation sequence involves navigating to the specific study, accessing the details section, and explicitly selecting the option to enable digital delegation, establishing a clear administrative workflow. • Default List Pre-Population: Once enabled, the study responsibilities section is automatically populated with a default list of responsibilities defined at the organizational level, providing a starting template for site customization. • Protocol-Specific Customization is Mandatory: The default list must be customized to precisely match the requirements of the study protocol, ensuring that the delegation log accurately reflects the specific tasks and roles defined for that clinical trial. • Creating New Responsibilities: To add a study-specific responsibility, the administrator must utilize the "add responsibility" function and define both a clear name and an appropriate category for the new entry before saving. • Streamlining for Compliance: The ability to delete non-applicable responsibilities from the default list is crucial for maintaining a streamlined and compliant delegation log, avoiding confusion and potential audit findings related to irrelevant entries. • Iterative Refinement: The video emphasizes that the process of creating and editing responsibilities must continue until the list is a perfect match for the protocol, highlighting the need for thoroughness in setting up regulatory documentation. • Veeva SiteVault Context: The entire process takes place within Veeva SiteVault, which functions as the eRegulatory/eISF system, positioning this task squarely within the scope of clinical documentation management and regulatory oversight. • Support Resources: The video directs users to the help center for detailed information on enabling digital delegation and creating study responsibilities, and provides a dedicated support email (sitevault support) for issues related to login or site access.

Tools/Resources Mentioned:

• Veeva SiteVault (eRegulatory / eISF system)
• SiteVault Help Center
• SiteVault Support Email (via.com)

Key Concepts:

• Digital Delegation Log: An electronic record used in clinical research to document which study team members are authorized to perform specific tasks, crucial for regulatory compliance (e.g., GxP, FDA 21 CFR Part 11).
• Study Responsibilities: A defined list of tasks and duties within a clinical trial protocol that must be assigned and delegated to qualified personnel.
• Site Administrator: A user role within Veeva SiteVault with elevated permissions necessary to configure system-wide or study-specific features, such as enabling digital delegation.
• eRegulatory / eISF: Electronic Regulatory/Investigator Site File systems, which manage essential study documentation digitally to ensure audit readiness and compliance.