The Site Activation Progress page presents study startup specialists with a view of overall progress across a study country, including a full list of sites and EDL items, so they can easily identify any blockers to a site’s greenlight. Site Activation Progress View: The critical path for site activation requires collecting site documents quickly, finalizing contracts and budgets, and ensuring local approvals are complete.Such applications should be thoroughly reviewed by regulatory specialists for completeness. Note that this is not an exclusive list of all documents required for applications and submissions. Country Intelligence accelerates the configuration of your Vault to better plan and execute global startup activities. To support this process Vault Study Startup includes a predefined set of Country Intelligence configurations, such as document types, template milestones, dependencies, EDLs, and expected documents that reflect the documents required by country-specific regulatory agencies. Country Intelligence: Study startup requires the collection of a variety of key documents, with requirements varying by country.Creating from a template ensures consistency across studies, as well as compliance with country-specific business practices. Template Milestones & Expected Documents: Milestone templates allow users to create study plans that are consistent across trials, and then create milestones, milestone dependencies, and expected documents in bulk for studies, study countries, study sites, study personnel, study organizations, and study products.With the Person, Organization, and Location objects, you can manage those people, places, and organizations, as well as the frequently-reused documents associated with them. Object Configuration: Vault Study Startup shares with other Clinical Operations applications a hierarchical structure of Study, Study Country, and Site objects, as well as related Study Person, Milestone, and Product objects.In addition, Study Startup provides these capabilities specific to starting a clinical trial: Vault Study Startup is built on the Vault platform and therefore has all features that we describe in the platform help topics. These applications share a common data model, but each provides additional pieces of functionality to help manage the clinical trial process. Within a single Vault, your organization can have one, two, or all of these applications. Vault Study Startup is part of the Vault Clinical Operations family of applications. ![]() It also features templates, lifecycles, and workflows to help you manage startup activities in a complete, efficient manner, and monitor and report on progress and performance. It includes standard document types that support the creation of Study Startup business process artifacts that are not filed into the TMF. Vault Study Startup improves your time to first patient, first visit by managing the process of collecting key documents and completing other activities in the course of starting up a clinical trial. Sample JSON Survey, Schedule, and Notification Templates Performing User Acceptance Testing (UAT) on an ePRO CollectionĪpproving, Upversioning, and Deleting an ePRO CollectionĬonnecting a SiteVault to Your ePRO CollectionĮxporting Survey, Adherence, and Audit Trail Data Veeva eConsent Authoring (Clinical Operations) ![]() Setting Up Study Site Agreements for Veeva Site ConnectĬonfiguring Veeva eConsent Authoring (Clinical Operations) Sending Documents & Document Requests (Veeva Site Connect) ![]() Working with Surveys for External RespondentsĬonfiguring Document Reconciliation (Veeva Site Connect)ĭistributing Safety Documents with Veeva Site Connectĭocument Reconciliation (Veeva Site Connect)ĭocument Transfer Behavior with Veeva Site Connect ![]() Using the Study Startup Specialist Homepage Using Site Activation Progress View (Study Startup) Study Budget Tracking with Vault PaymentsĪbout the Model & Artifact Objects (Study Startup)Īuto-Filing Documents in Study Startup BindersĬonfiguring Surveys for External Respondents Training Auto-classification Models for TMF Bot (eTMF) Yuzu Clinical Trial Notifications in CTMSĪbout the Model & Artifact Objects (eTMF & CTMS)Įvaluating TMF Bot Auto-classification Models Risk Based Study Management (RBSM) in CTMS Managing Studies, Study Countries & Study SitesĪbout the Clinical Operations to CDMS Vault ConnectionĬonfiguring the Clinical Operations to CDMS Vault ConnectionĬonfiguring Risk Based Study Management (CTMS)Ĭonfiguring Yuzu Clinical Trial Notifications in CTMS Managing the Person & Organization Objects About Investigator Initiated Studies (IIS)Ĭonfiguring Investigator Initiated StudiesĮnabling Document Packages & Setting Up Defaults
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