Description
(219-OD) PK Submit Administration
PK Submit Administration is an intermediate-level e-learning course designed for administrators and standards leads responsible for configuring, standardizing, and supporting PK Submit across their organization within Phoenix® 8.8. Rather than walking through a single study workflow, the course focuses on the organization-wide decisions that keep PK Submit consistent and audit-ready across teams: controlled terminology and standards libraries, house-style output templates, validation rule configuration, and change management as CDISC standards evolve.
Through guided demonstrations and configuration exercises, participants will learn how to establish and maintain company standards within PK Submit, roll out updates and version changes with minimal disruption to end users, and set up governance practices — such as standardized mapping specifications and validation rulesets — that reduce rework and support inspection readiness across studies.
Who Should Attend
This course is intended for PK administrators, CDISC standards or data governance leads, and power users who configure, maintain, or support PK Submit for their team or company. It is not intended as a first introduction to PK Submit; learners should already be comfortable performing the core PK Submit workflow, either through prior hands-on experience or by completing the introductory course below.
Prerequisites
Before taking this course, you should be familiar with:
- The standard end-to-end PK Submit workflow, including data import, NCA configuration, and CDISC domain creation
- Fundamental CDISC SDTM, SEND, and/or ADaM concepts
This familiarity may come from prior experience or from completing:
- (119-OD) Fundamentals of PK Submit (On-Demand Course)
About PK Submit
PK Submit was originally developed to help PK scientists generate PK-related CDISC domains without requiring programming expertise. Today, it provides a streamlined, end-to-end workflow supporting data import, preparation, noncompartmental analysis, and creation of submission-ready outputs. As adoption grows across an organization, administrators play a key role in keeping that workflow consistent — maintaining shared standards and validation rules so that every scientist's output is submission-ready and audit-consistent, regardless of who ran the analysis.
Course Access and Software Requirements
- Cost: This course is offered free to all PK Submit users.
- Software: To complete the configuration exercises, you must have Phoenix 8.8 with valid WinNonlin and PK Submit licenses. Administrative-level access to shared standards or template locations is recommended but not required to complete the course.
Certificate
By completing/passing this course, you will attain the certificate Certificate of Completion - 2026
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Classroom Courses
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Notification of Cancellation by Participant Amount of Refund| 1-30 Calendar Days | 0% Refund |
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