Designing Data Management Plans for the Advanced Practitioner
Dates
March 8 - April 13
Course Instructor
Anita Walden, Senior Informaticist, Duke Clinical Research Institute
Intended Audience
Beginner to intermediate experience in outlining and documenting clinical data management activities. Enrollment is limited to 15 students.
Course Instruction
This five-week asynchronous course combines self-study and instructor-led lessons. Participants complete one module per week, moving through the course as a group, including contribution to asynchronous discussions. Projects have deadlines according to a predetermined schedule. An orientation will be held via webcast one week prior to course start to discuss technology needs and course expectations.
Course Requirements
Participants are required to pass the pre-course tutorial for admission to the course. No exceptions will be granted. The tutorial is free. Registration will not be processed until the tutorial is completed.
Participants should be experienced data managers who have in depth knowledge of the majority of data management and related processes. Project Management experience is recommended but not required. This course will focus on the planning of data management processes for a trial or study with minimal discussion on how to complete data management tasks.
Once enrolled participants will need a computer with access to the Internet and the ability to print out course handouts.
Recommended time commitment is 9 hours per week to complete each module.
Course Content
The course will review documentation requirements and common practices and include examples and exercises using a fully developed training protocol. Online group discussions will be facilitated to benefit from common experiences and practices across organizations.
Participants completing the training should be able to accomplish the following objectives:
- Define key elements in a Data Management Plan
- Gather and organize the information describing the data handling processes used for a clinical trial
- Describe workflow for electronic and paper data capture, quality control and related data processing procedures and metrics
- Discuss clinical data management documentation requirements and rationale
- Apply standards for creating, approving and maintaining Data Management Plans
Course Organization & Methodology
A sequence of five modules will be offered, with one module delivered per week. The course also includes introductory and wrap-up activities. The course is organized into three sections:
Tutorial
Introduces terminology and broad concepts necessary for the course. Pre- and post-tests assess participants' level of understanding. Successful completion of the tutorial is required prior to the start of the course.
Course
A five-week asynchronous, online learning experience. Practical individual and group exercises will provide participants with the opportunity to analyze protocol sections to develop Data Management Plans. Participants will also develop flow processes and project timelines.
Deep Dive
Optional post-course assessment determines participants' readiness to take the DMP section of the CCDM® exam by testing their ability to answer questions based on competencies in the Data Management Plan domain.
Course Tuition
Enrollment: $850 members/$950 non-members
Refund Policy
Participants will receive a full refund if notice is provided in writing via post or email one week prior to the course start date. If cancellation occurs by the end of week one of the course, students will be allowed to apply 50% of the course fee to the next offering of the same course. No refunds will be offered after that time.
Continuing Education Credits
SCDM is authorized by IACET to offer 1.6 CEUs for this program.
