Overview of Data Management Plan and Query Process
Course Description:
This course provides a comprehensive and straightforward overview of the data management plan and query process. It explains the edit check process, why we use Case Report Form (CRF) instructions, and the difference between database and monitoring queries.
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Recognize the importance of issuing data management plans and the correct training methods for all relevant parties
- Understand and explain the query process
- Perform edit checks to ensure an accurate final data set and to eliminate the need for queries as much as possible
- Produce and distribute detailed instructions on how to complete CRFs
- Comprehend how database queries are generated in order to avoid the costly process of additional database queries
Who Should Enroll:
Clinical investigation administrative personnel and coordinators, clinical research associates, and professionals new to the area of clinical investigations are encouraged to enroll in this course.
Prerequisite Knowledge/Requirements:
The following series is required:
- Effective Monitoring of Medical Device Clinical Investigations (IDs 41–48, 59, 56, 50–55, 108, 96)