Data Management Plans

1 part webinar
60-minute presentation followed by 30-minute Q&A

Presenter
Anita Walden, 
 Senior Informaticist, Duke Clinical Research InstituteSenior Informaticist, cal Resea 

Overview

A data management plan ensures compliance with good clinical data management practices throughout the entire clinical trial. The ACDM Guidelines to Facilitate Production of a Data Handling Protocol defines the data management plan as “A document which describes and defines all data management activities for a study”. Data management plans not only describe data management activities, but also provide an agreement among all parties concerning responsibilities and deliverables related to clinical data management. While the style and format of data management plans differs across organizations, this webinar will identify the essential components of a data management plan. The components will be described in detail discussing the elements of each component. The participants in this webinar will be provided with a general template for a data management plan. This webinar will provide the skills and knowledge to create a data management plan to ensure compliance with good clinical data management practices.

Outcomes

  • Define the essential components of a data management plan.
  • Describe the elements of each component of a data management plan
  • Provide a general template for a data management plan.
  • Identify good clinical data management practices that should be addressed in a data management plan.

Level

Intermediate

Target Audience

CEOs, chief learning officers and trainers, clinical data managers, managers of data groups, quality control and quality assurance statisticians, biostatisticians, and project managers working within the clinical trials industry.

CDM Competencies addressed

Data Management Plans Project Management – Project Communications Overall Clinical Trials Process, Roles & Responsibilities

GCDMP Chapters addressed

Data Management Plan

Continuing Education Credit Opportunity 

Attendees are eligible for CEUs upon attendance and successful completion of assessment questions.
SCDM is authorized by IACET to offer .2 CEUs for this program.