Course runs January 23 - February 26, 2017
There has been a significant focus on the need for data management plans because of the sensitivities related to security, privacy, data provenance and data quality. As a result many agencies now require a data management plan as part of the proposal process to assess and determine funding or as a condition of award. The quality of the data management plan can benefit timelines, make better use of resources and improve data quality and in addition reveal the skills and expertise of an organization’s chain of custody procedures as it relates to data.
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 orientationwill be held via webcast one week prior to course start to discuss technology needs and course expectations.
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
Beginner to intermediate CDMs with experience in outlining and documenting clinical data management activities.
Anita Walden has a background in Clinical Research Data Management in Academic, Pharmaceutical and Contract Research Organizations. She has managed national and international clinical trial databases for over 25 studies along with serving as a project facilitator for developing international therapeutic data standards. Currently, she is a trainer for data management and informatics and servers on the SCDM Education and eTask force committees.
$1020 members/$1140 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.
SCDM is authorized by IACET to offer 2.0 CEUs for this program to participants who have successfully passed all assignements with at least 80%.