Developing Data Management Plans
- Orientation Session: TBC
- Pre-Course Activities: TBC
A data management plan (DMP) complements a study protocol by highlighting key areas of emphasis in a study. Before data collection begins, all clinical studies benefit from having a DMP in place to document the relevant conventions for that particular study. A well-designed DMP provides a road map of how to handle data under any foreseeable circumstances and establishes processes for how to deal with unforeseen issues.
The optimal result for a clinical data manager is to provide a study database that is accurate, secure, reliable, and ready for analysis. Many people will be involved in handling data throughout the course of a clinical study, so it is imperative that all parties refer to the DMP for a consistent approach to the processes and guidelines for conducting data management activities.
The DMP is an auditable document often asked for by regulatory inspectors and should be written in a manner that is professional and of high quality. During an audit, the inspectors may also seek to ascertain the degree to which the project team adheres to the processes described in the DMP.
In this course, you will:
- Define key elements in a Data Management Plan.
- Gather and organize information describing the data handling processes used for a clinical trial.
- Describe workflow for electronic and paper data collection, QC 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.
Who should attend
CDMs and others involved in study conduct that will be or are currently responsible for conducting clinical trials.
Experienced data managers can extend their skills in developing effective data management plans and those with less data management experience can gain fundamental data management plan development skills. The course will focus on the components of data management plans and their fundamental elements.
Once enrolled, participants will need a computer with access to the Internet and the ability to print out course materials. Recommended time commitment is 8-10 hours per week to complete each module (1 module = 1 week)
$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 5.0 CEUs for this program to participants who have successfully passed all assignments with at least 80%.