The Fundamentals of Clinical Data Management

The Fundamentals of Clinical Data Management

Being a successful clinical data manager requires understanding the drug development process, individual clinical trial protocols, and how to analyze data effectively.

This course focuses on learning how to interpret protocols, reference clinical data management documents, design a database, and review and validate study data. Additionally, our instructors will provide a detailed background on the drug approval process, its associated documentation, and an overview of the clinical research industry to view the clinical data management field comprehensively.

Our hands-on course in clinical data management will teach you the skills needed for a clinical data management position.

Who Should Take This Course

At the end of this course, learners will understand the general drug development process, the data management process, and its role in clinical research. Learners will also gain familiarity with data management documents, including data management plans, eCRF specifications, edit check specifications, a DTA, and more. Additionally, learners will understand how to accurately perform data management tasks such as UAT, data review, and data reconciliations.

This is an excellent program for a student or scientist looking to enter the clinical data management industry or a continued learning opportunity for a professional already working in clinical data management.

Duration and Prerequisites

A total of 8-10 weeks are needed to complete this program.

Education and/or Experience

Minimum Graduate-level education with any background, interested to pursue career in CDM. Degree in medical sciences, pharmacy or life sciences is preferred but not a requirement.

Fluent English with a strong grammatical command is essential.

Assessments

There is a quiz at the end of each module, and each learner will get 2 attempts at each quiz. There are 2 major assignments, one on eCRF review and one on edit check testing.

On completion of the course, there will be a final exam. You will receive a certificate upon completion, and your overall course score will be included on the completion certificate.

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