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Clinical
Data Management Certificate
Program Overview
Clinical data management
is an essential component of medical product development. Product
development involves in a complex and methodical process of
evaluating new products in a clinical setting to verify their
effectiveness. Field trials are an integral part of the ever-growing
medical products industry. Clinical Data Managers, Clinical
Trial Coordinators, Regulatory Analysts and Specialists support
or lead the data collection and management process in collaboration
with other product development professionals. The Clinical Data
Management Certificate is designed for students with a degree
in the life sciences (e.g., Nursing, Medical Imaging, Biology).
The certificate program also provides value to information technology
professionals wishing to transition into the clinical trial
and medical device research fields.
Clinical Data Management Certificate
Required Courses
| |
Regulatory
Environment for Medical Devices |
3 |
| |
Fundamentals
of Clinical Trials |
3 |
| |
Clinical Data
Management I |
3 |
| |
Clinical Data
Management II |
3 |
| |
Statistics
in Clinical Trials |
3 |
| |
|
|
| TOTAL
CERTIFICATE HOURS |
15 |
Course Descriptions
Regulatory
Environment for Medical Devices
This course provides
an understanding of the basics into the Food and Drug Administration
(FDA) regulation and compliance with an overview of how the
various activities and positions within a medical device company
are affected by regulations using the FDA as the primary focus.
Topics include the applicable laws and regulations enforced
by the FDA, an introduction to international standards, the
regulations controlling medical device design and development,
the medical device approval process, laboratory and clinical
studies, the introduction to the Quality System Regulations
(QSRs), and the FDA inspection process.
Fundamentals of Clinical Trials
This course provides an overview of the clinical research process,
and it emphasizes topics related to ethical, regulatory and
legal issues. It also covers the overall planning process of
clinical trials regulated by the FDA and European Medicines
Agency (EMEA). This course provides clinical investigators with
an awareness of the tools required to meet the requirements
of data management.
Clinical Data Management I
This is the first course in a two-part series. This introduction
to data management covers key terminology, the data management
life cycle, and good data management practices. It includes
the development of case report forms and source documents, database
security, systems validation. Applicable FDA regulations and
guidelines (Part 11) are referenced, and the documentation necessary
to satisfy the FDA is discussed.
Clinical Data Management II
This is the second course in a two-part series. It covers topics
related to the storage, retrieval, and electronic submissions
of clinical data. It also examines the issues and implications
associated with database setup. Participants have the opportunity
to analyze and discuss real-world examples provided by them
and by the instructor. Since data management relies heavily
on systems and computer applications, the course also discusses
the benefits and challenges of utilizing various systems in
the data management process. Applicable FDA regulations and
guidelines (Part 11) are referenced, and the documentation necessary
to satisfy the FDA is discussed in detail.
Statistics in Clinical Trials
This course covers the essential statistical concepts and terminology
associated with the clinical trials process. It prepares the
non-statistician with an understanding the statistics needed
to analyze clinical trials data. |
