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| Ask about our onsite seminars for your corporation. We will bring all the necessary training materials to you. Call 877-633-3322 for more information. |
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140-HR CRA Certificate Program
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Part 1: Online with text-book and regulatory CD-ROM provided. |
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Part 2: Two weeks hands on training with competency and regulatory exams. |
Fundamentals of Clinical Research, an interactive program providing online and
classroom training for the clinical research professional, begins with the
history of legislation and regulations that govern clinical research and an
overview of drug, biologic, and device development. Course participants develop
a thorough knowledge base of Good Clinical Practices and International
Conference of Harmonization guidelines (E6, E2A), gaining a solid understanding
of clinical trial development and management.
The Part 2 classroom training focuses on developing a
systematic approach to monitoring, conflict resolution, and problem solving. The
participants monitor 6 study subjects and 3 regulatory binders across two study
types. Writing effective and professional monitoring reports is also addressed.
During the review and discussion of GCP issues, the instructor highlights the
differences between device and drug/biologic studies.
Payment Schedule:
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$1,995 required for Part 1; this provides
the applicant with access to the online course. Course textbook and materials
sent via express mail; |
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$1,500 is due on, or prior to the Part 2 â??Trainingâ?? starting date. |
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