Product description
This course explains the basics of compliance and audits in clinical research in a clear and simple way.
It covers important topics like site audits, sponsor responsibilities, SOPs, electronic records and signatures, and conflict of interest. You will learn how audits are conducted and what regulators expect. The course also highlights common mistakes and how to avoid them.
It helps you understand how to maintain data accuracy and protect patient safety. Overall, it prepares you to handle audits and inspections with confidence.
Product content
- Welcome to the Course 'Compliance and Audits'
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Announcements
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Course Discussion Forum
- Chapter 1 - Site Audit and Overview
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Tutorial - Site Audit and Overview
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Assessment (C1-SAO)
- Chapter 2 - Sponsor Compliance and Audit
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Tutorial - Sponsor Compliance and Audit
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Assessment (C2-SCA)
- Chapter 3 - Standard Operating Procedures (SOP) in Clinical Research
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Tutorial - Standard Operating Procedures (SOP) in Clinical Research
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Assessment (C3-SOPCR)
- Chapter 4 - Electronic Records and Signatures
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Tutorial - Electronic Records and Signatures
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Assessment (C4-ERS)
- Chapter 5 - Conflict of Interest
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Tutorial - Conflict of Interest
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Assessment (C5-COI)
- Course Completion
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Final Assessment
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Certificate of Completion - CAA
