Description
What you’ll learn
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Understand the ethical considerations and regulatory framework governing clinical research.
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Master the process of study design, protocol development, and informed consent in accordance with regulatory guidelines.
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Gain proficiency in implementing Good Clinical Practice (GCP) guidelines and ensuring compliance throughout the research process.
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Navigate regulatory requirements for conducting clinical trials, including FDA regulations and international standards.
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Learn best practices for data management, record-keeping, and addressing challenges related to informed consent.
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Develop skills in monitoring and reporting clinical trials effectively to maintain data integrity and participant safety.
Welcome to Clinical Trials: GCP, Ethics & Compliance Mastery, a course meticulously designed for professionals looking to deepen their understanding and ensure the highest standards in the world of clinical research.
In this course, you will explore the ethical, regulatory, and practical aspects critical to the successful management of clinical trials.
The course begins with an introduction to the fundamentals of clinical research, providing insights into the roles and responsibilities of various stakeholders, along with an overview of the ethical and regulatory frameworks that guide clinical studies. You will learn about the pivotal aspects of Good Clinical Practice (GCP), which is essential for ensuring patient safety and the integrity of clinical data.
As we dive deeper, you will become adept at designing clinical trials, developing robust study protocols, and mastering the informed consent process. This includes understanding how to effectively communicate with diverse participant populations, addressing ethical challenges, and ensuring participants’ rights and welfare are protected.
The module on regulatory compliance covers vital topics such as FDA regulations, international standards, and how to prepare for audits and inspections. You’ll also gain skills in data management, record-keeping, and understanding the intricacies of monitoring and reporting to maintain adherence to all necessary regulations.
By the end of this course, you will be equipped to implement GCP guidelines confidently, manage clinical research projects efficiently, and navigate the complexities of ethical and regulatory compliance in clinical trials.
Whether you’re a budding clinical researcher or a seasoned professional, this course will enhance your capabilities and help you to contribute effectively to the field of clinical research.
Who this course is for:
- Clinical research coordinators
- Healthcare professionals involved in clinical trials
- Individuals interested in pursuing a career in clinical research
Course content
- Foundations of Clinical Research and Regulatory Framework6 lectures • 1hr 4min
- Foundations of Clinical Research and Regulatory Framework
- Study Design, Protocol Development, and Informed Consent6 lectures • 1hr 10min
- Study Design, Protocol Development, and Informed Consent
- Good Clinical Practice Guidelines and Compliance6 lectures • 59min
- Good Clinical Practice Guidelines and Compliance
- Regulatory Compliance in Clinical Research6 lectures • 1hr 3min
- Regulatory Compliance in Clinical Research
- Data Management, and Record Keeping Challenges6 lectures • 58min
- Data Management, and Record Keeping Challenges
- Monitoring and Reporting in Clinical Trials6 lectures • 1hr
- Monitoring and Reporting in Clinical Trials
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