Master the Arts & Science of GCP Compliance Clinical Trials

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Rudolf Malle

6:13:05

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1 - Foundations of Clinical Research and Regulatory Framework

1 - Ethical Considerations in Clinical Research.mp4

13:02

2 - Importance of Good Clinical Practice.mp4

09:54

3 - Understanding Regulatory Framework in Clinical Research.mp4

12:27

4 - Roles of Coordinators and Investigators.mp4

10:09

5 - Clinical Trial Success Recruitment Challenges and Retention.mp4

10:38

6 - Quality Assurance in Clinical Research.mp4

08:09

2 - Study Design Protocol Development and Informed Consent

7 - Protocol Development and Key Elements.mp4

10:09

8 - Protocol Amendments and Deviations.mp4

08:26

9 - Overview of Clinical Research Study.mp4

19:33

10 - Understanding Clinical Research Protocols.mp4

10:14

11 - Ensuring Inclusivity and Diversity.mp4

09:17

12 - Essential Documents in Clinical Research.mp4

11:57

3 - Good Clinical Practice Guidelines and Compliance

13 - Good Clinical Practice Guidelines.mp4

07:21

14 - Institutional Review Boards and Ethics Committees.mp4

08:49

15 - FDA Regulations and Guidelines in Clinical Research Conduct.mp4

09:52

16 - ICHGCP Principles.mp4

16:38

17 - GCP Compliance and Quality Assurance.mp4

07:14

18 - GCP Audit and Inspection Understanding the Differences.mp4

09:00

4 - Regulatory Compliance in Clinical Research

19 - Regulatory Affairs in Clinical Research.mp4

09:20

20 - FDA Regulations for Clinical Trials.mp4

08:59

21 - International Regulatory Requirements.mp4

10:41

22 - Protocol Amendments and Clinical Trials.mp4

09:16

23 - Importance of Safety Reporting.mp4

13:43

24 - Safety Reporting and Adverse Events.mp4

10:38

5 - Data Management and Record Keeping Challenges

25 - Clinical Data Management.mp4

07:55

26 - Data Collection in Clinical Research.mp4

18:09

27 - Essential Docs In Clinical Research.mp4

09:42

28 - Electronic Data Capture System in Clinical Research.mp4

07:31

29 - Data Validation and QC in Clinical Research.mp4

06:57

30 - Understanding the Essentials of TMF.mp4

07:35

6 - Monitoring and Reporting in Clinical Trials

31 - Introduction to Clinical Trial Monitoring.mp4

07:45

32 - Clinical Research Monitoring Importance and Actions.mp4

11:42

33 - Understanding the Role of CRC and Investigators.mp4

08:33

34 - Strategies for Ensuring Compliance and Conducting MV.mp4

11:00

35 - Research Monitoring Understanding Roles and Responsibilities.mp4

10:37

36 - Site Selection in Clinical Trials.mp4

10:13

Description

Navigate the complexities of clinical trials with expertise in GCP, ethical practices, and compliance.

What You'll Learn?

Understand the ethical considerations and regulatory framework governing clinical research.
Master the process of study design, protocol development, and informed consent in accordance with regulatory guidelines.
Gain proficiency in implementing Good Clinical Practice (GCP) guidelines and ensuring compliance throughout the research process.
Navigate regulatory requirements for conducting clinical trials, including FDA regulations and international standards.
Learn best practices for data management, record-keeping, and addressing challenges related to informed consent.
Develop skills in monitoring and reporting clinical trials effectively to maintain data integrity and participant safety.

Who is this for?

Clinical research coordinators

Healthcare professionals involved in clinical trials

Individuals interested in pursuing a career in clinical research

What You Need to Know?

Basic understanding of clinical research terminology and processes is beneficial but not mandatory.

More details

Description
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 youâ€™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

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Welcome to the world of clinical research, where expertise and precision lead to breakthroughs in patient care and medical advancements. I’m Rudolf Malle, your guide on this learning journey. With a Master’s Degree in Clinical Research Organization and Management from the Drexel School of Medicine and over 10 years of hands-on experience managing and supervising clinical trials, I bring a wealth of knowledge to our Udemy courses.Throughout my career, I have successfully managed intricate clinical trials across various therapeutic areas including oncology, cardiology, endocrinology, and more. I’ve served in pivotal roles at prestigious institutions such as Dendreon Pharmaceuticals, Northwell Health Medical Center, and Weill Cornell Medical College, handling everything from first-in-human studies to late-stage trials. My expertise spans clinical trial management, protocol development, regulatory compliance, and cross-functional team leadership.Why am I qualified to teach you? Because I've been where you are and understand the complexities of the field from the inside out. I’ve developed over 100 site management and compliance SOPs, coordinated significant research activities across multiple specialties, and contributed to the training and mentorship of clinical research professionals. My hands-on experience with various Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and electronic Trial Master Files (eTMF) ensures that you will learn the practical, applicable skills you need to excel in this field.I’m also a passionate educator who has trained teams, supervised clinical research coordinators, and facilitated community outreach to enhance study awareness and participation. My courses are designed to empower you with the knowledge to manage clinical trials effectively, ensure compliance with global regulations, and ultimately improve patient outcomes.Join me on Udemy to build a strong foundation in clinical research, backed by real-world applications and expert insights. Whether you are starting your career or looking to advance in the field, my courses will equip you with the necessary tools to succeed and lead in the ever-evolving landscape of clinical research.

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