
Learn to apply good clinical practices, GCP E6 Revision 2.0, approved by ICH, including steps and clauses for authorization, and understand evolving processes that ensure subject safety in clinical research.
Explain how ICH harmonises regulatory guidelines to ensure medicine quality, safety, and efficient global drug registration, while connecting producers with regulators via MedDRA and ongoing innovation.
Identify groups working within ICH, including founding regulatory and industry members, and learn ICH efficacy guidelines covering clinical trial process, safety, ethics, and recording and reporting of data.
Define good clinical practice and explain the link between ICH and GCP, including its E6 R2 origin, 1996 guidelines, and 13 principles safeguarding participant safety and trial data credibility.
Discusses ICH GCP E6 R2 guidelines, emphasizing ethical trials, risk-benefit assessment, informed consent, IRB/IEC review, data confidentiality, and GMP-compliant, well-documented protocols.
Understand the IRB/IEC responsibilities under ICH GCP, including record keeping of protocol amendments, consent forms, safety protocols, and investigator qualifications to protect participants and ensure ethical review.
learn how the irb/iec operates under ich gcp, covering team composition, record-keeping, review procedures, and how to handle amendments and incident reporting.
Learn how investigators meet GCP requirements, prove qualifications, manage resources, and safeguard participant safety and ethics throughout clinical trials.
Learn about IRB/IEC approval, consent and protocol requirements, deviations, randomization, and informed consent, with a focus on records, safety reporting, and final trial termination.
The sponsor implements a risk-based quality management system to ensure consistent trial design, data collection, and processing, with qualified personnel and CRO support to safeguard subject safety.
Explore ICH GCP clauses 5.10 to 5.23, detailing sponsor responsibilities for regulatory approval, investigational product handling, safety reporting, monitoring, audits, and multicenter trial requirements.
Explore the clinical trial protocol structure, including title, amendments, sponsors, investigators, and investigational product details, plus trial design, endpoints, randomization, blinding, and regulatory compliance.
Examine ICH GCP clauses 6.5–6.16, including subject selection, treatment details, safety reporting, efficacy assessment, and trial statistics to safeguard volunteers and study data.
Explore the investigator brochure core contents for human trials, including confidential handling, product identity, clinical and non-clinical data, pharmacology, pharmacokinetics, safety, and international marketing status across countries.
Summarize how essential documents and master files support planning, conduct, and post-trial closure in good clinical practice, detailing investigator, sponsor, IRB approvals, informed consent, and protocol amendments.
Discover a practical, organizational-level approach to risk management using ISO 31,000 frameworks, guided by Faizan, with strategies to elevate risk practices across your organization.
ISO 31000 defines risk as the effect of uncertainty on objectives, and risk management guides projects through opportunities and threats by considering probability and impact.
Understand why we take risks to pursue rewards and how to manage risk with calculated, minimal exposure. We will compare risk and issue in the next lesson.
Differentiate between risk and issue: risk is a future threat, issue is a problem already realized, tracked in risk and issue registers.
Clarify the difference and similarities between risk appetite and risk tolerance, illustrating appetite as willingness to risk to reach objectives and tolerance as the maximum loss the organization can bear.
Risk management is a coordinated process to direct and control an organization in risky situations, recognizing, evaluating, and prioritizing risks to minimize threats and maximize opportunities.
Make informed decisions based on data and risk prioritization, reducing surprises, and allocating resources effectively while reassuring stakeholders, as risk management spans finance, medical facilities, military, space science, and it.
***Why this course is considered as a TOP RATED and BEST SELLING course for the ICH GCP category on Udemy?***
See what students are talking about in this course:
5***** Star Rating
I’m very glad I enrolled in this class! There’s so much information to be absorbed and she did a great job in presenting everything in as much detail as possible, but at the same time simplifying it to make your learning experience a lot smoother. This is a great course if you’re just starting out and want to know the fundamentals of GCP. This master class has it all!
---Devon Roman
5***** Star Rating
She is a great instructor, very transparent, cuts out all the BS getting straight to the meat and potatoes of the subject at hand, exactly how I like to learn.
I am happy about investing in this course. The videos are over the shoulder at the right pace explaining the process of understanding the clauses.
The course has left me feeling confident that I can achieve my goals, plus I had so much fun learning.
If you create any more courses, you have a repeat customer in me.
--- Rebecca
5***** Star Rating
Very well constructed course covering all the topics I was interested in. Really liked the step-by-step approach and tasks broken into manageable chunks, allowing me to absorb the information. The tutor was great, the notes were very helpful and I made a lot of use of the Quizzes and Assignments section.
Highly recommend the course for either a beginner or someone with some experience but a bit rusty (such as me).
--- Reshma
5***** Star Rating
She is an amazing teacher, the best I could find so far. She is knowledgeable, explains very well, has a nice and soothing voice, and has a great sense of presentation.
The course is also more hands-on than a lot of other courses where you practically just watch guys read. She explains clauses practically who ICH GCP E6 document.
If you want to learn and understand GCP or clinical research in general, this is a great place to start.
--- Varun P
5***** Star Rating
This is an excellent, cost-effective, and comprehensive course and I'm so glad to enroll in the class. Plus, I've learned so much from the basics that have been taught. I'm so grateful to have the instructor spending time to develop this course and share knowledge. Again, thanks, and this course is highly recommended!
--- Dennis Clayton
5***** Star Rating
The content was helpful and this was a nice quick review.
--- Ayesha A. Rizvi, Ed.D.
5***** Star Rating
The information is explained in a detailed manner
--- Monique Brown
5***** Star Rating
Bravo
--- Tshering JAMTSHO
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COMPLETE COURSE DESCRIPTION:
Welcome to the complete ICH Good Clinical Practices E6 R2 course.
In this course, we will learn what Good clinical practices are, guidelines of what an ethical and safe trial is, the rights and importance of consent of the trial subjects, the duties of the sponsor and investigator of the trial, and much more. Basically, I will walk you through the entire GCP guidelines document step by step.
My name is Warda Naz, and I will be leading you through this course.
Here at Magine Solutions highly experienced instructors, engineers, and doctors with more than 10 years of experience in the industry will guide you through very high-quality online courses.
At the end of the course, you will be able to understand
What is International Council for harmonization?
Aims of ICH
How was ICH established?
The importance of ICH.
Groups working within ICH
Efficacy Guidelines
What are Good clinical Practices (GCP)?
The link between ICH and GCP
All about the Institutional review board, investigators, sponsors, clinical trial protocol and protocol amendment, investigator’s brochure, essential documents for the conduct of a clinical trial, and much more.
We will also learn to understand these concepts by looking at case studies to strengthen the theoretical concepts.
The ideal student for this course is anyone who wants to learn about the ICH GCP E6 document or an existing professional who wants to expand on their current skills. There are no requirements necessary to enroll. I only ask to come open-minded and ready to learn.
Feel free to take a look at the course description and I look forward to seeing you inside. Thank you!!
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