THAT´S WHAT INSPIRED US TO DEVELOP THIS GCP COURSE
We were tired of facing the same GCP non-compliances when conducting investigator site audits and hosting regulatory inspections, due to inefficient training in GCP, that was:
Not designed to increase the research site’s understanding of GCP requirements…
Lacking details on how to implement GCP requirements on the daily site’s activities…
Missing awareness of the impact of GCP non-compliances on the clinical trial subjects’ safety and trial data…
Thankfully, all of that is behind you...
INTRODUCING THE GCP COURSE
A course designed not only for investigators and site staff but also its content is key for CRAs, Clinical Operations staff, Clinical QA, and Regulatory Affairs departments.
This training course will help professionals, whether currently active in clinical research or planning to be involved, to understand their GCP roles and to manage a GCP compliance clinical trial.
The learners will receive practical information regarding key elements such as informed consent, investigational products handling, safety reporting and trial specific documentation, including data integrity key principles and Electronic Health Records (EHR) systems expectations.
Lesson | Topic |
Module 1 | Clinical Research Regulations and Guidelines |
Module 2 | ICH GCP Overview |
Module 3 | The Principles of ICH GCP |
Module 4 | Investigator’s Responsibilities |
4.1 | Investigator qualifications, agreements |
4.2 | Adequate resources |
4.3 | Medical care of trial subjects |
4.4 | Communication with IEC |
4.5 | Compliance with protocol |
4.6 | Investigational Product(s) |
4.7 | Randomization procedures and unblinding |
4.8 | Informed Consent of trial subjects |
4.9 | Records and reports |
4.10 | Progress and final reports |
4.11 | Safety reporting |
4.12 | Premature termination or suspension of a trial |
This training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
THIS GCP COURSE WILL HELP YOU TO:
Comprehend the key ICH-GCP requirements and regulatory expectations regarding conduct of clinical trials
Understand the responsibilities of an investigator/ investigator team within clinical trials
Know what, why and how clinical trial activities are to be performed and documented
Learn about the quality issues affecting clinical research
Identify commonly seen GCP deficiencies and learn how to improve compliance in your site/organization
Be inspection ready
WHAT MAKES THIS GCP COURSE DIFFERENT?
Expertise
Years of GCP Auditing and Clinical Quality Assurance experience have been incorporated into this course aiming to provide practical advice to clinical research professionals based on expert interpretation of GCP regulations
Practical Advice
Our focus is not only on summarizing the ICH GCP key sections and interpret them, but we also include explanations of other applicable regulatory requirements and/or accepted standard practices surrounding GCP that are not always covered in this type of trainings
Focused On Key Areas
The course highlights those GCP areas that we know are always problematic and we explain how to face them
Committed To Successful Trials
We try to avoid common occurrences during clinical trials conduct that may have a negative impact on the study subjects and/or data
NOT SURE YET WHETHER THIS GCP COURSE IS FOR YOU?
This GCP course is NOT for everyone, and we prefer to help you figure it out before you register rather than wasting your time and money
If your main goal is to attend a quick GCP course to obtain a GCP certificate but you are not interested in learning and improving your performance, this course is not for you
You can get a good feel for exactly what the content is and how much it offers with this video:
MEET THE TRAINER
The course was designed and written by Dr Leire Zúñiga with the input from recognized clinical research professionals worldwide.
Dr Leire Zúñiga is the Founding Director and Principal GCP Consultant of Pharmity.
Leire has worked in the Pharmaceutical, Biotech and CRO industries since 2003 within Quality Assurance.
Just before moving to the consulting area and setting up Pharmity, Leire worked as a Senior Quality Assurance Manager in one of the largest CROs working as part of a global compliance team for internal and external clients worldwide.
During her professional career Leire has developed an in-depth knowledge in Quality Assurance, having conducted GxP and CSV audits across the globe.
The training course was recorded by one of the Pharmity’s native English speaker collaborators.
FREQUENTLY ASKED QUESTIONS
So, you have questions? Let us try to answer those for you...
- Investigators
- Study-Coordinators
- Study-Nurses
- Clinical Trials Pharmacists
- Clinical Research Associates
- Clinical Operations staff overseeing clinical sites
- Clinical Quality Assurance Professionals
- GCP Regulatory Affairs Professionals
It doesn’t matter if you are completely new to GCP. No prior GCP knowledge is necessary to participate in this course.
Some of the modules contain downloadable attachments that aim to complement the learning process.
We recommend watching two/four videos a day, and then assimilate the main concepts explained and think how you can apply them to your daily clinical trial activities. Following this advice, it will take one week to complete the course.
JOIN NOW TO SECURE THIS SPECIAL COURSE PRICE
Get Instant Access to the Course!
This is what you'll get:
- 4 Modules & 12 Submodules
- 15+ Explanation Videos
- Certificate of Course Completion
- ...and more!
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