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…
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.
Clinical Research Regulations and Guidelines
ICH GCP Overview
The Principles of ICH GCP
Investigator qualifications, agreements
Medical care of trial subjects
Communication with IEC
Compliance with protocol
Randomization procedures and unblinding
Informed Consent of trial subjects
Records and reports
Progress and final reports
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.
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
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
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
The course highlights those GCP areas that we know are always problematic and we explain how to face them
We try to avoid common occurrences during clinical trials conduct that may have a negative impact on the study subjects and/or data
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:
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.
So, you have questions? Let us try to answer those for you...
This is what you'll get: