Announcing the latest addition to the GCP Central online course offerings: Expert ICH GCP Course for Sponsors in International Clinical Trials.
Our newest course is based on the Sponsors’ responsibilities, as documented in Section 5 of ICH GCP E6(R2). Explicitly covering the regulations for international clinical trials in ICH regions, this course is designed for clinical research professionals who initiate and monitor clinical trials. It is specifically for those who need to be aware of the sponsor responsibilities as laid down in the new Section 5 of the Good Clinical Practice guidelines applicable to clinical research with human subjects.
Our GCP Course for Sponsors
Our course offers tailor-made online training for Sponsors, designed with your specific ICH-GCP needs in mind. It consists of 6 online modules and covers the information you need for your unique role within clinical trials, from the design phase to closing and archiving.
The new section 5 of ICH GCP E6(R2) on the sponsors’ responsibilities and quality management takes up a central part. You’ll learn about the obligations you are subject to due to the required risk-based quality management approach, as well as the requirements for trial management and data handling.
After completing the expert ICH GCP course for Sponsors, you’ll be up to date on regulatory issues. You will know how to work with the test centers but also how to align your in-house processes.
The Essential Content in Detail
When taking our course, you don’t have to learn the content that isn’t relevant to you. It is designed explicitly for Sponsors, CRA’s, research coordinators, and initiating investigators to give you the knowledge and tools needed to initiate clinical research in ICH regions.
It translates the GCP framework to practice, and you’ll leave with the necessary know-how that can be directly implemented into your daily practice.
You’ll specifically learn about:
- the principles and background of ICH-GCP
- the responsibilities of the Sponsor according to section 5 of ICH-GCP in all stages of the trial
- the ethical and scientific quality standards that lead to reliable trial results
- quality management, internal quality controls, and quality assurance during the trial set-up
- the Sponsor’s involvement in gathering data and preparing documents to submit to the IRB/IEC, the reviewing committee
- the ethical review that happens before the first subject entering a trial
- the Sponsor’s role during the trial including monitoring the quality of the conduct of the trial, IP Management, Safety, and quality controls
- the requirements for closing the trial and archiving
It’ll take you 4 hours to complete the full expert course. Afterward, you’ll be up to date on regulatory issues and receive updates for the duration of your 12-month membership to myGCP. This means you’ll be able to keep up to date on any changes and be compliant for a full year after completing the course. Additionally, you will also receive your qualifying GCP certificate for compliance and inspection readiness.
Our Recognized Training and Learning Method
Our self-paced online course is designed with the busy research professional in mind. It allows 24/7 online learning flexibility and gives you the vital GCP knowledge to be directly implemented into your daily practice. The myGCP app offers easy access to the GCP training via smartphone, tablet, or desktop and can be completed on the go in your own time.
This course also complements the Expert ICH GCP for Investigators, fulfilling TransCelerate Biopharma’s minimum requirements for GCP Training for Investigators. TransCelerate recognition means that member organizations will recognize your current, compliant GCP certificate. No more repeating training to prove your compliance. Your training moves with you, from position to a new position.
You can also access your GCP certificate from the app dashboard, meaning that proof of compliance is with you all the time.
Take the next step
Learn everything you need to know to master ICH GCP’s Sponsor responsibilities for International Clinical trials via this highly interactive, self-paced, and certified GCP e-learning course. Visit the website and start your training today.