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The GCP Challenge

IS NOW AVAILABLE!
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Program
About the course

We’re thrilled to introduce The GCP Challenge – a groundbreaking GCP training program available now! Designed by auditors

and QA professionals who know the complexities of the field, this course goes beyond traditional learning. Instead, it provides engaging, practical experiences that mirror the real-life challenges clinical researchers encounter every day.

Our course is fully accessible on a user-friendly platform that also works seamlessly on mobile devices as an app, allowing

you to learn from anywhere – whether in the office, at home, or on the go.

The target audience for the course includes:

  • Experienced GCP-certified specialists: Those who have previously been certified in GCP and require re-certification to maintain compliance.
  • Clinical Research Associates (CRAs), Clinical Investigators, Study Coordinators, and QA professionals: Specialists responsible for ensuring that clinical trials are conducted ethically and in accordance with GCP guidelines.
  • Clinical Project Managers: Leaders who oversee trial operations and need up-to-date certification to ensure their projects comply with regulatory standards.
What can you expect from our course?
  • Interactive Learning
    Dive into 6 hours of self-paced gameplay designed to immerse you in realistic scenarios. You’ll navigate challenges and make decisions that mimic the complexities of clinical trials, helping you develop essential problem-solving skills
  • Engaging Content
    Explore a variety of real situations through case studies, cartoons, and quizzes that make learning both fun and effective
  • Expert Insights
    Participate in a live Q&A session with our rotating panel of GCP experts. Each month, you'll have the opportunity to learn from different champions in the field, gaining diverse perspectives and insights that keep you well-informed
  • TransCelerate Mutually Recognized GCP Certificate
    Upon completion of the course, you will receive a GCP certificate recognized by TransCelerate, demonstrating your commitment to quality and excellence in clinical research

Join us on this exciting journey toward mastering GCP with training crafted by experts who understand the industry’s challenges. Accessible anytime, anywhere – we can’t wait to see you thrive!

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COURSE CONTENTS
1
Interaction with IEC / IRB / RA - dos and don'ts
2
Informed Consent
3
IMP handling
4
Source documents/Source Data
5
CRF and study database
6
Investigator Site File (ISF) and Trial Master File (TMF)
7
Biosamples handling
8
Protocol Adherence/ Protocol Deviations
9
IT and Computer System Validation (CSV) for dummies
10
Safety Reporting
11
Oversight, monitoring and auditing
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This course is the perfect way to refresh your GCP skills while subscribing to our platform for a full year! With the subscription,

you will receive:


  • The GCP Challenge updated with upcoming GCP R3 at no extra cost!
  • Monthly expert-led webinars, offering updates, Q&A sessions, and insights into inspection and audit findings
Prices
Full Access Package:
€180 per person
€300

(VAT inclusive)


Includes:

  • Full access to the GCP Challenge content for one year
  • Monthly Webinar Series: The Challenges of GCP
Buy
Course-Only Package:
€150 per person
€250

(VAT inclusive)


Includes:

  • Full access to the GCP Challenge content for one year
  • Excludes Monthly Webinar Series
Buy
Webinar-Only Package:
€30 per person
€50

(VAT inclusive)


Includes:

  • Access to the monthly Webinar Series: The Challenges of GCP for one year
Buy
The Challenges of GCP Webinar Session №1: Principal Investigator
(PI) Replacement in Clinical Trials
Testimonials