CONDUCT A SUCCESSFUL CLINICAL TRIAL JUST GOT EASIER…

You’re Just Seconds Away From The Essential GCP Training & Advice

“ICH Good Clinical Practice (GCP) E6 (R2) for Investigators and Clinical Research staff”

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...

Who should join the course?
Anyone who wants to elevate their GCP knowledge, including but not limited to the following professionals:
  • 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
Everyone involved in the conduct of clinical research must be competent to perform their tasks, qualified by education, training and experience. This training course addresses the GCP aspects of this requirement.
It doesn’t matter if you are completely new to GCP. No prior GCP knowledge is necessary to participate in this course.
How long do I have to access to the course?
You can work through the course modules at your own pace. The course will remain available online for you for 6 months after your registration.
How is the course structured?
The course is made up of four learning modules consisting of narrated video tutorials.
Some of the modules contain downloadable attachments that aim to complement the learning process.
How long does it take to complete the four modules?
This depends on how much time you have to spend each day on watching the videos. The total duration of the course videos is 4 hours.
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.
Am I required to complete the four modules?
Yes, all four modules make up the required GCP training. The learners need to follow the pre-established modules order, not being allowed to progress to the following section of the course until they have completed the previous one.
Will I obtain a GCP Certificate?
Once you complete all the course modules you will be requested to take an online exam which consists of multiple-choice questions. A GCP certificate is issued once a minimum of 80% is achieved in the final quiz. The quiz can be taken multiple times until you pass with a satisfactory score.
Corporate licenses?
Multi-user licenses for corporate use are also available, please contact us for prices and further information. The larger the group, the better the price.

If there's anything at all that you're not certain about, anything we haven't made clear; any concerns or questions then please do contact us at and we'll help you out.

JOIN NOW TO SECURE THIS SPECIAL COURSE PRICE

 
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This is what you'll get:

  • 4 Modules & 12 Submodules
  • 15+ Explanation Videos
  • Certificate of Course Completion
  • ...and more!
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