GCP Training & Certification.

Get trained and certified at your convenience.

• PharmaGCP’s basic GCP online training/course is cost-effective with high quality – easy to understand and interactive.
  
  

  We have a very high examination passing score due to our clear training materials including tests during the training. Here are some of the feedbacks from our students:  “Thank you for the effective training. My GCP knowledge helped me a lot of when seeking jobs in clinical trials.” from a candidate in medicinal chemistry, Denmark – “The training was interactive and relevant, especially the tests.” from a life science company, Denmark – “I could take the training modules when it suited me and I liked the tests and examination with many good questions and case stories.” from an investigator, Hungary

• The training materials in pdf format contain all essential topics of Good Clinical Practice (GCP).
• The quiz includes both questions and interesting case stories from clinical trials in practice.
• You will  get a clear overview of different activities at the sponsor and at the trial site before, during and after a clinical trial.
• The training includes some of the aspects from the updated ICH GCP E6 (R2) 2016 (~ GCP addendum) as relevant for basic level.
• This basic GCP course is relevant for all roles within the conduct of clinical trials, for example trial manager, monitor, clinical trial associate, data manager, statistician, medical writer, safety adviser, regulatory, clinical trial supply manager.

The training consists of 7 modules. There are quiz after each module to test your understanding of the training materials. There is explanation when your answer is wrong.

Module 1: GCP history and 13 principles

Module 2: Institutional Review Board (IRB)/Independent Ethics Committee (IEC) – responsibilities, composition, functions and operations, procedures and records

Module 3: Investigator’s qualifications and responsibilities for subject protection and medical care, trial conduct and data handling

Module 4: Sponsor’s responsibilities before, during and after the trial.

Module 5: Monitoring – Planning, Conducting and Documenting

Module 6: Handling of Adverse Events – Identification, Assessment and Reporting of AE

Module 7: Handling of Investigational Medicinal Products (IMP) – How to handle IMP at the sponsor and at the trial site

In order to get the basic GCP certificate, you need to pass the examination. See further details below.

*TransCelerate is a non-profit organization with a mission to collaborate across the biopharmaceutical research and development community to identify, prioritize, design and facilitate the implementation of solutions to drive efficient, effective and high-quality delivery of new medicines, improving the health of people around the world.

The examination covers all essential topics of ICH GCP.

Some of the answers are either mentioned in the training materials or in ICH GCP. During the examination, it is allowed to use ICH GCP, training materials and other relevant documents, as the examination should reflect a real-life situation, where it is possible to seek information in relevant documents if in doubt.

The examination comprises of 20 questions; 16 of them are multiple choices (3 point each) and 4 of them are essay (13 points each).

The examination will take approximately 2 hours.

You will get feedback on your exam within 1-2 weeks. You need to pass 60% (= 60 points) in order to get your certificate, which will be sent to you by email.

With PharmaGCP certificate (TransCelerate approved), you will have a certification of basic competence in Clinical Research and GCP.

Exam fee is 85 Euro.

Link to ICH GCP E6 (R2)

https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf

You can always book us for a face-to-face GCP training for groups of people. The training will be tailored to the specific needs.

The advanced GCP training and refresher GCP workshop are for experienced clinical research staff who:

• have previously completed basic GCP training
• have recent practical experience of working in a clinical research environment
• and have a good understanding of the principles and quality standards of GCP and related frameworks.

PharmaGCP trainers have many years’ experience in clinical research such as GCP inspector, auditor, clinical quality assurance, monitoring, safety reporting and trial conduct.