Demonstrate your competency in GCP-related matters with Pharmaca's Good Clinical Practice Web Test for the Swedish Market!
This GCP web test meets the criteria for ICH GCP E6 training and meets the competency requirements for clinical trials in TransCelerate BioPharma member companies. When you pass the test, you will get a certificate in Swedish with which you can demonstrate your competence.
With the Swedish GCP web test and its source materials, you will gain a broad understanding of GCP issues. In the source materials you will find e.g., regulations and laws governing clinical trials in Sweden, the terminology of clinical trials, and the responsibilities of different kinds of professionals.
Want to take the test for the Finnish market? Read more here: GCP Web test for the Finnish Market.
The online test is suitable for anyone working in clinical trials, especially in the Swedish operating environment:
- Pharmaceutical industry clinical trial management, research managers, and CRAs
- Representatives of CROs
- Healthcare professionals such as researchers, research nurses and coordinators
- Industry authorities
- Healthcare ICT actors and those working in health technology and device research
- Patient organizations
In this training
- You will learn the key terminology of clinical trials
- You will learn what the roles, responsibilities, and obligations of different kinds of professionals are
- You will familiarize yourself with examples of good and effective ways to work in clinical trials
- You will acquire information about the regulations and laws governing clinical trials
Web Test is based on the following documents
- ICH Guideline for Good Clinical Practice E6 (R2, Step 5)
- Helsingforsdeklarationen (Declaration of Helsinki)
- Lag (2003:460) om etikprövning av forskning som avser människor
- Läkemedelslag (2015:315)
- Läkemedelsverkets föreskrifter (LVFS 2011:19) om kliniska läkemedelsprövningar på människor (inklusive ändringsföreskrifter 2016:10 och 2019:40)
TransCelerate BioPharma Mutual Recognition
This ICH E6 GCP Investigator Site 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.
Registration and price
The price of the online test is 190 € (+ VAT). The completion time is 31 days from registration.
Request an offer for unlimited organization access or a larger group here.
After registration, you will receive a confirmation email with instructions of logging in to e-learning environment (pharmacademia.com) with personal user account. Before taking the test, it is important to familiarize yourself with the source materials in the e-learning environment.
The test is in Swedish and consists of 38 multiple-choice questions, which take a total of about 1–2 hours to answer. You need 80 % of the maximum score to pass the test. Those who pass the test can print or save a certificate in Swedish. Pharmaca Health Intelligence Ltd keeps a record of those who passed the test.
The price includes
- Instructions and materials in electronic form
- One retake opportunity
- Printable certificate of passing the test
Please read the change and cancellation terms before registering under: Instructions for participants. Pharmaca reserves the right to make changes to the course.
We have expanded the registration features and sped up the invoice processing. In this training, you can use card payment and make a group registrations. When using the promotional code, please check that the final price is correct. If you chose an invoice as the payment option, it will be generated automatically based on the information you provide. Please also add the PO number when registering. Please use the company search on the form as a priority.