GCP and clinical trials – from study start to end

About the course

Welcome to an introductory e-course on how a clinical trial is conducted at an investigator site in Sweden, and how GCP (Good Clinical Practice) regulates the different steps.

The training meets the TransCelerate minimum criteria for ICH GCP Investigator Site Personnel Training.

E-course – whenever you want

Course Duration
The course takes approximately 1-3 hours to complete, depending on your prior knowledge.

Access to the Course
Direct access upon registration. You will then have 6 months to complete the course.

Course Certificate
Once all modules are marked as complete, you can download a personal course certificate.

Language
English and Swedish

Price
1-4 course licenses: 2 750 SEK excluding VAT per license
For the purchase of 5-10 course licenses, we offer a 15% discount. Use discount code: EKURS15
For booking of larger groups, please contact samira.blomback@lakemedelsakademin.se

Are you purchasing multiple licenses for your company?
If so, we can customize the training with your guidelines and internal information to tailor it to your specific needs.

Book e-course

Who should attend?

The training is suitable for individuals who are either new to working with clinical trials or are considering entering this field, seeking knowledge on the various aspects of a trial and GCP regululations. You can be an investigator, research nurse or other research support staff, or you may work in the pharmaceutical industry, pharmacy, or another field and need knowledge about how clinical trial work is conducted at the clinic.

Please note! This training describes how GCP and clinical trials are conducted at investigator sites in Sweden and is thus not suitable for persons working with clinical trials in other countries.

Training goals

To understand how GCP regulates the various stages of a clinical drug trial.

From our evaluations

Our GCP e-courses have received top ratings – 100% of participants recommend them!

The course provided a clear, step-by-step guide to GCP and included helpful scenarios where we could apply what we learned.

It was nice that the course was divided into clear sections and the information was well-organised, this made it easy to follow.

Very detailed and useful information and knowledge are shared through fun images, conversations, and stories, avoiding dull and lengthy texts.

Course content

Basic principles & concepts

GCP in clinical trial work – before trial start

A request arrives
Contact with the sponsor
Contracts and applications
Delegation and training within the team
Investigator site file
Source data
Planning of the initiation meeting

GCP during the trial

Deviations
Trial start
Recruitment of subjects
Informed consent
Screening and enrollment
Follow-up visits and adverse events

Monitoring

The monitor´s role
The monitor’s work during the visit
Audits and inspections

The investigational treatment continues

The investigational treatment continues according to the protocol
Changes during the course of the trial
Trial close-out, signing and archiving

Subject matter experts

The course has been developed in consultation with experts in the field:

Kajsa Öberg Holgersson, Research Nurse, Sahlgrenska Universitetssjukhuset
Lina Nordahl, Local Trial Manager, The Janssen Pharmaceutical Companies of Johnson & Johnson
Fact-checked by Gunnar Danielsson, former GCP Inspector at the Swedish Medical Products Agency/Läkemedelsverket

Many of the photographs in the course are taken at KPE Oncology Sahlgrenska, photographer Maria Fredriksson

TransCelerate minimum criteria

The training meets the TransCelerate minimum criteria for ICH GCP Investigator Site Personnel Training. ”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.”