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.
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.
The course is held in English but is also available in Swedish.
Training objective
To understand how GCP regulates the various stages of a clinical drug trial.
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
Course completion and certificate
After registration, you will have 6 months to complete the training. The training will take 1-3 hours to complete, depending on your prior knowledge. When all parts of the training are marked complete, you will be able to download a certificate. Please note, it is only possible to download the certificate during the 6 month access period.
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.”
Participation fee and registration
Single license: SEK 2,600 per license
Group license for 10–40 persons: SEK 1,950 per license (choose the option ”multiple enrolments” when registering. The booking confirmation will show the regular price of SEK 2,600 per license, but the price is adjusted to SEK 1,950 per license before the invoice is sent out.)
When purchasing more than 40 licenses, please contact Lena Mårtensson, lena.martensson@lakemedelsakademin.se
Please complete your course registration by clicking on the yellow button located in the upper right corner. Once payment is processed, you will have access to the course for a duration of 6 months.
Contact
For questions about the content, please contact
Samira Blombäck, samira.blomback@lakemedelsakademin.se and for practical questions: Jenny Hagberg, jenny.hagberg@lakemedelsakademin.se
Inlägget GCP and clinical trials – from study start to end dök först upp på Läkemedelsakademin.