GCP - Good Clinical Practice

Free of cost

by funding

Good Clinical Practice" refers to internationally recognized rules for the conduct of clinical trials. The course uses the ICH-GCP quality standard to impart regulatory knowledge, practical skills and the basics of artificial intelligence (AI) in this area.
  • Certificates: GCP - Good Clinical Practice" certificate
  • Examination: Practical project work with final presentation
  • Teaching Times: Full-time
    Monday to Friday from 8:30 a.m. to 3:35 p.m. (in weeks with public holidays from 8:30 a.m. to 5:10 p.m.)
  • Language of Instruction: German
  • Duration: 4 Weeks

Introduction and definitions (approx. 2 days)

Medical basics and terminology

Legal, regulatory and ethical framework conditions

Planning and organization of studies

Forms of studies, study methodology

Application to an ethics committee


GCP definitions/important GCP documents (approx. 3 days)

Legal basis and regulations in clinical research

National and international principles of pharmaceutical law/ICH-GCP

Declaration of Helsinki

ICH-GCP E6 (R2) regulations


Artificial intelligence (AI) in the work process

Presentation of specific AI technologies

and possible applications in the professional environment


Introduction to clinical trials (approx. 4 days)

Resource planning

Distribution of tasks in the team

Investigator contract

Relevant documents: protocol, investigator's brochure, information, CRF, etc.

Responsibilities (sponsor, CRO, monitor, investigator)


Introduction to the processes of clinical data management (approx. 3 days)

Electronic recording, plausibility check and coding of study data


Medical statistics and biometrics (approx. 1 day)

Basic statistical concepts

Data management

Database management


Audits/inspections (approx. 2 days)

Informing study participants; §40 and 41 AMG

Documentation and reporting of adverse events

Adverse events: Definitions, reporting channels, reporting deadlines

Quality management of clinical trials


Completion of the clinical trial (approx. 2 days)

Close Out Visit

Archiving and final study reports


Project work (approx. 3 days)

To consolidate the content learned

Presentation of the project results



Changes are possible. The course content is updated regularly.

You master the legal, ethical and administrative aspects of GCP as well as the specialist knowledge of clinical trials from planning to statistical evaluation.

Science learners, math learners, IT learners, medical learners and people from medical-technical professions.

Professional knowledge and consistent adherence to prescribed standards are required to ensure high quality in clinical trials. With these newly acquired skills, you will be in high demand in the pharmaceutical industry or at a contract research organization.

Didactic concept

Your lecturers are highly qualified both professionally and didactically and will teach you from the first to the last day (no self-study system).

You will learn in effective small groups. The courses usually consist of 6 to 25 participants. The general lessons are supplemented by numerous practical exercises in all course modules. The practice phase is an important part of the course, as it is during this time that you process what you have just learned and gain confidence and routine in its application. The final section of the course involves a project, a case study or a final exam.

 

Virtual classroom alfaview®

Lessons take place using modern alfaview® video technology - either from the comfort of your own home or at our premises at Bildungszentrum. The entire course can see each other face-to-face via alfaview®, communicate with each other in lip-sync voice quality and work on joint projects. Of course, you can also see and talk to your connected trainers live at any time and you will be taught by your lecturers in real time for the entire duration of the course. The lessons are not e-learning, but real live face-to-face lessons via video technology.

 

The courses at alfatraining are funded by Agentur für Arbeit and are certified in accordance with the AZAV approval regulation. When submitting a Bildungsgutscheinor Aktivierungs- und Vermittlungsgutschein, the entire course costs are usually covered by your funding body.
Funding is also possible via Europäischen Sozialfonds (ESF), Deutsche Rentenversicherung (DRV) or regional funding programs. As a regular soldier, you have the option of attending further training courses via Berufsförderungsdienst (BFD). Companies can also have their employees qualified via funding from Agentur für Arbeit (Qualifizierungschancengesetz).

We will gladly advise you free of charge. 0800 3456-500 Mon. - Fri. from 8 am to 5 pm
free of charge from all German networks.
Contact
We will gladly advise you free of charge. 0800 3456-500 Mon. - Fri. from 8 am to 5 pm free of charge from all German networks.