GCP-Refresher-Training

Content and Objective of the Course

Clinical trials on humans can only be justified if they are planned, carried out, assessed, and reported scientifically in accordance with ethical standards. In the field of clinical research, national laws, international guidelines, and their implementation have been under continuous development in the past few years. Therefore, it is important that all persons involved in a clinical study comply with these regulations and quality standards. This way, obtaining reliable study results can be assured.

The objective of this training is to equip participants with the knowledge necessary to competently handle the administrative, legal, and ethical elements of clinical trials. With the GCP Refresher Training you can renew your GCP certification on a regular basis. The training provides you with all recent regulatory updates in the EU.

The flexibility, adaptability, and accessibility of this online training are its advantages. Users can complete a training program at their own speed and location. Additionally, they have two months to access the training at any time. The online training is always up to date according to new regulations.

The online training has been accredited by the Medical Association of Bremen. 8 Continuing Medical Education points (CME) have been assigned.

Instructions for Participants and General Conditions

The content of this training was compiled by Dr. Andreas Grund based on his 18 years of experience in clinical trials and prepared with the experience and expertise of the GCP-Service team. The training content serves as a practical guide and clarifies widespread issues and misunderstandings that have come up in the recent past.

The online training consists of four modules, each lasting approximately 60 minutes:

The Declaration of Helsinki and the GCP Guidelines

Investigator Responsibilities – part 1

Investigator Responsibilities – part 2 /Sponsor responsibilities/ Audits

Current Legislations & Regulations on Clinical Trials in Europe

The modules are continuously updated in accordance with the current legal regulations and trends (no liability assumed). Each module consists of a presentation of approximately 60 minutes followed by a multiple-choice test which must be passed. The test consists of 15 questions which are randomly generated from a pool of 40 questions and takes approximately 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. After three test runs, the participant must start from the beginning. The individual modules can only be completed in the order of module 1-4. The attendees can download and print the training certificate themselves after finishing all courses and assessments. The certificate contains all topics required by the Ethics Committee and competent authorities to demonstrate the clinical research staff’s compliance with ICH GCP qualifications.

All training modules within a course must be completed within two months. If the two-month period has expired and the four questionnaires have not been answered correctly, the online training must be restarted.

Accredited by: Medical Association of Bremen