Content and Objective of the Course

The conduct of clinical studies on humans can only be justified if these are ethically appropriately planned, accomplished, evaluated and reported scientifically. In the field of clinical research, national laws, international guidelines and their implementation have been under continuous development in the past few years. It is important that all persons involved in a clinical study comply with these regulations and quality standards to obtain reliable study results.

The objective of this training is to provide competence in legal, ethical, and administrative as well as scientific aspects of a clinical trial.

The advantage of this online training is the extendibility, accessibility, and suitability. Users can proceed through a training program at their own pace and at their own place. They can also access the training at any time within 2 months. The online training is always up-to-date. The training presentations are always updated according to new regulations. The online training has been accredited by the Medical Association of Bremen. 16 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 by the GCP-Service team using its many years of practical experience. The training content serves as practical guide and clarifies ordinary issues and misunderstandings which have been developed during the recent years. The biometric module was created with assistance of Prof. Dr. Dr. Jürgen Timm and Mr. Werner Wosniok of the Competence Centre for Clinical Trials Bremen. It ensures that non-statisticians understand the approach of different study designs and the principle of sample size calculation.

The online training consists of eight modules, each lasting approx. 60 minutes:

1. Introduction: Development of drugs and medical devices
2. Basics of biometrics: different study designs and sample size calculation
3. The declaration of Helsinki and the GCP guidelines
4. GCP definitions/important GCP documents
5. Investigator responsibilities part 1
6. Investigator responsibilities part 2/Sponsor responsibilities/Audits
7. Inspections and the reporting of safety-related events
8. Current legislations & regulations on clinical trials in Europe - Regulation (EU) No 536/2014 (Clinical Trials Regulation - CTR), GDPR, Directive 2001/83/EC

The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approx. 45 minutes followed by a multiple choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approx. 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. Three test repeats are possible after which the attendee must start from the beginning. The individual modules can only be processed in the order of module 1-8. After completing all modules and tests, the attendees can download and print the training certificate independently. The certificate contains all topics required by the Ethics Committee and competent authorities to prove the qualification of clinical research staff according to ICH GCP.

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