GCP-Online-Training
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. 8 Continuing Medical Education points (CME) have been assigned.
Instructions for Attendees and General Conditions:
The content of this training was compiled by Dr. Andreas Grund based on his 14 years of experience in clinical trials. This content of the training course has been prepared by the GCP-Service team based on many years of practical experience. It should serve as practical guide and clarify ordinary issues and misunderstandings which have been developed during the last 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 and each module lasts approx. 60 minutes:
- Introduction: Development of drugs and medical devices
- Basics of biometrics: different study designs and sample size calculation
- The declaration of Helsinki and the GCP guidelines
- GCP definitions/important GCP documents
- Investigator responsibilities part 1
- Investigator responsibilities part 2/Sponsor responsibilities/Audits
- Inspections and the reporting of safety-related events
- Current legislations & regulations on clinical trials in Europe
The modules will be continuously updated and we try to keep it updated to the most current legal regulations and trends (no liability assumed). Each module consists of a video presentation that takes approx. 45 minutes. Afterwards a multiple choice test needs to be passed. The test consists of 15 questions that will be generated randomly from a pool of 40 questions. After each test the attendees will get a new randomized set of 15 questions. 80% of the questions need to be answered correctly to pass the test. 3 test repeats are possible before the attendee needs to start again from the beginning.The answering of the questions takes approx. 15-20 minutes. The individual modules can only be processed in the order of module 1-8. After completing all modules and tests the attendees can 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.
The entire training has to be done within two months. If the period has expired and the eight questionnaires are not answered correctly, the online training has to be restarted.
Costs and Registration:
The fee of the online training is 350 € plus 19% VAT (for non German persons with a VAT ID number no VAT will be charged). 10 € will be donated to UNICEF. In 2010 we donated 3000 Euro. We also like to offer different discounts to our clients.
After registration you will receive the username, password and the invoice. These login data are valid for two months. During this period you can pass the training modules and tests at any time. After two months your login data will expire.
Is your computer ready for our online training? Read the System Requirements.
For more information, please contact us at
onlinetraining@gcp-service.eu
