Study Nurse-Online-Training
Content and Objective of the Course
In the field of clinical research national laws and international guidelines have been under continuous development in the past few years. However, the necessary continuing education of a very important group of people within clinical trials is often neglected.
Thereby it is a well-known fact that the quality of study sites is often depending on the excellent work of study nurses/study coordinators. Study nurses/study coordinators have diversified and important tasks in the areas organisation and administration of clinical trials. Moreover they are responsible for assisting the investigator in informing and taking care of patients within clinical trials.
This training is intended for prospective study nurses/study coordinators or for those who are already experienced but would like to know more about working correctly within clinical trials. Moreover investigators should invest in the continuing education and motivation of their study nurses/study coordinators to significantly increase the quality of study data and the efficiency in conducting clinical trials.
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 six modules and each module lasts approx. 60 minutes:
- Development of Pharmaceuticals & Medical Devices
- The Declaration of Helsinki & GCP Guidelines
- GCP definitions and important documents
- Investigator responsibilities part 1
- Investigator responsibilities part 2 / sponsor responsibility & Audits
- Documentation and quality control of study data
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 - 60 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 1-6. After completing all modules and tests the attendees can print the training certificate independently. The certificate contains all topics required by the Ethics Committees 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 six questionnaires are not answered correctly, the online training has to be restarted.
Costs and Registration:
The fee of the online training is 200 € 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
