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, the study nurses, is often neglected.

Thereby it is well-known that the quality of study sites often depends on the excellent work of study nurses/study coordinators. Study nurses/study coordinators perform diversified and important tasks in the organisation and administration of clinical trials. Moreover they are responsible for assisting the investigator in communicating with and caring 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 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 recent years.

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

1. Development of pharmaceuticals & medical devices
2. The Declaration of Helsinki & GCP Guidelines
3. GCP definitions and important documents
4. Investigator responsibilities part 1
5. Investigator responsibilities part 2 / sponsor responsibility & Audits
6. Documentation and quality control of study data

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 1-6. 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 six questionnaires have not been answered correctly, the online training must be restarted.