GCP-Study Nurse-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 years. Within this field, however, continually maintaining the education of study nurses is often neglected despite the fact that study nurses are crucial to clinical trials.

It is notable that the quality of study sites often depends on the work of study nurses and study coordinators. Clinical Research Nurses and study coordinators perform diversified and important tasks in the organization and administration of clinical trials. Moreover, they are responsible for assisting the investigator in communicating with and caring for clinical trials patients.

This training is intended for prospective Clinical Research Nurses and study coordinators who are already experienced but would like to know more about working correctly within clinical trials. To dramatically improve the quality of research data and the effectiveness of conducting clinical trials, investigators should also engage in the ongoing training and motivation of their Clinical Research Nurses and study coordinators.

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 six modules, each lasting approximately 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 approximately 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 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 processed in the order of module 1-6. 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 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.