CRA-Basic-Training

Content and Objective of the Course

One of the most important and impactful tools of quality control in clinical studies is Clinical Monitoring. Clinical Monitoring is performed by clinical monitors or Clinical Research Associates (CRAs). Given how crucial clinical monitoring is to clinical research, there are a lot of career prospects in this field. There is a constant need to train people with a scientific and/or pharmaceutical background to become CRAs. However, being a CRA entails more than simply comprehending science and medicine. It also calls for a fundamental knowledge of regulations, the law, and finances. Soft skills like the handling of complex social interactions and cultural differences, time management, and communication skills are also important for a successful career as a CRA.

We recommend participating in this training to everyone with a scientific or pharmaceutical background who has an interest in the field of clinical research and monitoring to get an actual and thorough overview of your workplace as a CRA. This training was created by experts with more than 17 years of experience in clinical research, clinical monitoring, and project management. It covers a lot of useful information that CRAs should be familiar with and utilize on a regular basis. All topics are explained in detail and supported by exercises and questions. Anyone who wants to learn more about what a monitor does prior to, during, and following a clinical study is advised to attend the CRA-Basic-Training. We suggest doing our GCP-Basic-Training and ISO14155-Basic-Training in addition to the CRA-Basic-Training if you would also like to gain a general understanding of the legal requirements of a clinical trial.

Instructions for Participants and General Conditions

The online training consists of five modules, each lasting approximately 60 minutes:

1. Efficient Clinical Monitoring – Start-up Phase – Part 1
2. Efficient Clinical Monitoring – Start-up Phase – Part 2
3. Efficient Clinical Monitoring – During and After the Study – Part 1
4. Practical Exercise: The Source Data Verification
5. Efficient Clinical Monitoring – During and After the Study – Part 2

The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approximately 60 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 1-5. The attendees can download and print the training certificate themselves after finishing all courses and assessments.

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