Content and Objective of the Course

One of the most important and impactful tools of quality control in clinical studies is the so called "Clinical Monitoring". Clinical Monitoring is performed by clinical monitors or Clinical Research Associates (CRAs). Since clinical Monitoring is such an essential component of clinical research the job opportunities in this sector are very high. There is a constant need to train persons with a scientific and/or pharmaceutical background to become CRAs. However, not everyone will become a happy and successful CRA, as the job is not limited to scientific or pharmaceutical knowledge, but it includes regulatory, legal and financial basics as well. Also soft skills like the handling of difficult social interactions and cultural differences, time management, and communication skills are important for an long and successful career as a CRA.

We recommend the participation in this training to everyone with a scientific or pharmaceutical background, who has interest in the field of clinical research and monitoring in particular. Get a real 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 does include lots of practical topics a CRA should know and use on a daily basis. All topics are explained in detail and supported by exercises and questions. The training is suitable for everyone who wants to get an overview of the work of a monitor before, during and after a clinical study. To get an overview of the legal requirements of a clinical study, we recommend our „GCP-Basic-Training“ and our „ISO14155-Basic-Training“.

Instructions for participants and general conditions

The online training consists of five modules, each lasting approx. 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 approx. 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 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 1-5. After completing all modules and tests, the attendees can download and print the training certificate independently.

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.