Investigator

An investigator, also known as an investigator or clinical investigator, is responsible for conducting a clinical study at a study center. An investigator or clinical investigator has to implement a study according to GCP and in compliance with the AMG and has many obligations to fulfil.

Each study center has a principal investigator (Clinical Investigator) who is responsible for the legally compliant implementation of the study. He is responsible for the training of the other investigators and study nurses, communicates with the sponsor and the ethics committees and, in particular, ensures the protection of the patient. According to the AMG, an investigator must be a licensed physician and, in the case of interventional studies according to the AMG, must also be able to demonstrate qualifications. These qualifications are proven by GCP training or GCP certificates and are also presented to the ethics committees before the start of the study. Further qualifications required relate to knowledge of the investigational product, monitoring and auditing.

The investigator must demonstrate sufficient resources of the trial site in terms of suitable patients, time, and technical and personnel matters. Patient care and other patient rights, including under trial conditions, must be assured. In addition to patient care, the investigator also assumes responsibility for obtaining a positive ethics opinion prior to the start of the trial and also ensures the preparation of reports (e.g. annual report, final report). As a rule, the clinical investigator prepares the protocol or drafts it together with the Clinical Research Organisation.

Furthermore, the investigator is responsible for patient recruitment and thus also signs the written consent to the study and the data protection declaration, e.g. also personally after patient education. The investigator is also responsible for the timely, complete and correct documentation of patient data in the CRF (Case Report Form). The Clinical Investigator must also guarantee the correct archiving of the study documents for at least 10 (or 15-max. 30) years.

Finally, the investigator is always responsible for safety (pharmacovigilance) in the clinic and is responsible for reporting a Serious Adverse Event (SAE) to the sponsor and, if necessary, to the BfArM.

The individual obligations are usually stipulated in the contract - some of the services listed here are initially obligations of the sponsor and are often transferred to the investigator (principal investigator) of a centre or to a Clinical Research Organisation.