|Clinical Research Associate (CRA)||Klinischer Monitor|
|Clinical Research Associates (CRAs) or Clinical Monitors are either employees of the sponsor, a CRO or freelancers. On behalf of the sponsor, they monitor the conduct of a clinical trial. Thereby, their main objective is to safeguard the rights and security of the participating patients, the adherence to the study protocol, the conduct in accordance with the applicable regulations, and the collection of data in the study documents.
The responsibilities of a CRA at the study site include monitoring correct data collection via SDV (source data verification), safeguarding compliance with the study protocol, ensuring the presence of essential documents in the study folder, and preparing reports concerning the monitoring visits at the study sites.