What is CRA in Life Sciences?
The full name is Clinical Research Assistant, who assists the principal investigator in implementing clinical trials according to the trial protocol and GCP.
The CRA is the main contact person between the sponsor and the investigator. The number of CRAs and the frequency of visits depend on the complexity of the clinical trial and the number of medical institutions involved in the trial. CRAs should have appropriate medical, pharmaceutical, or related professional qualifications and undergo necessary training, be familiar with drug management-related regulations, be familiar with pre-clinical and clinical information about the investigational drug, and clinical trial protocols and related documents.
The purpose of their monitoring is to ensure that the rights of subjects in clinical trials are protected, that the data of trial records and reports are accurate, complete, and correct, and that the trials follow the approved protocols and relevant regulations.
