What Do Cras Do
A Clinical Research Associate (Cra) Is a Health Care or Life Sciences Professional Who Oversees Clinical Trials on Behalf of Pharmaceutical Companies, Medical...
A clinical research associate (CRA) is a health care or life sciences professional who oversees clinical trials on behalf of pharmaceutical companies, medical research institutes and government agencies.
What are the activities conducted by a CRA at the site during the monitoring visit?
CONDUCTING THE SITE MONITORING VISIT During a monitoring visit, the CRA will review specific data and regulatory documents related to the clinical protocol, as described in this section, and verify signed consent forms for each study subject.
What is the purpose of a site initiation visit?
These visits have several goals: to orient and train staff on the protocol and study related processes; to confirm readiness for study implementation; and to identify additional requirements that must be satisfied prior to site activation and subject recruitment.