The role of Clinical Research Associates (CRA’s) during events such as protocol deviations, adverse events, and Serious Adverse Events (SAE’s) is discussed. While CRA’s do not report these events, they are responsible for ensuring that the investigator successfully communicates to the Institutional Review Board (IRB).
While CRA’s are not responsible for reporting to the IRB, they are responsible for ensuring that reports are submitted by the investigator.
This video describes useful advertising strategies that do not require IRB (Institutional Review Board) approval. These type of advertisements must not include any details pertaining to any specific study.
Even when IRB approval is not available, advertising through Facebook may still be possible.
For those interested in entering the field of clinical research, you may be interested in this interview I recently conducted with a clinical research coordinator. We discussed being organized, knowing the protocol, how to act professionally, use your people skills effectively, and maintain the study participant’s safety at all times. Also included are important considerations before opening a Site Management Organization (SMO) or a standalone research clinic.