Clinical research has been a booming industry for more than two decades in India and across the globe. This sector has played a critical role in introducing new medicines and improving the health status of patients.

India has become a global destination for clinical research and has raised its standard to cure various illnesses and support wellness. The clinical trial is conducted at various affiliated academic medical hospitals and research centers.

In the past 15 years, the clinical research industry has witnessed many transformations requiring specialized resources in overseeing clinical research-related activities. However, one crucial role remains unchanged until now—CLINICAL RESEARCH ASSOCIATE (CRA). CRA plays a critical role in ‘monitoring’ a clinical trial, which includes the—

• rights and well-being of human subjects are protected,
• reported trial data are accurate, complete, and verifiable from source documents, and
• conduct of the trial follows the currently approved protocol/amendment(s), with Good clinical practices (GCP), and with the applicable regulatory requirement(s).

The GCP guideline mentions only those monitors must be trained and have the scientific and/or clinical knowledge required to monitor the trial and that a monitor’s qualifications must be documented.