Centralized Monitoring Coordinator Interview Questions and Answers

I have knowledge of clinical trial phases, RBM, and documents used in clinical research.

• Clinical trial phases include preclinical, phase 1, phase 2, phase 3, and phase 4.

• Risk-Based Monitoring (RBM) is an approach that focuses on identifying and managing risks in clinical trials.

• Documents used in clinical research include informed consent forms, case report forms, study protocols, and investigator brochures.

The pharmacovigilance regulatory body in India is the Central Drugs Standard Control Organization (CDSCO).

• CDSCO is responsible for regulating the safety, efficacy, and quality of pharmaceuticals in India.

• It oversees the reporting and monitoring of adverse drug reactions (ADRs) in the country.

• CDSCO collaborates with the National Pharmacovigilance Program for monitoring and reporting ADRs.

• It also works closely with the World Health Organization (WHO) for global pharmacovigilanc...read more

GCP guidelines are a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects.

• GCP stands for Good Clinical Practice.

• GCP guidelines ensure the protection of human subjects and the integrity of clinical trial data.

• They provide a framework for the conduct of clinical trials, including the responsibilities of sponsors, investigators, and IRBs.

• Adherence to GCP guidelines is mandatory ...read more