Clinical Research Associate 1 Interview Questions and Answers

SAE stands for Serious Adverse Event. SAE reporting timelines vary depending on the severity and type of event.

• SAE refers to any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.

• SAEs must be reported within specific timelines as per regulatory requirements.

• For example, in the United ...read more

SAE stands for Serious Adverse Event. SAE reporting timelines vary depending on the severity of the event.

• SAE refers to any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

• SAEs must be reported to the appropriate regulatory authorities and ethics committees within a specified timeframe...read more

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

• GCP stands for Good Clinical Practice

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

• They cover various aspects such as trial design, conduct, monitoring, auditing, and reporting

• Adherence to GCP guidelines is mandatory for all clinical trials involving human subjects