Clinical Research Associate Interview Questions and Answers for Freshers

Pharmacovigilance refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• It involves monitoring and evaluating the safety and efficacy of drugs

• It includes collecting and analyzing data on adverse drug reactions

• It helps in identifying new safety concerns and taking appropriate actions to minimize risks

• It is essential for ensuring patient safety and improving public health

• Exa...read more

ADE stands for Adverse Drug Event, which refers to any harmful or negative reaction caused by a medication or medical device.

• ADEs can range from mild side effects like nausea or dizziness to more severe reactions like anaphylaxis or organ damage.

• ADEs can occur due to a variety of factors, including patient characteristics, medication dosage, and drug interactions.

• Clinical trials and post-marketing surveillance are important for identifying and monitoring ADEs.

• Preventing ADEs ...read more

The 13 principles of ICH GCP are guidelines for conducting clinical trials to ensure the safety and well-being of participants.

• Informed consent must be obtained from all participants

• Risks and benefits must be carefully weighed

• Data must be accurately recorded and reported

• Confidentiality of participant information must be maintained

• Ethical principles must be followed throughout the trial