Top Clinical Research Interview Questions & Answers | Clinoxy

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Clinical research involves studying medicines, medical devices, and treatments in humans to ensure they are safe and effective.

A clinical trial is a type of clinical research where new drugs or treatments are tested on volunteers to check their safety and efficacy.

• Phase I: Tests safety in healthy volunteers.
• Phase II: Tests effectiveness in patients.
• Phase III: Confirms results on a large group.
• Phase IV: Conducted after marketing to monitor long-term effects.

GCP (Good Clinical Practice) is an international ethical and scientific quality standard for designing, conducting, and reporting clinical trials.

It ensures participants understand the purpose, risks, and benefits of a study before agreeing to join.

It’s a document that contains all known information about the investigational drug, including preclinical and clinical data.

A CRF is used to record data from each trial participant as per the study protocol.

A CRF is used to record data from each trial participant as per the study protocol.

A CRA monitors clinical trials, ensuring they follow GCP, protocol, and regulatory requirements.

It stands for International Council for Harmonisation – Good Clinical Practice. It provides global standards for ethical and scientific quality.

SAE (Serious Adverse Event) is any untoward medical occurrence that results in death, hospitalization, or disability.

AE (Adverse Event) is any unwanted effect experienced by a participant during a trial, not necessarily caused by the drug.

Randomization is assigning participants to treatment groups by chance to eliminate bias.

Blinding means keeping participants or investigators unaware of which treatment is being given to avoid bias.

A placebo is an inactive substance used to compare the effects of the actual drug.

SOP (Standard Operating Procedure) is a written document describing standard processes for performing tasks consistently.

It involves collecting, cleaning, and validating data to ensure accuracy and reliability.

• Efficacy: How well a drug works under controlled conditions.
• Effectiveness: How well it works in real-world use.

The PI is the person responsible for conducting and overseeing the clinical trial at a site.

Monitoring ensures that the trial is conducted according to the protocol, GCP, and regulatory requirements.

Monitoring ensures that the trial is conducted according to the protocol, GCP, and regulatory requirements.

• Audit: Internal process by the sponsor.
• Inspection: Conducted by regulatory authorities like DCGI, FDA, or EMA.

Original documents or records from which data are collected (e.g., patient medical reports).

It is the process of checking the accuracy and consistency of data entered into the database.

A group that ensures the rights, safety, and well-being of trial participants are protected.

They define who can or cannot participate in a clinical trial.

They ensure drugs and trials meet safety, efficacy, and ethical standards before approval.

A sponsor initiates, manages, and finances the clinical trial.

When a procedure or action in a trial is not followed as per the approved protocol.

Because it helps improve healthcare by developing new and better treatments while ensuring patient safety.