Clinical Process Coordinator

Clinical Process Coordinator Interview Questions and Answers

Updated 6 May 2024

Q1. What are 13 principal of GCP

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GCP principles are guidelines for conducting clinical trials. There are 13 principles that ensure ethical and scientific quality.

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I have worked on multiple systems including EMR, EHR, CRM, and clinical trial management systems.

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An adverse event is an unexpected or harmful reaction to a medication, medical device, or treatment.

Adverse events can range from mild to severe and can include side effects, allergic reactions, and medication errors.
They can occur during clinical trials or after a product has been approved and is on the market.
Examples of adverse events include nausea and vomiting from chemotherapy, a severe allergic reaction to a vaccine, or a medication error resulting in an overdose.
Adver...read more

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Serious adverse event is an unexpected, severe, or life-threatening reaction to a medication or medical device.

Serious adverse events are events that result in hospitalization, disability, or death.
They can be caused by medication errors, allergic reactions, or device malfunctions.
Examples include anaphylaxis, stroke, heart attack, and severe infections.
Serious adverse events must be reported to regulatory agencies.
Prevention strategies include proper medication administratio...read more

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Clinical trial phases and guidelines of ICH GCP

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Clinical research is a scientific study of the safety and effectiveness of medical treatments, devices, and interventions on human subjects.

It involves testing new drugs, therapies, and medical devices on human subjects
Clinical research is conducted to determine the safety and efficacy of medical treatments
It is regulated by ethical and legal guidelines to protect the rights and welfare of human subjects
Clinical research is essential for the development of new treatments and ...read more

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Phases of clinical trials include preclinical, phase 1, phase 2, phase 3, and phase 4.

Preclinical phase involves testing on animals and in vitro studies.
Phase 1 involves testing on a small group of healthy volunteers to determine safety and dosage.
Phase 2 involves testing on a larger group of patients to determine efficacy and side effects.
Phase 3 involves testing on an even larger group of patients to confirm efficacy and monitor adverse reactions.
Phase 4 involves post-marke...read more

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ICH-GCP stands for International Conference on Harmonisation - Good Clinical Practice.

ICH-GCP is a set of guidelines for conducting clinical trials on human subjects.
It outlines the ethical and scientific standards that must be followed during the trial.
It covers aspects such as trial design, subject recruitment, informed consent, safety reporting, and data management.
Adherence to ICH-GCP is mandatory for clinical trials conducted in the European Union, Japan, and the United ...read more