Prithvi Engineers And Contractors Interview Questions and Answers

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

• Informed consent of participants

• Protection of participant's privacy and confidentiality

• Adherence to the protocol

• Documentation of all data

• Monitoring of the trial

• Reporting of adverse events

• Qualification of investigators

• Maintenance of trial records

• Drug accountability

• Quality assurance and quality control

• Investigator's brochure

• Clinical study report

• Trial ...read more

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

• EMR (Electronic Medical Records)

• EHR (Electronic Health Records)

• CRM (Customer Relationship Management)

• Clinical trial management systems

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

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

Clinical trial phases and guidelines of ICH GCP

• Clinical trial phases: Phase 1, Phase 2, Phase 3, and Phase 4

• ICH GCP guidelines ensure the ethical conduct of clinical trials

• Phase 1 focuses on safety and dosage determination

• Phase 2 evaluates efficacy and side effects in a larger group

• Phase 3 compares the new treatment to standard treatment

• Phase 4 monitors long-term safety and effectiveness post-approval

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

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