clinical research interview preparation

What is clinical research?
Clinical research involves studying human health and illnesses to evaluate the safety, efficacy, and side effects of medical interventions such as drugs, devices, and treatment strategies. The goal is to improve patient outcomes and advance medical science.

What are the phases of clinical trials?

• Phase 1: Tests safety, dosage, and side effects in a small group of healthy volunteers or patients.

• Phase 2: Assesses efficacy and further evaluates safety in a larger group of patients.

• Phase 3: Confirms effectiveness, monitors side effects, and compares the new treatment to standard treatments in large groups.

• Phase 4: Conducted post-marketing to gather long-term safety and effectiveness data.

Why is informed consent important in clinical research?
Informed consent ensures that participants understand the study's purpose, risks, benefits, and procedures. It allows individuals to voluntarily decide whether to participate, respecting their autonomy and rights.

What is Good Clinical Practice (GCP)?
GCP is an international ethical and scientific standard for designing, conducting, and reporting clinical trials. It ensures the safety of participants and the reliability of trial data.

What is the role of a Clinical Research Associate (CRA)?
A CRA monitors clinical trials to ensure they are conducted according to the protocol, GCP guidelines, and regulatory requirements. They oversee site activities, verify data accuracy, and ensure participant safety.

What are the responsibilities of a Clinical Trial Coordinator (CTC)?
A CTC manages the day-to-day operations of a clinical trial at a site, including participant recruitment, scheduling visits, maintaining records, and coordinating with the sponsor and ethics committee.

What skills are essential for a clinical research professional?

• Attention to detail for accurate data collection and documentation.

• Knowledge of regulatory guidelines like ICH-GCP.

• Strong organizational and communication skills to coordinate with multiple stakeholders.

• Ability to analyze and interpret data.

What is the Declaration of Helsinki?
The Declaration of Helsinki is a set of ethical principles for medical research involving human subjects, emphasizing the need to prioritize participant welfare over the interests of science or society.

What is the difference between ICH-GCP and FDA guidelines?

• ICH-GCP: International guidelines for ethical and scientific conduct of clinical trials.

• FDA Guidelines: Specific regulations governing clinical trials in the United States, focusing on safety and efficacy for market approval.

What are essential documents in clinical research?

• Protocol: The study plan detailing objectives, methodology, and procedures.

• Informed Consent Form (ICF): Document ensuring participants' understanding of the study.

• Investigator’s Brochure (IB): Comprehensive information about the investigational product.

• Case Report Forms (CRFs): Forms used to collect trial data.

What is a protocol deviation?
A protocol deviation occurs when the study is not conducted according to the approved protocol. Examples include missed visits or administering the wrong dosage of a drug.

What is a placebo, and why is it used in clinical trials?
A placebo is an inactive substance designed to mimic the investigational product. It is used in trials to provide a comparison for evaluating the treatment's effectiveness.

What is a blinded study?
A blinded study is one in which participants, investigators, or both do not know who is receiving the investigational product or placebo. This minimizes bias in the trial results.

What is a randomized controlled trial (RCT)?
An RCT is a study design where participants are randomly assigned to different treatment groups to reduce bias and ensure the reliability of results.

What is the difference between efficacy and effectiveness?

• Efficacy: Measures how well a treatment works under ideal, controlled conditions (e.g., clinical trials).

• Effectiveness: Assesses how well the treatment works in real-world settings.

What is the role of Data Management in clinical trials?
Clinical data management involves collecting, cleaning, and validating trial data to ensure its accuracy and reliability for statistical analysis.

What are the responsibilities of a Data Safety Monitoring Board (DSMB)?
The DSMB monitors the safety and efficacy of an ongoing clinical trial, reviews interim data, and recommends whether the trial should continue, be modified, or stopped.

What are common challenges in clinical data collection?

• Missing or incomplete data.

• Errors in data entry.

• Variability in data due to differences in interpretation or measurement techniques.

What is the difference between a sponsor and an investigator?

• Sponsor: The organization or individual responsible for initiating, managing, and funding the trial.

• Investigator: The person conducting the trial at a site and ensuring its proper execution.

What is an adverse event (AE)? How is it reported?
An AE is any unwanted medical occurrence in a participant during a trial, regardless of its relation to the investigational product. It is reported in case report forms (CRFs) and forwarded to the ethics committee and regulatory authorities.

What is the difference between a clinical trial and an observational study?

• Clinical Trial: Participants are assigned interventions, and outcomes are actively measured.

• Observational Study: Researchers observe and analyze outcomes without intervening in participants' treatment.

What is a protocol amendment?
A protocol amendment is a change or addition to the approved study protocol, requiring review and approval by the ethics committee before implementation.