Clinical Research Interview Questions and Answers PDF Download 2023

If you want to get job in the Medical Field specially in Clinical Research, you have to face an interview where interviewer ask varieties of questions regarding your previous jobs and field specific questions. They will evaluate your overall abilities in terms of knowledge, skill sets, proficiencies so, it is very important to prepare well before the Interview.

This post provides you some Clinical Research Questions with Answers that are frequently asked in the interview round by interviewer. Check out the complete post to get an idea about questions and write your feedback or suggestions in the comment section below.

Useful for

These questions are very useful for those students or aspirants who are willing to get job as

  • Clinical Trial Coordinators
  • Clinical Trail Assistant
  • Clinical Research Associate
  • TMF (Trial Master Files) Specialist
  • Clinical Document Specialist

Clinical Research Interview Tips

Aspirants can follow these tips to improve their interview experience and distinguish themselves as a valuable candidate in the interview round for Clinical Research:

  • Be Punctual with time, it shows your professionalism and time management skills to the interviewer, if you arrive on time.
  • Do not hesitate while answering the interviewer: when your answer them confidently and convey your answers clearly, it reflects that your have a good communication skills.
  • Try to answer in industry-Specific language: Use any Specific Language of the particular industry to describe your answers also you can take the industry related examples to support your answers.
  • Deep Research on the company: Candidate must have done deep research on the company before submitting the job application form. Interviewers can also ask some questions on previous data and statistics of the company.
  • Use the STAR method: STAR stands for SituationTaskActionResult, it is an very effective method to demonstrate your efficiency while answering the Interviewer, with the help of this method candidates can create clear, concise and informative responses to the interviewer.

Clinical Research Interview Questions and Answers

Question 01: What is eTMF?

Answer :- It is an repository in which all the Clinical Trial document get archived in electronic format.

  • Help in eliminating cost related with paper document storage
  • help in real time tracking of TMF at any location
  • increase audit and inspection readiness
  • increase speeding of study start up and closeout activity.

Question 02: What is ALCOA?

Answer :- It is an tool to achieve Good documentation practice

  • Attributable: Information of who is taking data must be recorded
  • Legible: As retention period up to 5-15 years till that Document must be readable.
  • Contemporaneous: Data should be recorded, signed, dated in real time
  • Original: Any sticky notes, medical notes must be retained
  • Accurate: Honest and accurate representation of data describing conduct of study.

Question 03: What is ICH GCP?

Answer :- International council for Harmonization of technical requirement for pharmaceutical for Human use. ICH GCP (E6 R2) version used 4 guidelines: (QSEM)

  • Q for – Quality
  • S for – Safety
  • E for – Efficacy
  • M for – Multidisciplinary

Question 04: What is IRB/IEC?

Answer :- It is an committee which ensure protection of right, safety and well being of human subject.

Composition (IRB/IEC): 5-7 member

  • 1-2 medical scientists
  • 1-2 clinician
  • 1 Legal expert
  • 1 Social scientist
  • 1 lay person,1 philosopher

Question 05: Tell us Some important health authority names.

Answer :-

  • India: Director general of India (DCGI)
  • India: Control drug standard control organization (CDSCO)
  • Europe: European medicine agency (EMEA)
  • Japan: Ministry of health, labor and welfare (MHLW)
  • USA-Food and drug administration (FDA)
  • Canada: Health Canada

Question 06: What is HIPAA?

Answer :- HIPAA stands for Health Insurance portability and accountability act and its purpose is to maintain and protect confidentiality of human participant.

Question 07: Which CFR rule regulate electronic records?

Answer :- 21 CFR part 11 regulate electronic record and electronic signatures.

Question 08:- What are the List of documents that are collected during SIV List?

Answer :-

  • FDA 1572 form
  • Financial disclosure form
  • Protocol and protocol signature page
  • Investigator brochure and IB signature page
  • Duty Delegation log and site training log
  • Training certificate,medical license of site personnel
  • Document related with IRB Application, approval and membership

Question 09: What are the List of documents that collected during site closeout visit?

Answer :-

  • Inventory log
  • On site destruction form
  • IRB IEC final report
  • Accountability log
  • Duty Delegation log and site training log
  • Shipping record

Question 10: What is essential record?

Answer :- Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.

Example: Protocol, IB, Informed consent, Duty Delegation log, Site training log, 1572 form, financial disclosure

Question 11: What is Investigator Brochure?

Answer :- A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects

Question 12: What is Patient identifiable information?

Answer :-

  • As the name implies PII is any data that can identify person
  • Example: Name and address of human participant
  • DOB and address, fax and telephone number.

Question 13: What is 1572 FDA form?

Answer :- 1572 form is an agreement made by PI with sponsor so that PI need to share required trial related information with Sponsor and also assure that trial activity at site conducted in compliant with FDA rules and regulations

Question 14: What is Research Protocol?

Answer :- A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.

Question 15: What is Informed consent?

Answer :- JA A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.

Question 16: In which condition HIPAA allow disclosure of Patient identifiable information?

Answer :-

  • When Disclosure is required by law.
  • In case of abuse, neglect or domestic violence
  • For public health activity(in case of severe side effect)

Question 17: Who are standing member Regulatory member of ICH?

Answer :-

  • Canada (Helath Canada)
  • Swiss-medic (Switzerland)

Question 18: Who are founding regulatory member of ICH?

  • Europe (EMEA)
  • United states (FDA)

Question 19: What is Investigator site file (ISF)?

Answer :- Investigator site file contain minimum list of essential document that need to be maintained throughout Clinical trial.

Question 20: What is Financial Disclosure form?

Answer :- Financial disclosure form is an form from which one can come to know whether any person that are interested in study has any financial interest in Pharma Company or not.

Clinical Research Interview Questions PPT | Clinical Research Interview Questions for Freshers PDF

Get access to the Clinical research Interview Questions and Answers in which more than 50 Questions are given with detailed answers. Also, some unanswered question are given at the bottom section of the PDF for practice.

NOTE: If you need more study material like Syllabus, Previous Year Question Papers, Handwritten Notes, Printed Notes, Mock Tests, Practice Questions & Answers, or anything else regarding your exam then leave 📌 your demand or queries in the Comment Section below.

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