Interview preparation questions are invaluable tools for individuals seeking a career in clinical research. In this third part, we continue to explore the importance of interview preparation questions and how they can enhance your chances of success in the clinical research field. Demonstrate knowledge and expertise: Interview preparation questions help you showcase your knowledge and expertise in clinical research. By familiarizing yourself with common questions, you can articulate your understanding of key concepts, methodologies, regulations, and ethical considerations relevant to the field. This demonstrates your commitment to staying informed and up-to-date, and it impresses interviewers. Develop confidence and clarity: Answering interview preparation questions helps you develop confidence and clarity in expressing your thoughts and ideas. Through practice, you become more comfortable discussing your experiences, skills, and accomplishments, which enhances your ability to communicate effectively during the actual interview. Confidence and clarity are vital in making a positive impression on potential employers. Address complex scenarios: Clinical research often involves dealing with complex scenarios and ethical dilemmas. Interview preparation questions provide an opportunity to think critically and formulate well-reasoned responses to hypothetical situations. This allows you to demonstrate your problem-solving abilities, ethical decision-making skills, and adaptability to challenging circumstances. Highlight relevant experiences: Interview preparation questions prompt you to reflect on your past experiences and identify those that are most relevant to the clinical research position you are pursuing. This enables you to craft compelling and specific examples of your achievements, responsibilities, and contributions. By aligning your experiences with the requirements of the role, you increase your chances of standing out as a qualified candidate. Anticipate and prepare for specific questions: By familiarizing yourself with common interview questions in clinical research, you can anticipate what interviewers may ask and tailor your responses accordingly. This preparation enables you to emphasize your strengths, address any potential gaps or concerns, and provide well-structured and thoughtful answers. It helps you approach the interview with a strategic mindset.

1. Interview Preparation
Questions
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CLINICAL RESEARCH
PART-3
By Dr. K. Supriya
030/022023
Pharm-D

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What is Audit trial?
21
What is Good Clinical Practice (GCP)?
1 What is Case Study Report (CSR)?
22
What is Contract research organization?
23
What is Legally Acceptable Representative?
24
What is Impartial witness?
25
What is Essential Document?
26
What is Good Clinical Practice (GCP)?
27
What is Good Clinical Practice (GCP)?
28
Who is Investigator?
What is Randomization?
29
What is Monitoring?
What is Source document?
30
INDEX

3. What is Audit trail?
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Documentation that allows reconstruction of the course of
events.
Audit trails (or audit logs) act as record-keepers that
document evidence of certain events, procedures or
operations, so their purpose is to reduce fraud, material
errors, and unauthorized use.

4. What is Case study report(CSR)?
 A printed, optical, or electronic document designed to
record all of the protocol required information to be
reported to the sponsor on each trial subject.
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5. What is Contract research organization?
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Definition:A person or an organization (commercial,
academic, or other) contracted by the sponsor to perform
one or more of a sponsor's trial-related duties and
functions.
The main role of the CRO is to plan, coordinate, execute,
and supervise the processes involved in the development
of a clinical trial, being a central contact point between the
sponsor and other trial actors (e.g. ethics committees,
regulatory agencies, vendors, and hospitals).

6. What is Legally acceptable representative?
• An individual or juridical or other body authorized under
applicable law to consent, on behalf of a prospective
subject, to the subject's participation in the clinical trial.
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7. Impartial witness?
• A person, who is independent of the trial, who cannot be unfairly
influenced by people involved with the trial, who attends the
informed consent process if the subject or the subject’s legally
acceptable representative cannot read, and who reads the informed
consent form and any other written information supplied to the
subject.
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8. What is Essential document?
Essential Documents are those documents which individually and
collectively permit evaluation of the conduct of a trial and the
quality of the data produced. These documents serve to
demonstrate the compliance of the investigator, sponsor and
monitor with the standards of Good Clinical Practice and with all
applicable regulatory requirements.
 Essential Documents are classified into 3 different types:
 Before start of CT
 During the conduct of CT
 After the conduct of CT
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9. Who is Investigator?
 A person responsible for the conduct of the clinical trial at a trial site. If a
trial is conducted by a team of individuals at a trial site, the investigator is
the responsible leader of the team and may be called the principal
investigator.
Investigator’s Responsibilities
 Investigator’s Qualifications and Agreements
 Adequate Resources
 Medical care of Trial subjects
 Communication with IRB/IEC
 Compliance with protocol
 Investigational product
 Informed consent of Trial subjects
 Records and Reports
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10. What is Monitoring?
• The act of overseeing the progress of a clinical trial, and of
ensuring that it is conducted, recorded, and reported in
accordance with the protocol, Standard Operating Procedures
(SOPs), Good Clinical Practice (GCP), and the applicable regulatory
requirements.
• Monitor acts as main line of communication between sponsor and
investigator.
• At least 3 Monitoring visits:
Before start of the trial
During the trial
After the trial
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11. What is Randomization?
• Randomly assigning subjects to the treatment group based on element of
chance is called Randomization.
• Randomization is done to avoid bias.
Types of randomization
 Simple randomization: In simple randomization, the subjects are randomly
allocated to experiment/intervention groups based on a constant probability.
The advantage is that it eliminates selection bias.
 Block randomization: In block randomization, the subjects of similar
characteristics are classified into blocks. The aim of block randomization is to
balance the number of subjects allocated to each experiment/intervention
group.
 Stratified randomization: In stratified randomization, the subjects are
defined based on certain strata, which are covariates.
The advantage with this methodology is that it enables comparability between
experiment/intervention groups and thus makes result analysis more
efficient.
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12. What is source document?
 Original records or documents which shows the evidence
about methods and evaluation of results. (e.g., hospital
records, clinical and office charts, laboratory notes,
memoranda, subjects diaries or evaluation checklists,
pharmacy dispensing records, recorded data from automated
instruments, copies or transcriptions certified after verification
as being accurate copies, microfiches, photographic negatives,
microfilm or magnetic media, x-rays, subject files, and records
kept at the pharmacy, at the laboratories and at medico-
technical departments involved in the clinical trial).
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