Interview Question Series: Clinical Research

The interview question series on clinical research is important for several reasons:

Assessment of Knowledge and Experience: The series allows the interviewer to evaluate the candidate's knowledge and expertise in clinical research. By asking specific questions related to study protocols, GCP guidelines, data management, and participant safety, the interviewer can assess the candidate's depth of understanding and practical experience in the field.

Evaluation of Skills and Competencies: Clinical research requires a range of skills, such as attention to detail, problem-solving, communication, and adherence to ethical standards. Through the interview questions, the interviewer can gauge the candidate's proficiency in these areas and determine their suitability for the role.

Compliance with Regulations and Guidelines: Clinical research is governed by strict regulations and guidelines to protect the rights and safety of study participants and ensure the integrity of the data. By posing questions on GCP compliance, ethical considerations, and regulatory requirements, the interviewer can ascertain the candidate's understanding of these crucial aspects and their ability to adhere to them.

Assessment of Critical Thinking and Decision-Making: The interview questions can assess the candidate's ability to think critically and make informed decisions in various scenarios. Questions that prompt candidates to discuss challenges faced in clinical research projects and how they resolved them provide insight into their problem-solving skills and their capacity to handle real-world situations.

1. www.clinosol.com 1 CLINICAL RESEARCH INTERVIEW QUESTION SERIES B. Rajeshwari Pharm D Presented by 1 PART

2. www.clinosol.com 9 I N D E X

3. www.clinosol.com 5 1. What is New Drug Application (NDA)? Explain. New Drug Application (NDA) is an application submitted to US FDA or concerned Regulatory Authorities of the country containing Clinical and non clinical data or analysis reports along with drug chemistry information The NDA provides enough information to permit FDA reviews to reach S afety, Efficacy and quality for pharmaceutical production. It is a critical component in drug approval process

4. www.clinosol.com 6 2. What is Abbreviated New Drug Application (ANDA)? An abbreviated new drug application (ANDA) is an application for us generic drug approval for the an existing licensed medication or approved drug. It s termed as abbreviated because they generally not required to include preclinical and clinical data to establish safety and effectiveness. ANDA was approved if the generic was bioequivalent to original product

5. www.clinosol.com 6 3 . Drug safety is conducted in which phase of clinical trial? Safety of drug is conducted in Phase 0 Phase I Phase II Phase III

6. www.clinosol.com 6 4. What is the importance of ICF (Informed Consent Form) in a clinical trial? Informed Consent is 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 subjects decision to participate. Importance: the informed consent promotes the rights of patient as autonomous to ensure that they are treated with justice, beneficence and respect Neglecting its importance can lead to unethical behavior and loss of patient rights

7. www.clinosol.com 6 5. Define Protocol and its importance in clinical trials? Protocol: A document that describes the objective, design, methodology , statistical considerations and organization of a trial. Importance: The protocol usually gives the background and rationale for the trial. It ensures the safety of the trial subjects and integrity of the data collected.

8. www.clinosol.com 6 6. What is vulnerable subject? How do you differ vulnerable subjects from subjects? Vulnerable subjects: I ndividuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples: P atients with incurable diseases, unemployed persons, patients in emergency situations, homeless persons, minors, ethnic minority groups, members of armed forces etc.

9. www.clinosol.com 6 7. What is Nuremberg code? It is a set of research ethics principles for human experimentation set as a result of the subsequent N uremberg trials at the end of the second world war The 10 elements of the code are: Voluntary consent is essential The results of any experiment must be for greater good of society’ Prior experimentation on animals and prior knowledge of the problems Avoidance of unnecessary physical or mental injury Banning of known lethal or disable procedures Degree of risk should benefit risks Adequate facilities should be used to protect subjects Performance of experiments only by qualified persons Participants may freely end the experimentation The experiments must stop if it proves too dangerous

10. www.clinosol.com 6 8. What is cross over design? What are its advantages? Crossover design: A crossover design is a modified randomized block design in which each subject receives each treatment, in succession. For example, subject 1 receives treatment A, then treatment B, then treatment C Advantages: Each subject acts as his or her own control, and that a smaller number of patients are required in comparison to parallel group studies. It removes the inter patient variability from the comparison between treatments

11. www.clinosol.com 6 9. What is parallel study design? A Parallel design, also called a parallel group study, compares two or more treatments. Participants are randomly assigned to either group, treatments are administered, and then results are compared For example when two groups of treatments A and B are gives, so that one group receives only A while another group receives only B. Parallel d esign is more useful for studying conditions which are prone to change over time (pain, acute exacerbations of a disease, remissions)

12. www.clinosol.com 6 10. What is meant by Drug R epurposing? Give an example? Drug Repurposing (DR) also known as D rug Repositioning is a process of identifying new therapeutic uses for old/ existing/ available drugs. It is a effective strategy in discovering or developing drug molecules with new pharmacological/ therapeutic indications. Examples: DRUG ORIGINAL INDICATION NEW INDICATION Aspirin inflammation., pain Antiplatelet Azathioprine Rheumatoid arthritis Renal transplant

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