I created this questionnaire with answers to often asked questions in clinical trial interviews because if you are chosen for an interview at any organization and you are not prepared for the interview, you may not succeed.
1. What is Drug ?
Answer: A Drug is a chemical API (Active Pharmaceuticals Ingredients) that is used to identify, treat, prevent, cure, or Reduce the symptoms of an illness. It could be a biological material, a chemical compound, or both.
2. What is Dosage Form ?
Answer: A dosage form is the physical form—tablets, capsules, syrups, injections, or creams—that a patient receives their API Drug in. It establishes the delivery route as well as the pace of drug absorption and distribution within the body.
3. Difference between drug and dosage form ?
Answer: A dosage form is the particular physical form or formulation in which the drug is produced for patient administration, whereas a drug refers to the active pharmaceutical ingredient (API) or therapeutic component.
4. How important is drug development and discovery?
Answer: The identification, manufacturing, and testing of novel pharmaceuticals for therapeutic use are the results of the critical processes of drug discovery and development in the pharmaceutical business. Improving patient outcomes, solving unmet medical needs, and furthering medical science all depend on this process.
5. Methods of Drug Discovery and Development?
Answer: Target and lead compound identification, preclinical testing, clinical trials, formulation development, regulatory approval, and post-market surveillance are some of the Methods used in drug discovery and development.
6. What is Pre-clinical Trials?
Answer: Prior to human testing, prospective medication candidates undergo pre-clinical studies in laboratories to evaluate their pharmacological characteristics, safety, and efficacy. To assess the drug’s impact on biological systems, this involves toxicity research, animal testing, and in vitro investigations.
7. What is IND?
Answer: A novel drug candidate’s information and proposed schedule for human clinical trials are included in an IND, or investigational new drug, filing to the FDA or other appropriate regulatory body.
8. Clinical Trials 4 phases in detail?
Answer: Clinical studies are divided into four stages:
- Phase I: Evaluate dose and safety in a small sample of volunteers who are in good health.
- Phase II: Assess safety and effectiveness in a broader patient population suffering from the intended ailment.
- Phase III: Verify effectiveness and track side effects in a more extensive and varied patient group.
- Phase IV: Post-marketing surveillance to track the medication’s efficacy and safety in practical applications
9. What is NDA?
Answer: The FDA (or any appropriate regulatory body) receives New Drug Applications (NDAs), which are regulatory submissions that request permission to market a new drug in the US.
10. What is ANDA?
Answer: A regulatory submission to the FDA for the licensing of generic pharmaceuticals based on bioequivalence studies compared to a reference listed drug is known as an ANDA, or abbreviated new drug application.
11. Definition of GCP?
Answer: Good Clinical Practice, or GCP for short, is a global standard for the planning, execution, documentation, and reporting of clinical trials involving human subjects. It is a scientific and ethical quality standard.
12. Definition of ICH-GCP?
The International Council for Harmonization (ICH) created a set of guidelines known as ICH-GCP, or International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice, to standardize the conduct of clinical trials worldwide.
13. What are Principles of ICH GCP?
The ethical behavior, scientific integrity, regulatory compliance, safeguarding the rights and welfare of human subjects, and the accuracy and dependability of clinical trial data are among the ICH-GCP’s guiding principles.
14. What is a Protocol?
A protocol is a comprehensive plan that describes the goals, structure, methods, and procedures of a clinical trial. It offers direction to sponsors and investigators regarding the conduct of the trial and acts as a template for the study.
15. Important Components of a Protocol?
The study objectives, patient eligibility requirements, study design, treatment plan, outcomes, statistical analysis strategy, study procedures, and ethical considerations are all crucial parts of a protocol.
16. What is an Adverse Event?
Any unfavorable medical event that occurs in a patient or clinical trial participant who is given a pharmaceutical product but does not necessarily have a direct link to the treatment is considered an adverse event.
17. What is SAE?
The term “Serious Adverse Event,” or SAE for short, refers to an adverse event that is either a congenital anomaly or birth defect, results in permanent or major disability or incapacity, is life-threatening, or necessitates inpatient hospitalization or prolonging of previous hospitalization.
18. Types of SAE?
Deaths, hospitalizations, life-threatening incidents, impairments, congenital malformations, and other significant medical events need medical attention are examples of SAE types.
19. SAE Reporting?
According to study protocols and regulatory requirements, SAE reporting entails the prompt and accurate evaluation, documentation, and reporting of significant adverse events to sponsors, investigators, ethical committees, and regulatory authorities.
20. What is ICF?
The acronym for informed consent form is ICF. It is a document that gives participants comprehensive information about a clinical experiment, including the goals, methods, risks, rewards, and rights of the study. Enrollment in a clinical trial requires informed permission from participants.
21. Explain in detail ICF process?
A participant’s informed consent must be obtained through the ICF process prior to their enrollment in a clinical research. This procedure entails answering participants’ inquiries, making sure they are aware of the benefits and hazards of participating, and giving them written and spoken information about the study. The ICF must be willingly signed by participants to verify that they can participate.
22. Basics about IRB/IEC?
The independent committees known as the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) are in charge of examining and approving clinical trial procedures in order to guarantee the safety, welfare, and rights of participants. Research projects are subject to regulatory compliance, ethical and scientific merit reviews, and an evaluation by an IRB or IEC before they can move forward.
23. What is IP?
Any pharmaceutical product being evaluated or utilized as a part of a clinical trial is referred to as an investigational product, or IP for short. It could include experimental medications, biologics, gadgets, or other therapies that are being looked into for efficacy and safety.
24 . Basics about IP?
The formulation, dosage form, administration route, storage conditions, handling guidelines, and labeling specifications outlined in the study protocol are all fundamental aspects of IP. Participants get IP in compliance with the study protocol and applicable laws.
25. What is Adverse Drug Reactions ?
Adverse Drug Reaction, or ADR for short, is the term used to describe any adverse or inadvertent reaction to a pharmaceutical product, including experimental medications, vaccines, or medical devices, that happens at normal dosages during post-marketing surveillance or clinical studies.
26. Types of ADR?
ADRs can be classified into three categories: mild reactions, such headaches or nausea, moderate reactions, like allergic reactions or hypotension, and severe events, like organ failure or anaphylaxis. In addition, they can be categorized according to their causation, severity, and time.
27. What is Protocol Amendment?
A formal alteration or modification to the initial study protocol is known as a protocol amendment. It can entail changes to the trial’s endpoints, treatment strategies, eligibility requirements, research protocols, or other elements. Ethics committees, study sponsors, and regulatory agencies must all approve protocol changes.
28. What is Inclusion and Exclusion Criteria?
The particular qualities or circumstances that people need to meet in order to be qualified to take part in a clinical trial are known as inclusion criteria. Exclusion criteria are situations or elements that exclude people from taking part in the experiment for various reasons, such as potential interference with study results, safety concerns, or other reasons.
29. What is Randomization?
In clinical trials, randomization is a technique used to allocate patients to research arms or various treatment groups at random. This minimizes bias and confounding variables by guaranteeing that every participant has an equal probability of being randomized to any treatment group.
30. Screening in Clinical Trials?
In clinical trials, screening entails evaluating prospective subjects to see if they satisfy the requirements specified in the research protocol. In order to find qualified applicants for enrollment, this process may involve reviewing medical histories, performing physical exams, ordering laboratory testing, and performing other assessments.
31. What is Single Blind, Double blind, open label studies?
- In a single-blind study, the researchers know the treatment assignments but the participants are in the dark about what they are getting.
- In order to minimize bias and maintain impartiality, double-blind trials keep the treatment allocations a secret from both participants and researchers.
- Open-label studies, which may create bias but can be helpful for some types of research, involve both participants and researchers knowing the treatment allocations.
32. What is CRF/eCRF (e.g., ECG)?
The Case Report Form, or CRF for short, is a standardized form that is used to gather information about each clinical trial participant. Modern clinical trials frequently use the eCRF (electronic Case Report Form), a digital or electronic version of the CRF that makes data entry, maintenance, and collection easier. To record cardiac activity, an electrocardiogram, or ECG, can be made on a CRF or eCRF.
33. What is a Site Visit?
A planned inspection or visit to a clinical trial site by auditors, monitors, or regulatory authorities to evaluate adherence to the study protocol, GCP guidelines, and regulatory requirements is known as a site visit. Site visits may involve reviewing documents, speaking with investigators, and looking over research facilities.
34. What are Screen Failed, Rand, Dis Patient/Types of Patients?
- Patients who were evaluated for eligibility but were not enrolled in the trial because they either satisfied the exclusion or inclusion criteria (screen failed).
- Rand (Randomized): Individuals who have undergone randomization and been allocated to either a treatment group or a study arm.
- Dis (Discontinued): Individuals who have left the study early for any number of reasons, including protocol violations, adverse events, or withdrawal of permission.
35. CDM Start Up?
The first stage of establishing data management tasks for a clinical trial, such as protocol review, database design, CRF development, data validation plan formulation, and system validation, is referred to as CDM (Clinical Data Management) Start Up. It establishes the framework for gathering, handling, and analyzing data during the trial.
36. What is Annotated e-CRF?
An electronic Case Report Form (eCRF) that has been annotated with extra details, guidelines, or sources to help data entry staff properly complete the form is known as an Annotated e-CRF. Annotations might refer to data management policies, give coding instructions, or define data fields.
37. Basics about Database Building?
Designing and constructing a database system to house, handle, and evaluate clinical trial data is known as database building. In this procedure, data structures are defined, data entry screens (CRFs/eCRFs) are coded, data validation checks are put in place, and regulatory standards and best practices for data management are adhered to.
38. What is ECS?
Electronic Case Report Form (eCRF) System is known as ECS. It speaks of the electronic system or program that records, organizes, and keeps track of clinical trial data that is filled out on electronic Case Report Forms (eCRFs).
39. User Acceptance Testing (UAT)
During the User Acceptance Testing (UAT) stage of software testing, end users assess the system to make sure it satisfies their needs and performs as intended. Prior to deployment, the system must be tested in an actual setting to find any bugs or inconsistencies that must be fixed before final clearance.
40. what is Test Cases Writing?
Writing test cases entails developing comprehensive guidelines or scenarios to direct testers as they validate particular features or functionalities of a software system. Test cases specify the actions to be performed, the anticipated outcomes, and any prerequisites for conditions or data inputs.
41. What is Test Cases Execution?
Running or carrying out the test cases that have been created to verify the functionality, dependability, and performance of a software system is known as test case execution. Testers record the outcomes of each test and adhere to the guidelines provided in the test cases.
42. What is Re-Testing ?
Retesting is the process of running test cases that did not pass the first time around to make sure that any flaws or problems found during the first testing have been fixed and tested again. Retesting confirms that the issues identified have been successfully fixed by the developers’ changes.
43. What is Go Live?
The moment a software system or program is put into production and made accessible to end users is known as “Go Live.” It denotes that the system is prepared for use in its live environment and signals the end of the development and testing phase and the beginning of full-scale operation.
44. Where are the documents of Testing uploaded?
Documents related to testing, such as test cases, plans, results, and other artifacts, are usually submitted to a document management system or special repository. This guarantees testing documentation traceability, version control, and centralized access throughout the software development lifecycle.
45. What is Query Management?
The act of locating, monitoring, addressing, and recording questions or inconsistencies pertaining to clinical trial data that is gathered on Case Report Forms (CRFs/eCRFs) is known as query management. In order to assure data quality and integrity and to clarify or resolve difficulties, data managers, investigators, and site staff must communicate with one another.
46. Types of Query in Clinical Trials?
In clinical trials, there are several different kinds of queries, such as data validation, data clarification, discrepancy, and protocol violation queries. Data managers or monitors raise these queries in response to discrepancies, mistakes, or omissions from the gathered data.
47. What is Auto Query?
When automated procedures or rules are used in data management or electronic data capture (EDC) systems to automatically construct inquiries based on preset criteria or data validation checks, the term “auto query” is used. Auto queries detect any problems in real-time during data entry, which simplifies query management and enhances data quality.