LSSAE Quiz Set-1 - Learning labb Research Institute

Welcome to your LLRI Scholarship & Skills Assessment Exam (LSSAE)!

Name

Phone Number

How would 3 hours and 15 minutes be represented as a duration in ISO 8601?

P3H15M

PT3H15M

P03:15

P3.15

Which bioinformatics tool is used to predict the secondary structure of proteins?

BLAST

FASTA

PsiPred

ClustalW

Which SDTM variable is commonly used to link records from different domains for the same subject?

VISITNUM

STUDYID

USUBJID

DOMAIN

Which of the following is the correct ICD-10-CM code for a patient diagnosed with Type 1 Diabetes Mellitus without complications?

E10.9

E11.9

E10.5

E11.21

What does an Intent-to-Treat (ITT) analysis entail in a clinical trial?

Including only participants who completed the trial

Including all participants as randomized, regardless of completion

Analyzing only those who showed positive responses

Excluding participants with protocol deviations

Which ethical principle focuses on minimizing risks to clinical trial participants?

Beneficence

Autonomy

Justice

Non-maleficence

Under Schedule Y, who is ultimately responsible for ensuring the safety of trial participants?

The sponsor

The investigator

The Ethics Committee

The trial monitor

A table in a clinical database contains columns for PatientID, Medication, and SideEffects. How can it be normalized to 1NF?

Separate SideEffects into a different table

Ensure Medication and SideEffects columns are atomic

Use composite keys for PatientID and Medication

Remove the PatientID column

Which of the following statements about biosimilar products in the Purple Book is true?

Biosimilar products are identical to the reference product.

Biosimilar products have different safety profiles compared to the reference product.

Biosimilar products are not included in the Purple Book.

What is the role of metadata in lab data management?

To represent the primary data collected in the laboratory

To provide context and information about the laboratory data

To store laboratory equipment

To analyze laboratory samples

Which certification within an ANDA asserts that the patent listed for the innovator drug is invalid or will not be infringed by the manufacture of the generic drug?

Paragraph I

Paragraph II

Paragraph III

Paragraph IV

What is the primary purpose of a Risk Evaluation and Mitigation Strategy (REMS) in the U.S.?

To monitor manufacturing quality

To inform patients about potential drug interactions

To manage a known or potential serious risk associated with a drug

To track adverse events post-market

Which guideline primarily governs the structure and content of clinical trial protocols?

ICH E3

ICH E6

CONSORT

GCP Part 11

What is an “Investigator’s Brochure” (IB) in clinical trials?

A guide for preparing clinical trial submissions

A document summarizing the clinical and preclinical data of a drug for investigators

A regulatory report required post-approval

A document outlining the study results for marketing

Which of the following documents is critical for describing the manufacturing process of a drug?

Investigator’s Brochure

Summary of Product Characteristics (SmPC)

Chemistry, Manufacturing, and Controls (CMC)

Clinical Study Protocol

What does a “modifier -59” indicate in medical coding?

Unilateral procedure

Different site or organ

Reduced service

Distinct procedural service

You disagree with a teammate about the approach to a task. What is your response?

Insist on your approach because you believe it's better.

Listen to their perspective, share your ideas, and collaborate to find the best solution.

Escalate the issue to the supervisor immediately.

Allow them to proceed with their approach without sharing your opinion.

You are feeling overwhelmed by your workload. What do you do?

Complain to your supervisor about the excessive workload.

Take short breaks, prioritize tasks, and seek help if needed.

Work longer hours without notifying anyone about the issue.

Ignore the stress and continue working until it affects your performance.

A colleague critiques your work during a meeting. How do you respond?

Defend your work and criticize theirs.

Listen carefully, thank them, and address the feedback constructively.

Ignore the critique and continue working as before.

Leave the meeting to avoid further embarrassment.

You notice a teammate taking shortcuts that could compromise the quality of work. What should you do?

Report the behavior to your manager immediately.

Speak to the teammate privately and discuss the implications of their actions.

Ignore the issue to avoid confrontation.

Publicly call out the teammate during a team meeting.

Learning Labb Research Institute

Scholarship & Skills Assessment Exam