ACRP- CLINICAL RESEARCH

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ACRP- CLINICAL RESEARCH

KNOWLEDGE ASSESSMENT (CRKA)

WITH QUESTIONS AND A NSWERS

Question : Elements of a clinical research protocol include all

but which of the following?

• Study Rationale
• Research Objectives
• Study Design Description
• Selection and Withdrawal of Subjects
• Requirements and Ethical Approval and Oversight

F .Statistical Analysis Description

Correct answer: E

Question : When critically analyzing study results, the reader

may find flaws or limitations in which of the following areas?

• Limitations due to the sample size of the population

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• Lack of objectivity or presence of bias in the design of the

study or interpretation of the results

• Methodological issues in terms of the study design
• Lack of generalizability of applicability of results
• All of the above
• A and B only.

Correct answer: E

Question : The investigational new drug development process

consists of which of the following?

• Pre-clinical testing, 2 phases of clinical trials and

regulatory submission, review and approval of the marketing application.

• Pre-clinical testing, 3 phases of clinical trials and

regulatory submission, review and approval of the marketing application.

• Pre-clinical testing, 4 phases of clinical trials and

regulatory submission, review and approval of the marketing application.

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• Pre-clinical testing, 5 phases of clinical trials and

regulatory submission, review and approval of the marketing application.

Correct answer: B

Question : All but which of the following are key roles or

entities involved in clinical trials EXCEPT which?

• The Principal Investigator
• The Clinical Research Associate (CRA)
• The Sponsor
• The Contract Research Organization (CRO)
• The Institutional Review Board (IRB) or Independent

Ethics Committee (IEC)

• The Patient Advocate
• The Clinical Research Coordinator (CRC)
• The Independent Data Monitoring Committee (EDMC) or

Data Safety Management Board (DSMB)

• Regulatory Authorities.

Correct answer: F

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Question : According to GCPs, which of the following

methods best ensure transparency and allow for the reconstruction of the course of events taking place in a clinical trial?

• Audit Trail
• Source Document Verification
• Trial Master Files
• Case Report Forms
• None of the Above

Correct answer: A

Question : All of the following are examples of documents

and reports that are required in the context of clinical trial conduct EXCEPT which?

• Monitoring Visit Reports
• Expedited Safety Reports