Please provide guidance and answer for the question below.

(1) There are ethical issues specific for the clinical research study design, where the choice of the design may present ethical concerns. From the list, select one ethical issue that is NOT related to the study design,

(A) An RTC will study a new drug for a common disease and intends to include a placebo group

(B) The research question is vague, the effect size is small and the researcher needs a huge sample size for a small clinically relevant benefit.

(C) A participant had an exclusion criterion checked, but was enrolled in the study.

(D) Researchers plan to collect additional information that is unrelated to the research question but could be used in future research. However, this is not disclosed in the informed consent.

(E) The trial continued even though there was compelling evidence that the drug was more beneficial and the control should have it.

(F) The trial continued even though there was a compelling evidence that the drug was not safe

(G) The trial continued despite of high dropout rate, low enrollment and few outcome events.

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(2) Labeling the study participant's biospecimen(s) with a barcode instead of name orinitials contributes to___________________.Choose the correct answer.

(A) Preserving participant's confidentiality

(B) Compliance with ICH-GCP-11.

(C) Eliminates observer's bias for measurements

(D) Allows automation of lab procedures

(E) All of the above

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(3) Strategies to reduce the sample size in a study include all EXCEPT.

(A) re-visit the research hypothesis

(B) choose a study population where the effect size will be greater

(C) choose an outcome with a continuous measure

(D) Abandon the research question,

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(4) Which of the following pose ethical issues related to study research design?

(A) Enrolling subjects in a study with a small probability of producing clinically meaningful results

(B) Conducting a study in which treatment and care actually help prolong life, yet due to inadequate power, the results are unable to alter clinical practice?

(C) Continuing a study beyond the point where a significant effect is clear

(D) Once a safety issue arises, how many subjects will it take for the investigator to conclude there is a clear safety issue?

(E) All of the above

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(5) All of the following are a measure of disease frequency EXCEPT

(A ) count

(B) proportion

(c) ratio

(D) mortality

(E) rate

(F) Risk

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(6) Programming the database to flag missing data, out of range-, and illogical values contributes to all EXCEPT:

(A) Decrease of the need for imputing missing values in statistical analyses

(B) Decrease in the random errors during data entry

(C) Increase in source data precision

(D) Prevents from fabrication of study data and committing data fraud

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