M. Pharmacy Quiz-53

Which document provides detailed background information on the investigational product for investigators?

Case Report Form

Investigator’s Brochure

Clinical Study Report

Protocol

The Case Report Form (CRF) is primarily used to:

Summarize study outcome

Record trial subject data

Describe safety reporting requirements

Provide preclinical data

Which section of the protocol specifies inclusion and exclusion criteria?

Study design

Ethical considerations

Selection of study population

Investigator responsibilities

The Clinical Study Report (CSR) is prepared at which stage?

Before trial begins

During subject screening

After trial completion

During ADR reporting

Adverse Drug Reaction (ADR) seriousness is determined based on:

Investigator’s choice

Effect on the volunteer only

Duration of treatment

Outcome such as hospitalization, disability, or death

M. Pharmacy Quiz-53

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