Investigator Responsibilities & Reporting Flashcards
7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Investigator Responsibilities & Reporting flashcards as text
Under what circumstance may an investigator implement a protocol change without prior IRB approval?
Answer: When the change is necessary to eliminate an immediate hazard to a research subject
An investigator may implement a protocol change without prior IRB approval only when necessary to eliminate an immediate hazard to subjects, followed by prompt IRB notification.
What is the investigator's role in submitting an Investigational New Drug (IND) application for a sponsor-investigator study?
Answer: The sponsor-investigator bears full responsibility for submitting and maintaining the IND
As a sponsor-investigator, the individual assumes all sponsor responsibilities including submitting and maintaining the IND with the FDA.
A subject enrolled in a clinical trial becomes pregnant during the study. What is the investigator's typical obligation?
Answer: Follow the protocol's pregnancy management plan, which usually includes discontinuing the investigational product and reporting the pregnancy
Most protocols require investigational product discontinuation in pregnancy with follow-up reporting per the pregnancy management plan, as fetal risk is typically unknown.
Which of the following represents an investigator's financial conflict of interest that MUST be disclosed?
Answer: Holding equity interest in the company sponsoring the trial
Equity interest in the sponsoring company creates a significant financial conflict of interest that must be disclosed to the FDA and IRB per 21 CFR Part 54.
What should an investigator do if they believe the sponsor's monitoring visit findings are inaccurate?
Answer: Discuss the discrepancy with the monitor and document their position in writing
Investigators should resolve disagreements with monitors through professional dialogue and document their position in writing for the record.
When is it permissible for an investigator to begin a clinical trial at their site?
Answer: Only after receiving written IRB approval and sponsor authorization to initiate the site
Site initiation requires both written IRB approval and sponsor authorization; neither alone is sufficient to begin a clinical trial.
An investigator must report a SAE to the sponsor. Which timeframe applies to fatal or life-threatening unexpected SAEs?
Answer: As soon as possible but no later than 7 calendar days
Fatal or life-threatening unexpected SAEs must be reported to the sponsor as soon as possible but no later than 7 calendar days, per FDA regulations.