Mixed Deck — All CPI Topics Flashcards

In cellular network investigations, a tower dump request asks a carrier for:

Answer: All device identifiers that connected to a specific tower during a time window

A tower dump provides investigators with a list of all IMSIs/IMEIs that registered with a specific cell tower during a specified period.

In a meta-analysis, what does a funnel plot asymmetry most likely suggest?

Answer: Publication bias, with smaller negative studies underrepresented

Funnel plot asymmetry suggests that small studies with unfavorable results may not have been published, indicating publication bias.

An IRB requests additional clarification on a protocol amendment. What is the PI's most appropriate first step?

Answer: Provide a written response addressing each IRB concern specifically

The PI should respond in writing to each IRB concern directly and specifically to facilitate timely resolution.

When drafting a research protocol for IRB submission, which section must explicitly describe procedures to minimize risk to participants?

Answer: Risk-benefit analysis

The risk-benefit analysis section must explicitly outline procedures to minimize participant risk and demonstrate that potential benefits outweigh those risks.

What ethical issue arises when an investigator accepts payment from both the plaintiff and defendant in the same litigation matter?

Answer: It creates an irreconcilable conflict of interest that compromises loyalty and objectivity for both parties

Representing both adverse parties in litigation creates an irreconcilable conflict that prevents the investigator from fulfilling the duty of loyalty to either.

Which best describes the PI's responsibility when delegating tasks to sub-investigators?

Answer: The PI retains overall responsibility and must ensure sub-investigators are properly trained and documented on the delegation log

FDA regulations require a delegation log and specify that the PI retains ultimate responsibility for the conduct of the study regardless of delegation.

What is a dashboard in CPI reporting?

Answer: A visual display of key metrics for at-a-glance performance monitoring

A dashboard consolidates important metrics and trends visually for quick assessment of performance status.

Which bias can occur when study participants who drop out differ systematically from those who complete the study?

Answer: Attrition bias

Attrition bias (loss-to-follow-up bias) occurs when dropouts differ from completers in ways that affect the outcome, distorting results.

When a subject voluntarily withdraws from a clinical trial, the PI is required to:

Answer: Document the withdrawal and reason (if provided), and complete protocol-required safety follow-up assessments

Withdrawal must be documented with the subject's stated reason (if given), and any safety follow-up visits required by the protocol must be completed to protect the subject's well-being.

Under 21 CFR Part 11, electronic records used in clinical research must include which quality control feature?

Answer: Audit trail capturing who made changes and when

21 CFR Part 11 requires a secure, computer-generated audit trail that records the date and time of operator entries and actions that create, modify, or delete electronic records.

The term 'effect modification' (interaction) in epidemiology refers to:

Answer: The exposure-outcome relationship differing across strata of another variable

Effect modification occurs when the magnitude or direction of an exposure-outcome association varies by levels of a third variable (modifier).

Which document type provides the sponsor's detailed expectations for site monitoring visit frequency and procedures?

Answer: Monitoring Plan

The Monitoring Plan outlines the sponsor's risk-based strategy for oversight including visit frequency, scope, and required documentation reviews.

At study closeout, which action must be completed BEFORE destroying any study records?

Answer: Obtaining final IRB closure approval and confirming the regulatory retention period has elapsed

Records cannot be destroyed until the IRB has formally closed the study and the required retention period (often 7–15 years) has elapsed per regulatory requirements.

A corporate client requests a PI to analyze competitor intelligence gathered from public sources. The most significant legal boundary the PI must respect is:

Answer: Avoiding any collection methods that constitute unauthorized computer access or misrepresentation

Competitive intelligence gathering must stay within legal limits — unauthorized access to systems or impersonation to obtain data violates laws such as the CFAA.

A private investigator is hired to locate a subject using their vehicle. Which technology legally allows tracking without physical contact with the vehicle?

Answer: License plate reader (LPR) network data requests

License plate reader databases record vehicle movements passively on public roads; investigators can legally request records from operators without touching the vehicle.

A participant's capacity to provide informed consent becomes impaired during the study. What is the PI's primary obligation?

Answer: Obtain consent from a legally authorized representative and reassess participant's capacity regularly

When a participant loses capacity, the PI must seek consent from a legally authorized representative and continue to respect the participant's preferences and welfare.

What is the primary purpose of an 'activity log' maintained by a PI during an investigation?

Answer: To create a real-time, verifiable record of all investigative actions taken

An activity log provides a contemporaneous, verifiable record of investigator actions that can defend the integrity of the investigation if challenged in court.

What is a quality audit in CPI practice?

Answer: Evaluating whether quality standards and procedures are followed

Quality audits examine whether established standards and procedures are implemented effectively, identifying non-conformances.

Under which circumstance must a subject's eligibility typically be re-verified after initial enrollment?

Answer: Whenever the protocol specifies it, such as confirming lab values before each treatment cycle

Many protocols require re-verification of specific eligibility parameters (e.g., organ function labs) at defined time points to confirm the subject remains appropriate for continued treatment.

Which data analysis concept refers to the minimum amount of evidence required to establish a fact as more likely true than not in a civil investigation?

Answer: Preponderance of the evidence

Preponderance of the evidence (51% or more likely true) is the standard burden of proof in most civil cases, which is lower than the criminal standard.