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
Which of the following actions by a clinical investigator constitutes scientific misconduct?
Answer: Fabricating data in the case report form to fill in missed assessments
Fabricating or falsifying data in any research record is scientific misconduct and a serious regulatory violation subject to criminal penalties.
An investigator receives a Notice of Initiation of Disqualification Proceedings from the FDA. What does this mean?
Answer: The FDA has reason to believe the investigator has repeatedly or deliberately violated regulations and is initiating a process that could disqualify the investigator from conducting studies
An NIDPOE indicates FDA has evidence of repeated or deliberate regulatory violations and begins a formal process that may result in investigator disqualification.
What is the investigator's responsibility related to the Investigator Brochure (IB)?
Answer: Investigators must review the current IB and any updates to stay informed about the investigational product's risks and benefits
Investigators are responsible for reviewing the IB and its updates, as it is their primary reference for investigational product safety, pharmacology, and clinical data.
A subject in a clinical trial requests to withdraw from the study. What is the investigator's responsibility?
Answer: Respect the subject's decision, stop study procedures, and manage the withdrawal per protocol
Subjects have the absolute right to withdraw from research at any time without penalty; investigators must respect this right and follow protocol-specified withdrawal procedures.
When conducting a clinical trial, what is the investigator's obligation regarding unanticipated problems involving risks to subjects or others?
Answer: Report promptly to the IRB, applicable regulatory authorities, and the sponsor per institutional policy
Unanticipated problems must be reported promptly to the IRB, sponsor, and applicable regulatory authorities per institutional and federal requirements.
An investigator wants to add a co-investigator to the study team mid-trial. What is required before this person can perform study tasks?
Answer: The co-investigator must be trained on the protocol, qualified for their delegated tasks, added to the delegation log, and the IRB notified per institutional requirements
New study team members must receive protocol training, be qualified for their assigned tasks, be documented on the delegation log, and meet IRB notification requirements before performing study duties.
According to GCP guidelines, how should source documents be corrected if an error is found?
Answer: Draw a single line through the error, write the correction, initial, and date the change
GCP requires corrections to source documents to allow the original entry to remain legible; the corrector must draw a single line through the error, write the correction, and initial and date the change.