Site Management & Monitoring Flashcards
7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Site Management & Monitoring flashcards as text
A site wishes to add a new sub-investigator to the study team mid-trial. Which steps must be completed BEFORE the new sub-investigator performs any study-related duties?
Answer: The sub-investigator must complete protocol training, be added to the delegation log, and, in the US, added to an updated FDA 1572
Adding a new sub-investigator requires protocol training, delegation log entry, and an amended 1572 before any study activities are performed.
When assessing whether a site is suitable for a clinical trial, which factor is MOST critical to evaluate?
Answer: Adequate subject population, qualified staff, and sufficient facilities and resources
Feasibility assessment focuses on the site's ability to enroll an appropriate subject population, qualified personnel, and adequate infrastructure.
What is the key difference between a protocol deviation and a protocol violation in clinical trials?
Answer: A violation is a deviation that adversely affects subject safety, rights, or data integrity
A violation is a deviation significant enough to compromise subject safety, rights, or study data integrity and typically requires immediate escalation.
According to GCP, which of the following is an example of source data?
Answer: The original hospital laboratory report documenting a subject's baseline CBC
Source data is defined as original records (including hospital charts and lab reports) from which CRF data is derived.
A sponsor implements a remote monitoring strategy using electronic data capture (EDC). Which GCP principle must still be upheld regardless of monitoring method?
Answer: The sponsor must ensure data accuracy, completeness, and subject protection
Regardless of whether monitoring is remote or on-site, the sponsor remains responsible for ensuring subject protection and data quality per ICH E6(R2).
During a close-out visit, the CRA verifies that all open queries have been resolved. Which additional task is ESSENTIAL before the site file can be archived?
Answer: Confirming all investigational product has been accounted for and returned or destroyed
IP reconciliation and disposition must be completed and documented before a site can be formally closed and its records archived.
A subject withdraws consent mid-study and requests that all data collected be destroyed. Under ICH GCP and US regulations, what is the correct response?
Answer: Data already entered into the CRF may be retained, but no further data will be collected
Under GCP, a subject may withdraw consent for future data collection, but data already recorded may be retained for trial integrity and safety purposes unless local law requires otherwise.