Regulatory Guidelines and Compliance 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 Regulatory Guidelines and Compliance flashcards as text
Which element is NOT required to be included in an informed consent document per 21 CFR Part 50.25?
Answer: The name of the sponsor's legal counsel
21 CFR Part 50.25 lists required elements of informed consent but does not include the name of the sponsor's legal counsel as a mandatory disclosure.
ALCOA principles in clinical data management stand for:
Answer: Attributable, Legible, Contemporaneous, Original, Accurate
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate — the five core data quality standards enforced by regulatory authorities.
A site receives a for-cause FDA inspection triggered by safety concerns in a trial. What should the investigator do first when FDA investigators arrive unannounced?
Answer: Contact the sponsor or CRO immediately while welcoming inspectors
Investigators should welcome FDA inspectors and simultaneously notify the sponsor or CRO, as inspections are authorized under law and sponsors must be informed promptly.
The 'washout period' in a crossover clinical trial is required to:
Answer: Eliminate residual effects of a previous treatment before the next intervention
A washout period allows the prior treatment's effects to dissipate before subjects receive the next intervention, preventing carryover bias.
Under GCP, what is the primary purpose of source data verification (SDV) performed by a clinical monitor?
Answer: To confirm that case report form data accurately reflects source records
SDV ensures that data transcribed onto CRFs accurately reflects the original source documents, maintaining data integrity across the trial.
Which regulatory body issues the 'Clinical Trials Authorisation' (CTA) required before starting a clinical trial in the United Kingdom post-Brexit?
Answer: Medicines and Healthcare products Regulatory Agency (MHRA)
Post-Brexit, the MHRA is responsible for issuing Clinical Trial Authorisations for trials conducted in the United Kingdom.
According to ICH E6(R2), essential documents should be retained until at least:
Answer: Two years after the last approval of a marketing application
ICH E6(R2) requires that essential documents be retained for at least two years after the last approval of a marketing application, or two years after formal discontinuation.