Clinical Practices Guidelines 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 Clinical Practices Guidelines flashcards as text
In clinical practice guidelines for trials, 'source data' is best defined as:
Answer: Original information in original records and certified copies of original records of clinical findings, observations, or other activities
ICH E6 defines source data as all information in original records and certified copies necessary to reconstruct and evaluate the trial, including raw observations.
Which of the following constitutes an acceptable correction to a paper case report form (CRF) entry per GCP?
Answer: Drawing a single line through the error, writing the correction nearby, and initialing and dating the change
GCP requires that corrections to paper records allow the original entry to remain legible; the correction must be initialed and dated by the person making the change.
A sponsor's clinical trial agreement specifies that the investigator must notify the sponsor within 24 hours of learning of a subject's death. This is an example of:
Answer: A contractual obligation that supplements GCP reporting requirements
Clinical trial agreements (CTAs) create contractual reporting obligations that may be stricter than minimum regulatory thresholds and are legally binding on both parties.
According to GCP guidelines, who bears ultimate responsibility for the conduct of a clinical trial at an investigational site?
Answer: The principal investigator
The principal investigator is responsible for the proper conduct of the clinical trial at the site and for the integrity of data collected there.
When a CTA performs source data verification (SDV), what is being confirmed?
Answer: That CRF data accurately reflects the source documents from which it was transcribed
SDV confirms that data entered into the CRF is consistent, complete, and accurate when compared to the original source records.
If a subject withdraws consent during a clinical trial, which of the following actions is required under GCP?
Answer: Respect the withdrawal, discontinue study procedures, and document the withdrawal in accordance with the protocol
GCP and ethical principles require that a subject's withdrawal of consent be respected immediately; study procedures must stop, and the withdrawal must be documented per the protocol.
Under the Belmont Report, the principle of 'justice' in research ethics primarily requires that:
Answer: The burdens and benefits of research be distributed fairly across populations
The Belmont Report's justice principle requires equitable selection of subjects so that no group bears an unfair burden of research risks while others reap the benefits.