Knowledge Flashcards
6 cards from real SOCRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Knowledge flashcards as text
Under FDA regulations, how long must clinical trial records be retained?
Answer: 2 years after the last approval of a marketing application
Per 21 CFR 312.62, investigators must retain records for 2 years after the last approval of a marketing application or 2 years after investigation is discontinued.
What is the primary function of a Data Safety Monitoring Board (DSMB)?
Answer: To independently monitor participant safety and study data integrity during a trial
A DSMB is an independent committee that monitors safety data and study conduct, with the authority to recommend modifications or termination.
What is the purpose of an audit trail in electronic data systems?
Answer: To provide a secure, computer-generated record of all data changes with timestamps
An audit trail is a secure, computer-generated, time-stamped electronic record that allows reconstruction of events related to data creation, modification, and deletion.
What is a protocol deviation versus a protocol violation?
Answer: A deviation is any departure from the protocol; a violation is a deviation that affects safety or data integrity
A deviation is any unplanned departure from the protocol, while a violation is a significant deviation that may affect participant safety, rights, or data integrity.
What is the Belmont Report and why is it significant?
Answer: It identifies basic ethical principles for human subjects research: respect, beneficence, and justice
The Belmont Report (1979) identifies three core ethical principles: respect for persons, beneficence, and justice.
What is source data verification (SDV)?
Answer: Comparing CRF entries with original source documents to ensure accuracy
SDV is the process of comparing data in the CRF against original source documents to confirm accuracy and completeness.