Legal & Regulatory Compliance Flashcards
7 cards from real CRM practice questions. Tap to flip, then mark Knew It or Still Learning โ missed cards come back until you master them.
Read the first 7 Legal & Regulatory Compliance flashcards as text
Under the Federal Rules of Civil Procedure (FRCP), what is the term for the duty to preserve potentially relevant records once litigation is reasonably anticipated?
Answer: Litigation hold
A litigation hold (also called a legal hold) is the obligation to preserve records and data once litigation is reasonably anticipated, required under FRCP.
Which U.S. law establishes criminal penalties for destroying records with intent to obstruct a federal investigation?
Answer: Sarbanes-Oxley Act Section 802
SOX Section 802 makes it a federal crime to destroy, alter, or falsify records with intent to obstruct a federal investigation, with penalties up to 20 years.
What does the term 'spoliation' mean in the context of records and litigation?
Answer: The intentional or negligent destruction of evidence relevant to litigation
Spoliation refers to the destruction, alteration, or concealment of evidence relevant to pending or anticipated litigation, which can result in adverse inference sanctions.
Which regulation specifically governs records management requirements for U.S. federal agencies?
Answer: 44 U.S.C. Chapters 29, 31, and 33
44 U.S.C. Chapters 29, 31, and 33 (the Federal Records Act) establish the records management requirements for U.S. federal agencies.
A company receives a subpoena duces tecum. What must the records manager do immediately?
Answer: Issue a litigation hold and notify legal counsel
Upon receiving a subpoena duces tecum, the records manager must immediately issue a litigation hold and notify legal counsel to preserve relevant records.
Title 21 CFR Part 11 primarily applies to which type of records?
Answer: Electronic records and signatures in FDA-regulated industries
21 CFR Part 11 sets FDA requirements for electronic records and electronic signatures used in regulated industries such as pharmaceuticals and medical devices.
When a records retention schedule conflicts with a legal hold, which takes precedence?
Answer: The legal hold supersedes the retention schedule
A legal hold always supersedes the normal retention schedule; records subject to a hold must not be destroyed regardless of their scheduled retention period.