CRM Legal & Regulatory Compliance 2 — Questions and Answers
Question 1: 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?
- Litigation hold (Correct answer)
- Records freeze
- Evidence lock
- Discovery stay
Correct 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.
Question 2: Which U.S. law establishes criminal penalties for destroying records with intent to obstruct a federal investigation?
- Sarbanes-Oxley Act Section 802 (Correct answer)
- HIPAA Security Rule
- Freedom of Information Act
- Privacy Act of 1974
Correct 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.
Question 3: What does the term 'spoliation' mean in the context of records and litigation?
- The intentional or negligent destruction of evidence relevant to litigation (Correct answer)
- The classification of records as confidential
- The transfer of records to a third-party custodian
- The expiration of a records retention period
Correct 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.
Question 4: Which regulation specifically governs records management requirements for U.S. federal agencies?
- 44 U.S.C. Chapters 29, 31, and 33 (Correct answer)
- Title 21 CFR Part 11
- 45 CFR Part 164
- 12 CFR Part 30
Correct 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.
Question 5: A company receives a subpoena duces tecum. What must the records manager do immediately?
- Issue a litigation hold and notify legal counsel (Correct answer)
- Begin disposing of non-responsive records per schedule
- Transfer all records to off-site storage
- Encrypt all electronic records
Correct 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.
Question 6: Title 21 CFR Part 11 primarily applies to which type of records?
- Electronic records and signatures in FDA-regulated industries (Correct answer)
- Financial records of publicly traded companies
- Health insurance claims processing records
- Environmental compliance records
Correct 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.
Question 7: When a records retention schedule conflicts with a legal hold, which takes precedence?
- The legal hold supersedes the retention schedule (Correct answer)
- The retention schedule always governs destruction timelines
- The older document controls
- Whichever is more recent controls
Correct 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.
CRM Legal & Regulatory Compliance 2
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?