Which statement best describes how long study records must be retained?

Which statement best describes how long study records must be retained?

• A. Per sponsor requirements
• B. Per sponsor and regulatory requirements
• C. For 5 years
• D. Indefinitely

Answer: (B)

Records must be kept for a period set by both regulatory requirements and the sponsor’s policies. Regulators specify minimum retention to allow inspections and ongoing safety or efficacy review, while sponsors may require longer retention to support data verification, audits, and future research or regulatory needs. When both apply, you retain the documents for the longer period, and you follow the sponsor’s archiving procedures unless the regulatory obligation requires a longer time in that jurisdiction. In multinational trials, you must meet the strictest applicable retention period across the involved regulatory environments. This is why the best answer is that retention is determined by both sponsor and regulatory requirements.

Records must be kept for a period set by both regulatory requirements and the sponsor’s policies. Regulators specify minimum retention to allow inspections and ongoing safety or efficacy review, while sponsors may require longer retention to support data verification, audits, and future research or regulatory needs. When both apply, you retain the documents for the longer period, and you follow the sponsor’s archiving procedures unless the regulatory obligation requires a longer time in that jurisdiction. In multinational trials, you must meet the strictest applicable retention period across the involved regulatory environments. This is why the best answer is that retention is determined by both sponsor and regulatory requirements.