Plans for the maintenance and storage of study records and documents must be submitted by the principal investigator to the IRB for approval. These plans should define record storage procedures and conditions and identify those with access to the records. Electronic data should be saved on a device that has appropriate security safeguards to protect against data loss or theft and to avoid any potential breach in subjects’ privacy and confidentiality. IRB approval shall be based on documented assurance that all hard copy and electronic data is securely stored to prevent unauthorized access, disclosure, or loss. Principal Investigators should also submit for IRB approval provisions for destruction of study records after the required data retention period has elapsed if the destruction of study records is necessary for confidentiality or other matters that protect participants.