N.Y. Comp. Codes R. & Regs. tit. 9 § 132.11

Current through Register Vol. 46, No. 43, October 23, 2024

Section 132.11 - Record Retention

(a) A research licensee shall keep and maintain records required by this Part, or any other applicable federal or state rule or regulation, including all books and electronic records located on the premises, in a readily retrievable manner for at least seven years from the date of creation, unless a shorter time is specified by the Office.

(b) Records shall account for all activities of the research licensee. Records of all investigational products received, stored, delivered, distributed, dispensed, lost, or destroyed shall be readily retrievable and made available to the Office upon request. The research licensee shall provide accountability of all investigational products to help reduce the potential for theft or diversion. Records shall be legible and accurate.

(c) Records shall be stored in a secure area and in a manner in which they are protected from debris, moisture, contamination, hazardous waste, and theft.

(d) The failure of the research licensee to comply with the requirements set forth in this section may result in fines and possible suspension or revocation of licensure.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 132.11

Adopted New York State Register August 9, 2023/Volume XLV, Issue 32, eff. 8/9/2023