N.Y. Comp. Codes R. & Regs. tit. 9 § 132.10

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

Section 132.10 - Inspections and Audits

(a) Approved research study sites, regardless of the type of premises, and all records related to a research project, including but not limited to financial statements and corporate documents, shall be subject to inspection by the Office, by the duly authorized representatives of the Office, by any peace officer acting pursuant to his or her special duties, or by any police officer.

(b) All research projects that report serious adverse events shall be subject to inspection by the Office if the events are thought to jeopardize the immediate health, safety, or well-being of the research participants.

(c) A research licensee shall make themselves, or an agent thereof, available and present for any inspection required by the Office. Such inspection may include, but is not limited to, ensuring compliance by the research licensee with all requirements of the regulations pursuant thereto, and other applicable state and local building codes, fire, health, safety, and other applicable regulations.

(d) Any inspection finding, which the Office determines jeopardizes the immediate health, safety, or well-being of the public shall be deemed a critical deficiency and shall require a corrective action to remove the immediate risk and may result in the immediate suspension of the research license. The research licensee shall submit a corrective action plan to the Office within 24 hours of notification by the Office of the critical deficiency.

(e) If the Office determines that the corrective action plan needs modification, the research licensee shall modify the plan until it is in its final form, as accepted by the Office.

(f) Upon written approval of the Office, the research licensee shall implement the corrective action plan.

(g) Nothing herein shall limit the application of any other remedies or sanctions that are available through local, state, and federal laws, and these rules.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 132.10

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