N.Y. Comp. Codes R. & Regs. tit. 9 § 132.9

Current through Register Vol. 46, No. 25, June 18, 2024

Section 132.9 - Reporting Requirements

(a) A research licensee shall maintain and shall make available all documentation related to:

(1) the proper disposal of investigational products as required by this Part; and

(2) an occurrence that is reportable, including:

(i) any investigational products cultivated, produced, or acquired for use in an approved research project;

(ii) an annual report to the Board. The Board shall review such report and determine whether the research project continues to meet the research qualifications under this Part; and

(iii) any adverse events that occur during trial participation which shall be documented by the research licensee and reported to the Office, in a manner determined by the Office, if the event becomes serious. Serious adverse events shall be reported to the Office within 24 hours from the time of awareness.

(b) A research licensee shall immediately (within 24 hours) notify appropriate law enforcement authorities and the Office upon becoming aware of any:

(1) unresolved discrepancies identified in the inventory;

(2) diversion, theft, loss, or unauthorized destruction of any investigational products; or

(3) loss or unauthorized alteration of records related to investigational products, qualifying patients, or human subjects.

(c) A research licensee reporting an incident to duly authorized law enforcement shall notify the Office by way of a signed statement, which shall be made no later than 24 hours after discovery of the event, which details:

(1) the circumstances of the event;

(2) an accurate inventory of the quantity and brand names of investigational products diverted, stolen, lost, destroyed or damaged; and

(3) confirmation that local law enforcement authorities were notified.

(d) A research licensee shall notify the Office no later than the next business day upon discovery, followed by written notification, in a manner determined by the Office, no later than ten business days, of any of the following:

(1) an alarm activation or other event that requires response by public safety personnel;

(2) a breach of security; and

(3) the failure of any required security alarm system that may be required due to a loss of electrical support or mechanical malfunction that is expected to last longer than eight hours.

(e) Once the research project concludes, the research licensee shall provide a final synopsis or publication of the research project specific to the Office and the work undertaken as it aligns with the research license.

(1) Peer reviewed publications: If the research licensee intends to submit any part of their work to a peer review journal, it is acceptable to submit all papers, findings, and documentation to the Office after it is accepted for publication.

(2) No peer reviewed publications: If the research licensee does not intend to publish their work in a peer review journal, all copies of all final reports, findings, or documentation regarding the outcomes of approved research projects receiving a research license shall be submitted to the Office prior to being shared publicly.

(f) Research licensees shall submit to the Office all IRB determinations made related to a research project, including but not limited to, amendments and continuing reviews, within 10 business days of when the determination was received by the PI.

(g) Research licensees shall submit an application for an amendment to the Board prior to making a substantial change to the research project. Such application shall provide the following information, where applicable, in a manner and form as determined by the Board:

(1) updated research project information, including but not limited to:

(i) change in scope;

(ii) relocation of study site;

(iii) change in key personnel;

(iv) amount of investigational products required; and

(v) any other conditions determined by the Board;

(2) justification for why the change is necessary; and

(3) copies of updated IRB or IACUC approvals, documenting acknowledgement of the amendment, if applicable.

(h) Research licensees proposing to conduct any additional research projects under their research license shall have their research projects approved and registered by submitting the information listed in section 132.3 of this Part. The fee to add additional research projects shall be $150.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 132.9

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