SMART IRB Governance, Administration, and Operations Support (GAOS)

Amendment 01 The purpose of this amendment # 01 is to clarify the RFQ requirements by responding to questions submitted and also to add IT applicable clauses into the solicitation. Unless specifically noted, all other terms remain unchanged.

Note: The Offeror should acknowledge on the cover page or first pages on its Quote receipt of this amendment. Please see the attached Amendment 01_SMART for more details.

Title: SMART IRB Governance, Administration, and Operations Support (GAOS) This is a combined synopsis/solicitation for commercial items/services prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items; and FAR Part 12— Acquisition of Commercial Items; and is expected to exceed the simplified acquisition threshold. Introduction and Background Objectives The National Center for Translational Sciences (NCATS) requires a partner to facilitate user administration, process/workflow improvements, content development/moderation, requirements gathering, and dissemination of the SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials Institutional Review Board) portfolio of services. SMART IRB relies on three systems:

(1) the SMARTIRB.org website which is used for content distribution, notification, and educational purposes, (2) Joinder, through which institutions enter institutional information and sign the SMART IRB Authorization Agreement (AA), and (3) the Online Reliance System (ORS), through which Institutional Review Board (IRB) reliance arrangements under the SMART IRB Agreement are documented on a study-by-study basis. The selected partner will provide support in accordance with this SOW to aid in the facilitation and growth of SMART IRB. Please see the attached RFQ 75N98026Q00287 for more details