National Cancer Institute, Center for Cancer Research, Sponsor and Regulatory Oversight Support   3

The purpose of this acquisition is to provide for clinical trials sponsor and regulatory management support services to the National Cancer Institute (NCI), the Center for Cancer Research (CCR), and CCR investigators. Services shall include compliance with U.S. and international regulations, regulatory support to ensure Food and Drug Administration (FDA) regulation adherence, safety monitoring, oversight and reporting, clinical site assessment and interim monitoring, site essential regulatory documentation, trial master file support, sponsor quality management support, medical writing, administrative support, and computerized activity tracking, monitoring and reporting systems. The Contract shall also support management of multi-center trials in which the CCR is the Sponsor, and in non-CCR sites recruitment and management.

Please see the attached Request for Proposal document, "NCI_SROS_RFP_75N91020R00027", for additional information and proposal instructions.

(PLEASE NOTE: This RFP will NOT be available at the National Cancer Institute homepage (http://rcb.cancer.gov/rcb-internet/index.jsp.) as indicated in the pre-solicitation notice. )

Submit all questions in writing to: paula.wilkison@nih.gov

Responses to questions will be provided in Amendments to the Solicitation.

Questions received after 4:00 P.M. Eastern Time on October 30, 2020 may not be addressed.

AMENDMENTS:

October 5, 2020: Amendment 1 (see attachment)

November 3, 2020: Amendment 2 (see attachment)