Clinical Coordinating Center for NIDA’s Clinical Trials Network   5

Background
The National Institute on Drug Abuse (NIDA) is seeking a Clinical Coordinating Center for NIDA’s Clinical Trials Network. The purpose of this amendment # 01 is to clarify the RFP requirements by responding to questions submitted. The amendment clarifies that all other terms remain unchanged.

Work Details
The work details include various tasks and requirements such as reporting threats or hazards, accepting industry-accepted encryption standards, conducting vulnerability assessment scanning, maintaining the Study eTMF for all studies, providing estimates of IND and NDA submissions to the FDA, reviewing CTN’s policies and guidance documents, conducting on-site visits, providing DEA registrations for controlled substances, estimating storage space and packaging needs for study products, confirming qualitative and quantitative confirmatory analyses desired for the study product, and addressing various IT security requirements.

Period of Performance
The proposal due date is February 9th, 2024 at 3:00 P.M. (Eastern Time). The RFP specifies that the transition of work from the predecessor Contractor is expected to happen within 90 days of contract award.

Place of Performance
The contract will be performed at the National Institutes of Health, National Institute on Drug Abuse, Office of Acquisitions, located at 301 N Stonestreet Ave, Bethesda, MD 20892.