FDA’s Center for Tobacco Products (CTP) QA/QI program will include monitoring CTP conducted, supported, or funded intramural and extramural studies, to ensure they are conducted, recorded, and reported in compliance with the study protocol, study specific risk-appropriate quality monitoring plans, Standard Operating Procedures, FDA Research Involving Humans Subjects Committee (RIHSC) Policies and Procedures, Good Clinical Practice (GCP) standards and Federal regulation HHS 45 CFR § 46, as well as any additional applicable agency regulatory requirements.
The scope of this contract is to improve the QA/QI data collection process and support CTP QA/QI site monitoring.
Task 1: Transition-In
The purpose of the transition-in task is to ensure the Contractor has sufficient knowledge of the QA/QI program and processes to be effective in supporting CTP/OCE. The Contractor shall obtain knowledge, data, background, and artifacts to support the requirements detailed below. The Contractor shall work with CTP/OCE during a 60-day transition period. The Contractor key personnel shall meet with CTP via phone and web-conferencing to review QA/QI program information from the CTP/OCE.
The Contractor shall perform the following:
Conduct and coordinate all onboarding activities to include obtaining secure FDA badging for team personnel…
