Long-Term Nicotine Treatment of Mild Cognitive Impairment

Project: Research project

Project Details

Description

PROCEDURES 1. Ensure proper informed consent is obtained prior to any study-related procedures being performed. 2. Full compliance with specified inclusion/exclusion criteria cited in the protocol. 3. Full compliance with all procedures specified in the protocol, in the procedures manual and imaging technical manuals. 4. Carry out all evaluations within time limits specified in the procedures manual for the protocol. 5. Proper collection and submission of all required online data entry forms within the time limits specified in the procedures/technical manual(s) for the protocol. 6. Proper collection, storage and shipment of laboratory specimens for safety monitoring, laboratory surveillance, compliance monitoring, biomarker research and storage for future research studies. 7. Proper reporting of all adverse events (AE), with serious adverse events (SAE) being reported to the ATRI within 24 hrs of site notification. Follow up on participants with AEs until the events have subsided, the conditions are considered medically stable, or the participants are no longer available for follow up. 8. Prompt response to requests (administrative or data-related) from the Coordinating Center by email, phone, or through data query tool. 9. It is required that data from the screening visit be entered in the online data entry forms within 3 days of being generated by Site. Data from all subsequent visits within 5 days of being generated by Site. 10. MRI Data must be uploaded within 2 business days of imaging. 11. Ensure scanner compliance by following specified imaging protocols as specified in the Technical Manuals for MRI by reporting any modifications to scanners to the Coordinating Center and the MRI core (respectively) in case re-certification is required. 12. Ability to procure any study materials and supplies not provided by the Coordinating Center in order to conduct research-appropriate storage and accounting.
StatusFinished
Effective start/end date2/17/221/31/23

Funding

  • University of Southern California (SCON-00003468//2R56AG047992-07A1)
  • National Institute on Aging (SCON-00003468//2R56AG047992-07A1)

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