Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study year 2

Grants and Contracts Details

Description

HUMAN CLINICAL TRIAL - CONFIDENTIAL The A4 LEARN Observational Study is a companion study to the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s disease (A4) Trial. This Study shall be conducted according to the terms of this Subaward and the Protocol referenced above and incorporated herein by reference and which fully details the clinical research activities and responsibilities to be undertaken. The Institution agrees to conduct the trial pursuant to the respective Protocol and to accurately complete and promptly submit electronic case report forms (“eCRFs”) during the period specified for the conduct of the Study. Institution agrees to conduct this Study in strict accordance with the Protocol, which is incorporated by reference herein, (as it may be amended from time to time by the Company and/or UCSD), all applicable guidelines relevant to the conduct of clinical protocols, including, but not limited to the Federal Food, Drug and Cosmetic Act and regulations of the FDA, HIPAA, conditions imposed by the Institution’s IRB and the written instructions of UCSD relative to the administration of the Protocol. The Parties agree to comply with and to conduct the Study in accordance with all applicable federal, state and local laws and regulations. Each Party shall i) comply with the rules, rulings and directives of any governmental body or authority having jurisdiction over the Party or activities conducted hereunder; ii) not violate, cause the other to violate, or require the other to violate any applicable anticorruption or export control law or regulations, including but not limited to, United States laws relating to sanctioned countries and activities with parties appearing on the List of Denied Parties, the Specifically Designated Nationals and Blocked Persons List, the Specially Designated Global Terrorists List, the Debarred Parties List, the Denied Persons List, and similar lists; iii) not pay, offer, promise or authorize the payment or transfer of anything of value, directly or indirectly to any employee or official of a government or government owned or controlled entity which may viewed as an attempt to influence an official decision or to obtain an unfair advantage; or to any political party, party official, or candidate for public office; or without exception, to any person or entity if such payments or transfers would constitute a violation of applicable law by either UCSD or Institution.
StatusActive
Effective start/end date11/1/152/28/23

Funding

  • University of Southern California: $164,000.00

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