APREMILAST FOR THE TREATMENT OF ALCOHOL USE DISORDER -- CONTRACT RESEARCH ORGANIZATION STUDY AND DATA MANAGEMENT

NIH RePORTER · NIH · N01 · $5,811,442 · view on reporter.nih.gov ↗

Abstract

1. The Contract Research Organization (CRO) for the NIAAA Medications Development Extramural Clinical Program for the Treatment of Alcohol Use Disorder (AUD) was established under indefinite delivery/indefinite quantity (IDIQ) contract 75N94019D00001 whereby the CRO contractor provides CRO coordination and support services for clinical studies being performed at one or more clinical research sites established under other NIAAA contracts. Work for CRO coordination and support services is assigned via the issuance of independent Task Orders under the subject CRO IDIQ contract. CRO support services include, but are not limited to: clinical trial coordination, clinical site oversight and management, preparation of study documents, electronic data capture capabilities, Good Clinical Practice (GCP) monitoring services, acquisition and facilitation of packaging, shipping and coordination of study medication, logistical and meeting services, regulatory support, statistical and data analysis, and final clinical study report preparation.

Key facts

NIH application ID
11218300
Project number
75N94019D00001-0-759402400002-1
Recipient
FAST TRACK DRUGS AND BIOL
Principal Investigator
JANET RANSOM
Activity code
N01
Funding institute
NIH
Fiscal year
2024
Award amount
$5,811,442
Award type
Project period
2024-09-16 → 2026-09-15