The Clinical Operations Core serves a critical role in coordinating the day-to-day operations of the protocols. The Clinical Operations Core is divided into two main components: 1. Project Management - This team of Project Managers and Coordinators lead all of the day-to-day management of the conduct of the protocol including protocol and procedures development, timeline management, training, and study milestones during start-up, enrollment, maintenance, and close-out. 2. Process and Data Management - This team of Data Management and other support staff leads the effort related to standardization of Clinical Operations Core procedures, providing reliable and consistent support to the study-team at sites and the ADCS, as well as oversight and implementation of protocol specific Data Management activities. In particular the Data Management team focuses on eCRF design and development within the ADCS EDC system, responsibility for data quality controls, and study progress reporting.

Public Health Relevance

The Clinical Operations Core was integrally involved in all aspects ofthe performance of these protocols, including development of protocols and procedures, training and support of sites, coordination of day-to-day operations, and data management. During the current grant cycle, seven protocols initiated during previous grant cycles were carried to completion.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AG010483-23
Application #
8601642
Study Section
Special Emphasis Panel (ZAG1-ZIJ-7)
Project Start
Project End
Budget Start
2013-12-01
Budget End
2014-11-30
Support Year
23
Fiscal Year
2014
Total Cost
$451,012
Indirect Cost
Name
University of California San Diego
Department
Type
DUNS #
804355790
City
La Jolla
State
CA
Country
United States
Zip Code
92093
Mormino, Elizabeth C; Betensky, Rebecca A; Hedden, Trey et al. (2014) Amyloid and APOE ?4 interact to influence short-term decline in preclinical Alzheimer disease. Neurology 82:1760-7
Mormino, Elizabeth C; Betensky, Rebecca A; Hedden, Trey et al. (2014) Synergistic effect of ?-amyloid and neurodegeneration on cognitive decline in clinically normal individuals. JAMA Neurol 71:1379-85
Rafii, Michael S; Taylor, Curtis S; Kim, Hyun T et al. (2014) Neuropsychiatric symptoms and regional neocortical atrophy in mild cognitive impairment and Alzheimer's disease. Am J Alzheimers Dis Other Demen 29:159-65
Whitehouse, Peter J (2014) The end of Alzheimer's disease--from biochemical pharmacology to ecopsychosociology: a personal perspective. Biochem Pharmacol 88:677-81
Burstein, Aaron H; Grimes, Imogene; Galasko, Douglas R et al. (2014) Effect of TTP488 in patients with mild to moderate Alzheimer's disease. BMC Neurol 14:12
Donohue, Michael C; Jacqmin-Gadda, Hélène; Le Goff, Mélanie et al. (2014) Estimating long-term multivariate progression from short-term data. Alzheimers Dement 10:S400-10
Samieri, Cécilia; Proust-Lima, Cécile; M Glymour, Maria et al. (2014) Subjective cognitive concerns, episodic memory, and the APOE ?4 allele. Alzheimers Dement 10:752-759.e1
Galasko, Douglas; Bell, Joanne; Mancuso, Jessica Y et al. (2014) Clinical trial of an inhibitor of RAGE-A? interactions in Alzheimer disease. Neurology 82:1536-42
Sperling, Reisa A; Rentz, Dorene M; Johnson, Keith A et al. (2014) The A4 study: stopping AD before symptoms begin? Sci Transl Med 6:228fs13
Papay, Kimberly; Xie, Sharon X; Stern, Matthew et al. (2014) Naltrexone for impulse control disorders in Parkinson disease: a placebo-controlled study. Neurology 83:826-33

Showing the most recent 10 out of 14 publications