Groups

Biostatistics

The ATRI Biostatistics Section is an internationally recognized biostatistics research group specializing in the design, conduct and analysis of multi-center randomized clinical trials, natural history studies, participant registries and translational research in neurology with a focus on Alzheimer’s Disease (AD) and AD related disorders (ADRD). Section faculty and staff advance the Institute mission through innovative statistical research, biostatistical collaboration and leadership, and state-of-the-art education and training programs in biostatistics and clinical trials.

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Informatics Unit

The Informatics Unit is responsible for developing and maintaining the data collection system as well as providing data management support including the generation and maintenance of electronic case report forms, development and implementation of quality control procedures, data collection and study tracking. Informatics will develop and maintain the Informatics Platform to support the program and its scientific aims. The platform will serve as an extensible, secure, and scalable information, collaboration, and process management infrastructure to facilitate the effective execution of program- and study-related research activities by ATRI Units, investigators, study teams, and performance sites.

• Data Management

  The Data Management Unit is responsible for providing data management support including the generation and maintenance of electronic case report forms, development and implementation of quality control procedures, assuring resolution of all data queries, and developing optimal field-level form-level, visit-level, subject-level and study-level quality analysis.

  The quality assurance and reporting done by the Data management Unit ensures the quality of the data for analysis and supports the ATRI units in the management of ATRI studies.

• Software Development and Engineering

  The Software Development and Engineering group operates underneath the Informatics unit at ATRI.

• Information Technology

  Architect and Manage IT Infrastructure and Services

Medical Safety

Medical Safety is responsible for the clinical site monitors, interaction with the Data and Safety Monitoring Board (DSMB) and processing clinical and adverse event data. The Unit provides medical and regulatory supervision for all our clinical trials and studies. This is generally accomplished by three key activities: 1. Medical and safety monitoring; 2. Coding and review of all adverse and serious adverse events; 3: Responding to medical questions from sites regarding study conduct. The ultimate goal of the Medical unit is to develop better methods for clinical trials safety monitoring, including risk-based monitoring, semi-automated coding of adverse events and concomitant medications and real time support for clinical trial sites.

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• Medical Monitoring

  • SAE reviews
  • AE MedDRA coding
  • Eligibility questions
  • Medical management questions
  • Abnormal lab/ECG/MRI reviews
  • Protocol deviation reviews

• Clinical Monitoring

  • In-person and remote site visits
  • Site communication and documentation
  • Study timelines and deliverables
  • Source Document Verification
  • Drug Accountability Review
  • Query resolution

Administrative Group

The Administrative Group provides the overall administration of the Institute. Essential components include Regulatory Affairs, Fiscal Management, Contracts, Human Resources, Outreach Communications and Quality Assurance. The main areas of responsibility of the Administrative Unit are the the establishment and maintenance of subcontracts with each of the many sites participating in all ATRI trials and studies.

Biomarker Lab & Biorepository

The Biomarker Lab & Biorepository handles the sample processing and analyses of biospecimens collected during clinical trials. In a single day the wet labe may receive hundreds of samples for processing, and in some cases test plasma and Cerebrospinal fluid (CSF), the liquid around the brain and spinal cord, for Alzheimer’s disease biomarkers.

The Biorepository serves as a national library for federally funded AD trials. This primarily involves long term storage and sharing of study samples and data. This newly expanded facility now has the capacity to hold 248 minus 80ºC freezers which can hold 11.57 million samples.

Clinical Operations

The Clinical Operations Unit is responsible for developing, updating and distributing study documents (protocols, training and procedure manuals), coordinating and organizing the clinical trial activities at the sites, tracking enrollment and assigning open enrollment slots, managing and distributing study supplies, acting as the primary point of contact for the sites, and coordinating clinical operation activities.

Neuropsychology

The Neuropsychology Team, led by Cecily Jenkins, PhD manages activities involving assessment of cognition in observational and clinical trials coordinated by ATRI. Measuring memory function and other key thinking abilities of trial participants is a highly meaningful indicator of effectiveness of study ‘medications’ thought to have potential for slowing decline in cognition or improving other negative symptoms associated with Alzheimer’s disease.

Recruitment, Engagement and Retention

The ATRI Recruitment, Engagement and Retention section is responsible for developing, overseeing, managing, and implementing cutting-edge strategies and tactics to accelerate participant accrual, improve representation through enhanced participant demographic diversity, and maximize retention in studies managed by the Institute using culturally cognizant, data-driven, and evidence-based approaches. An important academic area of focus is the advancement of recruitment science to design and test strategies and tactics of engagement, and to evaluate the structure of the study to promote balanced participation across diverse populations.

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