Among its many responsibilities, the ADCS Administrative Core provides administrative, fiscal, and regulatory support for the organization as a whole. In addition, the Administrative Core, through its Minority Recruitment Core, oversees study participant recruitment and retention. The Administrative Core liaises with Steering Committee members, the External Advisory Board (EAB), as well as other external and internal stakeholders. The Administrative Core coordinates and executes all ADCS Steering Committee and related subcommittee meetings. The Administrative Core also makes decisions involving coordinating center policies, prioritizing work flows, and allocating resources and personnel. Likewise, it oversees the development of ADCS standard operating procedures (SOPs). Furthermore, the Administrative Core is essential to the function of the ADCS as a cohesive unit and ensures the entire cooperative study operates efficiently.
The Finance Unit of the Administrative Core provides fiscal control for the operations of the ADCS, generates payments to participating research sites for work completed, establishes and maintains contracts with vendors and research sites, and manages all aspects of ADCS grant proposal submissions.
Recruitment and Retention
The Recruitment and Retention Unit maximizes efficient enrollment of participants and subsequent successful retention. The recruitment coordinators use many well-thought-out techniques including newsletters, web-based communication, direct mail, press releases and placement of all studies on both public and private clinical study websites. They also provide training to the participating sites on recruitment, retention, and public relations and making use of local media. Tools are provided for the sites, including reference cards, bookmarks, flyers, brochures, protocol-specific information sheets, videos and DVDs, and newsletters. The team monitors enrollment at each site and offers assistance for identifying recruitment barriers and potential target audiences.
The Regulatory Affairs (RA) Unit manages the regulatory complexities of the ADCS clinical trials. The RA unit assists with protocol development and works with the Project Directors to ensure the protocol meets all regulatory requirements, including those for the informed consent, HIPAA and NIH data-sharing requirements. The unit creates, reviews, and assesses research material that is submitted to regulatory agencies, affiliated institutions, and their Institutional Review Boards (IRB). Regulatory files are maintained at the Coordinating Center and include current IRB approvals and other essential documents for each project where a research site participates. Ongoing communication with the IRB, sponsors, the FDA, and other regulatory agencies allows the RA unit to ensure submission and follow-up of appropriate documentation at the local level. The unit has designed a very thorough protocol initiation process and collaborates with study sites to work through this process in order for the RA to release study drug and approve sites for subject enrollment. In addition, the RA unit oversees and collects Conflict of Interest reports for all members of the ADCS.
Information Technology and Software Development
The Information Technology and Software Development Unit develops technology solutions and manages computing infrastructure, network connectivity and security for ADCS. The staff researches and develops software systems for the ADCS, such as the ADCS public website, the administrative website, the contact management system, the site payments system, the requisition management system, and the asset tracking system. It also provides technical services and support to the Administrative Core, Medical Core, Clinical Operations, and the ADCS Biomarker Lab.
The Biomarker Core provides laboratory support for all ADCS clinical trials. The core consists of a wet laboratory and a biospecimen bank. The core processes and banks blood, DNA, plasma/serum, and CSF samples from patients who participate in ADCS trials.
In addition, the Biomarker Core is responsible for ApoE genotyping analyses, and drug PK and compliance. The Biomarker Core works closely with the Clinical Operations Core to assemble supply lists, develop procedure manuals, and assist with protocols for ADCS Clinical trials. The goal of the Biomarker Core is to use bioassays to provide endpoint biomarker data on the impact of the treatment regime in clinical trials and to identify novel biomarkers for AD from a research perspective.
The Biostatistics Core provides biostatistical expertise for the design, management, and analysis of the Alzheimer’s Disease Cooperative Study (ADCS) clinical investigation and generates randomization sequences for treatment allocation for all ADCS RCTs. More specifically, the Biostatistics Core is charged with the following responsibilities:
- Study Design
- Study Analysis and Closeout
- External Collaborations
The Clinical Operations Core has directed the initiation, implementation, day-to-day activities, and close-out for 23 completed or ongoing multicenter clinical studies, as well as 7 multicenter protocols to develop novel instruments for use in AD clinical studies. This group provides ongoing daily support to the study centers, such as designing and providing graphic study materials, participant and study site newsletters, and other documents. The number of centers participating in each protocol has ranged from 9 to 80, with the majority of protocols consisting of 20 or more participating centers.
The Information Technology (IT) Core operates the ADCS Clinical Trials Monitoring System (CTMS) and effectively hosts ADCS websites, manages regulatory and disclosure web tools, provides help-desk support for systems and productivity software, creates software tools to enable payment of site activity based on validated EDC entries, and creates and maintains the network infrastructure for all ADCS Cores.
The IT Core works with the medical coder and data management personnel to develop data tables, spreadsheets, and data summaries related to adverse events, serious adverse events, and concomitant medications. The IT Core also has made progress in developing web-based tools and integrating existing systems to streamline coordinating center activities.
The Imaging Core serves the imaging needs of ADCS Clinical Trials, including imaging protocol design, site setup, imaging data QC and management, and quantitative analysis for secondary outcome measures.
The Imaging Core provides the following services:
- Magnetic Resonance Imaging (MRI)
- Positron Emission Tomography (PET)
For all studies, the data are to be managed, organized, and curated to assure a format that facilitates wide sharing of these valuable data once the study is complete, including robust procedures to confirm that these complex data objects are free of patient identifying information.
At study closeout, the Imaging Core works closely with other cores to procure high quality and optimally curated imaging data analyzed with state-of-the-art approaches.
The Informatics & Data Management Core provides computer analysis tools for the ADCS and assists with the daily operations of all ADCS clinical studies.
The Informatics group of the Informatics & Data Management Core provides computer programmers analysis for the ADCS. The Informatics group is committed to providing ADCS with a set of secure, high quality, and cutting-edge web-based data management services and applications to facilitate research activities such as:
- Online Clinical Trial Portals
- Electronic Data Capture
- Quality Assurance Toolkits
- Data Mining
- Online Reporting
- Distributed Document Repository
With a rich pipeline of new services and applications, this core is well positioned to continue to deliver innovative data management solutions to the ADCS.
As a leading-edge academic provider of Biomedical Informatics services, the Informatics group strives to develop and deploy innovative methods and solutions that enhance:
- Data Capture
- Data Integrity and Validity
- Ensure Regulatory Compliance
- Support the Efficient Completion of Research Objectives
Thus, accelerating the rate of scientific discovery and optimizing return on research investments. The staff of the Informatics group has extensive experience providing informatics services to facilitate the conduct of multi-site randomized clinical trials and observational studies.
The ADCS Data Management group is responsible for the day-to-day operations of all ADCS clinical studies from inception to final data analysis.
The Data Management group is comprised of the following groups:
- Data Entry
- Quality Control
- Data Systems
Data entry, data reporting, subject approval, randomization, quality control, analysis, and study tracking are implemented using the automated web based system connected to a central data base. All Project Directors and ADCS Coordinating Center staff has remote online access to a private intranet customized for each protocol. The Data Management group provides support for each protocol, including working with the Project Director and the ADCS Principal Investigator on protocol development and finalization, organizing and coordinating each protocol training meeting, generation of case report forms, ongoing training of new site staff, data collection and quality control, and study tracking.
Online reports are continually available for viewing by the Project Director and Coordinating Center staff using a web browser to track the progress of study enrollment and ongoing study visits from site to site. The staff manages data collection and quality control online. Data are entered electronically into the online system using a web interface via online electronic forms with embedded real time data checking algorithms to provide immediate quality feedback.
The Medical Safety Core (MSC) provides medical oversight of trial activities through a comprehensive system of medical and safety monitoring for all ADCS studies.
Medical Operations Aspect
The Medical Operations of the MSC provides immediate, independent Safety Physician review of all serious adverse events (SAEs), as well as clinical oversight to ensure patient safety by systematically processing, coding, and reviewing study-related safety data.
Clinical Monitoring Aspect
The Clinical Monitoring aspect of the MSC is to provide off-site review of eCRF’s, on-site monitoring of study procedural compliance and data in all ADCS clinical trials, as well as provide training and certification for all ADCS monitors.
The specific aims of the Minority Recruitment Core is to maximize participation of minorities in all aspects of ADCS research efforts and to ensure that their interests are represented in our research agenda. The Minority Recruitment Core provides a full range of recruitment and retention activities to increase minority participation, reviews protocols with Project Directors to reduce barriers to minority recruitment, evaluate sites for selection with regard to maximizing minority recruitment, supports and trains staff in recruitment and retention activities, and evaluates all ADCS activities to ensure compliance and effectiveness in minority recruitment.