ADCS Clinical Trial Management

The ADCS Clinical Trial Management System (CTMS) is a flexible, scalable, and secure web-based software solution which empowers the ADCS to demonstrate Good Clinical Practice (GCP) and manage all aspects of clinical trial activities including Regulatory Affairs and Ethics, Trial Master Files, Clinical Monitoring and Safety, Laboratory and Biospecimen Information, Supply Management, Site Payments, and Study Source Document Management. By leveraging a strong business process management approach, these solutions improve inspection readiness and allow the ADCS to expedite clinical trial operations in a more transparent, efficient and compliant manner. The CTMS allows users to seamlessly access EDC data through a built-in module which imports data collected through the data portals to the CTMS data warehouse.

Please log in to access the following CTMS modular capabilities:

Study Design and Planning

  • Protocol authoring
  • Protocol synopsis
  • Timeline and milestone planning
  • Study projections
  • Recruitment projections
  • Recruitment planning
  • Protocol recruitment plan
  • Protocol communications plan
  • Protocol recruitment plan template

Study Startup and Initiation

  • Site feasibility and selection
  • Site management
  • Site status tracking
  • Site participating protocol tracking
  • Contract management

Study Conduct

  • Contact management
  • Site protocol role assignment tracking
  • Delegation assignment tracking
  • Protocol deviation review and tracking
  • Source document upload and tracking

Study Management

  • Protocol management
  • Laboratory information management
  • Specimen tracking
  • Protocol deviation review and tracking
  • Query management
  • Alerts and notifications
  • Dashboards

Monitoring Management

  • Monitor site visit management
  • Packets review management
  • Monitoring visit reports
  • Monitor assignment tracking
  • Monitor visit tracking
  • Monitor travel tracking
  • Informed consent form tracking
  • Subject visit report tracking
  • Monitor training

Regulatory Compliance

  • Electronic Trial Master File (eTMF) management
  • Regulatory affairs management
  • Regulatory affairs "Green Light" tracking
  • Regulatory authority approval tracking
  • Investigator credentialing
  • Disclosure and conflict of interest management
  • Investigator master files
  • Audit readiness

Financial Management

  • Payment management
  • Site payment tracking
  • Budget management
  • Payment projection

Training Management

  • Training course and type management
  • Training assignment tracking
  • Training history tracking
  • Deliver various training materials

Report System

  • Site participation status
  • Site regulatory status
  • Projected subject visit report
  • IRB approval status
  • Protocol staff profile status
  • Payment projection report
  • Monitor packets review status
  • Monitor report tracking
  • Monitor assignment status
  • Monitoring visit projection
  • ADCS disclosure report
  • Training history report

Document Repository

  • Document management
  • Repository of all study-specific documents
  • Collected document tracking
  • Study recruitment materials
  • Standard operating procedures

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ADCS Preliminary Proposals

The ADCS requests preliminary proposals for therapeutic trials to be conducted by the ADCS with potential funding from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH). More...

ADCS Site Application

The ADCS is affiliated with investigators and research centers throughout the United States, Canada, and Europe. If you are interested in becoming an ADCS consortium site, More...

ADCS Upcoming Events

Steering committee Meeting

MEETING DATES

ADCS Steering Committee Meeting

Saturday, January 25, 2014

8:30 AM - 4:30 PM

Sunday, January 26, 2014

8:30 AM - 12:00 PM


MEETING LOCATION

The Palace Hotel

2 New Montgomery Street

San Francisco, CA 94105


MEETING REGISTRATION

Steering Committee meetings are by invitation only. Invitations are sent via e-mail to all Steering Committee members. If you feel that you should have received an invitation to either the ADCS or ADNI Steering Committee meeting, please contact the ADCS Travel Team at adcstravel@ucsd.edu. More...

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