Network Coordinating Center

Major Functions of the ACTG Network Coordinating Center (NCC)

The AIDS Clinical Trials Group (ACTG) Network Coordinating Center (NCC) provides technical, scientific, and administrative expertise under the authority and direction of the Network Principal Investigator and ACTG Executive Committee, and works in close collaboration with the Network Leadership:  the ACTG Network Principal Investigator/Chair, Vice Chair, and International Vice Chair. The NCC, located at Social & Scientific Systems, Inc. (SSS), http://www.s-3.com, has supported the ACTG Network since its inception in 1987.

As an ACTG Network Consortium Partner, the NCC Director is a member of the ACTG Executive Committee (AEC) and the NCC facilitates implementation of the overall ACTG scientific research agenda, harmonizes Network responsibilities, and ensures compliance with policy and procedures among Division of AIDS (DAIDS)/National Institute of Allergy and Infectious Diseases (NIAID), the ACTG Leadership, Clinical Trials Units (CTUs) and Clinical Research Sites (CRSs), Industry, the network laboratories, the Statistical and Data Management Center (SDMC), and other NIAID research networks.  NCC performs the following major functions:

  • Administrative, management, technical, and clinical support for the Network Leadership, committees, and community advocates
  • Management and technical support for protocol development, implementation, and publication
  • Network laboratory structure development and quality assurance
  • Site capacity development and quality assurance
  • Network communications structure, management, and support: meetings, conference calls, web meetings, public and member websites, and portals
  • Development and management of a library of standard operating procedures (SOPs)
  • Quality assurance for information stored on the Management Information System (MIS) which provides  central data tracking and reporting for areas of Network support described below
  • Secure web-based document management system and integration with Network websites

Network Leadership and Committee Support

  • Supports the scientific, resource, study monitoring, and leadership committees
  • Manages communications, meeting coordination, and agenda development
  • Manages ACTG site, laboratory, and network performance evaluation programs
  • Supports the financial disclosure and conflict of interest programs
  • Participates in cross-network activities with other DAIDS-funded networks

Protocol Development, Review, and Implementation Support

  • Manages all aspects of study protocol development through proposal, development, implementation, management, and closure, including protocol documents, amendments, letters of amendment, clarification memoranda, manuals of procedures, and the safety monitoring processes
  • Assists in preparation, submission, and review of manuscripts
  • Registers new non-IND protocols and updates existing non-IND protocols on https://clinicaltrials.gov/
  • Develops and coordinates protocol-specific site training programs at all CRSs

Laboratory Support

  • Conducts international laboratory assessments and approves laboratories to conduct testing for ACTG clinical trials
  • Implements new external quality assurance programs
  • Coordinates the international laboratory infrastructure and  personnel training
  • With the ACTG Leadership Operations Center (LOC), identifies outsourced laboratory resources, materials, and shipping services
  • Tracks specialty laboratory work capabilities and work load for pharmacology laboratories

U.S. and International Site Support

  • Provides support for U.S. and international sites to build research capacity
  • Provides site protocol activations for all ACTG studies
  • Develops and implements site training for participation in ACTG Network and studies
  • Conducts site assessment and training visits
  • Coordinates site establishment and preparedness activities including quality management programs
  • Facilitates participation of community representatives of affected communities in Network activities