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Site Management and Clinical Trials Logistics Coordination Objectives for 2018

Site Management Coordination Objective #1: Work closely with network staff, OCSO and other DAIDS offices to identify and address priority site management issues. Strategies and activities to support this objective:

  • Network Leaders, OCSO, and other stakeholders will identify an evolving list of site management issues and opportunities to better coordinate their respective efforts. This list may include: SDMC issues, reducing confusion around site monitoring by clarifying site new performance monitoring policies, clarifying DAIDS and networks respective responsibilities, harmonizing site establishment and protocol activation processes, identifying fiscal management best practices, and ensuring site preparedness for regulatory audits.
  • HANC will disseminate OPCRO and OCSO policies, memos, SOPs for comment and/or general distribution to network operation centers as requested.
  • HANC will hold monthly calls with HANC and OCSO leadership to facilitate communication and coordination of sitelevel activities.
  • HANC will convene topic-specific working groups on an ad-hoc basis to address site-level issues.

Site Management Coordination Objective #2: Discuss and address issues relevant to harmonization of policies, procedures, and training at the site level across the networks core operations centers. Strategies and activities to support this objective:

  • The Site Management Coordination Working Group will hold monthly site coordinator teleconferences dedicated to addressing significant site issues common across the networks.
  • The Site Management Coordination Working Group will identify opportunities to harmonize the protocol site activation process and procedures across the core/op centers and SDMCs.
  • The Site Management Coordination Working Group will discuss issues that emerge with network leadership, core/operations centers, OCSO, and/or the Office of the DAIDS Director as appropriate.
  • The Site Management Coordination Working Group will provide site-level perspective to DAIDS, SDMCs, and or core/operations centers on new or revised policies and procedures.
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