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Site Management and Clinical Trials Logistics Coordination Objectives for 2017

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 and harmonizing site establishment and protocol activation processes.
  • 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 site-level 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 address 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 collaborate with representatives from the Cross-Network Evaluation Committee and Community Partners on the process and assessment of impact and quality of community participation at the CAB level.
  • The Site Management Coordination Working Group will discuss issues that emerge from the Site Coordinator WG with the network leaders, 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.

Site Management Coordination Objective #3: Analyze and address security issues associated with physical mailing of Investigator Brochures to institutions and sites.

Strategies and activities to support this objective:

  • Advocate for a secure online electronic database where investigator brochures can be made accessible to sites, institutions, and other stakeholders. This system would eliminate the risks associated with sending physical media in the mail, eliminate the cost of postage, and provide a unified and secure means of accessing sensitive material.
  • Publicize tool if implemented, working with HANC and regulatory groups to ensure broad dissemination.

 

 
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