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Data Management

​The network Statistical and Data Management Centers (SDMCs) have identified key areas in which the sharing of expertise, resources, and procedures will strengthen the capacity and increase the efficiency of data management operations. Most critically, the Data Management Working Groups are concerned with harmonization of data collection processes and coordination of site infrastructure changes.

SDMC partners include:

 

HANC supports three active data management related working groups:

  • The DMC Harmonization Working Group (DMCWG)
  • The AIDS Defining Events Working Group (ADEWG)
  • The Appendix 100 Working Group (App100WG).

Key DMC Objectives

 

HANC-facilitated data management working groups address objectives outlined in the HANC work plan.

Current priorities include:

  • Ongoing consideration of DAIDS policies affecting network studies.
  • Coordinating and harmonizing ongoing activities at DAIDS and the networks around clinical event data collection and adverse event reporting.
  • Sharing DMC perspective and feedback to DAIDS leadership and program staff.
  • Collaborating with the cross-network Training Committee to identify and address data management training needs.

 

​New Resources!

    IT Best Practices & Standards for DAIDS Sites 

    “The Information Technology Best Practice Standards at Division of AIDS Clinical Trials Study Sites and Site Affiliated Laboratories” is an IT Best Practices and Standards resource for DAIDS sites.  The document was created by the SDMCs and NIH collaborators. 

    More information

    DAIDS Network Studies and EAE Reporting Manual Listing

    The following table contains information for reference purposes only and is updated monthly by the DAIDS-ES Team. It contains the following information, by protocol, about use of  the Manual for Expedited Reporting of Adverse Events to DAIDS:

      • Network
      • Protocol
      • Protocol current status (Pending, Open to Accrual, Enrolling and Closed to Accrual)
      • Expedited Reporting Manual version in effect
      • Reporting methods available (i.e. EAE, SAE and/or SUSAR)
      • Earliest protocol version/LOA available in DAIDS-ES using the noted version of the DAIDS Expedited Reporting Manual.

    This information is provided as a central reference source only.  Always refer to your current protocol for additional EAE reporting information.  Please consult with the protocol team and the Regulatory Support Center to obtain the most up to date protocol and site regulatory information.

    More information

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FSTRF

Frontier Science and Research Foundation (FSTRF) is the data management center for ACTG and IMPAACT clinical trials.

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​SCHARP

The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) is the statistical and data management center for HPTN, HVTN, and MTN clinical trials.

More information

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