Data Management

Data Management Links

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:

Guidelines and Standards

IT Best Practices & Standards for DAIDS Sites

The "Information Technology Best Practice Standards at NIH HIV/AIDS Clinical Research Networks' 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.

IT Best Practices and Standards for Sites (Last Updated Dec 2018)

Cross-Network Pregnancy Data Standards

The Cross-Network Pregnancy Data Standards present a harmonized approach for capturing pregnancy outcome data variables in the clinical database through common identifiers and naming, question text, SDTM annotations, data type, and response options. These standards are used by the SDMCs of the HIV/AIDS clinical trials networks.

Cross-Network Pregnancy Data Standards V1.0
Cross-Network Pregnancy Data Standards Release Notes V1.0
Cross-Network Pregnancy Data Standards Revision History V1.0

Excel spreadsheet versions of the standards and revision history are available upon request by emailing hancadmin@hanc.info.

Resources

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.

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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.

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