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DMC Coordination Objectives for 2018

DMC Coordination Objective #1: Convene monthly teleconferences to discuss various ongoing data quality assurance projects, identify areas for improvement, provide recommendations, and implement new processes and procedures as appropriate. Strategies and activities to support this objective:

  • Solicit agenda items from the DMCWG for the monthly DAIDS-ES All Collaborators call.
  • Monitor cross-DMC standardization support needs for AE/EAE reconciliation. Strategies to support this include: working with DAIDS to identify data elements that are required to be reconciled, maintain ongoing dialogue with DAIDS staff regarding challenges encountered with reconciliation.
  • Liaise with NIAID CRMS team to identify areas for collaboration and enhanced data sharing across NIAID CRMs and the SDMCs.
  • Share CDISC implementation activities across DMCs; e.g., regularly check in with CDISC consultant, assist in coordination, and discuss developments across the networks.

DMC Coordination Objective #2: Work with appropriate regulatory groups to assist in the development of procedures and processes related to electronic data capture (EDC), electronic signatures, protocol deviation reporting, etc. Share developments in these procedures and processes across networks and data management centers. Strategies and activities to support this objective:

  • Disperse information on EDC to networks and sites for new and transitioning studies.
  • Liaise with network performance/evaluation committees and OCSO to adapt new policies and procedures as appropriate for the transition to EDC as it impacts site performance evaluation metrics and site monitoring procedures.
  • Liaise with OPCRO and OSCO to provide feedback on proposed policies and procedures.

DMC Coordination Objective #3: Work with HANC to provide broad access to DMC-related online training resources on topics such as the DAIDS Toxicity Table and Electronic Data Capture (EDC) systems. Strategies and activities to support this objective:

  • Select appropriate training resources for consolidation in the HANC training library, working with other groups to ensure relevant and broad selection of appropriate training materials.
  • Publicize training opportunities by reaching out to network DMCs and other network members through HANC and other means as appropriate.
  • Respond to requests for training materials, update training topics when appropriate, and monitor resource usage via HANC staff.
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