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DMC Coordination Objectives for 2017

DMC Coordination Objective #1: Convene monthly teleconferences to discuss various ongoing data quality assurance projects, identify areas for improvement, provide recommendations, and implement as appropriate.

Strategies and activities to support this objective: 

  • Solicit agenda items from the DMC WG 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 DAIDS Enterprise System (DAIDS ES) team to identify areas for collaboration and enhanced data sharing across DAIDS ES 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: Harmonization of MedDRA coding and revisions of the HIVSTAGE coding program.

Strategies and activities to support this objective: 

  • The HANC-facilitated AIDS Defining Events Working Group (ADEWG) mapped MedDRA codes for CDC and WHO HIV stages for protocol team utilization. The ADEWG consults with the MedDRA Implementation Work Group, facilitated by DAIDS, on MedDRA up-versioning and related MedDRA issues. The HIVSTAGE program is revised based on the recommendations of the ADEWG and maintained by SDAC.

DMC Coordination Objective #3: 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:

  • Consider revising and combining Essential Documents and Source Documents guidance into one document for ease of use by sites.
  • 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 related to electronic signing of CRFs and protocol deviation reporting

DMC Coordination Objective #4: Work with HANC to provide broad access to DMC-related online training resources on topics such as DAIDS toxicity table and MedDRA codes, and Electronic Data Capture (EDC).

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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