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. HANC supports two active data management related working groups.

• The DMC Harmonization Working Group includes representatives from Frontier Science and Technology Research Foundation (FSTRF), the Statistical Center for AIDS Research and Prevention (SCHARP), and University of Minnesota. The Working Group meets on monthly teleconferences, and carries out activities to address cross-network data management coordination objectives.
• AIDS Defining Events Working Group includes representatives from FSTRF, the Statistical and data Analysis Center, (SDAC), and SCHARP and meets on monthly teleconferences, and is charged with mapping CDC stage 3 and WHO stages 3 and 4 events into MedDRA codes for intra-DMC use.

Y5 Work Plan Objectives

1. Implement Information Technology Best Practice Standards developed in Year 3 at DAIDS clinical trials study sites/affiliated laboratories and monitor infrastructure changes.
   
   Strategies and activities to support this objective:
• The IT Best Practice standards document will be finalized and made available to all DAIDS Clinical Trials study sites and affiliated laboratories.
• Ongoing monitoring to ensure that infrastructure changes made by one group would not negatively impact the systems used by another IT. The monthly DMC Harmonization calls serve as a forum to discuss proposed changes.
• Consult with OTIS and OCSO and establish understanding of how the organizations will work with the networks.
  
  
2. Complete Laboratory Data Management Systems / Multi-LIMS Manifest harmonization.
   
   The three unique LIMS systems in use in the HVTN network (site affiliated labs use the Laboratory Data Management System (LDMS) as provided by FSTRF; the NICD lab in South Africa; and an endpoint lab use the HVTN LabWare LIMS. The DAIDS Repository (BBI/SeraCare) uses the DAIDS Repository BSI-II LIMS) and was designed to generate system-specific barcode label formats and shipping manifest file formats. Following successful efforts to modify LDMS to accept, import and export manifest files between HVTN LabWare and DAIDS BSI-II LIMS systems, SCHARP and FSTRF propose to work with BBI/SeraCare and HVTN Labware to make additional changes to the manifest format, in order to complete Manifest Harmonization efforts.
   
   Strategies and activities to support this objective:
• SCHARP and FSTRF will maintain code mappings across the LIMS systems as needed; and modify the specimen inventory data elements as requested by SCHARP to appropriately track and QA the data.
• SCHARP and FSTRF will work with each individual collaborating partner to ensure that previously identified common data elements are included and supported in electronic manifest files can be read across multiple systems and reported back to SCHARP as part of an inventory data feed.
  
  
3. Identify site DMC training and support needs and in collaboration with the cross-network lab and training groups. Develop recommended funding and implementation suggestions to address them.
   
   Strategies and activities to support this objective:
• The DMC Harmonization Working Group will collaborate with the cross-network Training Committee to identify and address data management training needs.
  
  
4. Harmonization of MedDRA coding.
   
   It would be advantageous in the long run to ensure that a consistent MedDRA coding of adverse events (e.g., a single reported verbatim has one corresponding MedDRA term) is maintained across network studies. The DMC working group will work with the DAIDS MedDRA consultant and DAIDS MedDRA Working Group (DMWG) towards harmonization of MedDRA coding. These efforts will also achieve a higher standard of MedDRA coding.
   
   Strategies and activities to support this objective:
• The HANC-facilitated AIDS Defining Events will map CDC stage 3 and WHO stages 3 and 4 events into MedDRA codes for intra-DMC use.
• Each network will designate a lead coder who will have completed formal training in MedDRA. This individual may be shared across networks.
• The lead coders are organized into the MedDRA Working Group, which is currently chaired by the DAIDS MedDRA consultant. Eventually it will be chaired by one of the lead coders, at which time the chair will be rotated annually. The Working Group conducts conference calls at least once per month, and will meet face-to-face at least once per year, rotating between network locations.
• The DMWG members developed a DAIDS MedDRA Terms Selection Guidelines document that is a supplement to the MSSO Terms Selection document. The group also developed the MedDRA Versioning Policy for DAIDS that outlines the procedures for updating the network databases with bi-yearly MSSO releases.
• The members of this working group will periodically exchange lists of MedDRA codes used for the first time which will be reviewed by the other coders in light of DAIDS enterprise coding policies. Disagreements in coding will be reported to the chair. The chair will collate the responses and redistribute to the entire working group for discussion and resolution during the monthly conference call. This group is also responsible for reviewing any nominations for the DAIDS-ES synonym list, collecting and reviewing change requests for possible submission to the MedDRA Maintenance and Support Services Organization (MSSO), as well as discussing other MedDRA-related issues and issue consensus statements as appropriate.
  
  
5. Harmonize data definitions and standards for compatible all network use. 
   
   Strategies and activities to support this objective:
• In consultation with DAIDS and network operation centers, SCHARP, SDAC, FSTRF, University of Minnesota will collaborate to determine the feasibility of the project determine to whom, when, and how data elements should be harmonized.
• The group will draft a recommendations document to be circulated to DAIDS and Network Leadership for approval.
  
  
6. Implement clinicaltrials.gov results reporting requirements.
   
   Strategies and activities to support this objective:
• Identify policies and mechanisms for affected studies and existing data management systems.
• SCHARP and FSTRF will continue to communicate challenges and requests to DAIDS and Network Leaders. Experiences will be reported to the full DMC Working Group as needed.
  
  
7. Harmonize clinical event collection policies and procedures to make recommendations on Adverse Events Reporting.
   
   Strategies and activities to support this objective:
• Working group members will review vigilance reporting (FDA requirements and CTA agreements), pregnancy outcomes, the collection of non-AIDS defining events and toxicity tables, and develop in consultation with DAIDS recommendations for standardized cross-network policies and procedures.
  
  
8. Monitor implementation of the DAIDS Expedited Adverse Events Reporting System (DAERS).
   
   Strategies and activities to support this objective:
• Explore the formation of an Adverse Events Reporting Taskforce with representatives from the networks, SCHARP, FSTRF and DAIDS Office of Safety and Pharmacovigilance.
• Maintain ongoing dialogue with DAIDS staff regarding the development and requirements of the DAERS.
• Share experiences interfacing with the DAERS system on monthly DMC conference calls.
  
  
9. Coordinate a one day DMC face-to-face meeting.
   DMC representatives will use the time to present ongoing intra-DMC projects and consider additional areas of coordination.
   
10. Create an email alias for DMCs and network operation center staff.
    The list serve will be a vehicle to share important DAIDS updates and HANC working group
    activities.