Data Access & Management Committee

Goals

  1. Recommend to the Registry Executive (CCEDRRN EC) approval for access to data for approved Registry Studies, Non-Registry Studies and Single Site Studies and writing groups in compliance with the Membership Agreement.
  2. Ensure patient privacy and ethical conduct of research conducted with CCEDRRN data according to World Health Organization guidelines on the ethical conduct of research during public health emergencies.1
  3. Ensure access to CCEDRRN data is in-line with applicable regulations and standards in Canada, while allowing researchers timely access to study data.
  4. Promote access to data in line with the Membership Agreement and the Joint Statement of sharing research data and findings relevant to the novel Coronavirus (nCoV) outbreak.2
  5. Manage the data elements, quality and timeliness of the data entry
  6. Address any UBC data breaches to privacy in compliance with the UBC (insert ref to UBC breach management protocol or policy).
  7. Ensure all sites are aware they must address all local privacy breaches in accordance with local privacy policy through to resolution.
  8. Review concerns relating to data access from member institutions and make recommendations to the CCEDRRN EC.

Deliverables

Deliverables

  • Prompt review of all Registry study and non-Registry study protocol summaries received from the PRPC requesting access to Network Data.
  • Prompt review of all Registry study writing group proposals received from PRPC
  • Timely recommendations to the CCEDRRN EC on all study protocols
  • Provide access to datasets for approved Registry studies, non-Registry studies and Single Site studies, consistent with the provisions set out in the Membership Agreement.
  • Develop a Privacy Impact Assessment (PIA), a Security Threat and Risk Assessment (STRA), and Data Management Plan (DMP).
  • Maintain the Data Management Plan to ensure it is current at all times.
  • Determine data cut points for analysis and data access.
  • Develop data cleaning protocols to ensure high quality data.
  • Identify secure and appropriate data access or transfer mechanisms.
  • Ensure secure storage of verified records for all relevant registry data transfers.

Membership

  • The NPI-assigned DAMC Chair
  • Vice-Chair elected from members
  • 1 UBC Data Manager
  • 8 Provincial Liaisons (1 per province)
  • 1 External Scientist with expertise in registry, clinical decision rules, ethics and privacy
  • VCHRI (Vancouver Costal Health Research Institute) Privacy Officer
  • UBC Ethics
  • Ex-officio members: VCHRI/UBC Legal Officer, HDRN liaison, Biostatistician, Graduate Student and/or Post-Doctoral Fellow) may serve an advisory role as needed, at the invitation of the DAMC chair.
  • Membership terms will be two-year in length with the possibility of renewal

Governance

  • All votes require a minimum quorum of five (5) committee members, including at least 2 individual members who are not CCEDRRN Site or Provincial Leads, or the Steering Committee Chair or Vice Chair. In the absence of quorum, decisions are to be circulated electronically to Committee membership via email with option to revisit decisions, as required. Voting may occur via email. Approval must be unanimous in order to recommend data access approval to the Executive Committee.
  • Members must avoid potential conflicts of interest that may arise from financial ties to any commercial concerns likely to be affected by the outcome of the study, or the appearance of a conflict of interest such as a professional or other affiliation that could cause others to question the objectivity of their deliberations.