Fall 2019 NAACCR Narrative Leave a comment

Castine Clerkin, MS, CTR
NAACCR Program Manager of Virtual Pooled Registry



Phase II Pilot Testing

We are excited to share that VPR-CLS pilot testing of Phase II will begin this Fall. Phase II of the VPR-CLS supports a streamlined process of applying for release of individual-level cancer data on matched cases identified in the Phase I linkages. When complete, The Phase II functionality will include use of a web-based Templated IRB/Registry Application (TIRA), a dedicated Central IRB to review minimal risk linkage studies, and a robust and comprehensive tracking system. While the Central IRB is not yet available, the upcoming pilot testing with the Childhood Cancer Survivor Study and the Transplant Cancer Match Study will include use of the TIRA in 33 of the 38 participating registries.

Templated Data Use Agreement (DUA) Task Force

Seven individuals with registry, research, and legal perspectives have been meeting twice a month to develop a Templated DUA that can be adopted by registries participating in VPR minimal risk linkage studies. This small but mighty Task Force has been diligently reviewing existing DUAs, discussing common requirements, and identifying areas where new language is needed to facilitate approved data sharing and publication of results. Once finalized the Templated DUA will be vetted with registries for review and feedback.

Data Sharing Workgroup Volunteers

NAACCR is seeking volunteers to contribute insights and solutions regarding secondary sharing of de-identified study data that includes registry information. According to the final NIH Statement on Sharing Research Data (February, 26, 2003), “Data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data.” Within this succinctly written goal is a complex interplay between Federal mandates and State law, regulations, and registry policies:

  • NIH Data Sharing Policy (effective October 1, 2003) states that applicants receiving NIH funding of $500,000 or more annually must make de-identified data available to other investigators.
  • State laws or registry Data Use Agreements may limit, or not address, such re-release of registry data outside the originally approved study.

The NAACCR Data Sharing Workgroup will seek to better understand the registry context and concerns regarding data sharing, explore the intent/extent of the NIH policy, and develop a plan that will support the NIH Data Sharing Policy while protecting the registry data. Individuals interested in participating can contact Castine Clerkin (cclerkin@naaccr.org).


As always, please contact me if you have any comments or questions!




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