Winter 2019 NAACCR Narrative Leave a comment


Castine Clerkin, MS, CTR
NAACCR Program Manager of Virtual Pooled Registry
cclerkin@naaccr.org

 

 

I’m excited to welcome in 2019! We found out late last year that the NCI funds intended to support registry participation in future VPR-CLS linkages were not going to be available due to budget cuts. While somewhat disappointed, we informed registries that we’d aim for funding in 2020 and quickly focused on the silver lining. This grace period allows us more time to (1) test the full VPR-CLS functionality with additional cohorts, (2) perform registry outreach to expand acceptance of the Templated IRB/Registry Application, (3) establish a contract for the NCI Central IRB, and, (4) explore other key initiatives that support a streamlined application and data release process.

VPR-CLS Pilot Testing: Last October we completed our first pilot test of the Phase I VPR-CLS functionality which included linkage using Match*Pro and release of aggregate match counts to the researcher. This test between the Childhood Cancer Survivor Study and 35 registries was very successful and provided the study investigators with valuable information. In 2019, we will expand our testing to include the Phase II functionality. Phase II allows the streamlined submission and tracking of registry/IRB requests for release of individual-level data on matched cases identified during Phase I. Phase II will include use of the Templated IRB/Registry Application. We have identified five cohort studies, including the Childhood Cancer Survivor Study, that are excited to participate in the next round of testing, with 2-3 studies testing all the way through Phase II.

Templated IRB/Registry Application: This application compiled common questions from across over 50 registry and IRB applications and has undergone one round of vetting with cancer registries. An updated version of the Templated IRB/Registry Application was recently finalized. Over the next few weeks this document will be shared with registries for any additional feedback. I will also be talking with states that had yet to decide whether they were able to adopt this form for minimal risk linkage studies coming through the VPR-CLS. The aim is to address any concerns about the Template and expand acceptance.

Central IRB: NCI and NAACCR are currently holding informational calls with registries/IRBs to better understand the requirements and mechanisms necessary for a local/state IRB to cede review to the Central IRB, as well as how local context issues are to be handled. This information will help guide the inclusion of this task as a requirement within the statement of work and estimated cost for the RFP. NCI also plans to hold industry calls with commercial IRBs, entities which don’t normally follow the government RFP release websites, to talk about the CIRB plans and respond to questions. The RFP will include a copy of the Templated IRB/Registry Application that the Central IRB will be asked to use. The goal is to post the RFP this spring.

Other Key Initiatives: Another high priority initiative is to develop a Templated Data Use Agreement (DUA) that can be used in lieu of state-specific DUAs. NAACCR is creating a Templated DUA Task Force and anyone interested in actively contributing to this important initiative can contact me at cclerkin@naaccr.org.

As always, I’m happy to hear from registries with any comments, questions, or concerns!

 

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