It Takes a Village: The Collaborative Review Process That Makes VPR Linkages Possible

Since its official launch in 2022, NAACCR’s Virtual Pooled Registry (VPR) has been used in more than 30 minimal risk linkage studies. Each linkage request must meet strict criteria and undergo internal NAACCR review before registries and their Institutional Review Boards (IRB)s evaluate a study for release of cancer data.

VPR linkages happen in two phases. Phase I is the linkage itself, between a researcher’s cohort and the 45 central registries participating in the VPR, and provision of aggregate match counts. Phase II involves the researcher navigating the review and approval process to receive individual-level data on matched cases from selected registries.

Study Criteria

For a study to utilize the VPR, the following requirements must be met:

• Study has (or will have) an existing cohort that meets the following criteria:
  • At least 75% of records contain 9-digit SSN, DOB and either First Name OR Last Name; OR
  • At least 75% of records contain First Name, Last Name, DOB, Gender, and at least one of the following: 4-digit SSN, Phone Number, OR Full Address (excluding P.O. Box).
• Study has a current IRB-approval, IRB exempt determination, or documentation of Not Human Subjects Research.
• Study protocol includes linkage with cancer registries.
• Study consent form includes linkage with cancer registries OR study has a specific waiver of informed consent to link with registries.

Initial Review

When a new VPR linkage request is submitted, NAACCR ensures that all supporting documents are uploaded, the request is clearly written and addresses areas of importance for registries, the linkage with registries makes sense, and the study Personally Identifiable Information (PII) is complete enough to result in a high-quality standardized linkage. Below are the steps we have implemented:

1. Requestor fills out the VPR linkage requests, which captures all the content needed for Phase I linkage assessment and Phase II registry/IRB review.
2. NAACCR staff review the linkage request.
   1. The Program Manager of Virtual Pooled Registry reviews the linkage request with registries and IRBs in mind, ensures that all supporting documents are uploaded, and provides detailed feedback on necessary revisions.
   2. The NAACCR Program Manager of Data Use and Research reviews the list of requested data items, compares it to the study aims, and provides feedback on necessary changes.
3. VPR Research Review Committee (RRC) evaluates the linkage request against standard criteria and provides feedback/questions for the researcher to address. The RRC membership includes representatives from the National Cancer Institute (NCI), Centers for Disease Control and Prevention (CDC), American Cancer Society (ACS), NAACCR, and three central cancer registries. A quorum of five members votes on each linkage request, and the majority must approve the study for it to proceed with Phase I linkage.

Phase I Linkage Development and Testing

1. Upon approval by the RRC, the researcher uploads the study cohort file which has been validated, edited, and encrypted using Match*Pro Linkage Software (Match*Pro).
2. Information Management Services (IMS), NAACCR’s biomedical computing contractor, reviews and validates the study file, provides feedback to the researcher, and creates a linkage configuration file for all registries to use.
3. A volunteer central registry tests the linkage configuration and writes up instructions that undergo further testing by three additional volunteer registries in advance of releasing the study for linkage by the remaining VPR registries.

Phase II

1. After the Phase I linkage is complete and the researcher has selected registries for Phase II, a Central Institutional Review Board (CIRB), managed by the Biomedical Research Alliance of New York (BRANY), reviews the VPR linkage request for any registries whose IRB has delegated review to the CIRB. The CIRB determination letter is made available for all VPR registries, including those using their own IRB.
2. Once approved by the CIRB, study staff complete any remaining applications and Data Use Agreements (DUAs) (compiled in the VPR) required for the registry/IRB review and approval process.
3. Automated reminders and interactive data entry allow the researcher and VPR registries to efficiently process and track the study requests.
4. When approval and fully executed DUAs are in place, registries export the Phase I matches from Match*Pro (cohort ID and requested cancer outcome) and securely transmit the file to the researcher.

It Takes a Village

VPR linkage requests undergo rigorous scrutiny and testing to make the linkage, review, and data release process more streamlined and efficient for registries and IRBs.

NAACCR would like to recognize and thank the member registries involved in reviewing and testing VPR linkages:

• Georgia Cancer Registry
• Cancer Data Registry of Idaho
• Kentucky Cancer Registry
• North Carolina Central Cancer Registry
• South Carolina Cancer Registry
• Connecticut Tumor Registry