Presented by: Don Green

Slides:



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Presentation transcript:

Presented by: Don Green greend@imseb.com Web Portal for Virtual Pooled Registry Cancer Linkage System (VPR-CLS) NAACCR 2019 Conference June 12, 2019 Presented by: Don Green greend@imseb.com

Acknowledgements Funded by the National Cancer Institute (NCI) Coordinated by the North American Association of Central Cancer Registries (NAACCR) Developed by Information Management Services, Inc. (IMS)

Overview Website Functionality Linkage Request Workflow and Website Demo Status of the VPR-CLS development

Website Functionality Tracking of Each Request Automated Notifications Security and Privacy Exchange of Files

Tracking of Each Request Every step in workflow is monitored and displayed via the website Registries involved in a particular request and associated status Examples of information that are tracked for each request: When initial application for VPR linkage is approved/denied When a requestor’s study file is posted for registries to download Which registries have performed the linkage with the study file and the resultant linkage counts Type of application required to request individual-level data and status of the request Requestor and registry liaison update system information at certain points in the workflow

Automated Notifications E-mail notifications sent when action taken for any request or if an action has not been taken in a timely manner Examples of requestor notifications: When the status of a request has changed When linkage match counts have been submitted by a registry Reminders for reporting of publications or study renewal Examples of registry notifications: When a new study has been approved for VPR linkage When the study file for an approved study is ready for registry linkage When a Requestor submits Templated Application (TIRA) to receive data on matched cases When anticipated IRB/Registry review date has passed and no approval status is known

Security and Privacy An account will be needed in order to apply for a request All file transactions will be secure Requestors and Registries will only be able to view, update and exchange files related to requests they are involved with Release of registry record-level data will go directly from the registry to the requestor and not through the VPR-CLS

Exchange of Files Standardized requestor study file Match*Pro configuration files Registry match count reports Templated IRB/Registry application and supporting documents (e.g. study protocol, consent form, institutional IRB approval, etc.) Registry/IRB approval and signed DUA

Linkage Request Workflow and Website Demo Website Structure and Content Linkage Request Workflow Phase I Workflow Phase II Workflow Registry Dashboard Reports

VPR-CLS Home Page Resources About Virtual Pooled Registry VPR Fact Sheets Preparing a Study Data File Provided Software General FAQ’s Participating Registries

Linkage Request Workflow 1 Requestor Submits a Request to Link 2 Request Reviewed by NAACCR and Voted on by Research Review Committee 3 Requestor Submits a Study File 4 IMS Study File Validation and Creation of Match*Pro Configuration File 5 Registry Performs a Linkage and Uploads the Match Counts 6 Requestor Reviews Matches and Selects Registries to Approach to Obtain Record-Level Data 7 Templated IRB Application Form (TIRA) is Submitted by the Requestor 8 Additional Required Registry/State forms are Submitted by the Requestor 9 Registry/State Approves the Request and Releases Record-Level Data 10 Renewal and Reporting 11 Data Destruction Phase I Phase II

Phase I Workflow Notifications 1 Requestor Submits a Request to Link 2 Request Reviewed by NAACCR and Voted on by Research Review Committee 3 Requestor Submits a Study File 4 IMS Study File Validation and Creation of Match*Pro Configuration File 5 Registry Performs a Linkage and Uploads the Match Counts Requestor is notified that request was received. NAACCR notified to review request.

Phase I Workflow Notifications 1 Requestor Submits a Request to Link 2 Request Reviewed by NAACCR and Voted on by Research Review Committee 3 Requestor Submits a Study File 4 IMS Study File Validation and Creation of Match*Pro Configuration File 5 Registry Performs a Linkage and Uploads the Match Counts If NAACCR approves: Committee members are notified that they can vote. If approved by the committee: IMS notified to review request and sign IMS DUA. All registries involved in the request are notified. The Requestor is notified of approval and asked to upload their study data file.

Phase I Workflow Notifications 1 Requestor Submits a Request to Link 2 Request Reviewed by NAACCR and Voted on by Research Review Committee 3 Requestor Submits a Study File 4 IMS Study File Validation and Creation of Match*Pro Configuration File 5 Registry Performs a Linkage and Uploads the Match Counts IMS notified that file has been uploaded.

Phase I Workflow Notifications 1 Requestor Submits a Request to Link 2 Request Reviewed by NAACCR and Voted on by Research Review Committee 3 Requestor Submits a Study File 4 IMS Study File Validation and Creation of Match*Pro Configuration File 5 Registry Performs a Linkage and Uploads the Match Counts Registries notified to download the files, perform the linkage, and upload the Match Counts. NAACCR is notified that the registries can now upload the Match Counts.

Phase I Workflow Notifications 1 Requestor Submits a Request to Link 2 Request Reviewed by NAACCR and Voted on by Research Review Committee 3 Requestor Submits a Study File 4 IMS Study File Validation and Creation of Match*Pro Configuration File 5 Registry Performs a Linkage and Uploads the Match Counts Registries reminded when they are overdue uploading their match counts – given 2.5 weeks. Requestor is notified when 80% of the registries have uploaded their match counts. Requestor notified when all registries have uploaded their counts.

Phase II Workflow Notifications 1 Requestor Reviews Matches and Selects Registries to Approach to Obtain Record-Level Data 2 Templated IRB Application Form (TIRA) is Submitted by the Requestor 3 Additional Required Registry/State forms are Submitted by the Requestor 4 Registry/State Approves the Request and Releases Record-Level Data 5 Renewal and Reporting 6 Data Destruction All registries selected are notified once the Requestor checks out.

Phase II Workflow Notifications 1 Requestor Reviews Matches and Selects Registries to Approach to Obtain Record-Level Data 2 Templated IRB Application Form (TIRA) is Submitted by the Requestor 3 Additional Required Registry/State forms are Submitted by the Requestor 4 Registry/State Approves the Request and Releases Record-Level Data 5 Renewal and Reporting 6 Data Destruction Registries are notified that the TIRA has been submitted. NAACCR notified.

Phase II Workflow Notifications 1 Requestor Reviews Matches and Selects Registries to Approach to Obtain Record-Level Data 2 Templated IRB Application Form (TIRA) is Submitted by the Requestor 3 Additional Required Registry/State forms are Submitted by the Requestor 4 Registry/State Approves the Request and Releases Record-Level Data 5 Renewal and Reporting 6 Data Destruction Each registry involved is notified when the Requestor indicates they have completed the forms.

Phase II Workflow Notifications 1 Requestor Reviews Matches and Selects Registries to Approach to Obtain Record-Level Data 2 Templated IRB Application Form (TIRA) is Submitted by the Requestor 3 Additional Required Registry/State forms are Submitted by the Requestor 4 Registry/State Approves the Request and Releases Record-Level Data 5 Renewal and Reporting 6 Data Destruction Requestor is notified when registry responds. Requestor is notified when they need to provide more information or resend a form. Registries notified if they are tardy.

Phase II Workflow Notifications 1 Requestor Reviews Matches and Selects Registries to Approach to Obtain Record-Level Data 2 Templated IRB Application Form (TIRA) is Submitted by the Requestor 3 Additional Required Registry/State forms are Submitted by the Requestor 4 Registry/State Approves the Request and Releases Record-Level Data 5 Renewal and Reporting 6 Data Destruction Requestor notified of pending dates. Requestor notified of late dates.

Phase II Workflow Notifications 1 Requestor Reviews Matches and Selects Registries to Approach to Obtain Record-Level Data 2 Templated IRB Application Form (TIRA) is Submitted by the Requestor 3 Additional Required Registry/State forms are Submitted by the Requestor 4 Registry/State Approves the Request and Releases Record-Level Data 5 Renewal and Reporting 6 Data Destruction Requestor notified when to remove data. Registries notified of data destruction.

Registry Dashboard Reports Upcoming/Pending Requests Phase I – Match at Registry Phase II – Registry/IRB Review Completed Requests Report by Due Date and Action Required

Development Timeline Phase I: Phase II: Round two of pilot testing underway Phase II: Pilot testing this summer Anticipated to be completed by the end of 2019

Thank You