92 Honest Broker Tool to Automate Data Extraction from Clinical Research Data Warehouse
OBJECTIVES/GOALS: To describe an Honest Broker (HB) tool and workflow integrated with the Institutional Review Board (IRB) to automate requests, approvals and delivery of both de-identified and identified data extractions from a clinical research data warehouse (CRDW). METHODS/STUDY POPULATION: The...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
Cambridge University Press
2024-04-01
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| Series: | Journal of Clinical and Translational Science |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866124000906/type/journal_article |
| _version_ | 1797226902437494784 |
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| author | Ernest K. Amankwah Bradley Taylor |
| author_facet | Ernest K. Amankwah Bradley Taylor |
| author_sort | Ernest K. Amankwah |
| collection | DOAJ |
| description | OBJECTIVES/GOALS: To describe an Honest Broker (HB) tool and workflow integrated with the Institutional Review Board (IRB) to automate requests, approvals and delivery of both de-identified and identified data extractions from a clinical research data warehouse (CRDW). METHODS/STUDY POPULATION: The HB tool has predefined domain tables and is closely integrated IRB for quick and easy review and approval. Investigators can access patient data using query tools, barcodes from biospecimens or build a query in TriNetX and provide the patient list as an input for the HB tool. For de-identified data extraction, the required data domain tables and date ranges can be selected and submitted in the HB tool. For identified data extractions, investigators with an approved IRB protocol can enter the protocol number and the approved date range in the HB tool. This request is automatically forwarded to the IRB for review. RESULTS/ANTICIPATED RESULTS: For de-identified data extraction, an email alert is automatically sent to the investigator once the data extract is completed. For identified data extraction, if IRB approves the request, an HB is immediately notified to release the data. Data release triggers two emails to the investigator: (1) a link to an encrypted zipped file with the requested data, and (2) a password to unlock the encrypted file. If the request is denied, the IRB sends an email to the investigator with the reason for denial and options for remediation. The entire HB workflow is accomplished in a secure environment with an audit trail from the initial data request to data download by the investigator. Since the launch of the HB tool, the time from data request to delivery is approximately an hour for deidentified data and 24 hrs for identified data. DISCUSSION/SIGNIFICANCE: The HB tool has increased successful data delivery in support of publications, grant submissions, and clinical trial recruitment. Optimization of data extraction from the CRDW through automation and integration with the IRB can minimize interaction with data analysts and IRB staff, thus accelerating the conduct of clinical research. |
| first_indexed | 2024-04-24T14:32:17Z |
| format | Article |
| id | doaj.art-a5045e15b7b343d4aa1a8c6926587737 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-24T14:32:17Z |
| publishDate | 2024-04-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-a5045e15b7b343d4aa1a8c69265877372024-04-03T02:00:33ZengCambridge University PressJournal of Clinical and Translational Science2059-86612024-04-018242510.1017/cts.2024.9092 Honest Broker Tool to Automate Data Extraction from Clinical Research Data WarehouseErnest K. Amankwah0Bradley Taylor1The Medical College of WisconsinThe Medical College of WisconsinOBJECTIVES/GOALS: To describe an Honest Broker (HB) tool and workflow integrated with the Institutional Review Board (IRB) to automate requests, approvals and delivery of both de-identified and identified data extractions from a clinical research data warehouse (CRDW). METHODS/STUDY POPULATION: The HB tool has predefined domain tables and is closely integrated IRB for quick and easy review and approval. Investigators can access patient data using query tools, barcodes from biospecimens or build a query in TriNetX and provide the patient list as an input for the HB tool. For de-identified data extraction, the required data domain tables and date ranges can be selected and submitted in the HB tool. For identified data extractions, investigators with an approved IRB protocol can enter the protocol number and the approved date range in the HB tool. This request is automatically forwarded to the IRB for review. RESULTS/ANTICIPATED RESULTS: For de-identified data extraction, an email alert is automatically sent to the investigator once the data extract is completed. For identified data extraction, if IRB approves the request, an HB is immediately notified to release the data. Data release triggers two emails to the investigator: (1) a link to an encrypted zipped file with the requested data, and (2) a password to unlock the encrypted file. If the request is denied, the IRB sends an email to the investigator with the reason for denial and options for remediation. The entire HB workflow is accomplished in a secure environment with an audit trail from the initial data request to data download by the investigator. Since the launch of the HB tool, the time from data request to delivery is approximately an hour for deidentified data and 24 hrs for identified data. DISCUSSION/SIGNIFICANCE: The HB tool has increased successful data delivery in support of publications, grant submissions, and clinical trial recruitment. Optimization of data extraction from the CRDW through automation and integration with the IRB can minimize interaction with data analysts and IRB staff, thus accelerating the conduct of clinical research.https://www.cambridge.org/core/product/identifier/S2059866124000906/type/journal_article |
| spellingShingle | Ernest K. Amankwah Bradley Taylor 92 Honest Broker Tool to Automate Data Extraction from Clinical Research Data Warehouse Journal of Clinical and Translational Science |
| title | 92 Honest Broker Tool to Automate Data Extraction from Clinical Research Data Warehouse |
| title_full | 92 Honest Broker Tool to Automate Data Extraction from Clinical Research Data Warehouse |
| title_fullStr | 92 Honest Broker Tool to Automate Data Extraction from Clinical Research Data Warehouse |
| title_full_unstemmed | 92 Honest Broker Tool to Automate Data Extraction from Clinical Research Data Warehouse |
| title_short | 92 Honest Broker Tool to Automate Data Extraction from Clinical Research Data Warehouse |
| title_sort | 92 honest broker tool to automate data extraction from clinical research data warehouse |
| url | https://www.cambridge.org/core/product/identifier/S2059866124000906/type/journal_article |
| work_keys_str_mv | AT ernestkamankwah 92honestbrokertooltoautomatedataextractionfromclinicalresearchdatawarehouse AT bradleytaylor 92honestbrokertooltoautomatedataextractionfromclinicalresearchdatawarehouse |