About Research Management Data Mart
The vision of Research Management Data Mart (RMDM) is to create the single source of truth for administrative decision making across Duke Health. In order to achieve this--
- Data is integrated from MaestroCare (EPIC), IRB (eIRB), CTMS (eResearch), Finance (SAP and PDC), HR (Faculty and Staff) and other base operational systems to present a complete view of SOM administrative and research portfolio.
- Reports and Dashboards (such as Enrollment, Protocol, Finance etc.) are created to assist with monitoring of individual projects by Principal Investigators and study teams; and, aid administrative management by SOM leadership and CRU management.
A semantic layer of the Business Objects Universe has been created to provide end users the ability to intuitively query and retrieve data consistently. Schematic below shows the current state and long term vision for RMDM.
Use your Net ID and Password to access these Reports and Dashboard. Access is restricted to authorized users. To request access, please contact ORI Research Data Solutions or submit a request through the Service Now Portal.
Note regarding Report Data:
RMDM protocol and enrollment reports are currently unavailable. Duke transitioned to a new IRB system, called iRIS, on May 21st, 2018. Replacement reports will be developed and posted to the website as soon as possible. Enrollment reports should be run through the OnCore system.
If you require assistance with IRB data, please contact the Data Solutions team at ORI-Reports@dm.duke.edu. If you require assistance with enrollment data, please submit a request to the OnCore-Admin-DOCR-ORI queue in Service Now.
Enrollment Reports contain sensitive MRN information and are restricted to approved users. If you are an approved user (e.g. an ARPM, FPM, etc.) and need access to these reports, please submit a request via myRESEARCHnavigators. myRESEARCHnavigators will then route this request to business owners for their approval (e.g. Research Practice Managers).
Enrollment (Portfolio View) (not currently available) - This report displays information (e.g., total enrollment, institutional approval date) on all studies that have ever been approved by the DUHS IRB for a given CRU. Enrollment information on protocols that were institutionally approved prior to MaestroCare go-live (July 1, 2013) is included; these protocols are are noted with a flag.
Enrollment Quick View (Summary) (not currently available) - This report displays demographic information, as well as enrollment status, on all Duke patients enrolled in a given study. Each row represents a unique patient. Enrollment information on protocols that were institutionally approved prior to MaestroCare go-live (July 1, 2013) is included; these protocols are are noted with a flag.
Maestro Care Enrollment Transaction Log (not currently available) - This report displays all enrollment activities logged for all patients in a given study. Enrollment information on protocols that were institutionally approved prior to MaestroCare go-live (July 1,2013) is included; these protocols are are noted with a flag.
View All Studies of Subjects in a Protocol (not currently available) - This report displays information on all studies in which a given patient is enrolled. Users may search for protocols that were approved prior to MaestroCare go-live (July 1, 2013).
Enrollment Counts by Month (not currently available)- This report shows total enrollment, by month, broken down by Clinical Research Unit. The enrollment counts here are based on the algorithm employed by the Enrollment Dashboard. Note: this does NOT include enrollment on protocols institutionally approved prior to MaestroCare go-live (July 1,2013).
Finance Reports (Leadership Users)
Finance Reports contain sensitive financial information and are restricted to approved users designated by School of Medicine, Finance leadership. These reports will refresh data on a monthly basis and will be run ‘on-demand’ by SOM-Finance leadership or their designees for the fifteen Clinical Departments.
Variance Report - This report shows summarized transactions for fifteen clinical departments across both the School of Medicine and the Private Diagnostic Clinic. It allows for calculating variance between the current month’s transactions and the transactions of the prior year month, as well as between the current year-to-date and prior year-to-date.
SAP Reconciliation Report - This report checks the data transferred from School of Medicine SAP source.
PDC Reconciliation Report - This report checks the data transferred from the Private Diagnostic Clinic source.
Finance Reports (Departmental Users)
Variance Report (Departmental) - This report will serve as the Finance Variance Report for departmental users.
RSH010 for Excel Export - This report displays financial transactions (hospital and/or professional billing), to assist FPMs in research HAR reconciliation.
RSH010 by BFR - This report allows users to search financial transactions by BFR.
MaestroCare Protocol Access Report - This report will allow authorized users (RPM/FPM) to view a list of personnel who can view a protocol in MaestroCare, along with their role and user ID. This report will only return protocols for which there is at least one personnel with viewing rights in MaestroCare.
RSH038 HB Charges Awaiting Review - Technical Charges (Accounts) on CRC Review Workqueue (previously known as the Workqueue 2062 report)
RSH061 PB Charges Awaiting Review - Professional Charges Awaiting Coordinator Review.
Charge Reconciliation Report - This report, based off the logic employed in the RSH 010 report, is to help financial personnel reconcile charges between MaestroCare and SAP.
Charge Reconciliation Report Tip Sheet - This tip sheet is provided to help with the Charge Reconciliation Report.
RSH050 Charge Reconciliation Report by Fund Code (Version 2) - This is an updated version of the Charge Reconciliation Report, to assist in SAP - Maestro payment reconciliation. This supports search by one or more fund codes (comma-separated). This report replaces the Charge Reconciliation Report for periods starting Apr 2018 going forward.
RSH50 Charge Reconciliation Report by Fund Code Tip Sheet - This tip sheet provides instructions for Version 2 of the Charge Reconciliation Report
All Key Personnel per Protocol - Be sure to list each IRB number with "Pro" followed by eight digits. You can enter multiple IRB numbers separated by spaces. To paste a list from Excel, copy vertical column of information and click on a blank cell; choose the paste option "Transpose" and then copy the new horizontal area; paste into report field. After searching, you'll need to select the desired results and "Insert" them into the "Choices" box before clicking "Finish." Note: “wildcards” (e.g. %) do not work for this query. This includes studies with a status of 'Approved' or 'Exempt Research'.
Personnel by CRU (not currently available) - This report is delivered in the Web Intelligence (WebI) format, and allows for searching across entire Clinical Research Units (CRU). To search across all CRUs, simply run the report without selecting a specific CRU and all CRUs will be returned. Every user who has access to this report can see across all CRUs. This includes studies with a status of 'Approved' or 'Exempt Research'; this report also includes the CITI Expiration Date for personnel listed.
Specific Personnel by Person DUID - Search by Duke Unique ID (7 digits, including leading zeros). The report will display all studies for which a person is listed as key personnel regardless of CRU. This includes studies with a status of 'Approved' or 'Exempt Research'. Last updated 11/26/2018
Specific Personnel by Person Name (not currently available) - Search by Name. The report will display all studies for which a person is listed as key personnel regardless of CRU. This includes studies with a status of 'Approved' or 'Exempt Research'.
Search by Protocol ID, any CRU (Not currently available) - This report includes basic study and personnel information for specified studies across any CRU. Be sure to list each IRB number with "Pro" followed by eight digits. You can enter multiple IRB numbers separated by spaces. To paste a list from Excel, copy vertical column of information and click on a blank cell; choose the paste option "Transpose" and then copy the new horizontal area; paste into report field. After searching, you'll need to select the desired results and "Insert" them into the "Choices" box before clicking "Finish."
Studies by CRU: All Studies Currently Open with the IRB (Updated January 28, 2019) - Filter based on which IRB Review Type(s) you wish to view. A blank "IRB Approval Date" field indicates a paper conversion, with the original approval date not stored in eIRB. The Healthy Volunteers [Permitted] field will be mostly blank. The process for populating this study attribute in eResearch as part of the grid review process began in 2011. DOCR has plans to back-fill the remainder of data in the future, but study teams now still have the ability to identify subjects they enter in eResearch as healthy volunteers for any "Yes" or blank designated studies.
Studies by Funding Source Type Currently Open with the IRB (not currently available) - If a study has more than one Funding Sponsor of a selected type, or if you choose more than one Funding Source type and the study has Funding Sponsors of both types, the study will be displayed multiple times.
Studies by Phase (not currently available) - Currently Open with the IRB - "Studies not identified as Phase I - IV" is a catch-all for blank or N/A "Phase" fields, as well as options that are no longer available (e.g. "Pilot"); choosing "Select All" should give a complete list of open protocols belonging to your CRU.
Studies with IDEs (not currently available) - Currently Open with the IRB - Filter based on the date range of IRB approval you wish to view. Note that studies with IRB approval dates outside of this range, IRB paper conversion studies, and studies not yet approved will not appear.
Studies with INDs (not currently available) - Currently Open with the IRB - Filter based on the date range of IRB approval you wish to view. Note that studies with IRB approval dates outside of this range, IRB paper conversion studies, and studies not yet approved will not appear.
Studies Currently in Review (not currently available) - This report displays all studies belonging to your CRU submitted to the IRB for review but not yet approved.
Protocol Deviations (not currently available) - This report lists safety events of the type 'Protocol Deviation/Violation, and information on these safety events. Access is restricted by Clinical Research Unit.
All Safety Events (not currently available) - This report lists safety events, and information on these safety events. This report is NOT restricted to a specific type of safety event. Access is restricted by Clinical Research Unit.
Financial Practice Manager - IRB Report (not currently available) - This report displays Initial (IRB) Approvals, Institutional Approvals, Continuing Reviews, and Amendments within the selected date range (inclusive) for protocols within a given Clinical Research Unit (CRU). Initial Approvals, Institutional Approvals, Continuing Reviews, and Amendments are considered to fall within the given date range if they are 'Approved' within that date range. Users will be limited to results within their CRU.
CRU Portfolio (not currently available) - This report will generate aggregate counts, per CRU, of :
- All studies associated with a particular CRU
- Studies with Billing Risk
- Various types of funding supporting, prioritized*, with study statuses of either 'Approved' or 'Exempt Research' within a chosen timeframe
*Funding Sponsor calculation: devised so that there is only one funding sponsor type counted, even if there are multiple funding sponsor types per study. If any funding sponsors are federal/state/local government agencies, then 'Federal.' If any funding sponsors are Industrial/Commercial, then 'Industry.' If any funding sponsors are non-profit/foundation agencies, then 'Foundation'. If any funding sponsors are DUHS, Other, or null, then 'Internal.'
These reports were specifically designed to aggregate data from multiple systems and display it in one report.
Combined Access Report - This report shows key personnel from eIRB, in addition to providers from MaestroCare, giving the user an overview of who is authorized to view what protocols in each system. Users may search by Person Name OR Protocol ID; the report will then group appropriately.
Central Office Finance
eIRB Study Fund Code in MaestroCare - This report shows protocol data from eIRB, eResearch, and MaestroCare (EPIC). It is intended as a replacement for the ART Report of the same name. This report now displays protocols, regardless of IRB status (previously, only protocols with an IRB status of 'Approved' were included).
SAP/eIRB/SPS/MaestroCare Cross System View - This report will display information on protocols from multiple source systems (SAP, eIRB, MaestroCare, and SPS). For each of the key data points available (SAP BFR, SAP Fund Code, eIRB Protocol ID, and SPS Proposal ID) a user will be able to search across systems.
SAP/eIRB/SPS/MaestroCare Cross System View Tip Sheet - This document provides a brief overview of the Cross System View Report.
IRB Charging Report - This report will display information on protocols, amendments, and continuing reviews eligible for charging.
Leadership (Business Metrics) Reports
Leadership Report - This report, in Web Intelligence, displays business process metrics across the protocol lifecycle -- users will be restricted to protocols within their Clinical Research Unit. The report will present timelines (average and medians) of business processes across Fiscal Years, Fiscal Quarters, and Fiscal Periods. Each metric has a start date and an end date and is measured in business days. Note: This report is currently off-line, pending connection with the new OCRC system. Please contact ORI-Reports@dm.duke.edu for any questions.
Leadership Report Guide - This guide is provided to help with using the Leadership Report.
CTSA WOW Metrics - This report calculates CTSA WOW Metrics for DOCR. Included metrics are Contact Sent to Site to Contract Execution at Site and Contract Execution at Site to Site Initiation. Note: This report is currently off-line, pending connection with the new OCRC system. Please contact ORI-Reports@dm.duke.edu for any questions.
Data Guide and Other Information
Federally Funded Multi-Site Research
Sub-sites under U.S. government-funded research where a Duke investigator is the primary grant awardee require their own valid Federal-wide Assurances (FWAs) and IRB approval (occurring at least annually) for the life of the study, regardless of whether sub-sites are domestic or foreign. In addition, sub-sites, regardless of location, must be compliant with the requirements of 45 CFR 46 and applicable OHRP guidance. The DUHS IRB will work with study teams to ensure that the teams have adequate monitoring processes for their sub-sites.
HIPAA and Data Collected Internationally
When the data are in the host country, their privacy regulations apply, but when the data come back to Duke, the HIPAA regulations apply (starting with the determination of whether or not the data are individually identifiable health information (IIHI)). If it is IIHI at Duke Medicine, it is Protected Health Information (PHI), and we need to apply the same controls to the data that we do for our own patients, including the storage of electronic data on our Duke Medicine servers when the data are here. There are some "extra" things that we have to do to address the lack of an individual authorization associated with consent for research. Please contact the DUHS IRB or the Office of Audit, Risk and Compliance (OARC) for help in these circumstances.
Reviewing Patient Charges and Payment Routing
To verify charges and routing, use the Research Billing Review button in Maestro Care. A tip sheet provides complete instructions.
For questions about Research Management Data Mart, or to schedule a Demo of Reports and Dashboard, or to participate in our working groups, please contact The ORI Research Data Team.
The ORI Research Data Solutions team is here to assist you with your research reporting needs. We can develop ad-hoc data requests (data pulls), standing reports, Tableau dashboards or provide access to existing reports.
RMDM is supported in part by the Duke CTSA grant [UL1TR001117].