Research Business Reports

RSH010 for Excel Exports - The RSH010 reports display financial transactions (hospital and/or professional billing), to assist Financial Practice Managers in reviewing charges as part of FAM processing.

     RSH010 Search by Fund Code

     RSH010 Search by Protocol

     RSH010 Search by BFR 

RSH038 HB Charges Awaiting Review - Technical Charges (Accounts) on CRC Review Workqueue (previously known as the Workqueue 2062 report)

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.

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'. 

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'.

Study Contacts - This report pulls the study teams/contacts and upcoming expiration dates on all Approved, open Exempt, or Re-Opened studies by CRU for reference. Note: The report takes up to 4 min to run depending on the number of CRUs for which you have access.

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 CRU: All Studies Closed with the IRB within Time Frame - Returns all of the non-exempt studies within your CRU(s) that have closed with the IRB office within the time frame that you specify. All information is from iRIS except where noted.  Accompanying is the OnCore closure information, in the columns furthest to the right.  (When a study was abandoned in OnCore rather than closed, this information is substituted.)

Protocol Deviations - This report lists safety events of the type 'Protocol Deviation/Violation, and information on these safety events. Access is restricted by Clinical Research Unit.

iRIS Study Fund Code in MaestroCare - This report shows comprehensive protocol information from iRIS, OnCore, and MaestroCare (EPIC).

CRU Review Metrics – Returns all studies and respective review milestones within your CRU(s) that have been approved within the time frame that you specify. Tab 1: high-level review milestones for each study, with one row per study, showing the dates for when CRU, IRB, and specialty committees began review and approved (if applicable). Tab 2: CRU level detail: granular level with one row for each CRU review per study (so that there may be multiple rows per study when the application is passed back to the study team for revisions).

iRIS IND Drug Search – Searches for up to three drugs (identified by drug name) being employed by any studies Approved, Emergency Use, Exempt, Re-opened, or Closed. This is open to studies from all CRUs and regardless of whether the drug has an IND.

Industry Sponsored Closeout Timeline Report – Active fund codes in SAP with IRB status/aging.  Additional tab showing fund codes that could not be linked against Oncore.  SAP data in this report will be updated periodically (not daily).

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.