Clinical Research Update - July 2018

Wednesday, July 25, 2018
By Clinical Research Update - July 2018

OnCore Community News
iRIS Community News
Research Community News
DOCR News
Did You Know?
Training Opportunities
Clinical Research Employee Highlights
Partner Resources


OnCore Community News

 

OnCore/iRIS Interface: Key Personnel Changes

Key Personnel changes in iRIS are not coming over the interface into OnCore. Staff additions will eventually move through the interface, however until that phase is implemented in iRIS, all staff additions that need to be in OnCore must be entered manually.

Staff deletions should be handled by adding an end date on the staff list in OnCore.

Amendments are not consistently pushing from iRIS to OnCore. If you have an iRIS amendment where there were consent form changes, please manually update the amendment review date in OnCore (if it is not present) and add the revised consent form in OnCore.

 

OnCore/iRIS Interface: Key Personnel Changes

OnCore task lists are being used to manage the DOCR study start-up process, including submission of the study documents and information required to begin the review for ClinicalTrials.gov, calendar, and Maestro Care build requirements. For new protocols submitted in iRIS, the Protocol Creator (i.e. study staff who pushed the “Sync to API” button in iRIS) should check their Active and Upcoming Tasks in OnCore to keep the start-up process moving. Tasks can be viewed via the “Status” tab in PC Console.

 

OnCore Tips, Tricks, and Did You Know?

Visit this link for more information


iRIS Community News

 

iRIS Numbering System for Protocol Submissions

One difference between the previous eIRB system and the new iRIS system is the way the systems number the items submitted to the IRB. In the iRIS system, each item submitted related to a protocol (whether initial submission, continuing review, amendment, or safety event, etc.) will have a unique reference number. The reference numbers are sequential for all submissions added to iRIS at Duke (and inclusive of all areas using iRIS). Study team members will be able to search for specific items using this reference number, just like you search for a PRO number to find a protocol. After finding the proper protocol, study team members will look for the appropriate reference number to find the specific amendment, safety event, etc. they need to view or work on.

 

Adding a Sponsor and Funding Source to a New Protocol Application in iRIS

Section 700 Sponsor and Funding Source in the iRIS New Protocol Application ask the study teams to “Add a New Sponsor to the Protocol”.  Upon Selecting “Add a New Sponsor to the Protocol”, a pop out window will appear. 

At this point:

  1. Look up the appropriate sponsor name. 
  • If the sponsor name is in the system, the sponsor can be added to the study.
  • If the sponsor name is not in the system, you will need to submit a Service Now ticket to request that the sponsor be added to the system.  These sponsor add tickets are being routed to the Office of Research Informatics OnCore Team.  To submit a Self-Service Ticket to the DHTS Service Desk for Help (24/7): https://duke.service-now.com/ess/fix_it.do
  • Note:  If the sponsor you selected in the eIRB system was “Department/Division/Faculty/PI”, users should now select “Duke University”

 

Troubleshooting Tips: CITI Training Record in the iRIS System

If the training record does not seem to be synching properly between the iRIS and CITI systems, have the individual update their Institutional email address within the CITI system to the user’s duke Net ID@duke.edu as this is the email format that iRIS utilizes to identify you.  After making this change, allow at least 6 hours for the two systems to synchronize again before assuming that this potential fix did not work.

For instructions on how to update your Institutional email address in the CITI system, go to the CITI program support center.

For additional information along with screen shots, see the Checking CITI Training for an Individual in iRIS tip sheet located on the DOCR iRIS Support Page.

 

Troubleshooting Tips: Adding Key Personnel to a Study

When attempting to add a staff member to Key Personnel for your study, there are several common sources of difficulty.

  1. Staff member’s name not found.  If a current Duke Health staff member’s name does not appear in the search field this typically means that the staff member either was not on any study key personnel in the system as of May 2018 or that s/he has not yet logged in to iRIS.  In this case, ask the staff member to log-into iris.duke.edu using their Duke NetID and password.  After an initial log-in, their name should appear in the system for potential KP inclusion.
  2. CITI Training Notification.  In this case, the staff member’s name is in the system and you successfully add them to the Key Personnel Change Form, but at some point in the KSP Change process you receive notice that the individual cannot be added because her/his CITI Training is not up to date.  In this case, you can check on an individual’s CITI status within iRIS.  For step by step instructions on checking an individual’s CITI status in the iRIS system, see the tip sheet Checking CITI Training for an Individual in iRIS.

 

Research Data Storage Plan (RDSP) Migration into eGRC

RDSP migration continues to proceed well.  We have identified two issues below.  You can email infosec@dm.duke.edu for assistance with the subject lines:

  • Legacy RDSP update – ISO can open amendment and assign it to you, you can then perform the edit and send it for review.
  • Cannot log into eGRC - you may have an inactive account due to non-use.  Contact ISO and we can reactivate your account.

 

iRIS Online Training Modules Available

There are two online training modules available for the iRIS system.  These modules are located in the Duke Learning Management System and provide an overview to the iRIS system and forms submissions.

Module 1:  Introduction to Submitting an IRB Application in iRIS

This course is designed to outline the basic process for IRB application submission using the iRIS system.

The module will describe the workflow among the two main research workflow systems iRIS and OnCore and will introduce users to the iRIS system, basic navigation and initial protocol submission.

Module 2:  Post Approval Submission Forms in iRIS

This course is designed to outline the basic functions of post approval submission forms using the iRIS system including:

  • DUHS IRB Amendment Forms
  • DUHS IRB Migration Amendment Forms
  • DUHS IRB SAE/AE Forms
  • DUHS IRB Continuing Review Forms
  • DUHS IRB Study Closure Forms
  • DUHS IRB KSP Forms

 


Research Community News

 

Innovate Database and Interface with myRESEARCHhome

The Office of Research Contracts (ORC) has updated its website with information regarding its new Innovate database and interface with MyResearchHome.  Together, Innovate and MyResearchHome provide the research community the ability to quickly access and track the status of pending research contracts, to find detailed information regarding the current contract status and a timeline of the progress, and to access signed versions of the contracts.

To access the new information and video tutorials on using the Innovate database and MyResearchHome Patents and Agreement Widgets, please go to:

https://medschool.duke.edu/research/research-support-offices/office-research-contracts/innovate-resources

 

Training for the ClinCard System

ClinCard training consists of online modules administered through LMS based on a user’s role in the system. Employee Travel and Reimbursements (ET&R) will assign training modules to individual users once they receive a new user request form from the overseeing CRU. For questions regarding training and access to Clincard please contact ET&R at clincard-request@duke.edu. For questions regarding ClinCard pick up and business process please contact Catee Mullen at catee.mullen@duke.edu.

 

Social Security Number (SSN) Exception Changes for Subject Payment

There are recent updates to the Social Security Number Exception for subject payments. If you use ClinCard for subject payments, check the box in the Research Data Storage Plan (RDSP) and follow your Clinical Research Unit (CRU) Policy. If you use paper or some other electronic form for subject payments, enter a record in the SSN Exception in the eGRC system as usual. The recent change is annual renewals are no longer required. Existing records in the SSN Exception form will be updated. Remember to close the records when you are done collecting SSNs. If you collect SSNs for other electronic purposes (such as National Death Index searches), you will still need to enter a record in the SSN Exception and do annual renewals. Contact Doc Muhlbaier if you have questions (lawrence.muhlbaier@duke.edu).

 

Duke Health System Secure Use Memo (SSUM) Updated

The Duke Health System Secure Use Memo (SSUM) has been recently updated. Please read the updated Secure System Usage Memo for important information on how to stay secure at Duke.

 

Lesson Learned: Judge Rules in Favor of the Office of Civil Rights (OCR) and Requires a Texas Cancer Center to Pay $4.3 Million in Penalties for HIPAA Violations

On June 1st, a U.S. Department of Health and Human Services administrative law judge ruled in favor of the OCR, fining M.D. Anderson over $4.3 million for breaches involving unencrypted devices, resulting from the theft of a researcher’s laptop and the loss of two USB drives.  M.D. Anderson claimed that HIPAA did not apply to the lost and stolen ePHI because it was research data and outside HIPAA’s reach.  The judge disagreed, stating that this argument was “at best a fanciful interpretation of governing regulations” and lacked merit.

To be sure, Duke Health treats individually identified health information as PHI, whether if comes from our patients or not.

For more information, click here.

 

Collaborative Funding Opportunity Available from CTSI

Carolinas Collaborative now accepting funding applications for 2018–2019

CTSAs at Duke, the Medical University of South Carolina, UNC-CH, and Wake Forest, have partnered with Health Sciences South Carolina to create a pilot program designed to encourage and facilitate novel clinical and translational research that applies or accelerates discovery into testing in clinical or population settings. The research must use the component electronic health record data warehouses from at least two of the four CTSAs.

View the RFA

 

Translating Duke Health Cardiovascular Disease Initiative: Request for Proposals

The Translating Duke Health Cardiovascular Disease Initiative is pleased to announce a call for proposals to identify areas for investment that will accelerate research in the area of Cardiovascular Resistance, Resilience and Rejuvenation.  Our goal is to build on existing Duke expertise and resources to create a small number of research ‘force multipliers’ or platforms for multidisciplinary work addressing important areas of unmet needs.  We are looking for proposals across the continuum of bench to bedside to population health. Successful ideas will greatly enhance our environment for discovery and will have potential for both scientific and public health impact.

Deadline: Proposals must be received by 5 PM EST, August 1, 2018

Full details on this initiative can be found on the School of Medicine website.

Questions and completed applications should be submitted as one combined pdf file to: translatingdukehealth@duke.edu.

 

Clinical Research Training Program Accepting Applications

The Clinical Research Training Program (CRTP) of the Duke University School of Medicine Biostatistics and Bioinformatics Department provides academic training in the quantitative and methodological principles of clinical research.  CRTP is designed primarily for faculty, fellows, and other health professionals.  The program offers formal courses in research design, research management, medical genetics, comparative effectiveness, translational methodologies, and statistical analysis.

Information about the program can be found at http://crtp.mc.duke.edu. The application deadline for priority review was May 15, 2018. All applicants in this pool will be notified of admission decisions no later than July 1, 2018. Regular applications, space permitting, will be accepted up until the start of the fall term. Registration for fall term courses begins on July 9th and classes begin on August 27th.

For more information, contact Gail Ladd, CRTP Program Coordinator, at 681-4560 or gail.ladd@duke.edu.

 

Save the Date: Basic Science Day

Basic Science Day, a celebration of Basic Science Research at the Duke University School of Medicine, will be held on Wednesday, September 12, 2018, 9 AM – 5 PM in the Trent Semans Center Great Hall. This year’s event will feature James A. Spudich, PhD, speaking on “The Myosin Mesa and Hypertrophic Cardiomyopathy: Mutations to Mechanisms to Therapies”. For additional information and to register: https://medschool.duke.edu/research/basic-science-research/basic-science...

 

Save the Date: Keeping the Heart Young: The Science of Cardiovascular Resistance, Resilience and Rejuvenation

Translating Duke Health will be hosting this daylong event Saturday, October 6, 2018, 8 AM – 3:30 PM. The event will bring together national experts in Cardiovascular Disease to address the science of keeping the heart young. For more information and to register, visit the School of Medicine website.

 

Save the Date: 2018 Clinical Research Appreciation for Faculty and Staff

The 2018 Clinical Research Appreciation for Faculty and Staff, sponsored by the Duke Office of Clinical Research, is scheduled for Tuesday, October 16th, 11:00 AM – 1:30 PM, Trent Semans Center Great Hall. This drop-in event is open to all faculty and staff involved in Clinical Research at Duke and will feature informational tables from Clinical Research Administrative groups and Partners as well as food, music, dancing, and door prizes.

 

Save the Date: Technologies and Innovations in Human Immunology

Translating Duke Health Immunology & Transplant Initiative will be hosting a half day event Friday, November 2, 2018, 8:00 AM – Noon.  The event will acquaint the Duke research community with ongoing intramural research efforts in the field of human immunology with the goal of bringing together new collaborations and identifying opportunities for future projects.  For more information and to register: https://duke.qualtrics.com/jfe/form/SV_5hUsrABzCmArMCp.


DOCR News

 

Research Professional’s Network (RPN) Volunteer Opportunities

The RPN is looking for interested and enthusiastic members of the Duke research community to help manage the RPN meeting logistics for the upcoming RPN year (July 2018-June 2019). Please see below for more information about this volunteer opportunity:

Managing RPN meeting logistics (1-2 members needed)

  • Time commitment: 1-2 hours per month remote coordinating and 2-3 hours/month in-person for the meetings; 1 hour/month for RPN Project Team meeting
  • Announce upcoming RPN opportunities and introduce the speaker/facilitator at RPN monthly meetings (or coordinate a member to serve in this role if you are unable to attend a meeting)
  • Coordinate members to assist with check-in and room set up/take down for monthly RPN meetings

 

If you are inter­ested in this role and being a part of the RPN Project Team, please discuss the volunteer role and time commitment with your manager and fill out this REDCap survey. We do not expect RPN volunteer time to replace work time, but some activities will occur during standard business hours. Therefore, a link will be sent to your manager confirming their support for you to volunteer out­side of your assigned job responsibilities before the role is confirmed.

Volunteers will be recognized though a letter from the RPN Project Team and Steering Committee to their manager, Research Practice Manager, and CRU Director at the end of their completed service.  This letter will describe your contribution to the RPN and Duke Clinical Research Community and can be included in your tier advancement portfolio in support of leadership competencies.


Did You Know?

 

REDCap Matrix Groups

REDCap can display a matrix group of fields in either Single Answer format (i.e. radio buttons) or Multiple Answer format (i.e. checkboxes).  A matrix allows you to display a group of similar multiple choice fields in a very compact area on a page making data entry forms and surveys look much shorter.  A matrix can have as many rows or columns as needed.  Although, the more choices you have, the narrower each choice column becomes.  For long matrices, the Sticky Matrix Headers External Module can be used.  This module makes the matrix header for a matrix of fields always visible (as long as the matrix is visible).

Once this module has been enabled no configuration is needed.  The matrix headers will stay with the matrix for the length of the entire matrix.  Once the matrix has ended the header will go away.

 

REDCap Remote Office Hours

The DOCR REDCap team has added NEW Remote Office Hours; this is a great time to get help with your REDCap project if you are not able to attend our weekly office hours in person.  Every Thursday at 2 PM, you can join the call via WebEx to get answers to any REDCap questions.  Join us via WebEx by clicking here to join the call.

Don’t forget the REDCap in-person weekly office hours, held every Tuesday from in the Medical Center Library & Archives Seeley G. Mudd Building conference room 212C and the first Thursday of the month in DMP 2W96, both are from 10 AM – 11 AM.

 
DOCR Outreach Services

The DOCR Outreach Team includes a Project Management Resource for clinical research. Research Program Leaders can be enlisted on a percent effort basis to provide an array of services for program- or project-level management and support. Individual RPLs support program leadership and individual teams by working to develop plans and processes, facilitate communications, and coordinate stakeholders both internal and external. They will ensure that your project stays on schedule, within budget, and that goals are met.

Available services include:

  • Consultations for planning study logistics and resources (free!)
  • Protocol development and study management
  • Research program and portfolio management (e.g., U01, P50, etc.)
  • Research program communication management (e.g., newsletters, website, etc.)
  • Manuscript development
  • Coordination of clinical research grant development, packaging, and editing
  • Development and management of research colloquia, symposia, and consortia
  • SOP development
  • Other project related needs

Please contact docr.help@dm.duke.edu for more information.

 


Training Opportunities

 

Upcoming DOCR Training Offerings

DOCR training offerings are available in the Duke LMS. There are 2 easy ways to find all DOCR classes: Enter “DOCR” in the search field and click Search, or click the Category link, and then click the DOCR link. The results display all the offerings currently available from DOCR. Hint: If you want to bookmark the Duke LMS in your browser, edit the bookmark to this address: https://lms.duhs.duke.edu/Saba/Web/Cloud

Detailed information about each offering and direct links to the offering are also available on the DOCR Calendar.

 


Clinical Research Employee Highlights

  • The Medicine Clinical Research Unit Hematology Division welcomes Lindsey Muller as a CRC beginning on July 16th.
  • The Medicine Clinical Research Unit Center for Study of Aging welcomes DeAndra Bodiford as a CRC.
  • The Medicine Clinical Research Unit Pulmonary Critical Care Research Team welcomed Raha Manyara as a CRC starting June 1st.

 


Partner Resources

 

 

DUHS Compliance Office Newsletter

Catch up on news from the DUHS Compliance Quarterly Newsletter.

Subscribe to the Clinical and Translational Science Institute (CTSI) Bi-Weekly Newsletter

Stay up to date on news, funding, and education opportunities in translational science at Duke by subscribing to CTSI UPDATES. Read past newsletters and subscribe at https://www.ctsi.duke.edu/news/newsletters.

 

To be added or removed from the distribution list for the DOCR Clinical Research Update newsletter, please contact the DOCR at docr.help@dm.duke.edu.