Clinical Research Update - October 2018

Friday, October 5, 2018
By Duke Office of Clinical Research (DOCR)

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

 

 
Adding a Staff Member to Multiple Protocols

When you have a new staff member to add to a number of protocols, you have the ability to add the person to several protocols at the same time as opposed to adding them to each protocol individually.  Remember that staff must be approved as Key Study Personnel (KSP) in iRIS prior to adding them to a study in OnCore.

To add a staff member to multiple protocols:

  • Run a Protocol Search (via Protocols > Protocol Search) on all protocols in your Management Group or Department.
  • Select the protocols you would like to add a staff member to using the checkboxes in the “Add Staff?” column on the right-hand side of the screen.
  • Once the desired protocols are selected, click the “Add Staff” button at the top of the screen.
  • A pop-up window will open asking you for the staff name and role
  • Click “Submit” to add the staff to all protocols selected in the “Add Staff?” column
 
OnCore Tips

Complete OnCore Training Prior to Submitting an Account Request
OnCore training is required to get an account or to expand your role within OnCore.  Go to the DOCR OnCore Support Page and identify what training courses to take for your functional role.  Once you have completed the appropriate courses, verify that you have completed training in the Duke Learning Management System prior to submitting an account request.

 

Unable to View a Protocol?  Make Sure You are on the Staff List
If you have an account in OnCore and are unable to see a protocol, verify that you are on the OnCore staff list for that protocol with the Primary Regulatory Coordinator or Study Coordinator prior to submitting a support ticket.  If you need to be added to a study, a Regulatory Coordinator on that study will need to add you to the study.  If you submit a support ticket to be added to the study, the OnCore support team will direct you back to the Regulatory Coordinator to get you added.  Recall that users should be on the Key Study Personnel list in iRIS prior to being added to the Staff list in OnCore.  Also, Key Personnel who have a role of “other” in iRIS do not migrate to OnCore.  If these staff need access to OnCore, they can be entered in OnCore by the Regulatory Coordinator and a functional role must be selected for them.

 

OnCore Tips, Tricks, and Did You Know?

Visit this link for more information

 

 


iRIS Community News

 
 
iRIS Enhancements

An upcoming release to the iRIS System in October will provide several feature enhancements to the iRIS product. This is the first in a series of enhancements to iRIS that have been requested by Duke. The majority of upgrades in the first round will impact IRB operations with the intention of enabling the IRB to more efficiently process submissions:

  • The system will capture person and date information for modifications
    • This will designate who performed an action and when, allowing for greater transparency and eliminating some of the back and forth between the IRB and the study teams
  • Modifications will return directly to the chair during expedited review
    • This will eliminate an analyst needing to re-review each submission correction
  • Change to allow previously submitted documents to be added to modifications
    • This will prevent the need for study teams to submit additional amendments to make changes requested in renewals

 
Additionally, end users will see the following changes:

  • Expiring studies will have an expiration time of 00:00:01 on the expiration date rather than 3:00 AM
  • Links in emailed notifications will take the user directly to the task requiring attention rather than the iRIS dashboard
  • Issue where users log in and are immediately logged out of the system will no longer occur
  • The instance of multiple consent forms appearing in an approval packet will no longer occur

 

Tip Sheet:  How to Enter Sub-Award Funding in a New Protocol Application in iRIS

A new iRIS tip sheet is now available on “How to Enter Sub-Award Funding in a New Protocol Application in iRIS”.  Visit the iRIS Support Page on the DOCR website to view this tip sheet and access iRIS online training as well as additional tip sheets and job aids.

 

iRIS Tip:  Naming Files

When naming files to upload to iRIS, please do not include special characters (& @ # *) in file names.  Documents with special characters in their file names will have difficulty opening in the iRIS system.

 

 

 


Research Community News

 

GAP 200.420, Processing Payments to Research Participants--Updated

An important update was made to Duke GAP 200.420, Processing Payments to Research Participants. The GAP now includes information about the new Duke ClinCard, a reloadable debit card, as a primary and preferred option for compensating study participants. Questions regarding payments to research participants using a Duke ClinCard should be directed to Employee Travel & Reimbursement at (919) 668-3877.

 

Clinical Quality Management Program (CQMP)

The Clinical Quality Management Program (CQMP) was established to develop and implement a comprehensive, standardized clinical research monitoring program to replace the Quality Assurance Monitoring Review Standards for Clinical Research Policy. The Clinical Quality Management Program pilot CRUs received training in July 2018 and we are rolling out the program to additional CRUs via bi-monthly training sessions. The program focuses on helping CRUs develop Clinical Quality Management Plans for all consenting and prospective studies that are not externally or independently monitored and that do not have ongoing approved monitoring plans. These plans focus on identifying key quality indicators, like the informed consent process, participant eligibility, and safety reporting that may affect study conduct.  A designated trained Quality Management (QM) reviewer will conduct regulatory file and participant chart reviews at predetermined time points. For questions regarding the CQMP, please e-mail CQMP@duke.edu.

 

2018 Research Staff Appreciation Awards

The School of Medicine Research Staff Appreciation Awards recognize staff members who provide exemplary support in the conduct of research.

Nominations for these awards are now being accepted and can be submitted online at the link below. A nomination can be submitted by any School of Medicine faculty or staff member. Nominators may only nominate one candidate. The application requires endorsement from the respective chair or center/institute director of the staff member. If the nominator is also the nominee’s direct supervisor and entity leader, please seek out letters of support to provide additional perspectives. Self-nominations will not be accepted.

To submit nominations for the 2018 SOM Research Staff Awards:

  • To apply, visit My Research Proposal, click on “Create New User” (or log in if you already have an account).
  • A step-by-step user’s guide for applying via the MyResearchProposal software is available on the CTSI website page ‘MyResearchProposal’.  Please click on the Applicant instructions.
  • Enter Access Code ‘SOM’ then select the “School of Medicine Research Staff Appreciation Awards 2018” opportunity and follow the instructions.
  • For questions concerning MyResearchProposal passwords or system issues, please contact myresearchproposal@duke.edu.

Applications are due October 24, 2018, and winners will be announced in December. Three awards will be presented.  Each winner will receive a certificate and $500.00.

 

School of Medicine Research Staff Awards

To be eligible for an award, an individual must meet all of the following criteria:

  • Research Assistants, Research Specialists, Clinical Research Coordinators, Project Leaders, or any staff member employed by the School of Medicine, who provides exemplary support in the conduct of research. Not Eligible: Faculty or staff members who have primary investigator status; research fellows, postdoctoral fellows and graduate students; administrative professionals.
  • Current role provides technical expertise to support any research program (including translational, clinical, data sciences, or basic science research) in a manner which underpins the effective and efficient promotion of the research mission in the School of Medicine.
  • At least 5 years of continuous service in a research role in the School of Medicine.
  • Demonstrated record of excellent performance.

 

Encrypted Voice Recorders

As high quality portable voice recorders have become very affordable, the Duke Research community needs to use them for any recordings of research subjects.  Research teams need to plan and budget for purchasing encrypted recorders, as the Information Security Office (ISO) is unlikely to approve or renew exceptions to their use.  Remember, individually owned smartphones may NOT be used for recordings, even if encrypted; Duke owned and managed smartphones are fine to use.

 

Test Your Phishing Detection Skills

As part of National Cyber Security Awareness Month in October, Duke staff, faculty and students can take a quiz to test their phishing detection skills. All Duke users who take the quiz will be entered into a drawing to win an AppleWatch.

In addition, any Duke users who report a phishing email to security@duke.edu in October will be entered into a separate drawing to receive a special gold challenge coin recognizing them as a Duke information security ambassador.

Visit security.duke.edu for details and to take the quiz.

 

Funding Opportunities from CTSI 

Duke/UNC CTSA Consortium Collaborative (Deadline: October 11, 2018)

  • Up to $25,000 per institution ($50,000 total)
  • Purpose: Develop inter-institutional collaborations for new investigator teams conducting novel clinical and translational research that applies or accelerates discovery into testing in clinical or population settings.
  • More information and application details

 

 

Funding Opportunity for Duke Junior Faculty, Fellows, and Postdocs

Multidisciplinary K12 Urologic Research Career Development Program (KURe-K12) KURe.medschool.duke.edu

The KURe is open to all types of disciplines, clinicians and non-clinicians with doctoral degrees.

Letter of Intent (Required) Due: October 15, 2018

Applications Due: November 1, 2018

The KURe is seeking qualified clinical, translational, and basic science researchers from diverse disciplines who are interested in building an independent research career using collaborative, multidisciplinary approaches to benign urological research questions. MDs, DOs, PhDs and MD/PhDs (junior faculty, fellows, and postdocs) from any department and interested in research applicable to benign urology may apply to the KURe program. KURe Scholars will receive mentoring and salary support up to $100,000 per year for 75% of full professional effort (50% - 75% if a surgical specialty). Research and Career Development Support up to $40,000 per year will be provided for research supplies, equipment and technical personnel, tuition and fees related to didactic courses or career development, and travel to research meetings. Scholars are expected to publish and apply for independent grant funding by year 3. Maximum support is for 5 years. There is currently one open position. The target date to appoint the new KURe Scholar is January 2019. For additional information see KURe.medschool.duke.edu  or contact friederike.jayes@duke.edu or cindy.amundsen@duke.edu.

 

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

 

DOCR 2018 Annual Satisfaction Results and Survey Winner Announced

The annual satisfaction survey polls the clinical research community regarding use, benefit, knowledge and courtesy of DOCR services and staff.  These data are used in DOCR strategic planning to improve services to the research community in the future.  This year’s survey was taken by a wide range of researchers in a variety of roles.  Here is a quick view of Median Responses:

2018 DOCR Survey Results

Congratulations to Kim Ward, Duke Cancer Network (DCN) Research Administration, who is this year’s winner of a $100 gift card to the Duke University Bookstore.   Kim’s name was selected from those who completed the Annual DOCR Satisfaction Survey.  Thank you to everyone who completed the satisfaction survey.  Congratulations Kim!

 

 

DOCR REDCap Day a Success

DOCR had its 1st REDCap day on September 26th.  There were several informative presentations, including an introductory session on REDCap aimed at new users, or people who are trying to gain more experience building projects with REDCap, several Administrative uses of REDCap, and eConsent.

Read more about the event, here, https://medschool.duke.edu/about-us/news-and-communications/med-school-blog/redcap-day-2018

 


Did You Know?

 

 
Printing Lab Results Using Result Report (By Patient) in Maestro Care

Study teams should use the following process to ensure meeting compliance requirements for printing lab results for patients.

  • Use Result Report (By Patient) to print lab result reports from Maestro Care. 
  • Printing using this activity is the recommended legal lab result print document. 
  • Additional details are on the Result Report (By Patient) printed document, and thus the Chart Review printed document is not recommended.
  • Click here for Tip Sheet.

 

Monitor/Auditor Access to Maestro Care

Monitors/auditors are granted temporary access to medical records in Maestro Care through the Duke MedLink application. The use of Duke MedLink restricts a monitor/auditor from being provided with open access to the Maestro Care electronic health record and its patient population and limits access to the participants enrolled in a specific research protocol (s) for the defined monitoring/auditing period.

A link to request Monitor/Auditor access to Maestro Care is located on the DOCR website.

 


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 Course Listing.

 


Clinical Research Employee Highlights

 

  • Paul Lantos, MD joined the IRB as a Chair. He is an Associate Professor of Medicine and Pediatrics with a specialization in infectious diseases. Paul is an active researcher focused on the spatial epidemiology of infectious diseases. He will be a member of IRB 7 and conduct expedited reviews prior to assuming meeting chair duties at the beginning of 2019.
  • Monica Molina, JD, CIP joined the IRB as a Senior IRB Specialist. She was formerly an IRB assistant director at Appalachian State University and has significant experience in IRB operations. Previously she served as a research coordinator at the University of Miami and has experience with pediatric research.
  • The School of Nursing CRU welcomes Norma Garcia-Ortiz as a Clinical Research Specialist, Sr.
  • The Office of Research Contracts is happy to welcome John Swanson to the staff of the Duke Site Based Research group.  John is an alumnus of the University of Florida, received a MPH from the University of North Carolina at Chapel Hill, and a JD from Western Michigan University. John has worked in private practice, consulting, academic medicine, and health research.
  • Congratulations to Chris Pruitt on his advancement to CRC Tier 2 in the Cath Lab research cluster of the Heart Center CRU.
  • The Children’s Clinical Research Unit welcomes to the:
    • Division of Medical Genetics: Cindy Li CRS, Sr.; Lauren Nolley CRC Tier 1 and Samayra Siddiqui CRC Tier 1
    • Obesity Prevention and Treatment Research Center: Callan Loflin CRC Tier 1; Charles Sarria CRC Tier 1 and Cameron Catherine CRC Tier 1
    • Neonatology: Caitlin Stone CRC Sr.
    • Neurology: Stephanie Threa CRC Tier 1
  • Radiation Oncology welcomes the following new staff:
    • Bijal Shah BS MS who joined Radiation Oncology as a CRC
    • Josephine Gaston BSN MPH MA who joined Radiation Oncology as a CRNC

 

We have successfully completed the Tier Advancement cycle effective October 2018! We are sincerely grateful for all of the effort that the clinical research community has put into this important initiative!

Congratulations are in order for the following Clinical Research Coordinators, Clinical Research Nurse Coordinators, and Regulatory Coordinators for their professional advancement to Tier 2.

Anne Boyd from Radiology

Catrin Davies from Oncology

Chris Pruitt from Heart Center

Christine Daly from Oncology

Christopher Vallanat from Radiology

Cristina Van Sant from Orthopedic Surgery

Crystal Cates from Dermatology/Pathology

Diane Pinder from Oncology

Emily Bonnabeau from School of Nursing

Hildy Donner from Pediatrics

Jessica Pennell from Oncology

Julie Poe from Pediatrics

Katelyn Arroyo from Medicine

Kelly Onyenwoke from Oncology

Kerry Hoyle from Pediatrics

Kimberly Leathers from CTSI

Lauren Nelson from Medicine

Louie Labate from Pediatrics

Melissa Harward from Pediatrics

Midori McCarty from Medicine

Olivia Kohrman from DOCR

Pamela Bonner from Radiology

Sara Battles from Psychiatry

Seung-Hye Jung from DOCR

Shruti Desai from Anesthesiology

Stephanie Smith from DHVI

Susana Almeida-Peters from Medicine

Tina Lucas from Medicine

 

Congratulations are in order for the following Clinical Research Coordinators, Clinical Research Nurse Coordinators, and Regulatory Coordinators for their professional advancement to Tier 3.

Cameron Howes from Orthopedic Surgery

Karen Grace from Neurology

Maria Antoinette Santoro from Anesthesiology

Mary Key from Medicine

Micki Roseman from CTSI

Stephen Gazda from Radiology

Victoria Sutton from DEPRU

 

Congratulations are in order for the following Research Program Leaders for their professional advancement to Tier 2.

Brittany Ploss from Medicine

Carolyn Winters from Oncology

Carrissa Dixon from DOCR

Colleen Riggan from Oncology

Margaret Pendzich from DOCR

 


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.