Clinical Research Update - April 2019

Wednesday, April 3, 2019
By Duke Office of Clinical Research (DOCR)
Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

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


Research Community News

 

Adding Captcha to Public REDCap Surveys for Existing and New Studies

According to the DUHS IRB, an amendment does not need to be submitted to add captcha to public REDCap surveys for existing studies.  A clause should be included in the research summary for new studies planning to use captcha. For instance, "We will be using a redcap for data collection, with the addition of captcha for added security".

 

Record Retention for Recording Devices

Have you ever wondered what the record retention requirements are for data captured on recording devices?  If the study team has a transcription of the recording done by a company and the transcription has been verified, the study team can delete the audio recording at that point.  Study teams should specify their transcription and verification plans in the IRB application and document the process in a SOP.  This method of transcription and verification is preferred when by doing so the study team is further protecting the participant's identity (such as with an HIV study).

However, if the study team is not collecting sensitive information and has the option to move the audio files onto a secure/restricted Duke network location, then the team may want to retain the audio for the life of the study (6 years, or longer as determined by population and sponsor).

If a study team chooses transcription with verification, it is important that the study team has a detailed process for verifying the transcriptions, as even with reputable companies transcription errors can occur.

 

Preparing for the Upcoming Epic Upgrade

Maestro Care will be upgraded to the August 2019 version of the Epic electronic health record during scheduled maintenance on Sunday, April 14th.  Upgrade training materials will be posted to the DOCR website and on the CRC Dashboard in Maestro Care when available.

 

Minimum Footprint—New Studies Tip Sheet Updated

The Minimum Footprint - New Studies tip sheet has been updated based on feedback from the February 12th Research Wednesday session.

The updated version of the Minimum Footprint – New Studies tip sheet is Version 3. Versioning is listed in the footer of the tip sheet.  Be sure you are using the most recent tip sheet when completing the minimum footprint.

Minimum Footprint tip sheets have also been created for Retrospective and Exempt studies.  Note that all retrospective studies can be opened and closed to accrual immediately after institutional approval. 

You can find all of the Minimum Footprint tip sheets on the DOCR OnCore support page under the Additional OnCore Job Aids and Tip Sheets section:

If you were unable to attend the Research Wednesday session, a video regarding Minimum Footprint can be found here:  Minimum Footprint - 2/13/2019 Research Wednesdays

 

Office of Civil Rights (OCR):  ePHI Used for Clinical Research Purposes Still Constitutes ePHI that Must Be Protected

The University of Texas MD Anderson Cancer Center (MD Anderson) was fined $4.3 million for failing to protect electronic Protected Health Information (ePHI) in violation of the Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health (HITECH) Act. MD Anderson disputed the fine on the premise that the data was for research and was not required to be protected under HIPAA or HITECH, this argument was rejected by the Administrative Law Judge (ALJ) that reviewed the case and made the ruling in June of 2018.

The Office for Civil Rights (OCR) investigated three separate breaches.  In the first privacy breach, a laptop was stolen from an employee’s house. The laptop was not password protected and was never encrypted. The laptop was used as a telework computer, and contained ePHI for about 29,000 individuals. In the second privacy breach, an unencrypted universal serial bus (USB) thumb drive was lost by a summer intern. The summer intern believed the USB was misplaced on an MD Anderson shuttle, and contained Microsoft Excel files containing ePHI of about 2,200 individuals. In the third privacy breach, an unencrypted USB thumb drive was misplaced by a visiting researcher. The researcher kept the USB in a tray on her desk and last saw it before she left for Thanksgiving and could not find it when she returned.  In all three breaches the lost or stolen items were never recovered and are unprotected from an unauthorized person being able to access the ePHI on the device.

The ALJ noted that not only did MD Anderson have a duty to protect ePHI—even if only used for research purposes—and that lost information does not need to be viewed in order to constitute an inappropriate disclosure. The ALJ commented that the employees using the USB were transporting data for work-related activities, even if doing so violated MD Anderson polices, but their actions were not outside of the scope of their official duties.  You may visit OCR’s website to view the full ALJ opinion.

The Duke Health Secure System Usage Memo lists how DUHS Workforce Members are required to protect ePHI including the use of secure email, multi-factor authentication, protecting workstations and laptops, and protecting data storage.  Please review this document to make sure you are properly protecting patient information.

 

April Research Town Hall

Please join us for a Research Town Hall on April 10th from 1:00 PM -3:00 PM entitled “Caring for Your Data: Data Management Resources at Duke.” Come learn about data management resources at Duke to help care for your data throughout the data life cycle! You can RSVP at the link.

The Duke Research Town Hall Series is a recurring, engaging series developed to reinforce a strong research culture at Duke University. Monthly sessions will feature research best practices, research tools, and new research initiatives.  If you have suggested topics, please contact ASIST (ASIST@duke.edu).

 

Investigational New Drug Application (IND) Forms:  Updates and Best Practices

The Duke Office of Regulatory Affairs and Quality (ORAQ) will host a one-hour workshop on IND forms.  Forms FDA 1571, 1572 and 3674 will be reviewed, all of which are required for initial IND submissions for investigational drug studies.  Recent changes in these forms will be emphasized and best practices will be reviewed.  Discussion will be encouraged.  This workshop is recommended for regulatory coordinators, study coordinators and anyone else who may be involved in the preparation of forms for IND submissions to the FDA.

Speaker: Daniel Tonkin, PhD, RAC
Monday, April 15
3:00 PM - 4:00 PM
Duke Medical Pavilion Room 2W96

Registration is required.  Register at https://medschool.duke.edu/research/research-support-offices/office-regulatory-affairs-and-quality/education-and-training-opportunties

 

REACH Equity Colloquium

The 2019 REACH Equity Colloquium, Understanding and Mitigating the Effects of Implicit Bias in Healthcare, will take place Friday, May 3, 2019, 8:30 AM – 3:00 PM, Great Hall, Trent Semans Center.  For a list of speakers and to register:  https://sites.duke.edu/reachequity/events-education/2019-colloquium/

 

Theater Delta

Tuesday, April 23rd, 2019, 8:00 AM - 2:30 PM

Theater Delta is an Interactive Theater Performance and Workshop focused on mentoring relationships, research bias and research ethics.  Each session will begin with the professional troupe performance of a real-life scenario followed by audience participation and feedback.  Specific learning objectives for each session are available, and attendance fulfills the in person RCR (Responsible Conduct of Research) credit. 

Registration link: https://medschool.duke.edu/about-us/calendar/theater-delta-interactive-theater-social-change

 

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.

A degree option in the program leads to a Master of Health Sciences in Clinical Research, a professional degree awarded by the School of Medicine.  An advanced degree in a clinical health science (or two years of medical school) from an accredited institution is a prerequisite for admission either as a degree candidate or as a non-degree participant.  In addition, CRTP offers non-degree and certificate options for individuals interested in taking one or more courses.

The program is now accepting applications for the academic year 2019-2020. For a detailed description of the program, the course offerings, and a link to the online application, please visit the CRTP website at http://crtp.mc.duke.edu. The application deadline for priority review is May 15, 2019. Applications will be accepted through August 1, 2019. On-line registration for fall term courses begin on July 8, and classes begin on August 26.

 

Summer Scholarly Writing Retreat

The Faculty Write Program is pleased to offer the 7th annual Summer Scholarly Writing Retreat, May 20 – 23, 9:00 AM – 5:00 PM, King’s Daughters Inn in Durham, NC. The retreat provides an immersive experience and includes time for writing, workshops on writing and project planning, and opportunities for feedback on works-in-progress. In workshops, writers learn powerful practices that can help them to incorporate their role as a writer among their many commitments. Each day includes both hands-on workshops and time to write independently in a comfortable, relaxed space. Learn practical skills about productive writing habits, make progress on a writing project, and participate in a writing community. Breakfast and lunch are provided. Space is limited to 25 participants. Cost: $250. 

Learn more about faculty experiences in the summer retreat in the Duke News article At summer retreat, faculty brush up on their writing and faculty testimonials here. Questions? Contact jahern@duke.edu. Facilitators:  Monique Dufour and Jennifer Ahern-Dodson

Registrations will be accepted through May 8 or until the retreat is full. To register, please complete this form and submit with payment (payment options are listed on form): 2019 Scholarly Writing Retreat

 

CTSI Funding Opportunities Announced

Duke/NC State Translational Research Agreement (Deadline: May 2, 2019)

  • Up to $25,000 per institution (Up to $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

  

CTSI Translational Accelerator Funding Agreements (Deadline: September 5, 2019)

  • Up to $150,000
  • Purpose: Support for cross-disciplinary scientific research addressing the development of therapies diagnostics, or devices applicable to human disease, clinical research trials (excluding Phase 2 and beyond), epidemiological studies, and/or community-based research.
  • More information and application details

 

CTSI Transformative Funding Agreements (Deadline: September 5, 2019)

  • Up to $500,000
  • Purpose: Supporting the development of mature research with the potential to attract significant interest for external partnering, thus enabling and accelerating translation of research out of the academic environment.
  • More information and application details

DOCR News

 

iRIS Office Hours Available

The Duke Office of Clinical Research hosts Office Hours twice per month.  Instructors are available to assist end users with general questions regarding using the iRIS system to submit protocols to the DUHS IRB.  Please bring a laptop if possible along with your protocol specific questions to the sessions.

Dates and locations for April are:

  • April 8, 11 AM – Noon, DMP 2W91
  • April 22, 11 AM – Noon, DMP 2W91
  • May 6, 11 AM – Noon, DMP 2W91
  • May 20, 11 AM – Noon, DMP 2W91

Did You Know?

 

 

REDCap and Text Messaging/Interactive Voice Response

REDCap now supports text messaging and interactive voice response capabilities, using a third-party application called Twilio.  A REDCap project can be setup to deliver a survey/collect data in one of the following ways:

  • Send SMS link to a survey
  • Collect data using two-way texting
  • Send reminders or interventional messages
  • Voice call survey (IVR)

Click on the link for a demonstration of this functionality. There is a monthly fee to use Twillio ($.50-$2.00/month for the line) and messages cost $0.0075 per message. There is also a fee for DOCR to assist with setting up Twilio to work with your REDCap project. 

Please feel free to contact us with any questions via DOCR REDCap Support or join us during weekly office to learn more about Twilio.



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

 

  • The Department of Neurosurgery welcomes:
    • Karen Grace, Duke Spine Center RPL
    • Claudia Pamanes, Duran CRC
    • Callie Vivian, CRC
    • Tammy O’Brien, CRNC
  • The Department of Neurosurgery congratulates:
    • Beth Perry, retitled to RPM
    • Anna Thirakul, promoted to CRS, Sr.
    • Allison Spell, promoted to CRC, Sr.
  • The Oncology CRU and Gynecologic Oncology research program welcomes Kara Hagler as Clinical Research Nurse Coordinator.

 


Partner Resources

 

 

DUHS Compliance Office Newsletter

Catch up on news from the DUHS Compliance Quarterly Newsletter.

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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.

 

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