Duke Clinical Research Update September 9, 2021

Thursday, September 9, 2021
This image is the Duke Clinical Research Update Banner

 

 

 

 

 

 

SUPPORT OFFICE HOURS

 

REDCap Office Hours

Email redcap-docr@duke.edu to schedule a virtual session at one of the times indicated below.

 

  • Tuesdays 10 AM, virtual sessions
  • Wednesdays 10 AM, virtual sessions
  • Thursdays 2 PM, virtual sessions
  • Fridays 10 AM, virtual sessions

 

SlicerDicer Office Hours

 

PACE Office Hours

Every other Tuesday, 1 PM, via WebEx.  Click for information.

 

RESEARCH COMMUNITY NEWS

 

Revised Industry-Funded Clinical Trial F&A Rate Application

Effective October 1, 2021, the School of Medicine’s F&A rate for industry-funded clinical trials will be changed from 33% MTDC to 33% TDC.  This means that any expenses previously excluded from F&A rate calculations like patient care costs, capital, and sub-award costs > $25K will now be included in the actual calculation of the charge for F&A applied to individual study projects. 

 

This rate is effective for industry-funded clinical trials being negotiated as of October 1, 2021 and will not retroactively apply to any studies active or currently under negotiation with an industry sponsor.  The rate adjustment is included in the School of Medicine’s guidance document located at this address:

https://resources.finance.duke.edu/resources/docs_sec/SOM_FA_Waiver_Guidelines_Oct2021.pdf

 

Should you have any questions, please contact the SOM Finance Office, ORA, or DOCR.

 

WBSE Expansion to 9 Digits - Effective October 1, 2021

Effective October 1, 2021, all University non-capital project WBSEs will be created as nine (9) digits. The new WBSEs will return to sight recognition within the 3xx range. The last six (6) digits will be generic.

  • The first digit indicates a restricted WBSE
  • The second digit identifies the sponsor
  • The third digit identifies the type of activity funded.

 

There will be no changes or conversions for existing WBSEs – codes will remain as is (7 digits) until they are closed. There will be no changes for cost centers or profit centers.

 

This decision to change some WBS Elements length to nine (9) digits was part of S/4 planning and made in order to:

  • Return to sight recognition in first three (3) digits
  • Provide significant headroom in historical ranges

 

For more information on this change, please review the Related Materials under the WBSE Expansion to 9 Digits training on the Duke Financial Services page: https://finance.duke.edu/systems/training

 

Planning to Host an Intern in the Spring of 2022?

Is your department, unit, or research group interested in hosting an intern in the spring of 2022? Both undergraduate and graduate interns that come to Duke from other institutions for work on clinical research projects must register and onboard with the School of Medicine. The Clinical Research Internship Program (CRISP) will help you navigate that process and can assist with matching your needs to a student from an area college or university who is looking to expand his or her horizons with real world experience. Both undergraduate and graduate interns are currently allowed to be on campus, but must follow any COVID guidelines (https://medschool.duke.edu/about-us/news-and-communications/school-medicine-covid-19-response).

 

If you are interested in hosting a student next spring, whether you have a specific student in mind or are just generally interested, please submit your research opportunities here.

 

If you want to host a student from a university not currently affiliated with Duke, please email crisp@duke.edu to inquire about the possibility of obtaining the requisite affiliation agreement for that student’s home university. Duke currently has agreements with Campbell University, Durham Technical Community College, North Carolina Central University, and the University of North Carolina at Wilmington.

 

New CITI Module Available:  IRB Risk Assessment of Technologies in Human Subjects Research

The following CITI module is now available to the Duke Health Research Community:  IRB Risk Assessment of Technologies in Human Subjects Research.

This module provides IRB members and administrators with a framework for assessing the risks of technologies, whether the technology is helping conduct the research or is itself the subject of the research. It also identifies strategies to mitigate such risks. For researchers, this module provides context for how the IRB will review their work on and/or involving technology. It identifies ethical and regulatory dimensions of novel technology and considers ways to assess the risk of technology in research. The case studies in this module illustrate examples of using a risk assessment framework for both social-behavioral-educational and biomedical research.

This module has been added as an optional module to the Duke Health Biomedical Research with GCP - Basic/Refresher Stage 1 - Basic Course.  To take this course:

  • Log into your single sign on CITI account:  https://about.citiprogram.org/
  • Under Institutional Courses, next to Duke Health, select View Courses
  • Scroll to your completed Duke Health Biomedical Research with GCP - Basic/Refresher Stage 1 - Basic Course and select Review Course
  • Under Optional Modules, select:  IRB Risk Assessment of Technologies in Human Subjects Research

 

Celebrating Henrietta Lacks: Building Trust - The Path Forward

On Tuesday, August 31, 2021, researchers from Virginia Commonwealth University Massey Cancer Center, VCU Wright Center for Clinical and Translational Research, Duke Cancer Institute and the Duke Clinical and Translational Sciences Institute, held a virtual event kicking off a series of conversations aimed at building trustworthy medical and research establishments, which have historically alienated, ostracized and abused marginalized and minoritized populations. The ultimate goal of the series is to make medicine and research more inclusive and accessible.

 

The event honored the life and legacy of Henrietta Lacks, whose unique cervical cancer cells, dubbed “HeLa cells,” were integral to global medical advances enabling the treatment or prevention of diseases such as polio, AIDS and cancer – all without her or her family’s consent. Lacks died from cervical cancer in 1951, at the age of 31.

 

Read the complete write up of this event:  http://dukecancerinstitute.org/news/massey-duke-and-community-members-begin-charting-path-trust-research

 

View a recording of the event:  https://www.youtube.com/watch?v=n9yV6feexzk

 

A Few Words on Data from the Duke University Libraries Research Data Working Group

Duke Research Data Repository Logo

 

Upcoming Fall 2021 Data Management Workshops

Duke University Libraries Center for Data and Visualization Services (CDVS) hosts a variety of virtual and in-person data related workshops throughout the semester. A number of research data management workshops are now open for registration focusing on the data management best practices and tools, ethics of data management and sharing, writing data management plans to comply with federal funding agencies, designing reproducible workflows, and preparing data for publishing. Many of these workshops also qualify for Responsible Conduct of Research (RCR) credit via either the Graduate School or the Office of Scientific Integrity. Visit the CDVS website to see available workshops and register today!

 

Data Drop: A Highlight from the Duke Research Data Repository

The Cancer Microbiome Atlas (TCMA) is a collection of curated, decontaminated microbial compositions of oropharyngeal, esophageal, gastrointestinal, and colorectal tissues. The data is available in RDR and can be explored further via the TCMA database on the project website. 

Title: Data from: The Cancer Microbiome Atlas (TCMA): A Pan-Cancer Comparative Analysis to Distinguish Organ-Associated Microbiota from Contaminants

Project Website:  https://tcma.pratt.duke.edu

Affiliation: Duke Biomedical Engineering

Subject: Multi-omics, Host-microbe interactions, Human microbiome, colorectal cancer

Contact: Dr. Xiling Shen; xiling.shen@duke.edu

 

 

IRIS/ONCORE UPDATES

 

Institutional Approval required for Intermediate-Sized Expanded Access INDs and Protocols

Intermediate-Sized Patient Population Expanded Access INDs and Protocols that sync from iRIS to OnCore will begin moving through the Institutional Approval process. These protocols are required to register participants in OnCore. They will not require an RDSP.

       

Note: Individual patient INDs & Individual patient expanded access protocols do not come over the interface from iRIS and do not require institutional approval. HUD/HDE studies do not require institutional approval and should be Abandoned in OnCore after Initial IRB Approval is received. 

 

Two NEW tip sheets are now available at the links below to guide the OnCore updates needed for the following protocol types:

 

•      Expanded Access (also referred to as compassionate use)

•      Humanitarian Use Device (HUD)/ Humanitarian Device Exemption (HDE) studies

 

 

DOCR NEWS

 

New Online Training Module – Fundamentals of Clinical Research Data Management & Collection (Approx - 45min)

Fundamentals of Clinical Research Data Management and Collection opening screen shot.

 

This new online module is now available in the LMS and takes about 45 minutes to complete.

 

The purpose of this online module is to provide an introductory overview and resources to help clinical research study teams at Duke collect and manage research data in a way that ensures data security, integrity, and provenance. Learners will be introduced to resources for planning appropriate data management and key concepts related to research data collection and database design.

 

IMPORTANT – please note: This new training module has replaced TWO previously available DOCR trainings, these include:

 

  1. The old LMS module Research Data Integrity and Security (DOCR-RES-330)
  2. The in-person Research Database Design Principles (DOCR-RES-410) course that is a prerequisite for attending DOCR REDCap courses. The new module will replace this one as a REDCap prerequisite.

 

The available Onboarding Learning Plans are updated with this change, so be sure to download the newest versions! If you have these courses listed in other onboarding materials, please replace them with the link below and the new title.

 

The content in this module provides guidance to help develop the following WE-R clinical research competencies: Data Collection and Entry | Data Security and Provenance

 

Link to course

 

You can also find this course on the DOCR WE-R Competency Training page under the competencies listed above.

 

Change in Phlebotomy Class Dates for October - December 2021

Due to instructor availability we find it necessary to change the dates for the Phlebotomy Competency for Research Classes in October, November and December 2021.  We apologize for any inconvenience this may cause.  The new dates for the classes are listed below.  Staff who were registered for a class have been re-registered for the new class date in the same month. 

 

 

 

 

 

 

Research Professionals Network (RPN):  Empowering the Participant Voice: Research Participant Perceptions Survey

Thursday September 16th at 1:00 on Zoom

 

Investigators, ethics boards, research managers, and coordinators are all enthusiastic about receiving research participant feedback. Participants are usually eager to provide their perspectives, including the reasons for joining, declining to join, or leaving a research study, which may be complex and may differ for specific communities based on historical experiences, social, educational or other factors. Only by asking participants about their experiences can we begin to tailor research to enhance those experiences. Even more importantly, efforts to protect the rights, autonomy, and safety of research participants result in practices that are implemented, with little information about which way works best. Historically the adequacy of these protections has been judged by committees and institutions.

 

The effectiveness of practices designed on behalf of participants, should be judged, at least in part, by the experiences of the participants themselves.

 

In collaboration with a U01 consortium led by Rhonda Kost at the University of Rockefeller, Duke is participating in a program to create a platform for distributing a validated research participant perceptions survey using REDCap. At the next RPN, we will describe how Duke is participating, how studies and participants will be identified for participation, how surveys will be distributed, and how data will be shared and visualized locally and across the consortium. As stakeholder in the program, attendees will have an opportunity to share their feedback with us as we work to socialize the program across the institution.

 

Speaker:  Jamie Roberts

 

Join Zoom Meeting

https://duke.zoom.us/j/94120218041?pwd=Y3FKbkwzTWp3bDRCZXRHVUV2bEZudz09

 

Meeting ID: 941 2021 8041

Passcode: 778759

One tap mobile

+13126266799,,94120218041# US (Chicago) 16468769923,,94120218041# US

+(New York)

 

Join by SIP

94120218041@zoomcrc.com <mailto:94120218041@zoomcrc.com

 

Learn more about the Research Professionals Network at docr.som.duke.edu

 

 

RECRUITMENT INNOVATION CORNER

Introducing the Engagement, Recruitment, and Retention Program Fall 2021 Cohort!

Congratulations to the 26 Clinical Research Professionals who were nominated and accepted into the Duke Engagement, Recruitment, and Retention certificate program Fall 2021 cohort! Their classes will begin in September and over a period of 6 months, they will hear from many experts in these topics. We admire their desire to become resources for their units and bolster their skills in meaningful and inclusive participant engagement practices.

 

Welcome to the program:

 

  • Tiffany Beaver,  CRC in Psychiatry – Behavioral Medicine and Neurosciences
  • Santos Bermejo, CRC in Medicine – Pulmonary Allergy and Critical Care
  • DeAndra Bodiford, CRC Tier 2 in Medicine – Center for Aging
  • Kristin Byrne, CRNC Tier 3 in Medicine – Hematology
  • Kathleen Coles, CRC Tier 2 in Medicine – Pulmonology
  • Nisha Datta, CRC Sr. at UNC Chapel Hill in the Clinical & Translational Science Institute
  • Katelyn Dempsey, CRC in Medicine – Pulmonary Allergy and Critical Care
  • Eileen Duffy, CRNC Tier 3 in Oncology – Radiation Oncology
  • Katelyn Ehle, CRC in Population Health Sciences
  • Kaitlin Mae Foy, CRS Sr. in Medicine – Pulmonary
  • Taylor Hayes, CRC in OB/GYN – Oncology
  • Joshua Hoover, CRC in Neurosurgery – Spine
  • Catherine Jarboe, Communication Strategist in Child and Family Mental Health & the Center for Autism and Brain Development 
  • Kay Johnson, CRC in Oncology – Melanoma Research
  • Kimberly Leathers, CRC Tier 2 in the Clinical & Translational Science Institute
  • Sierra Lindo, Project Planner in the Clinical & Translational Science Institute
  • Tina Lucas, CRC Tier 2 in Medicine – Gastroenterology
  • Amanda Mandy, CRC in Medicine – Gastroenterology 
  • Brittany McDowell, CRC Tier 2 in Medicine – Pulmonary Allergy and Critical Care
  • Julie Miller, CRC Tier 2 in Population Health Sciences
  • Kimberly Perez, CRC in OB/GYN
  • Gloria Pinero, CRC Tier 3 in the Duke Office of Clinical Research
  • Tiffani Reeves, CRC Tier 2 in Medicine – Center for Aging
  • Maurice Smith, CRC in the Clinical & Translational Science Institute
  • Stephanie Taylor, CRC in the Duke Early Phase Clinical Research Unit
  • Jennifer Thomas, CRC Tier 2 in Population Health Sciences

 

We’re excited to start this next series with all of you!

 

So far, we have “graduated” 62 participants from the ER&R program, most of whom have gone back to serve their departments, divisions, CRUs and colleagues as knowledgeable engagement, recruitment and retention resources. Ask your RPMs who they are if you’d like to connect with them.

 

 

DID YOU KNOW?

REDCap:  New special functions: left(), right(), mid(), length(), find(), trim(), upper(), lower(), and concat()

These nine new functions can be specifically used when dealing with text values and may be especially useful when using them in conjunction with the @CALCTEXT action tag. To learn more and to see some practical examples of their usage, click the blue 'Special Functions' button in the Online Designer in any project.

 

  • left (text, number of characters) - Returns the leftmost characters from a text value. For example, left([last_name], 3) would return 'Tay' if the value of [last_name] is 'Taylor'.
  • right (text, number of characters) - Returns the rightmost characters from a text value. For example, right([last_name], 4) would return 'ylor' if the value of [last_name] is 'Taylor'.
  • length (text) - Returns the number of characters in a text string. For example, length([last_name]) would return '6' if the value of [last_name] is 'Taylor'.
  • find (needle, haystack) - Finds one text value within another. Is case insensitive. The "needle" may be one or more characters long. For example, find('y', [last_name']) would return '3' if the value of [last_name] is 'Taylor'. The value '0' will be returned if "needle" is not found within "haystack".
  • mid (text, start position, number of characters) - Returns a specific number of characters from a text string starting at the position you specify. The second parameter denotes the starting position, in which the beginning of the text value would be '1'. The third parameter represents how many characters to return. For example, mid([last_name], 2, 3) would return 'AYL' if the value of [last_name] is 'TAYLOR'.
  • concat (text,text,...) - Combines/concatenates the text from multiple text strings into a single text value. For example, concat([first_name], ' ', [last_name]) would return something like 'Rob Taylor'. Each item inside the function must be separated by commas. Each item might be static text (wrapped in single quotes or double quotes), a field variable, or a Smart Variable.
  • upper (text) - Converts text to uppercase. For example, upper('John Doe') will return 'JOHN DOE'.
  • lower (text) - Converts text to lowercase. For example, lower('John Doe') will return 'john doe'.
  • trim (text) - Removes any spaces from both the beginning and end of a text value. For example, trim(' Sentence with spaces on end. ') will return 'Sentence with spaces on end.'.

 

The following link allows you to test these features in a REDCap Survey:

https://redcap.duke.edu/redcap/surveys/?s=DCYWC9JPLK

 

 

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

 

Upcoming training offerings can be viewed by month on the DOCR Calendar.

 

Detailed information about each offering and direct links to the offering are also available on the DOCR website under Available DOCR Trainings.

 

 

CLINICAL RESEARCH EMPLOYEE HIGHLIGHTS

  • The Dermatology Pathology CRU welcomes Kirstie Jenkins as a Clinical Research Nurse Coordinator.
  • The Dermatology Pathology CRU welcomes Jill Collins as a Research Technician and Lisa Haertel as a Certified Histotechnologist in the BRPC.
  • Population Health welcomes Sarah Hantzmon, CRS, Sr, who started August 30.
  • The Children’s CRU announces Eileen Phifer, CRC with Pediatric Transplant and Cellular Therapy, started August 2.
  • The Children’s CRU announces Candice Wade, CRC with the Marcus Center for Cellular Cures (MC3) started  August 2.

 

Send your Clinical Research Employee Highlights to Holly.Tiemann@duke.edu

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

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