Duke Clinical Research Update February 3, 2021

Wednesday, February 3, 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

Thursdays, 2 PM, via WebEx

Click for SlicerDicer Tipsheets

 

PACE Office Hours

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

 

RESEARCH COMMUNITY NEWS

 

Introducing myRESEARCHpath, the institution-wide interactive research roadmap

myRESEARCHpath logo

 

A new tool is available through myRESEARCHhome to guide Duke’s research community to policy, process, and helpful resources throughout a research project lifecycle. This new tool, myRESEARCHpath, brings together information from over 35 research support offices across the institution so researchers can easily access the information they need to navigate tasks from idea generation to project closeout. Access this brief tutorial video to learn more about the features and functionality of myRESEARCHpath.

 

myRESEARCHpath is intended to support faculty, scientific staff, research administrators, and trainees throughout Duke University and the Duke University Health System. This tool was made possible by support from the Duke Office of Research and the Duke Clinical and Translational Science Institute.

 

Exception to Enroll a Single Patient Outside of Inclusion/Exclusion Criteria

If an investigator encounters a potential research participant who does not satisfy all of the inclusion/exclusion (I/E) criteria of a research protocol, and the investigator concludes that such a person is so close to meeting I/E criteria that the person’s inclusion would not place him/her at an increased risk of harm from study participation, and participation in the study would be in the person’s best interest because alternatives are limited to less favorable options, and the research is not DHHS regulated, the investigator has several choices:

  • Not recruit the person; or
  • Obtain IRB approval of an amendment to alter the overall I/E criteria to permit inclusion of the person and other such people; or
  • If time does not permit the investigator to submit & obtain such an amendment, or if the sponsor chooses not to amend the overall study, but does approve the change in I/E criteria for this single person, the investigator must submit an amendment in iRIS, requesting to include this single subject, with a justification to the IRB that the person’s inclusion represents appropriate medical practice.  The amendment must include:
    • assurance that the proposed research is not subject to DHHS regulations;
    • confirmation from the study’s principal investigator and sponsor that the potential research participant may be included and will not be unevaluable based on not meeting I/E criteria;
    • declaration that participation in the study would be in the person’s best interest because alternatives are limited to less favorable options;
    • confirmation from a colleague uninvolved in the care of the person that alternatives are limited to less favorable options.
       

For more information, please see the policy:  https://irb.duhs.duke.edu/policies-and-regulations/policies/waiver-single-person

 

New:  Process for Adding Duke Students, Unpaid Volunteers, and Visiting Trainees/Interns to Study Personnel

The DUHS IRB has added Process for Adding Duke Students, Unpaid Volunteers, and Visiting Trainees/Interns to Study Personnel to their website.

 

With the issuance of this new policy, remote plans for undergraduate students are no longer required to be submitted via REDCap.

 

Click Here for a PDF Version of the Process for Adding Duke Students, Unpaid Volunteers, and Visiting Trainees/Interns to Study Personnel

 

ESSENTIAL ELEMENTS OF THIS POLICY

  • Unpaid Duke undergraduates and volunteers may not have access to the Epic Electronic Medical Record (EMR).
  • Any external (non-Duke) personnel placed on study teams as unpaid volunteers, visiting students, or visiting trainee/interns must pass sanction and criminal background checks and must complete all required Duke Health CITI modules, Responsible Conduct of Research (RCR) training, HIPAA for Researchers training, and LMS Workforce Policy Acknowledgment module (includes electronic signature for Confidentiality Agreement, Code of Conduct Attestation, and Secure System Usage Memorandum).
  • All personnel are required to comply with all Duke Health policies and procedures, including privacy and security policies and procedures.

 

The website also includes:

  • Requirements for adding Duke University Schools of Medicine and Nursing graduate students
  • Requirements for adding Duke University campus graduate students to Key Personnel
  • Requirements for adding Duke undergraduate students to Key Personnel
  • Requirements for adding other unpaid volunteers, visiting trainees/interns to Key Personnel

 

For visiting research scholars, please contact DOCR.help@dm.duke.edu.

 

Use of Standardized Measures or Validated Assessment Tools for Research Quality Improvement Studies

In response to the use of standardized measures or validated assessment tools in research quality improvement studies, the Office of Licensing and Ventures has identified two tools which are not suitable for use at Duke.

Duke Investigators who use standardized measures OR validated assessment tools for Research and Quality Improvement studies should NOT use:

 

  • Morisky Scale (medication non-adherence assessment tool).  As an alternative to using the Morisky Scale, the Office of Licensing and Ventures recommends using the Self-Reported Medication Nonadherence Measurement, developed by Dr. Corrine Voils.  If your study is interested in using this tool, please contact David Chang Villacreses at the Office of Licensing and Ventures.  The Self-Reported Medication Nonadherence Measurement is also available in Spanish, Singaporean Malay, and Singaporean Chinese translations.  For more information and a link to publications:  https://www.surgery.wisc.edu/research/researchers-labs/corrine-voils-phd/self-reported-medication-nonadherence-measurement/.
  • CERAD modification of the Boston Naming test (neuropsychological assessment tool).  Those interested in this measure must get permission from the copyright holders of the Boston Naming test.

 

Reminder:  Sponsored Accounts Required for Affiliate Access to REDCap

New affiliates who need to access Duke’s REDCap system will require a sponsored account before they can be added to REDCap.

 

Affiliates are defined as individuals who are not recorded in a system of record, such as the Duke Human Resources system (SAP) or the Duke University student system (SISS). Affiliates can include collaborators at other research sites as well as visiting faculty, visiting scholars and post-docs, medical residents, and contractors.

 

  • Visit the Sponsored Guest site and follow the directions on the page to request a Guest Account. For the type of account please select a Research/Academic Collaborator, and only request a NetID.
    • Please review the updated tip sheet available for you here.
  • Only Duke employees can sponsor an affiliate for an electronic identity (Duke Unique ID and NetID).
  • Requests will be processed on a first-come, first-served basis and can take up to three business days.
    • You can also check the status of your request on the same website.

 

Once your affiliate has a NetID then you can follow the process to have them set-up an account on REDCap and submit a request to add them to your project.

 

Existing affiliate users will transition to a Sponsored Account at a later date. We will notify these users in advance.  If an existing affiliate user forgets their password, they will need to transition to a Sponsored Account.  The old password cannot be reset.

 

Duke ClinCard Update:  TIN Validation

Employee Travel & Reimbursement announces the new TIN Validation functionality within Duke ClinCard.  This new process is validation of Taxpayer Identification Numbers which is handled by a real-time interface with the designated Internal Revenue Service database.  For the purposes of the ClinCard system, the participant’s TIN is the social security number (SSN).  The new feature was activated in the Duke ClinCard system effective January 2021.  Previously, the TIN validation process is handled by the Employee Travel Reimbursement (ET&R) team after the payments are posted to the ClinCards.  The ET&R team members follow up with departments as discrepancies are identified.  This new functionality will transition the validation process to the front end.

Some highlights of what to expect with the new feature include:

  • The TIN validation will occur during the Participant Registration process and will immediately alert the site coordinator of the results.   
  • All new study participants registered after TIN validation is activated will go through the validation process.
  • All study participants previously enrolled in a study, will go through the validation process during the activation of TIN validation.  The site coordinator will see the results of an invalid TIN when the participant’s profile is updated or a payment is made.
  • An invalid TIN-Name combination will not prevent participant registration or payment.  However, it is critical that the site coordinator update the system with the correct TIN-Name combination, as soon as possible.
  • The invalid TIN-Name combination will continue to display an error in the system until the correct information is updated. 
  • A site coordinator may attempt to enter the study participant’s legal first name, last name, and TIN combination, for validation, up to 4 times before the system will block the user from additional submissions.  The system will present an error message when this occurs.  The system will reset overnight to allow access to the site coordinator the next day.
  • ET&R will monitor invalid TIN-Name combinations on a monthly basis and will follow up with departments regarding any outstanding discrepancies.  In order to ensure compliance with the regulatory requirement, it will be important to update the corrected information in a timely manner.  Backup withholding will be necessary in the event errors are not corrected timely. 

 

Additional information regarding the changes, including information regarding registering study participants, can be found here.

If you have any questions or need additional information, please contact ClinCard-Request@duke.edu.

 

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

Center for Data and Visualization Sciences

Spring 2021 Data Management Workshops

Duke University Libraries Center for Data and Visualization Services (CDVS) hosts a variety of virtual data related workshops throughout the semester. A number of research data management workshops are now open for registration focusing on the Duke Research Data Repository, 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. Visit the CDVS website to see available workshops and register today!

 

Researcher Highlight: Martin Fischer, PhD

The Research Data Curation team has the privilege to collaborate with exceptional Duke researchers and scholars who are advancing their fields through open data sharing in the Duke Research Data Repository (RDR). One such researcher, Martin Fischer, Ph.D. says the process of depositing data in the RDR “was a breeze.” Dr. Fischer values the opportunity for research development that open data sharing creates, stating that “maybe somebody else will develop a routine or develop something that is better, easier than what we have.” See the related blog post here

 

Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator INDs and IDEs

The Office of Regulatory Affairs and Quality announces two upcoming workshops:

 

The Investigational New Drug (IND) Workshop

Speakers: Rachel Johnson, PhD, RAC, Katherine Deland, PhD

March 5, 2021, 9:00 AM – 11:00 AM

 

This workshop will:

  • Define an investigational drug, including off-label use of FDA approved drugs
  • Provide guidance on determining when the IND regulations apply to research studies
  • Discuss the preparation and submission of IND applications to FDA
  • Review maintenance and safety reporting requirements
  • Encourage participant discussion of case scenarios

 

The Investigational Device Exemption (IDE) Workshop

Speakers: Alysa Vereen, PharmD, David Jensen, PhD, RAC

March 12, 2021, 9:00 AM – 11:00 AM

This workshop will:

  • Discuss FDA’s approach to regulation of devices in clinical studies and for marketing
  • Provide guidance on when the IDE regulations apply and discuss possible exemptions
  • Review significant risk and non-significant risk device studies
  • Discuss the preparation, submission, and maintenance of IDE applications
  • Encourage participant discussion of case scenarios

 

Registration Link:

https://medschool.duke.edu/research/research-support-offices/office-regulatory-affairs-and-quality/education-and-training-opportunties

 

Clinical Research Training Program (CTRP) is accepting applications for Academic Year 2021-2022

The program is now accepting applications for academic year 2021-2022. 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.duke.edu.

 

CRTP trains clinical researchers in leading-edge investigative practices grounded in sound scientific principles promoting reproducible research and rigorous ethics training and practice.

 

Last year, CRTP launched the Basic Science Research Track (BSRT), a customized curriculum designed for physician scientists and trainees across a range of discovery sciences. The curriculum includes new coursework that prepare researchers to: perform rigorous basic science; manage, analyze, and present data; oversee a laboratory; and successfully compete for research funding.

 

As one of the oldest clinical research training programs in the nation, we are committed to producing the next generation of leaders shaping clinical research today and building on Duke’s pioneering role in biomedical research.

 

The application deadline for priority review is April 15, 2021. Applications will be accepted through August 1, 2021.

 

Duke Roybal Center Webinar:  Supporting knee osteoarthritis care with technology- research from Australia

UNC CCCR Speaker Series:  Rana Hinman

 

Please join us for this presentation on Tuesday, February 16, 2021 from 4 PM – 5 PM EST (Wednesday, February 17, 2021 from 8-9am AEDT) brought to you by the UNC Core Center for Clinical Research (CCCR) and Duke University's Translational Research for Mobility and Healthy Longevity.

 

Register here

 

 

IRIS/ONCORE UPDATES

 

No Protected Health Information (PHI) Allowed in iRIS System

iRIS must be a PHI-free system, so take special care to be sure there is no PHI contained in the documents you upload to iRIS.  This is especially the case for safety events.  Please make sure that participants’ names, MRNs, and other direct identifiers are redacted from the documents you upload to the system.

 

If you realize you have mistakenly uploaded a document containing a participant’s PHI, contact your IRB Specialist immediately.

 

The IRB Specialist responsible for your CRU/Dept can be found here:  https://irb.duhs.duke.edu/about-us/staff-and-chairs

 

iRIS 1 on 1 Training Sessions Available

DOCR is offering 1 on 1 iRIS training sessions that can be taken as part of onboarding for those who are new to using the iRIS system. During this 1 on 1 training session, an experienced Regulatory Coordinator will walk through iRIS, providing tips and tricks and answering any questions the learner has about the system. The training can be requested as needed, but will only be offered once for a single individual.

 

This one-time training is open to anyone in a clinical research position and can be requested by emailing DOCR-Training@dm.duke.edu.

 

PLEASE NOTE: Prior to requesting a 1 on 1 iRIS training session, both of the online iRIS training modules in the LMS, Intro to Submitting an IRB Application (00133297) and Post Approval Submission Forms (00121335), must be completed. This is important because it will allow you to familiarize yourself with IRIS and will help you come up with any questions you may have.

 

OnCore Tip:  Use of Calendar Tool

When selecting a date from the calendar drop-down tool in OnCore, be careful to select just one day and verify it in the “Date” box.

OnCore Calendar image

 

There have been a few instances where 12/31/1969 has populated the “Date” box.  This occurs when dragging from one day to another day.

OnCore calendar image

 

Since the “Date” impacts several functions in OnCore, please avoid dragging and always double check the “Date” box before clicking Submit.

 

We appreciate your help in preventing the wrong date from being entered in OnCore.

 

What is the easiest way to find the OnCore Tip Sheets on myResearchPath (MRP)?

Search for “OnCore Tip Sheets”. 

 

Links to the tip sheets are located under the Tools, Templates, and Forms section on the Resources tab.

myRESEARCHpath resources tab

 

Click on the OnCore Tip Sheets link to be taken to the Box folder. 

 

From here copy the URL to add it to your My Links dashboard in MyResearchHome and star the folder to add it as a favorite in Box

myRESEARCHpath OnCore Tip Sheets My Links

 

To find eReg Tip Sheets, search for eReg and click on this link located on the Resources tab

Image of Resources for using the eRegulatory (eReg) management System link in myRESEARCHpath

 

 

DOCR NEWS

 

Research Professionals Network:  Understanding the Burden of COVID-19 in Healthcare Workers: Early Results from the HERO Program

Thursday February 18th, 2021 at 1:00 on Zoom

 

The HERO Registry is a prospective study that launched in April 2020 to evaluate the burden of COVID-19 in Healthcare Workers (HCWs) in the United States. The overall goal of the registry is to create and engage a community of HCWs, and their household members, who may be eligible for participation in future research studies; including those of COVID-19 prophylaxis and treatment. Via an online portal, participants contribute data on medical history, employment characteristics, COVID testing/diagnosis. The HERO registry is the foundation for HERO-Together, a newly launched prospective, observational, multicenter cohort study of vaccinated HCWs. Healthcare workers are able to self-enroll via an online portal and complete surveys on unexpected medical care received post-vaccine. These data will help fill gaps in evidence about long-term outcomes after COVID-19 vaccination.

 

Speaker: Emily O’Brien, PhD, FAHA

 

Zoom Link: https://duke.zoom.us/j/93525152054?pwd=WUpEelY5WHlkSGZiUFR4ZlhxSjBsUT09

 

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

 

New:  Standard Operating Procedure for Using Duke Box for Clinical Research Study Monitoring

A new standard Operating procedure:  Standard Operating Procedure for Using Duke Box for Clinical Research Study Monitoring, has been added to the DOCR website.

 

  • This SOP clarifies the use of Duke Box when remote monitor visits are requested.

 

Full text of this SOP can be found here, and also on the DOCR website Policies and Procedures under OnGoing Study Management.

 

Update on DOCR.help@dm.duke.edu email address

DOCR would like to update the research community that the DOCR.help@dm.duke.edu email address is once again functioning as expected.

 

Please be sure to note the full email address.  The entire email address must be used in order for the message to enter the DOCR Help Service Now queue.

 

Please contact susan.budinger@duke.edu with any questions.

 

 

RECRUITMENT INNOVATION CORNER

Duke Health Brand Center

Brand image

What is “branding” and why is it important?

Beyond just a memorable logo, good branding increases the trustworthiness of a company, provides employees with direction and motivation, and makes acquiring new customers (or participants!) easier.

A brand represents the people’s perception of a company’s customer service, reputation, advertising and logo. In addition, when all of these parts of the company are working well together, the overall brand tends to be a healthy representation.

Brand image

What does the Duke Health Brand Center Do?

The Duke Health Brand Center provides guidelines to help you apply the Duke Health brand to your next project.  They offer suggestions and resources for:

  • Duke Health Logo
  • Colors
  • Creation of IRB appropriate flyers
  • Fonts and Typefaces
  • Photography
  • Apps and Web Usage
  • Apparel, Event Giveaways and Display Items
  • Duke Health Writing Style
  • Signage
  • Video
  • Patient Education
  • Clinical Trials and Research

 

Participant materials for clinical research, including study flyers, advertisements, social media posts, marketing materials and informed consent forms, should be participant-centric, engaging and written using plain language. These materials also must adhere to the Duke Health brand guidelines, which includes following their standards for font, color and style.  There are customizable templates for study flyers, brochures, posters, and rack cards that can be created on the Brand Center.

 

Here is an all-in-one resource to help you understand the Duke Health brand and style.

Contact Us graphic

As always, please Contact us for any of your research needs!  We can help you develop engaging eConsents, MyChart messages, websites, engagement letters, research notices, and more!

Follow us on Facebook at Discover Duke Research.

 

 

DID YOU KNOW?

REDCap:  Field Embedding

REDCap now has Field Embedding (some may be aware of this functionality as SHAZAM).  This functionality allows a form to be customize, surveys and data collection instruments can look exactly how you want. Field Embedding allows to repositioning of field elements on a survey page or data entry form so that they get embedded in a new location on that same page. 

 

For example, fields a can be side-by-side.

REDCap field examples

 

TRAINING OPPORTUNITIES

NEW: Express Start Onboarding Modules now available for Research Practice Managers (RPMs) and Assistant Research Practice Managers (ARPMs)

We have officially launched Express Start Onboarding for those in the RPM and ARPM roles! The modules are available in the LMS and you may sign up using the register link below.

 

Register for full program here. Modules within the RPM/ARPM Express Start series may also be registered for individually. Links are provided in the course list below.

 

The Express Start Onboarding Program for RPM/ARPM consists of five self-paced e-learning courses that will provide an overview of clinical research activities, roles, regulations, and workflows at Duke. This self-guided program is intended to provide new hires in clinical research roles with online courses that can help orient them to the “lay of the land” of clinical research at Duke. By completing these modules, new CRU leaders will learn the basics that will begin to prepare them for their role as a RPM or ARPM at Duke.

 

Learning Objectives for the RPM/ARPM Express Start include:

  • Describe the roles and responsibilities of a RPM or ARPM
  • Identify the offices, programs, and resources that support clinical research at Duke
  • Recognize the structure of your team and roles you can expect to manage and interact with
  • Identify the clinical research systems used at Duke and recognize how they interact with one another
  • Recall regulations, guidelines, and policies for conducting clinical research at Duke Health
  • Describe RPM and ARPM responsibilities related to WE-R initiatives and Tier Advancement for employees

 

Courses Included in the Program:

 

What people are saying about RPM/ARPM Express Start:

Text box:  The Navigating Clinical Research course is such a useful module!

Text box:  These modules are fantastic!

Text box:  These looked great.

Text box:  Thank you for creating these

Registration information for other available self-paced Express Start Programs are available on the WE-R Onboarding and Training webpage and additional role-based Express Start Programs will be added here is they become available. 

 

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 School of Nursing CRU welcomes Megan Freed who has joined the team as an RPL for Health Innovation.
  • The Department of Medicine CRU welcomes:
    • Katelyn Dempsey, who joined the Medicine - Pulmonary Division as a CRC on January 19, 2021
    • Cassandra Terry, who joined Medicine -  Center for Aging as a CRS, Sr. on January 19, 2021
  • The Duke Office of Clinical Research welcomes:
    • Sally Taylor, CRC joined DOCR January 13, 2021
    • Caroline Sanners, CRNC joined DOCR January 13, 2021
    • Jessica Wilson, CRC joins DOCR February 4, 2021

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

Image of Duke South Campus building

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