Duke Clinical Research Update January 6, 2021

Wednesday, January 6, 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

 

COMING SOON – Survey of the Duke Research Climate 2021!

In mid-February, all research faculty, staff, postdocs, and graduate/medical students campus-wide will receive an email request to participate in the Duke University Survey of Organizational Research Climate (SOURCE).  

The survey was developed and validated by the National Center for Professional and Research Ethics (NCPRE) at the University of Illinois at Urbana-Champaign and NCPRE will conduct the survey on behalf of Duke. 

The survey results will provide an assessment of Duke University’s climate for scholarly and research integrity, and will be used to evaluate and develop policies or target interventions to make this a better place to conduct research and other scholarly work.

The email request will provide a link so you can complete the anonymous survey online, and it will take about 15 minutes of your time.  The survey is anonymous, and survey responses will be linked only to the participants’ unit; only aggregated response information will be collected and reviewed.

The more participation we have, the better the survey data will be!  We hope all researchers will consider participation to help us improve the research climate at Duke.  If you have any questions about the survey, please feel free to contact the project coordinator, Donna Kessler, PhD, at 919-668-5115.

 

Public Summit on The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies

The Clinical Trials Transformation Initiative (CTTI) will host a public summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, on Wednesday, January 13 at 10:30am EST. The summit, conducted as a webinar and moderated by Pamela Tenaerts, CTTI, will include a welcome from Janet Woodcock, Operation Warp Speed; a call-to-action from Robert M. Califf, Verily and Google Health; remarks from Mark McClellan, Duke-Margolis Center for Health Policy; and a panel discussion moderated by Esther Krofah, FasterCures. The panel discussion will focus on solutions related to scaling master protocols, including:

 

  • Overcoming barriers to starting up sites
  • Increasing participants at existing sites
  • Using the COVID experience to inform our preparedness for future pandemics

 

This public summit will also address the status of COVID-19 clinical trials, including results from a recent CTTI analysis of data from ClinicalTrials.gov and other research, and examine the use of common platforms to optimize the design of master protocols for multiple therapies attempting to treat the same diseases or specific health problems.

Also, please take our pre-summit survey for stakeholders involved in (or wanting to be involved in) COVID-19 treatment master protocols - specifically, those involved in setting up new sites or recruiting participants at existing sites. CTTI will summarize the survey findings to inform the summit discussion of common hurdles and potential solutions for advancing master protocol treatment trials. 

Visit CTTI’s website for more information regarding the summit and links to selected master protocol web pages.

 

Link to Register
 

 

IRIS/ONCORE UPDATES

 

New 1 on 1 iRIS Training Sessions Available

 Do you have a new team member joining your unit? Are you new to using clinical research systems at Duke? OR are you just a little lost when it comes to using the iRIS system effectively? If the answer to any of these questions is yes, do we have some good news for you!

 

DOCR is now 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 for Noely.

 

Special thanks to Noely Martinez Overby, Regulatory Coordinator in Dermatology, for making these sessions possible!

 

OnCore: Navigating to eReg

A link to eReg has been added in the OnCore Help Menu.  To access the Help Menu, click the arrow next to your name in the upper right hand corner.

Screen shot showing the link to eReg in OnCore

 

eReg Updates

The CITI Credential names have been updated to clarify which documents should be uploaded under each credential type. “Good Clinical Practice/Human Subjects Protection Training” has been renamed “Good Clinical Practice or CITI GCP”. “CITI” has been renamed “CITI – Other Training”.

 

Please note no documents will be moved automatically. For assistance or questions please contact your CRU’s eReg Regulatory Manager (RPM or ARPM) or oncore@duke.edu.

 

 

DOCR NEWS

 

DOCR.help Request Routing

Until further notice, please route DOCR.help requests for DOCR assistance to DOCR-training@dm.duke.edu.

 

DOCR is working to address technical issues with the DOCR.help mailbox. If you have submitted a previous request to DOCR.help and have not received a response, please resend the request to DOCR-training or contact Susan Budinger at susan.budinger@duke.edu.

 

Policy Update:  Lab and Leave Process for Clinical Research Labs Standard Operating Procedure

The Lab and Leave Process for Clinical Research Labs Standard Operating Procedure has been updated.

 

Updates include:

  • Clarification that sites listed within the document do not provide services to COVID positive or suspected COVID patients
  • Even though an appointment is not required, it is now recommended for the North Duke Street location, the Heritage Clinic and Lennox Baker.
  • The South Durham Clinic and the Brier Creek Clinic on Cerny Street are NOT Lab and Leave locations.  Do not direct patients to these locations.
  • Do not direct patients to any Lab and Leave location if the testing ordered is STAT.  Any patient with lab work needing to be ordered as STAT needs to be directed to Clinic 1D if adult and to the CHC if pediatrics. 
  • Locations within the document have been updated and times clarified.
    • All locations provide service from 8am-5pm, Monday through Friday except Lennox Baker.  Lennox Baker hours are 8am-4pm, Monday-Friday. 

 

Full text of policy can be found here.

 

Have You Registered for Your Society for Clinical Research Sites Account?

The Society for Clinical Research Sites (SCRS) was founded in 2012 in response to the growing need for a global organization representative of the needs of clinical research sites. SCRS currently represents over 9,500 research sites in 47 countries. SCRS’ mission is to unify the voice of the global clinical research site community for site sustainability. SCRS is an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise.

 

Duke has a membership to SCRS that allows employees to create a free account.  Follow these instructions to create your free account and explore the mySRCS benefits available to you!

 

  • Go to myscrs.org
  • Click "Join SCRS" in the top right to create an account
  • Indicate your organization is already and SCRS member and select Duke University Medical Center
  • User your duke.edu email address when registering

 

Membership includes access to Webinars, Newsletters, Site Management Modules, and Virtual Trial Capability Training.

 

 

RECRUITMENT INNOVATION CORNER

New Year, New Recruitment Strategies!

 

The Recruitment Innovation Center (RIC) provides Duke’s clinical research community with connections, collaborations and resources to support efficient and effective engagement, recruitment and retention, including strategic planning, data-driven tactics, and patient engagement resources. 

So what does that include?  Below are all of the services we offer to the research community that are all FREE!

 

Comprehensive Recruitment and Retention Planning Consultations

Our tailored one-on-one consultation services, studios and training options include:

  • Development/review of patient-facing materials, including consent forms, advertisements, social media, MyChart invitations, etc.
  • Assistance with NIH Forms E Recruitment and Retention Plans
  • E-Recruitment and Retention Plans
  • Stakeholder Engagement Planning
  • Grant planning
  • Data-driven cohort discovery using DEDUCE, Slicer-Dicer and i2b2/SHRINE
  • Collaborator Identification and/or access to research networks like PCORNet and the Trial Innovation Network

 

MyChart and Direct-to-Patient Messaging review

  • If you are planning to use MyChart to send research invitations to potentially eligible patients we can help you craft an engaging, informative invitation with a clear call to action.

 

Social Media Marketing Service

 

Patient Engagement Studios

  • Bring your research idea and materials to a group of trained and empowered patient research advocates.
  • Obtain feedback, insight and advice on your plans and materials to make them more patient-centered, lay-friendly, and feasible. 
  • Complete this request form for a free myRESEARCHpartners Patient Engagement Studio to get the process started.

 

Plain Language Mini-Consult

  • Our plain language mini-consult will provide you with a lay-summary of your research, bulleted statements and taglines that you can use in your advertising materials and a lay-friendly concise summary of your project that you can use in your informed consent form.

 

Clinical Trials Directory Management

We will help you post your study on the Duke Clinical Trials Directory

IRB review and approval of listings on the directory is not required as long as the information provided is basic trial information, such as: the title, purpose of the study, protocol summary, basic eligibility criteria, study site location(s), and how to contact the site for further information.

 

Please Contact us for any of the above research needs!  You can also Email us at studyrecruitment@dm.duke.edu  if you have any questions!

 

 

Follow us on Facebook at Discover Duke Research.

 

 

 

 

 

DID YOU KNOW?

We have created 11,000 REDCap Projects! 

 

 

The use of REDCap continues to grow, we just hit 10,000 projects in August.  The growth continues as faculty, staff, and students are using it to collect their research data securely.  REDCap has also been used for several administrative project as well.  REDCap is a HIPAA compliant, secure web application for building and managing online surveys and databases.

 

Learn more about by watching a brief video.  REDCap can be access at https://redcap.duke.edu and a practice project can be requested here.  REDCap office hours are now held 4 times a week to help answer questions about your project, visit the REDCap Homepage for days/times and to schedule a session.

 

Contact us at redcap-docr@duke.edu with any questions.

 

 

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 Duke Neurosurgery Clinical Research Unit welcomes Joshua Hoover, CRC.
  • The Department of Medicine CRU announces the following recent additions and changes to the DOM CRU team:
    • Chad Harrell joined PCRC/GIM as a CRS, Sr.
    • Vivek Pisharody joined PCRC/GIM as a CRS, Sr.
    • Lani Banez joined CAGPM as a CRC
    • Katherine Williford joined the DAAAC/Pulmonary team as a CRC
    • Kelly Stanly transferred within ID to CRC

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

Image of Duke West Campus Building.

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