Duke Clinical Research Update March 17, 2021

Wednesday, March 17, 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

 

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

The Process for Adding Duke Students, Unpaid Volunteers, and Visiting Trainees/Interns to Study Personnel policy has been updated based on community feedback.

  • For the DUHS/SOM Academic Affiliation Agreement, we have added Susan Hayden in ORC as the contact (“Consult with Susan Hayden in Office of Research Contracts (ORC): susan.hayden@duke.edu”)
  • For required training, course names and direct links to the courses have been added to the document
  • A copy of the signed student agreement with CRU Director approval will be sent to DOCR
  • Enhanced wording to differentiate between the access permitted for visiting trainees/interns vs. non-Duke volunteers.
  • Enhanced wording to differentiate Table 1 Consented Clinical Research Data and Table 2 Non-consented Clinical Research Data

The Process for Adding Duke Students, Unpaid Volunteers, and Visiting Trainees/Interns to Study Personnel policy will now be housed on the DOCR website.

Additionally, the March 24th Research Wednesdays topic will be The Roles of Students and Volunteers in Clinical Research, presented by Stephanie Freel, Holly Hough, Amanda McMillan, and Sue Budinger. 

The session will be held via WebEx from 1 PM – 2 PM.

WebEx:

Meeting number (access code): 120 567 4957

Meeting password:  737pxJw963g

Link to join:  https://dukemed.webex.com/dukemed/j.php?MTID=m5a94cd053356309e8b0c415bbb6eae48

 

Submitting ClinCard Requests and ClinCard Pickup Process

The ClinCard request process has been updated.

Requests can now go straight to the ClinCard email box:  clincard-request@duke.edu

Regarding ClinCard Pickup:

COVID Pickup precautions are still in place.  Please follow this process to pickup your ClinCards:

  • Pickup is by appointment only.
  • Card must be picked up by the designated person.  If this changes, Employee Travel and Reimbursement (ET&R) must be notified in advance by the Site Administrator.
  • Current restrictions are still in place for entering Duke Facilities (masks must be worn and employees must complete symptom monitoring prior to entering the building).

 

2022 Calendar of IRB Meeting Dates

The 2022 calendar of IRB Meetings has been posted to the IRB web site and is available for you:

https://irb.duhs.duke.edu/irb-review-process/irb-meetings

 

Radiation Safety Specialty Committee: NEW Web Tool for Creating Your Radiation Risk Templates

There is a new on-line tool for creating study-specific “radiation risk statements” for consent forms.

 

The new “Pre-Prepared Statements” tool organizes the most commonly used radiation exams and MRIs into groups that reflect the different types of protocols.  For example, if you’re working on a trial that involves a novel therapy for cancer, you can select the “Oncology Study” button and get a checklist of the radiation exams that are frequently used in cancer drug protocols.

 

The new “Pre-Prepared Statements” tool is accessible from the home page of the “Radiation Safety Committee” web site at https://lsw.duhs.duke.edu/radsafety/consents/default.asp .

 

Office of Research Contracts Data Transfer Intake Form (DTIF)

The Office of Research Contracts (ORC) has now made the Data Transfer Intake Form (DTIF) available in REDCap format.  The Word version of the DTIF will no longer be used.  You can access the new DTIF format in REDCap at https://redcap.duke.edu/redcap/surveys/?s=A93JJ7PNFW.  Once you confirm your submission, you will receive an email with instructions on next steps.  ​The DTIF should be completed whenever you are working with ORC to generate a data transfer agreement.  

 

Any questions can be directed to an Office of Research Contracts Agreement Manager for assistance with the process.

 

Policy:  Use of VA Data for Research at Duke and Durham VA Data Use Compliance Training

A new policy has been created:  Use of VA Data for Research at Duke

The VA has specific data requirements for research data requests involving the use of VA data outside of the secure VA environment, when a HIPAA authorization has not been obtained. To meet VA data security requirements, Duke will maintain VA data within a FISMA moderate environment.

The policy lists requirements for the Use of VA Data for Research at Duke.  One of these requirements includes completion of the online module Durham VA Data Use Compliance Training (00157654).

Training Description: This training is intended for individuals at Duke who will engage with be using Durham Veterans Affairs (VA) data for their research while at Duke. The training describes requirements for transfer and storage of VA data at Duke.

Title: Durham VA Data Use Compliance Training

 

Postdoc Positions Available:  NIH National Cancer Institute Center for Cancer Research

A fully-funded postdoctoral position is available immediately in the McEachron lab in the Pediatric Oncology Branch.

 

Our focus is on studying the immune and non-immune microenvironment of pediatric sarcomas, with a particular emphasis on osteosarcoma. Our goal is to answer challenging clinically relevant questions by interrogating in vitro and in vivo model systems and patient specimens using an integrated multiparametric approach.

 

The Center for Cancer Research (CCR) comprises nearly 250 teams conducting basic, translational and clinical research in the NCI intramural program—an environment supporting innovative science aimed at improving human health.  CCR’s clinical program is housed at the NIH Clinical Center—the world’s largest hospital dedicated to clinical research.  For more information about CCR and its programs, visit ccr.cancer.gov.

 

To apply:  Visit the CCR Careers website for specific positions and applications.

 

Direct questions to Rebecca Shim.

 

 

IRIS/ONCORE UPDATES

 

OnCore Upgrade

OnCore is being upgraded on Monday, March 22.  The system may be unavailable from 5 PM to 10 PM.

Look for more information about new functionality in the next newsletter.

 

iRIS/OnCore:  Consent Forms

Why do you need to add a Consent Category in iRIS? 

 

Please ensure you always select a consent category when submitting consent forms in iRIS.  A consent category must be selected in iRIS in order for the application approval details to push into OnCore (initial review, amendments and continuing reviews).  If the consent is missing a category type in iRIS, the associated review and approval details will NOT push into OnCore from iRIS.   If you notice missing IRB approval information in OnCore, contact OnCore@dm.duke.edu or submit a service now ticket for support. 

Screen shot of OnCore Protocol Consent Revision Category field.

 

 

DOCR NEWS

 

Research Professionals Network (RPN):  Using Social Media to Recruit (During a Pandemic)

Patients and potential research participants are online, embracing social media, and adapting their information-seeking and information-sharing behaviors to the dynamic digital landscape. Social media has created a paradigm shift in the conduct of clinical trials by facilitating multi-directional communication among patient, advocate, research, and clinician communities. Social media marketing can play a major part in informing clinicians, patients, and potential participants about participation in clinical trials and can provide abundant opportunities to use multi-media tools to connect with online audiences.

 

To respond to the growing interest among Duke study teams wanting to use social media to advertise their research, a new standard operating procedure (SOP) was created in 2020. The SOP provides guidance and structure on how social media is, and should be, used to recruit research participants. During the next Research Professionals Network meeting, you will:

 

  • Understand existing guidance and policies regarding advertising for research
    • Understand Duke’s SOP on the Use of Social Media to Recruit to Research and the Discover Duke Research Facebook page as well as our new Google AdWords account
  • Learn how to build a social media campaign
  • Review existing social media campaigns and how we monitor their effectiveness
  • Recall pitfalls to avoid and how to maximize a campaign’s effectiveness

 

Speaker: Jamie Roberts and Nick Eberlein

 

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

 

Zoom Link:  https://duke.zoom.us/j/97227871532                        

 

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

 

 

RECRUITMENT INNOVATION CORNER

Returning the Results: Disseminating Research Findings to Participants

 

Historically, returning study-level research results to participants has not been standard or common place.  However, as we move into more participant-centered research, it is becoming more of a regular practice. 

Why is this so important? Think about it: the data we get from research studies may be of great use to study participants, their caregivers and clinicians to better understand their health.  It makes participants feel valued, and a part of the team.  It many engage them enough to participate in another trial! More importantly, it demonstrates respect for their time, effort and participation by sharing with them what was learned.

Lay audiences, including patients, caregivers, and others who are not experts in clinical research, often do not have access to clinical journals, nor are they written in a way that is comprehensible to the non-scientific community. Therefore, alternative dissemination methods and distribution channels should be planned.

When communicating to participants who are not regularly engaged in the clinical research enterprise, ensure that the information is accessible by disseminating through the following options:

  • Patient advocacy groups
  • Study-specific websites
  • Newsletters
  • Emails
  • Social media
  • News media

Logo for the Adaptable Study

A great example of a study-specific website is the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial which is comparing the effectiveness of two daily doses of aspirin.  The ADAPTABLE study team routinely releases information about what they are doing, results that have been found, as well as any other news that pertains to participants. As they have been writing their primary outcome paper, they are also writing the lay summary of the study and developing an infographic that will clearly demonstrate what was learned. And, their lay summary and infographic are being designed in collaboration with their stakeholder advisors (the ADAPTORS)!

 

The Recruitment Innovation Center has created a Resource document that carefully lays out strategies for communicating about science and health research to the general public and provides a template for creating your study’s lay summary.  We strongly encourage you to make your participants part of the team and respect their participation by communicating the study results with them through channels they regularly use!

Coming Soon: Return of Results Resource and Service Center. We are in the process of creating work flows and a service center to support research teams in the development of their research study lay summaries and infographics.

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.

 

 

 

 

 

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

  • Congratulations to Liezl Fos who was promoted to Clinical Research Coordinator with Medicine - DMPI March 15, 2021

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

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