Duke Clinical Research Update August 19 2020

Wednesday, August 19, 2020
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, 1 PM, via WebEx

 

PACE Office Hours

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

 

RESEARCH COMMUNITY NEWS

 

Research Involving COVID-19 Positive Participants

The COVID-19 Specific Protocols: Guidance for Clinical Research Involving Participants Currently or Previously Infected with COVID19 document provides general guidance for clinical research study teams working on COVID-19 specific protocols that may be physically interacting with or collecting biospecimens from research participants that have been infected with or considered a Person Under Investigation (PUI) for SARS-CoV-2 (COVID-19). This guidance is based on our current knowledge and recommendations from Duke’s Biological Safety Division (Biological Safety) of the Occupational and Environmental Safety Office (OESO) and Duke University Health System. Please share with any colleagues who are working or planning such research studies.  Questions can be directed to SOMclinicalresearch@dm.duke.edu

 

As a reminder, anyone engaging in COVID-19 research or activities must notify Duke by submitting a form via MyResearchHome (MRH). The MRH form will route to multiple entities for review including Biological Safety and the Clinical Research Task Force.  The Clinical Research Task Force must review and approve all clinical research that targets enrollment of COVID19+/PUI or their close contacts, collects or uses biospecimens from COVID+/PUI or their close contacts, and/or involves the review, analysis, or transfer of electronic health records or clinical research data from COVID19+/PUI or their close contacts prior to IRB submission. Biological Safety must review all proposed research activities that involve any direct interactions with COVID-19+ participants and/or their biospecimens prior to obtaining institutional approval.

 

COVID-19 Human Subjects/Clinical Research FAQs

In addition to Phase 3 Return to Research information, the Duke COVID-19 Human Subjects/Clinical Research website contains helpful FAQ information to assist study teams.

Topics include:

  • Resuming clinical research activities
  • Essential studies
  • Screening, triage, and management of participants
  • General
  • Going Remote
  • IRB,FDA, & Sponsors

 

Digitization of Clinical Trials

The position paper “Digitization of Clinical Trials” builds on the US National Institutes of Health (NIH) and the National Science Foundation (NSF) workshop which brought together experts in clinical trials, digital technology, and digital analytics to discuss strategies to implement the use of digital technologies in clinical trials while considering potential challenges.

 

This position paper describes the current state of the art for digital clinical trials including (1) defining and outlining the composition and elements of digital trials; (2) describing recruitment and retention using digital technology; (3) outlining data collection elements including mobile health, wearable technologies, application programming interfaces (APIs), digital transmission of data, and consideration of regulatory oversight and guidance for data security, privacy, and remotely provided informed consent; (4) elucidating digital analytics and data science approaches leveraging artificial intelligence and machine learning algorithms; and (5) setting future priorities and strategies that should be addressed to successfully harness digital methods and the myriad benefits of such technologies for clinical research.

This image is a summary of the key elements of a digital clinical trial

 

Maestro Care Upgrade Completed

There was a significant upgrade to Maestro Care completed on August 16, 2020.  The upgrade changes the way that information appears in the Research Studies Activity.  The changes distinguish studies that involve both the patient participant and Maestro Care user from those on which the patient participates, but the user is not listed on the RSH record.  The order in which the studies appear on the Research Studies Activity also depends on which studies the patient and user have in common.  Accessing links for adding a timeline, editing an existing timeline, editing a time point for a linked appointment and viewing the appointment link history are also a bit different. 

 

Please review the Maestro Care August 16, 2020 Research Upgrade Job Aid and use it as a guide as you navigate the system after the upgrade.

 

Additional upgrade materials:  Clinical Upgrade Documents

 

DEPRU Website has Moved—Update your Bookmark

Did you know that the DEPRU webpage has recently transitioned to the DOCR website? 

This transition means that you will need to update your browser bookmarks for the DEPRU webpage in order land on the new site.  Clearing your browser cache will also help ensure you reach the updated site.

Visit the new DEPRU website today to for information about capabilities, available studies, the volunteer registry, and more!

This image summarizes the areas of expertise of the Duke Early Phase Clinical Research Unit

 

IRIS/ONCORE UPDATES

 

Did you know you can add or edit your phone number and job title in OnCore?

Access the pull-down menu by your name in the upper right hand corner and click on User Profile.  From there you can add or edit your title and phone number.

This image is a screen shot of teh User Profile option in OnCore

 

Updates to the Minimum Footprint

The Minimum Footprint policy has been updated to include the Rare Disease field in the list of required elements. This field is required for studies that are open at any time from 7/1/2020 forward.  

  • For non-oncology studies, your RPM will be contacting you to determine which studies meet the criteria included on the NIH site, https://rarediseases.info.nih.gov/
  • For all studies in the oncology library, the DCI will complete this field based on NCI criteria.

The field will be updated centrally using the information provided. Please start completing this field for all new studies moving forward.

 

The following fields are no longer required as part of the minimum footprint:

  • Exclude Protocol on Web:  This field is completed by the RIC and should not be edited by the research team.
  • Involves Therapy:  The functionality that prevents entering an on study date when the subject is in an active status on another study has created issues for study teams and will be deactivated. Although no longer required, the Involves Therapy field is used as a filter in Insights and is useful to have completed.
  • Summary Accrual Info. Only:  If the summary accrual workflow is being used, the field needs to be marked YES to activate the summary accrual screen.  However, for studies not using summary accrual, completion of this field is no longer required.

Updated tip sheets for new studies are posted on the web. The Minimum Footprint reports are being updated and will be in production soon.

 

iRIS:  Global Study Access Users

With the recent upgrade to 11.02.01, users have identified an issue where the ‘Find a Protocol’ button is no longer available on the Protocol Dashboard.  We are currently working with iMedRIS to permanently resolve this issue. 

This image shows the  missing space for the find a prototcol button in iRIS

 

In the interim, please use the following pathway to navigate to the Find a Protocol search activity.  My Workspaces> Research Workspace> Protocol/CRU/Specialty Committee/CPC Assistant> Find a Protocol

This image shows the My Workspace Protocol Assistant section in the iRIS system.

 

iRIS:  Removing Key Personnel

When removing Key Study Personnel, it has been identified that the ability to scroll has been removed.  Protocols with extensive list of personnel may not display appropriately inhibiting users from removing KP that do not display due to the limited scrolling.  Our team is actively working with iMedRIS to permanently resolve this issue.   

This image shows the Setup Protocol Personnel panel in iRIS.

 

 

DOCR NEWS

 

Society for Clinical Research Sites (SCRS) Memberships Available

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 globally. 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 Clinical Research Community Members may join SCRS for free.  Click the Join SCRS button in the top right corner of the website and be sure to use your email@duke.edu domain when registering.

 

Once you have registered, you will have access to:

  • Webinars
  • Trial Opportunity Platform
  • News and Publications

 

 

RECRUITMENT INNOVATION CORNER

Discover Duke Research Facebook page

 

Introducing . . .

This image is the Discover Duke Research logo

The brand new Discover Duke Research Facebook page! The CTSI Recruitment Innovation Center (RIC) now manages Discover Duke Research as a channel to engage our community with content about upcoming, ongoing, and recently completed Duke Clinical Research.

 

This account will also be a platform for Duke investigators and study teams to use for marketing and advertising their clinical research through purchased ads. The RIC will facilitate the posting of DUHS IRB-approved ads through this page in accordance with the new Social Media Clinical Research Marketing policy.

 

This is exciting news! We now have a central location for sharing information about Duke research and Duke studies, including:

 

  • Study Results
  • Researcher and Participant Profiles/Interviews
  • Connections to new or ongoing studies our community may be interested in (recruitment ads)
  • Stories about completed and ongoing studies
  • Interviews, profiles, and stories about our research staff and teams
  • Information and resources from trusted and reliable sources

 

As more and more studies go virtual and remote and look for effective ways to engage and encourage participation in their studies, having an officially approved Facebook page dedicated to Duke Research is even more necessary and important than ever. With more than 70% of Americans using Facebook, we know this is an opportune place to talk about and share the research we are doing with our community and the world. 

This image is the Facebook Like button.

For more information about the new Discover Duke Research Facebook page, or for a social media marketing consult, please get in touch with us at studyrecruitment@dm.duke.edu.

This is a 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!

 

 

 

 

DID YOU KNOW?

Maestro Care:  Coordinator Reviewed Changed to Study User Reviewed

Epic replaced “Coordinator Reviewed” with “Study User Reviewed.”  This is only a name change, it does not affect any existing rules or other build.  For example, the “Coordinator Reviewed” phrase in the Research Billing Review activity is now “Study User Reviewed.”  Users will see this name change in various other reports and activities, including Reporting Workbench reports that referenced “Coordinator Review.”

 

 

TRAINING OPPORTUNITIES

Phlebotomy Competency for Research Classes Scheduled

The following Phlebotomy Competency for Research classes have been added to the DOCR course calendar.  Links for class registration follows.

 

Title:  Phlebotomy Competency for Research - DOCR

Date & Time:  Thursday, September 17, 1-3p via WebEx

Course ID:  DOCR-RES-320

Offering ID:  00150188

Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000103720

 

 

Title:  Phlebotomy Competency for Research - DOCR

Date & Time:  Thursday, October 15, 1-3p via WebEx

Course ID:  DOCR-RES-320

Offering ID:  00150189

Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000103721

 

 

Title:  Phlebotomy Competency for Research - DOCR

Date & Time:  Thursday, November 12, 1-3p via WebEx

Course ID:  DOCR-RES-320

Offering ID:  00150190

Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000103722

 

 

Title:  Phlebotomy Competency for Research - DOCR

Date & Time:  Thursday, December 10, 1-3p via WebEx

Course ID:  DOCR-RES-320

Offering ID:  00150191

Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000103723

 

 

New Training Module: Developing the Informed Consent Form

This image is the opening slide of the new Developing the Informed Consent Form online module.

 

This new DOCR course is available in the LMS and takes about 20 minutes to complete. The course is supplemental to the new Informed Consent Process and Procedures course, and dives a little deeper into the Informed Consent Form itself for those specifically responsible for developing ICFs.

  

This module is designed to provide study teams with fundamental or refresher information on developing the informed consent form. Upon completion you will be able to develop the informed consent form to meet Duke Health IRB and federal standards. The course provides guidance to help develop a baseline in the following WE-R clinical research competency:

 

  • Safety and Ethics: Development of Informed Consent Doc and Plan

 

Link to course

 

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 DHVI CRU would like to welcome Carter Lovvorn, CRS, Sr., as the newest team member.  We are thrilled to have Carter join the team!

 

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