Duke Clinical Research Update December 2 2020

Wednesday, December 2, 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, 2 PM, via WebEx

Click for SlicerDicer Tipsheets

 

PACE Office Hours

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

 

RESEARCH COMMUNITY NEWS

 

Two Year Check-In Form Now Available in iRIS

On November 21, 2020 the new IRB Two Year Check-In form became available for your use in iRIS.  This form has been combined with the Continuing Review (CR) form in iRIS.  To complete a Two Year Check-In form, select “DUHS IRB Continuing Review/Two Year Check-In”.  In the Study Information section, a new question has been added, asking users to select the type of form needed.  New branching logic has been added to route users to the appropriate questions based on selection of either Continuing Review or Two Year Check-In.

 

Under the Revised Common Rule, which took effect on January 21, 2019, most minimal risk studies that received an initial expedited review on or after January 21, 2019 were given a Two Year Check-In requirement.  ( see https://irb.duhs.duke.edu/about-us/irb-news/updated-key-points-new-common-rule-communication-research-community )  Additionally, minimal risk studies that were allowed to transition to the Revised Common Rule were given a Two Year Check-In requirement.  If you have any question about which form (CR form or Two Year Check-In form) you need to complete to renew your IRB approval, please talk with the IRB Specialist assigned to your CRU/Department:  https://irb.duhs.duke.edu/about-us/staff-and-chairs.

 

When it is time to submit a Two Year Check-In form on a study, between 60 to 45 days prior to the study’s expiration date, please complete and submit the Two Year Check-In form in iRIS.  The IRB will review it and if the IRB does not have any outstanding concerns about the study, the study will then be released from all future continuing review or two year check-ins, and will be given an expiration date of 01/01/2100.  If the IRB does have concerns and requires ongoing review, you will be notified in the approval notice.

 

*PLEASE NOTE*:  

 

  • All changes to research and personnel must continue to be reported to the IRB via Amendment, for as long as your study remains open. 
  • All Safety Events must continue to be reported to the IRB according to IRB reporting criteria and timelines. 
  • Closure (Final Progress) Reports are also required as usual when studies close.
  • All FDA regulated studies will still require annual Continuing Review (or more often than annual, if specified by the IRB).

 

Clinical Quality Management Program (CQMP) QM Reviewer Training and General Updates

The next Clinical Quality Management Program (CQMP) QM Reviewer training session has been scheduled for December 7, 2020 from 1-4 pm. Please contact the CQMP office at CQMP@duke.edu if you wish to register for this WebEx training session. The schedule for QM Reviewer Training sessions for 2021 has been posted to our website.

 

Before creating a new record in the Clinical Quality Management database in REDCap, make sure there is not already an existing record ID associated with the study’s protocol number. Upon creation of a new record, you must save a draft of the Clinical Quality Management Plan form including, at a minimum, the Protocol Title, IRB Number, and Clinical Research Unit before exiting REDCap. This will ensure the new record is assigned the Group ID number associated with your Data Access Group (DAG) and that the record is displayed in the Record Status Dashboard under your DAG the next time you log into REDCap. 

 

As a reminder, QM Reviewers are required to document all findings/observations as discrepancies in the Clinical Quality Management database in REDCap, including those that are addressed and resolved during the QM Review visit. This requirement applies to both Regulatory and Participant Chart reviews. 

If the finding/observation was addressed and resolved during the QM Review visit, enter the finding/observation as a discrepancy, the action taken by the study team to resolve it, mark it resolved, and enter the date of resolution. See sample below:

This is a screen shot of question 5 Is the ICF documentation uploaded into Maestro Care?

 

 

IRIS/ONCORE UPDATES

 

iRIS:  Printing Approved Consents

A bug has been identified when users attempt to generate their study’s PDF Packet.  Users may find that multiple consent forms that are no longer approved, as well as multiple protocol documents and submission forms, display on screen for selection and printing.  While the iRIS team diligently works with iMedRIS to resolve this issue, please use the following pathway to find and print the most current approved consent form. 

  • Open the study from the Protocol Dashboard

 

  • Select ‘Informed Consents’

This iRIS screen shot shows the Informed Consents selection.

  • Find the ‘Approved’ tab

This iRIS screen shot shows the Approved selection tab.

  • Find the ‘Approved Consent’ column and select the PDF icon. 

This iRIS screen shot shows the PDF icon in the Approved Consent column.

  • A new window will populate displaying the consent form.  Please select the Print button located in the top right corner of the screen. 

 

If you have any questions, comments or concerns, please submit a Service Now request to the iRIS Support team.

 

 

DOCR NEWS

 

New Online Training Module: Clinical Research Recruitment Regulations, Best Practices, and Tools

Opening screen shot of online Clinical Research Recruitment Regulations, Best Practices, and Tools class.

There is a new online course available that covers the basics of clinical research recruitment at Duke! This course is available in the LMS and takes about 30 minutes to complete.

 

The course includes information about Duke participant engagement policies, obtaining IRB approval for recruitment plans and materials, branding requirements when targeting Duke Health patients, and Maestro Care tools that support efforts to identify people who are eligible for studies. The course provides guidance to help develop a baseline in the Research Operations: Recruitment WE-R clinical research competency.

 

Please note: This new online course is intended to replace the in-person 1 on 1 Recruitment Regulations and Tools session offered by the Recruitment Innovation Center (RIC). If you have the RIC’s 1 on 1 session listed in any onboarding materials, please replace it with the link listed below and the new title. As always, feel free to reach out to the RIC with any questions or consultations as needed.

 

Link to course

 

Research Professionals Network:  The Many Roles of the Registered Dietitian + Healthy Eating During the Holidays

Thursday  December 10th, 2020 at 1:00PM WebEx

 

How can I continue to eat healthy during the holidays while enjoying this season of celebration? Join us to hear from two Registered Dietitians about tips for eating healthy during the holiday season! In addition, learn more about their dual role as dietitians and clinical research coordinators; a unique position that allows for simultaneous involvement in research and clinical practice.

 

Speakers:  Hilary Miller and Laura Niederer

 

WebEx:

https://dukemed.webex.com/dukemed/j.php?MTID=ma1ee3bea1930b49285d0ad151b57797b

 

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

 

 

RECRUITMENT INNOVATION CORNER

Empowering the Participant Voice:  The Research Participant Perception Survey

 

The Recruitment Innovation Center, led by Drs. Ranee Chatterjee Montgomery and Schuyler Jones, will join several other CTSA sites in collaboration on a National Center for Accelerating Clinical Translational Science (NCATS) grant awarded to Rockefeller University.  Duke will work with the other sites to develop a new infrastructure facilitating collection of research participant feedback for widespread adoption using the REDCap platform.

Graphic image of hands taking online survey.

In order to improve upon and expand Duke Research, we will survey a wide variety of research participants to assess the quality of their experiences in research studies and to identify areas of improvement.  We will be using 1 of 3 validated surveys that are available on paper and in the REDCap library.

 

We plan on engaging PIs and study teams across different therapeutic areas of research with the hopes of having them use this tool with their participants. We will also be engaging PIs that conduct different types of research (observational, interventional etc.), as we hope this will give us a diverse pool of research participants across a wide variety of studies from which we can learn.

If you or your team would be interested in piloting this survey, or if you just want to learn more about this study-please CONTACT US!  We would be happy to go over the details with you!

 

Our Research Aims:

  1. Develop a novel Research Participant Perception Survey/REDCap (RPPS/REDCap) collaborative infrastructure and standard implementation models
  2. Demonstrate that the collaborative RPPS/REDCap infrastructure and implementation model is an effective approach to collect institutional benchmarks and actionable data
  3. Disseminate the infrastructure, catalyze research-on-research and transform evaluation by empowering the participant voice

Graphic image of raised hands with questions.

We hope that this study can provide us with enough information for ongoing improvement of the quality and integrity of the research we do here at Duke! Research participants’ perceptions of their experiences during a research study can be used to design and test processes to improve their experiences, and possibly improve study recruitment, retention, and research integrity as well.

Graphic image of heads with thought bubbles.

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, social media marketing, and more!  Our services are FREE and you can Email us at studyrecruitment@dm.duke.edu  if you have any questions!

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

  • The Neurology CRU welcomes Michelle Ward, RN, as a new Neurology CRNC.

 

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.help@dm.duke.edu