Duke Clinical Research Update June 16, 2021

 

 

 

 

 

 

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

 

Update on Automatic Release of Notes to Patient’s MyChart to Comply with 21st Century Cures Act

In a recent update, CRC Research Encounters were deemed primarily administrative and are blocked from MyChart.  Any note written within a CRC Research Encounter is not visible to the patient in MyChart.  Even if the “Share w/Patient” button is present in a Progress Note written within a CRC Research Encounter, the note will not show to the patient in MyChart.

Screen shot of a Progress Note written within a CRC Research Encounter in MyChart

 

If the Encounter itself is blocked from release to the patient, any note written in that Encounter cannot be seen by the patient.

 

For more information about the changes that went into effect April 11, 2021 related to the 21st Century Cures Act and which notes and lab results will immediately be released to the patient’s MyChart in both inpatient and outpatient settings, please refer to pages 3-5 the Maestro Care 11Apr2021 Upgrade Research Job Aid.

 

Radiology Logistics Implementation Review Form

We are excited to announce the Radiology Logistics Implementation Review Form is now available as a REDCap survey.  Use the following hyperlink to access the survey:  https://redcap.duke.edu/redcap/surveys/?s=FMWXRDFRRW. 

When applicable to your study, the link can also be found under the OnCore task labeled “Radiology Logistics Implementation Review”.

Please contact the Radiology Protocol Review Team via email with any questions: RSHReview@dm.duke.edu  

 

Reminder:  Sharing Pre-Screening Information with Sponsors

When sponsors request information regarding what activities have taken place on a study, it is important to make sure that no participant identifiers are included in the information sent to the sponsor unless stated in the informed consent and contract language.

For example, if you are planning on sending pre-screening logs to the sponsor in response to a request for completed study activities, initials and dates (and other identifiers)  of unconsented participants should not be provided.  

 

NIH:  New and Updated Resources Available to Help Design Rigorous Clinical Trials

The National Institutes of Health (NIH) Office of Extramural Research has recently revamped the NIH Research Methods Resources website that NIH’s Office of Disease Prevention (ODP) launched in 2017.

Highlights of these changes and the new available tools and resources that can help you better plan the design, conduct, and analysis of rigorous NIH-defined clinical trials can be found in the summary article: New and Updated Resources Available to Help Design Rigorous Clinical Trials

 

 

IRIS/ONCORE UPDATES

 

eReg to be upgraded Tuesday June 22nd

eReg Regulatory Coordinators and Managers should have received an email with links to updated tip sheets, as well as an invitation to a WebEx training reviewing the new functionalities! If you have any questions please email oncore@dm.duke.edu.

 

 

DOCR NEWS

 

Policy:  Protocol Training for Clinical Research Professionals

The policy Protocol Training for Clinical Research Professionals defines training requirements for clinical research personnel listed on the Delegation of Authority Log.  All clinical research personnel must complete training for all tasks that are delegated to them prior to performing the task.

Click to read the full policy. 

This policy is also posted on the DOCR Policies and Procedures page and can be found under the Training Policies accordion.

 

New Online Training Module – Readability Fundamentals for Clinical Research Participant Engagement Materials (25 min)

Opening screen shot for the online Readability Fundamentals and Participant-Facing Engagement Materials class

This new interactive online module is now available in the LMS! This module was developed in collaboration with the RIC, DOCR, and DCRI and takes about 25 minutes to complete. The purpose of this online module is to provide clinical research staff with the foundational information needed to create readable engagement materials for clinical research studies. There are resources, tools, and tips within this module that will help clinical research personnel work through this critical part of their role.

 

The module addresses the following learning objectives:

  • Define readability and health literacy
  • Recognize the fundamentals of readability in the context of clinical research
  • Recognize the importance of producing materials that participants can understand
  • Identify ways to assess readability of materials and confirm participant understanding

 

The content provides guidance to help develop the following WE-R clinical research competencies: Recruitment, Participant Retention

 

Link to course

You can also find this course on the DOCR WE-R Competency Training page under the Recruitment and Participant Retention competencies.

 

 

RECRUITMENT INNOVATION CORNER

Patient Engagement Over Time (Even in a Pandemic!)

Graphic of people holding hands

Did you know that the average dropout rate across clinical trials is 30 percent!?1 

Take a look at your study (ies) - how do your retention rates compare?  Have you considered some out-of-the-box ideas on how to engage participants during the time between study visits?  How about sending a card to celebrate Glaucoma Awareness Month or Oral Cancer month?  Something so small can mean much more to participants than we think!  It shows that we are thinking of them even when they’re not in front of us.

Graphic of a network connecting people

Visit the Healthline website that lists the 2021 Health Awareness Calendar!  This unique website highlights heath issue awareness months, weeks, and days, which are so important as they can rally us together to raise awareness and show support.  Think about your portfolio; if you’re doing research in study specific conditions or therapeutic areas, this could be a great way to interact, engage, and potentially recruit to other studies. 

 

In addition to sending notes about awareness, you can also consider any of the following:

  • A quick phone call to check in and tell someone you’re thinking of them, especially those you know may be isolated and alone
  • An personal email sent to them (not just a big chain email)
  • A letter in the mail with a real signature and hand-addressed envelope
  • An update about the study to share what has been learned so far
  • Notifications about new and upcoming studies they may be interested in

 

You have an opportunity to offer information, comfort and reassurance to your new and existing participants as you interact with them in novel ways. The more reassuring you are, the more likely they are to stay engaged and feel cherished for their participation.

 

1 Forte Research: https://forteresearch.com/news/infographic/infographic-retention-in-clinical-trials-keeping-patients-on-protocols/

 

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, returning aggregate study results and more!

 

Follow us on Facebook at Discover Duke Research.

 

 

DID YOU KNOW?

REDCap Upgrade to v10.6

REDCap will be offline between 8:00 PM and 11:30 PM on Thursday, June 17th. During this time, REDCap will be unavailable. You will not be able to log in to the system or complete any surveys.  If you require access to your data during this downtime we recommend exporting a copy before the system is taken offline.

 

Some new features include:

  • New Feature: Select and modify multiple fields together on the Online Designer - Users may select multiple fields on the Online Designer by holding the Ctrl, Shift, or Cmd key on their keyboard while clicking on the field in the table, which will reveal the options to Move, Copy, or Delete all the selected fields.
  • New Action Tag: @CALCDATE – Performs a date calculation by adding or subtracting a specified amount of time from a specified date or datetime field and then provides the result as a date or datetime value.

 

View a full list of new features and improvements to REDCap here.

 

If you have any questions or concerns please contact us at redcap-docr@duke.edu. 

 

 

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 Department of Neurology welcomes Randy Smith as a CRC
  • The Department of Neurosurgery welcomes Shalynn Fields to the NSU Spine Division as a CRC
  • The Oncology CRU congratulates Lucas David, Thoracic Oncology, on his promotion to Regulatory Coordinator, Senior
  • The Medicine CRU announces:
    • Deirdre Clinton joined Medicine - Center for Aging as a CRC on May 17
    • Nonna Stepanov, MD joined Medicine - CAGPM as a CRNC, Sr. on June 1
    • Kaitlin Foy joined the Medicine – Pulmonary DAAAC team as a CRS Sr on June 1
    • Connor Spies joined the Medicine – Pulmonary Lung Transplant team as a CRS Sr on June 1
    • Allie Frear was promoted within Medicine – Pulmonary to RPL effective May 3

 

 

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

 

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