Duke Clinical Research Update October 21 2020

Wednesday, October 21, 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

 

Update on Conducting International Research

For study teams who have protocols resuming outside of the United States, the Duke Global Administrative Travel and Support Office can be in important resource.  The Duke Global Administrative Travel and Support Office has experience with on-the-ground conditions and have information that touches on safety aspects to consider such as communication capabilities in remote areas including how information could be conveyed back to the study team located in the United States.

If you have protocols resuming outside the US, you may want to consider looping in the Duke Global Administrative Travel and Support Office. 

 

Additionally, the COVID19 Duke Research Human Subjects/Clinical Research page has the following regarding screening participants at international sites:

 

My study has international sites. Do we still need to screen participants at international sites? 
At this time, Duke does not require screening at international sites. We recognize the difficulty in creating an implementation plan in countries where contacts, policies, and resources may be different or unknown.  We ask Principal Investigators to consider the relative risk to their research staff and research participants at these sites and to devise a plan that best ensures safety.  When possible, our travel aid screening tool may be used and supplemented with local procedures and contact numbers. 

 

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Updated

DUHS IRB has posted a summary of changes to the “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” that was revised on September 21, 2020.  This document is not to be considered a summary of all changes to the guidance but only representative of the most relevant changes. 

 

For additional information about the changes, visit the IRB web site:  https://irb.duhs.duke.edu/node/4722

 

To see the guidance in its entirety, visit https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency .

 

Flu Vaccination Policy Compliance Deadline:  November 10th, 10:00 AM

All faculty, staff and students in School of Medicine clinical and basic science departments, centers, institutes, and administrative units are expected to comply with the SoM’s flu vaccination policy by receiving a flu vaccination or an approved exemption. Vaccinations are available at both on-campus and off-campus EOHW sites, or from your provider or local pharmacy. Documentation of vaccinations received from a provider, including Duke providers, or a local pharmacy must be submitted to EOHW using the VaxTrax system. Additional information and instructions are available at medschool.duke.edu/fluvaccinepolicy.

 

October is Cybersecurity Awareness Month

With Cybersecurity Awareness Month in October, Duke IT professionals are urging staff, faculty and students to #ThinkSecure to avoid falling for cybercrime. During the special campaign, “Security 2020: Protecting Yourself and Your Data in a New Threat Landscape,” staff, faculty and students can participate in webinars and other online activities to spot and report suspicious activity.

 

Please consider participating in our October training activities at duke.securityeducation.com for a chance to win great prizes. 

 

Also, see the recent article from Duke Today titled:  Protect Yourself Against Phishing, Win Apple Watch, Learn best practices for fighting phishing during Cybersecurity Month

 

Psychiatry Research Day

The Department of Psychiatry & Behavioral Sciences recently hosted its first annual Psychiatry Research Day—a half-day departmental symposium, “Leading Clinical Research with Engagement, Equity and Inclusion.” With this theme, their intent was to meet the moment and contribute toward departmental and institutional efforts to dismantle systemic racism. The line-up included speakers from Duke; the National Institute on Minority Health and Health Disparities; and the Center for Truth, Racial Healing & Transformation; as well as a panel discussion with community representatives. Visit the Psychiatry & Behavioral Sciences website to view the sessions, and please feel free to share the article and recordings with others.

 

Duke CTSI Multidisciplinary Vision Program (MVP) Award

The Duke CTSI Multidisciplinary Vision Program (MVP) Award provides funding to support novel translational research focused on improving health and healthy equity. We anticipate awarding up to three grants and have a total of $110,000 for awards. Award amounts vary based upon amount requested and budget evaluation by the Program Leadership Committee. Please note that the funding period is from 05/01/2021- 04/30/2022.

 

Proposals from teams of investigators from different disciplines are encouraged. Collaborations that bring together ideas, theories, methods and approaches from disparate scientific disciplines are particularly encouraged.

  • Letter of ‘Intent to Submit’ (Mandatory): October 22, 2020
  • Application Submission Deadline: November 19, 2020
  • Final Selection: January/February 2021
  • Project Planning Run-In Period: February 2021 through April 30, 2021
  • Funding Period: May 1, 2021 through April 30, 2022

 

Download the complete RFA.

 

2020 NIH Virtual Seminar on Program Funding and Grants Administration

Tuesday, October 27 – Thursday, October 29

 

The 2020 NIH Virtual Seminar on Program Funding and Grants Administration has been designed to provide you with a unique opportunity to learn about the NIH grants process, programs, and policies directly from NIH & HHS experts.

 

This event is intended to help:

  • Demystify the application and review process;
  • Clarify federal regulations and policies; and
  • Highlight current areas of special interest or concern.

 

Agenda and registration information can be found here:  https://nihvirtualseminar2020.vfairs.com/en/about-page

 

Duke Roybal Center "Developing Theory-Based Interventions" Workshop

The Duke Roybal Center Translational Research for Improving Mobility and Healthy Longevity will be hosting an Intervention Development Workshop:  Developing Theory-Based Interventions.  The session will be held Friday, October 30, 3:00 PM – 5:00 PM via Zoom.

 

Session Objectives:

  1. Introduce the value of incorporating behavioral science theory into the process of behavioral intervention development for enhancing health outcomes.
  2. Demonstrate a process for identifying, translating, and incorporating a relevant theory into a new or adapted behavioral intervention.
  3. Identify some widely-used theories that have guided existing behavioral interventions for health.
  4. Collaborate with workshop leaders and other participants to share ideas and suggestions for each participant’s new intervention.

 

REGISTER HERE for Duke Roybal Center's "Developing Theory-Based Interventions" Workshop.  Registration will be capped at 20 participants with a waitlist.

 

 

IRIS/ONCORE UPDATES

 

The OnCore Annotations Tab is Changing on October 27, 2020

On Tuesday, 10/27, the information on the OnCore Annotations Tab will be updated to incorporate additional fields for the teams supporting your CQMP, ClinicalTrials.gov registrations and Maestro Care builds.  The annotations page will continue to track the items needed for institutional approval.

 

IF you have saved Protocol Searches: 

Check your searches to determine if you are including data from the annotations tab.  The changes to the annotations will remove any fields you have checked under the annotations section of your saved searches.  This will most likely impact saved protocol searches used to track pending studies or RDSP entry.

 

BEFORE the annotations update is released: 

We recommend taking a screen shot of your saved searches to remember what fields you have checked.

 

AFTER the annotations update is released: 

Revise any saved Protocol Search that uses data from the annotations tab and save again. 

 

Select the saved search from the Protocol Search Console

This image shows the OnCore Protocol Search Saved Searches screen.

 

Recheck the items to include in the saved search

This image shows the check boxes to indicate what to include in the saved search.

 

Select UPDATE to save

 

If you do not have any saved protocol searches and would like to review additional guidance on how to set up a protocol search for your studies, please reference the Tip Sheets available below: 

 

Selecting iRIS KP Roles That Flow Automatically into OnCore

Recent changes in the iRIS application were made to better identify those Key Personnel Roles that do not flow automatically into OnCore. Specifically, the iRIS to OnCore interface creates study records in OnCore that have been synced using the “Sync Data Over API” button in Section 700 of the DUHS IRB Application in iRIS. When pushed, an iRIS protocol’s Key Personnel list is automatically added to the OnCore protocol’s Staff tab, with a few exceptions.

KP with the following Roles do NOT get synced from iRIS to OnCore:

  • Analyst*
  • Collaborator*
  • Computer Programmer*
  • Grant Support Personnel*
  • Other*
  • Pathologist/Lab Personnel*

 

If personnel with one of these iRIS roles requires access to the protocol in OnCore, they will need to be manually added to the OnCore protocol by a Regulatory Coordinator.

In addition, three roles from the iRIS list of All Other Key Personnel are Duplicates and should not be selected:

  • Collaborator (Duplicate)*
  • Regulatory Coordinator (Duplicate)*
  • Study Coordinator (Duplicate)*

 

The correct Roles to select that do flow to OnCore from the list would be Regulatory Coordinator and Study Coordinator (CRC/CRNC/RPL).

This image shows the Role Selection Options in the Add Personnel Role section.

 

 

DUHS Amendment

A new section entitled, “Calendar/ Budget/ Maestro Care” has been added to the DUHS Amendment form.  The following question is being added:

 

Will this amendment affect the protocol calendar in OnCore, the study budget, or any element of the study's set-up in Maestro Care (DUHS billing status, timeline, order set, or treatment plan)?

If the user answers “Yes” or “Unsure,” the user will be directed to a REDCap survey in order to provide additional information about the amendment to the DOCR Startup team.  The DOCR Startup team will then coordinate any necessary changes to the OnCore calendar, budget, and/or Maestro Care build.

 

 

 

DUHS IRB COI section revision

Within the IRB application the question, “Do any key personnel have a conflict of interest management plan (issued by the Duke University School of Medicine Research Integrity Office) with this company?” has been revised to state, “Do any key personnel have a conflict of interest management plan or cautionary memo issued by DOSI-COI related to this research?” 

 Study teams often fail to report COI in this section for investigators who have a cautionary memo but do not have a management plan.  One purpose of this question is to help identify when COI disclosure is required in the consent form, which is true for both management plans and cautionary memos. 

 

OnCore Deep Dives and Refreshers:  October 23rd, 2020, 2:00 PM – 3:00 PM

Please join us for the OnCore Deep Dives and Refreshers Session on Reporting in OnCore, Tracking your Institutional Approval and Protocol Searches

 

These sessions are designed to offer you the opportunity to learn and apply useful information, workflow optimizations, and discuss topics of interest to the OnCore user community. We welcome all OnCore users to these sessions regardless of to your role or level of mastery in OnCore.

 

WebEx:

Meeting number (access code): 120 168 7959

Meeting password: 4nsN3e7h5Ex 

Link to join:  https://dukemed.webex.com/dukemed/j.php?MTID=mb1790403e45642c765aed385122043ea

 

Join by phone 
Tap to call in from a mobile device (attendees only) 
1-650-479-3207 Call-in toll number (US/Canada)

 

Discrepancies Between the Submission Number in the eIRB System and iRIS System

PLEASE KEEP THIS MEMO IN YOUR REGULATORY BINDER/STUDY RECORDS

 

There are discrepancies between submission numbering in the former eIRB system and the current iRIS system.  This is a known issue, and appears to originate from when the submissions were migrated over from the eIRB into iRIS.  Submissions that had been withdrawn or otherwise cancelled in eIRB were not moved over to iRIS.  As a result, the numbering for those withdrawn or cancelled submissions did not transfer over to iRIS and thus was not accounted for in iRIS.  The iRIS system continued assigning consecutive numbers, thereby reissuing numbers already used in eIRB.

 

This issue is illustrated in the following example:  if a user submitted SAE 1, then drafted but withdrew SAE 2, then submitted SAE 3, (all in eIRB), they are labeled as SAE 1, 2, and 3 respectively in eIRB.  However, in iRIS, the withdrawn SAE (SAE 2) was not moved over, so the resulting numbering of SAEs in iRIS would be SAE 1 and 2 (wherein SAE 2 is the same as SAE 3 from eIRB).  In iRIS the numbering displays as SAE 1 appropriately, and then the SAE that was SAE 3 in eIRB will appear as SAE 2 in iRIS.  Thus the numbering of subsequent SAEs for that study is also affected.

 

This numbering issue appears to affect all submission types, e.g., SAEs, Amendments, etc. 

 

 

Discrepancy Between the Submission Number that Appears on the Outcome Letter in iRIS and the Submission Number that Displays in iRIS 

 

On January 17th, 2020, changes were made to the iRIS system impacting how submission numbers (item numbers) display:

 

  • Submission numbers were reformatted from being a six digit number to now display as Protocol Number–Form Abbreviation – Version Number (i.e., PRO001XXXXX-INIT-1.0)

 

  • Draft forms which had been created by the study team but never submitted to the IRB had to be deleted from iRIS because their existence prevented study teams from submitting anything new.

 

Since the system generates the submission number based on the number of forms submitted to the IRB  and not based on the number of forms created, some submission numbers changed, causing the outcome letters associated with them to display the old (now incorrect) submission number.  If an outcome letter was generated by the IRB prior to January 17th, 2020 then there may be a discrepancy between the submission number that appears on the outcome letter and the submission number that displays in the iRIS system now.  

This image illustrates the Submission number displays example outlined in the text.

 

 

Figure 1: Submission number displays as 19.0

 

Figure 1 displays submission number 19.0 of the amendment form version 21.0 pictured in figure 2. This was the 19th amendment form submitted to the IRB.  Two forms were created, but remained in draft, and were never submitted to the IRB.

 

Figure 2: Form version displays as 21.0

This image illustrates how the form version will appear from the text example.

 

DOCR NEWS

 

Research Professionals Network:  Diversity in Clinical Research:  What We Have Learned

Thursday October 22, 2020 at 1:00 on Zoom

 

Clinical research generates new evidence (or validates old evidence) about the efficacy and safety of new therapies. However, how groups of the population respond to a new therapy may vary; men may respond differently than women, older people may respond differently than younger people, and members of a certain racial or ethnic group may respond differently than another. Identifying these differences makes it imperative that we enroll diverse groups of participants into our research studies to ensure that the results are representative of the people who will make use of the therapy or treatment, thereby improving outcomes and, hopefully, reducing disparities. Unfortunately, racial and ethnic minorities have been historically underrepresented in research, creating scientific, ethical/moral, and medical issues by biasing results that are also not generalizable to the broader population.

 

More recently, the COVID pandemic has been real wake-up call for all of us, demonstrating how important it is that we reach out and engage minority populations in meaningful research so that we can ensure that the treatments and vaccines we develop are as appropriate for them as they are for others.

 

People come from all walks of life and each walk presents its own barriers to opportunity. It is not enough that opportunity exists; we must ensure that there is a clear path to accessing that opportunity, whether through the provision of additional time, effort, or resources. As researchers and research staff, we cannot simply seek answers. We must also seek to remove barriers that prohibit us from answering those questions in populations that often need us the most and are yet underrepresented in our studies. – Nicole Daniels, CRS, Sr.

 

We have assembled a panel of study staff and investigators who will share their experiences engaging and enrolling underserved and underrepresented populations in their research projects. The panel will provide insight and ideas, from engaging at the level of selecting a question and designing a study to answer it, all the way through planning the dissemination of study results.

 

Speakers:  Nadine Barrett and Dane Whicker

 

Join Zoom Meeting
https://duke.zoom.us/j/97756478901

 

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

 

Research Wednesdays Moves to Full One Hour Format

Beginning with the October 28th Research Wednesdays session on Cybersecurity Awareness Month presented by Shelly Epps, the Research Wednesdays series will move to a full one hour format.

 

Sessions will start promptly at 1:00 PM and end at 2:00 PM.  This new one hour format will allow the Research Wednesdays program to align with certain Responsible Conduct of Research requirements.  This will allow the Research Wednesdays series to offer RCR credit for certain pre-identified sessions in addition to JA credit which is offered for all sessions.

 

Watch the Research Wednesdays session announcements for additional details.

 

Upcoming scheduled topics along with recordings of past sessions can be found on the Research Wednesdays page on the DOCR website.

 

 

RECRUITMENT INNOVATION CORNER

Health Literacy Month October 1 - 31

Image of the Health Literacy Month banner with dates October 1 - 31.

What is health literacy, why do we need to know about it, and whom does it effect?

Seal with the words Finding the Right Words for Better Health.

Health literacy is the extent to which a person can “obtain, process, and understand basic health information and services needed to make appropriate health decisions.”1

Studies consistently show that a significant number of people have problems reading, understanding, and acting on health information for a variety of reasons. We, as people working in healthcare, have a distinct advantage when it comes to health literacy - we live it daily! However, we must carefully consider the needs of our community, our patients, and our research participants when developing material we are asking them to comprehend and use to make decisions. 

 

Consider this list of health literacy principles in clinical research:

  • Communications should be clear and easy to understand.
  • Clear communication is necessary throughout the entire clinical research life cycle.
  • Research communications should be developed by partnering with the intended audience(s).
  • Cultural respect is an integral part of communicating appropriately about clinical research.
  • Research materials should integrate health literacy practices, including plain language, numeracy, clear design techniques, and cultural considerations.
  • Research materials for participants should be evaluated to ensure the intended audience(s) can understand the information.
  • In-person communication with the intended audience(s) should encourage dialogue and confirm understanding.
  • All clinical research stakeholders should support the development and implementation of organizational policies that integrate health literacy into clinical research.
  • Integration of health literacy into clinical research requires proactive planning to develop, test, modify, and confirm understanding of clinical research communications.

Image with words Be a Health Literacy Hero!

For more information and resources to support the use of principles of health literacy in clinical research communication, visit the Multi-Regional Clinical Trials Website or the Health Literacy Month Website

Image with words Contact Us.

As always, please Contact us for any of your research needs!  We are happy to help researchers learn this important skill and give you resources to help refine it.  We can help you develop engaging eConsents, MyChart messages, phone scripts, websites, engagement letters, research notices, and more! 

 

1)U.S. Department of Health and Human Services. 2000. Healthy People 2010. Washington, DC: U.S. Government Printing Office. Originally developed for Ratzan SC, Parker RM. 2000. Introduction. In National Library of Medicine Current Bibliographies in Medicine: Health Literacy. Selden CR, Zorn M, Ratzan SC, Parker RM, Editors. NLM Pub. No. CBM 2000-1. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services.

 

 

 

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 DHVI CRU welcomes Carter Lovvorn and Brenderia Cameron to the team, both CRS. Srs.

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

This is an image of a 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