Duke Clinical Research Update October 6, 2021

Tuesday, October 5, 2021

 

 

 

 

 

 

SUPPORT OFFICE HOURS

REDCap Office Hours

 

Please submit a request through the REDCap Support Request portal: https://redcap.duke.edu/redcap/surveys/?s=TPMKTCAFKM

 

  • 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

 

Updated IRB Policies Posted to Web Site

DUHS IRB policies have been updated, as part of this year’s AAHRPP re-accreditation activities.  Please note, they reflect requirements of the Revised Common Rule, 45 CFR 46.  The policies are found on the IRB web site:  https://irb.duhs.duke.edu/policies-and-regulations/policies .  Most often, the fastest way to find a specific policy is to type a keyword or keywords into the Search bar at the top right corner of the web site.

 

On-site Vaccine Requirement for Monitors

Study monitors are required to be vaccinated against COVID-19 in order to work on-site at Duke, which is consistent with institutional policies for employees. A notification letter template is available for distribution to monitors in advance of on-site visits. The letter should be placed on departmental letterhead before distribution. Study teams do not need to copy or store the monitor’s vaccination information.

 

Maestro Care Upgrade Scheduled for October 17

On October 17, 2021 Maestro Care will undergo an upgrade that will involve changes in the Research Studies Activity, including the ability to:

  • Scroll through the Study Administration Record
  • View information about the study branch in research reports and In Basket messages
  • Find the study start date in the research studies list view
  • See when patient’s last accessed their MyChart account from the MyChart bubble icon in Storyboard
  • View information about the patient’s opioid use from Storyboard

The upgrade will also include changes to SlicerDicer.  On or around November 1, users will also notice a change in the color of the research banner and bubble icon in Storyboard from pink to turquoise.  The bubble icon will be present when a patient has at least one of the possible research study statuses, but the banner will only be present when the patient has at least one active study status. 

 

Please review the Maestro Care 17OCT2021 Upgrade Research Job Aid and use it as a guide as you navigate the system after the upgrade.

 

Additional upgrade materials:  Clinical Upgrade Documents

 

Research Blood Order Draws on Inpatients at Duke Hospital Reminders

In order to help facilitate the process of collecting Inpatient Research Blood Order samples, please be sure to complete all fields in the email template when requesting services.  Incomplete information will cause delays in having the samples drawn.  For step by step instructions please refer to Tip Sheet Process for Research Blood Order Draws on Inpatients at Duke Hospital

Screen shot of email template for Research collection of blood draws

 

Guidance on the Destruction of Study Records

The IRB maintains a policy titled Retention of IRB Records and Other Documents.  This policy outlines the length of time records need to be retained and the types of documents that need to be retained.

  • All IRB files and documents that relate to the protection of human research participants are retained for at least six years following completion of the study.  Study records involving pediatric research participants must be maintained until the youngest child on study is 21 years old, or for six years following completion of the study, whichever is longer.  If a protocol is cancelled without participant enrollment, IRB records are maintained for at least six years after cancellation.  Always refer to your Clinical Trials Agreement to assure you are meeting the agreed upon retention period. Sometimes CTAs require a longer retention period than Duke policy.
  • A signed and dated consent form (on paper with original signature, or electronic) must be maintained by the investigator at DUHS for as long as the research records are retained --- at least 6 years after the study is completed, or if the subject is a child, until the youngest child on study reaches the age of 21, whichever is longer. This can be satisfied by placing the signed consent form in the medical record or by keeping it in the study's research files.
  • Access the myRESEARCHpath “Archive data and documents” page for information about approved archival options for study records.

 

Once the period of retention has passed, it is possible to destroy study documents.  Guidance on study document destruction and the documentation of document destruction follows:

  • Keep a binder of note to files or a log recording:
    •  The protocol #
    • PI
    • Date of destruction
    • Name and initials of person destroying the records
    • How documents were destroyed (shredding of paper records, deletion of electronic records, etc.)
    • Always refer to your Clinical Trials Agreement to assure you are meeting the agreed upon retention period. Sometimes CTAs require a longer retention period than Duke policy.
    • Copy of the PI’s agreement (i.e., email) for the record destruction, if available

 

Certificate of Confidentiality (CoC) Guidance

For research involving human participants, a Certificate of Confidentiality (CoC) provides additional protections to investigators and the institution against compulsory disclosure of identifying information about enrolled participants. The process for obtaining a CoC varies depending on the sponsor and the project oversite. To help navigate CoC requests, new guidance is now available on myRESEARCHpath, including identifying the designated signing official for your project.

 

Reporting Security Incidents

The Duke Health Information Security Office has created a short, instructional video on methods of recognizing IT security incidents and how to report them.

 

Reporting Security Incidents

 

Please take the two minutes to watch the video and feel free to contact security@duke.edu with any related questions!

 

A Few Words on Data from the Duke University Libraries Research Data Working Group

Logo for the Duke University Libraries Research Data Working Group

Change is coming - are you open to it?

Open Scholarship is a trend that has been growing in academia for some time from publishing in open access journals to making other research outputs including data, code, and software more broadly available. There are numerous benefits to these practices both for the public and for individual researchers including increasing the impact and trustworthiness of Duke research. Recent U.S. funder policies and laws are further codifying these practices. If you are ready to engage in more open practices, Duke Libraries can help. Read more about these growing trends and how we might support your goals in our recent blog post

 

Use the DMPTool to write your data management plan

It’s grant season! Do you need to write a data management plan as part of your grant proposal? If you are generating data, the answer is most likely yes. Duke has support and resources to help, including the DMPTool.org. The DMPTool facilitates writing plans that comply with funder requirements, lets you store the plan for easy access and collaboration, and now you can assign a persistent identifier to the plan. After writing a plan, consultants are also available by request to provide feedback on the plan. If you are looking for a repository to share your data, the Duke Research Data Repository can provide boilerplate language to add to your plan. Contact datamanagement@duke.edu for assistance. 

 

Cybersecurity Awareness Month

In honor of Cybersecurity Awareness Month, Duke staff, faculty, and students are invited to join the Duke Security Challenge and compete for chances to win more than 50 prizes, including books personalized by Duke Basketball Coach Mike Krzyzewski.

Duke Security Challenge participants will receive credit for steps they've already taken to help keep Duke safe, such as setting a strong password or staying current on security training. To review your standing and see how you can improve it, please log into the Duke Security Challenge dashboard (https://idms-web-selfservice.oit.duke.edu/security). Be sure to opt in to simulated phishing tests by October 1 for the most opportunities to earn points (https://groups.oit.duke.edu/groupmanager/group?id=c85d8d13563346aba90086ad9fba4fcb).
 

For more information about Cybersecurity Awareness Month activities, please visit the Duke Security Website (https://security.duke.edu/october).

 

 

IRIS/ONCORE UPDATES

 

How to enter Summary Accrual in OnCore

Summary accrual must be entered at a minimum on a quarterly basis for CRU metrics.  For greater accuracy in accrual reporting consider entering accrual on a monthly basis.  The Summary Accrual tip sheet will help guide you through the process. 

 

The first entry for the study will be from the Open to Accrual date until the end of the quarter (or month).
All dates need to be within the same quarter (or month).   
The quarters for Fiscal Year 22 are 7/1/2021 – 9/30/2021, 10/1/2021 – 12/31/2021, 1/1/2022 – 3/31/2022 and 4/1/2022 – 6/30/2022.
Summary accrual must be entered +/- 5 days from the end of the quarter but the data entered should all be from the same quarter.  For example if you were entering quarterly accrual data on October 3, you would only enter enrollment from 7/1/2021 – 9/30/2021 for the first quarter, not from 7/1/2021 – 10/3/2021.

 

 

 

DOCR NEWS

 

ClinicalTrials.gov Corner

Are you interested in an overview on the ClinicalTrials.gov registration and results submissions process at Duke?  If so, the DOCR ClinicalTrials.gov team is holding a training via WebEx on October 19th from 9-11 AM.  You can register for the training in LMS via this link.  The training session will cover the below topics.  We’d love to have you join if interested! 

 

  • Discuss why registration and results information should be submitted to ClinicalTrials.gov
  • Identify who is responsible for submission
  • Outline what information must be included
  • Understand completion dates and outcome measures
  • Describe the Duke process
  • Identify resources (institutional & national)

 

REDCap Support Request Portal

The new REDCap Support Request portal is now live! If you need to Request a New Project, Add/Change/Remove User’s rights, Request REDCap Office Hours, or Request a REDCap Project closure, please submit a request through the REDCap Support Request portal: https://redcap.duke.edu/redcap/surveys/?s=TPMKTCAFKM

 

This link is located on the main REDCap page in the same location.

Screen shot of REDCap Support Request form

 

This portal has new features that will help make filling out these requests easier for you. Some examples of new features:

  • For New Projects Requests: You can now request that some external modules be active on your new project
  • For User Rights Requests: You can use any predefined role as the base to create a custom role
  • For User Rights Requests: Submit multiple user rights requests per project
  • NEW: You can now request REDCap Office Hours through this portal rather than emailing. Select your preferred days for office hours and/or select the day you would like to meet
  • NEW: You can now request a REDCap Project Closure. Just enter project title, PID and reason for closure to complete the form

 

Research Professionals Network (RPN):  Holding a Space for Possibility:  Flexible Thinking at Work and Home

October 21, 1:00 PM

 

Flexible Thinking is the ability to think about the same task in new way or from a different perspective.  Being able to approach work and life situations from a flexible perspective can open possibilities and lead to better overall outcomes.

 

In this session we will:

  • Define Flexible Thinking
  • Reflect on situations in the workplace where flexible thinking can be advantageous
  • Practice ways to cultivate flexible thinking within ourselves
  • Discuss “Changing Our Lens” as a means of approaching work and life situations

 

Join Zoom Meeting

https://duke.zoom.us/j/92618523019?pwd=aHRQWjd1T3M4OWF4VC9TSXd2SkhqZz09

 

Meeting ID: 926 1852 3019

Passcode: 229017

 

One tap mobile

+16468769923,,92618523019# US (New York) 13017158592,,92618523019# US

+(Washington DC)

 

 

RECRUITMENT INNOVATION CORNER

Hispanic Heritage Month: Increasing Latinx Participation in Research

 

Graphic for Hispanic Heritage Month

Happy Hispanic Heritage Month! Hispanic Heritage month, September 15th – October 15th, gives us time to celebrate the rich history and impact that Hispanic culture has had on the United States.

 

There are various barriers to Latinx participation in research. Some of these barriers include fear of discrimination, distrust of the research process, loss of confidentiality, competing demands, or anticipation of an excessive time burden with participation. Other major obstacles can include language barriers and concerns about immigration status. In order to promote diversity and equity throughout research, we must address these barriers and implement strategies to reduce their impact on Latinx participation.

 

Strategies to Increase Latinx Participation in Research

There are many things researchers can do to appeal to the Latinx. These include:

  • Having Spanish speaking team members that are closely aligned with the target population’s culture
  • Avoid collecting data about citizenship status or country of origin

Graphic for Latinx Communities

Another strategy that can help boost recruitment is training and maintaining Promotoras. Promotoras are community members that are trained to bridge the gap between research staff and the community. They can build a rapport with participants quickly and often identify with the targeted population’s culture. Building and maintaining relationships with promotoras helps investigators develop research studies that are culturally appropriate and aid in boosting recruitment and retention by assisting researchers in promoting their studies ways that resonate with the target population.

 

Having culturally competent research staff physically present at clinics or events recruiting participants may also help boost recruitment. A recent study has shown that participants are more likely to enroll and schedule interviews for a study when the researcher was already on site. Having researchers available to communicate with the target populations at community events, Hispanic/Latinx organizations, and churches can also aid in these efforts.

 

Overall, having direct contact with potential participants is one of the most effective methods to increase recruitment and retention among the Latinx population. Developing relationships with participants and other community members will help build rapport and a sense of trust that can benefit researchers for future studies designed to improve the health and well-being of Latinx communities.

 

We’re still looking for study teams using standard OnCore accrual who are willing to allow us to survey their participants for the Empowering the Participant Voice: Research Participant Perceptions Survey Programthis is your chance to be part of shaping a program that will eventually be conducted for ALL studies at Duke. Make your voice heard! Complete this short survey to tell us about your study.

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:  New Action Tag: @PREFILL

You can now set a field's value to static text or dynamic/piped text whenever a data entry form or survey page is loaded, in which it will always overwrite an existing value of the field.

 

The format must follow the pattern @PREFILL="????", in which the desired value should be inside single or double quotes. A field with @PREFILL will always be read-only, thus its value cannot be modified manually on the data entry form or survey page.

  • For text fields, you may pipe and concatenate values from other fields in the project - e.g., @PREFILL='Name: [first_name] [last_name], DOB: [dob]'.
  • For checkbox fields, simply separate multiple checkbox values with commas - e.g., @PREFILL='1,3,[other_field:value]'.

 

NOTE: The piped value does *not* get applied during any data imports (via API or Data Import Tool) but only operates when viewing survey pages and data entry forms.

 

NOTE: A field with @PREFILL will have its value updated ONLY when the page loads, which means that its value will not be updated in real-time if you modify other fields on the same page that are piped into the @PREFILL tag. NOTE: If being used on a date or datetime field, the date value inside the quotes must be in Y-M-D format - e.g., @PREFILL='2007-12-25' - regardless of the field's set date format.

 

NOTE: The only difference between @PREFILL and @DEFAULT is that @DEFAULT is only applied when an instrument has no data yet, whereas @PREFILL will always be applied on an instrument, meaning that @PREFILL will ALWAYS overwrite the value if a field value already exists.

 

TIP: To pipe the value of one multiple choice field into another multiple choice field, make sure you append ':value' to the variable being piped - e.g., @PREFILL='[my_dropdown:value]'.

REDCap screen shot of Action Tags/Field Annotation field

REDCap screen shot of Prefill text box

 

The following link allows you to test this feature in a REDCap Survey:

https://redcap.duke.edu/redcap/surveys/?s=DCYWC9JPLK

 

 

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 Population Health Sciences CRU welcomes Laura Mkumba, CRC.
  • Medicine CRU welcomes the following new staff:
    • David Ptashnick, CRC , PH cluster started 9/20/2021
    • Shayna Wolery, CRC, Critical care cluster  started 9/27/2021
    • Nkiruka Azuogalanya, GIM CRC started 9/27/2021
    • Morgan Mangum, GIM CRS, Sr started 9/27/2021

 

Send your Clinical Research Employee Highlights to Holly.Tiemann@duke.edu

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

Image of Duke South 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