Duke Clinical Research Update August 11, 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

 

Duke Research at Pickett Facility now open for business!

Originally opened in October 2020 for COVID-19 vaccine and treatment trials, the Duke Research at Pickett facility and service center is now open for all types of outpatient and community-engaged research studies.  This free-standing, research-only facility has 30 exam rooms equipped with standard equipment and supplies, free parking, accessible ground level entry, and is staffed with a team of 12 CRCs, CRNCs, a Physician Assistant, a regulatory coordinator, and a front desk scheduler. Located at 3024 Pickett Rd. behind University Tower, we are just a few minutes from main Duke hospital and clinics. To find out more about services, costs, available equipment, or to schedule a tour of the facility, contact us at: ResearchAtPickett_Request@dm.duke.edu.

 

Need a location for outpatient or community-engaged research visits?

Duke Research at Pickett has exam and conference room spaces for your study teams to conduct research visits. Please note, Duke Research at Pickett is a research-only facility, no standard of care visits or procedures billed to insurance can be done at this site.

 

Need coordinators, research nurses or a PA to assist with your study visits?

Managed by a team of DOCR Directors and RPMs, our team of CRCs, CRNCs, and a PA can work with you and your study team to conduct research visits or specific research tasks at the Pickett site or at Duke Regional Hospital.

 

Need a study team to run your study?

Duke Research at Pickett management will assign a team (CRCs, CRNCs, PA, and regulatory coordinator) to work with you on your study at Pickett Rd. or DRH and will work closely with your CRU for start-up and oversight.

 

Want to expand enrollment at Duke Regional Hospital?

Duke Research at Pickett managers can work with you to establish a plan for enrolling participants at DRH and can assign a team of coordinators who are experienced working with DRH to enroll participants, collect samples, and conduct research visits at DRH.

 

Having difficulty recruiting?

The Research at Pickett team has dedicated bi-lingual recruitment services for studies using the Research at Pickett site.

 

Want an efficient and convenient way for sample collection?

Duke Research at Pickett offers an on-site processing service for all samples collected at Pickett and is launching a new Lab and Leave service for quick, convenient collection and shipment to your evaluation lab of choice. Please note, no procedures billed to insurance can be done at this site.

 

Need to connect with your Spanish-speaking participant community?

The Duke Research at Pickett team includes several coordinators who are bilingual in Spanish and English and are available for document translation, recruitment, or conduct of study visits with Spanish speaking participants.

 

Research Administration Changes:  Late Waivers

The School of Medicine has adopted a Late Submission fee as of July 1, 2021 for applications not submitted to ORA by the stated 5-business day internal deadline.   

  • The late submission fee will be $500 per late submission for all units with a late waiver/submission rate of 10% or less, and $1000 per late submission for units with a ratio above 10%.  
  • The fee per waiver will be assessed to the owning department/center/institute of the application (rather than to individual faculty) on a quarterly basis.  
  • Late submissions of RPPRs will result in a flat fee of $1500 per late submission.

 

Applications may not be submitted if ORA receives the application 2 business days or less from the submission deadline, or if certain fundamental elements are incorrect:

  • FOA instructions or Duke/Sponsor policy not met
  • Major issues with Budget or Budget Justification
  • Irreconcilable Conflicts of Interest or Commitment
  • Work that Cannot Be Carried Out by Duke
  • Issues of Budgetary, Commitment or Scientific Overlap

 

The best way to avoid last minute issues is to complete an Intent To Submit (ITS) form through myRESEARCHhome well in-advance of the submission deadline. 

 

The “Develop and Submit Proposal” section in myRESEARCHpath is also a good resource for navigating the internal process for a smooth submission to the sponsor.

  

Virtual Security Academy Sessions Announced

The Duke Health Technology Solutions Information Security Office is excited to provide the following schedule for upcoming Virtual Security Academy sessions.  At this time, no registration is necessary.  Just click this link DHTS Virtual Security Academy at the scheduled time.  All VSA sessions occur on the 3rd Thursday of each month from 3:00 PM to 4:30 PM beginning in August 2021, with the exception of December 2021.

 

The Virtual Security Academy is a monthly virtual learning session hosted on Zoom by information security subject matter experts from the ISO and ITSO.  Topics are relevant to everyone who works at Duke, and provide a security-centric point of view on current events and how we interact with technology.  These sessions are meant for EVERYONE at Duke so start working your networks now making people aware and encouraging them to attend. We’ll be using ‘real world’ examples and a storytelling approach in these talks and hope many people from your networks can join us.

 

A Teams channel for the Virtual Security Academy has been created and it is also open to everyone at Duke.  Use the following link to access the channel to see the schedule for upcoming VSA topics.

This link will take you to the Teams Virtual Security Academy site.  

The DHTS Information Security Office looks forward to seeing you there!

 

Process Update:  Research Blood Order Draws on Inpatients at Duke Hospital

The process for requesting Research Blood Order Draws on Inpatients at Duke Hospital has been updated.

 

For a step by step process for the collection of Research Blood Order draws refer to the updated Tip Sheet Process for Research Blood Order Draws on Inpatients at Duke Hospital.  This new process involves a new shared email for notifications along with an email template for teams to use. 

 

A few important reminders to study teams:

  • Phlebotomists on the floor do not have direct access to Maestro Care on their Rover devices.  Therefore, phlebotomists are unable to view notes and instructions left within Research Blood Order and/or Maestro Care.  It is essential that all instructions are outlined in the email request including the number of tubes to be filled.

 

  • If a Research Blood Order Draw order is placed STAT, the order goes directly to the Unit Nursing Staff.  Phlebotomists do not receive STAT orders.  If you have placed a STAT order and have questions about the order, see the Unit Nursing Staff.

 

  • Phlebotomy does not do timed draws.  Phlebotomy does sweeps of the house and is not able to collect at specific times.  

 

The Clinical Laboratory Phlebotomy Service currently collects inpatient Research Blood Order draws on the following units:

There will no longer be a need to associate a standard of care lab in order to get these drawn.

 

As part of this new service, Clinical Laboratory Phlebotomy Service will charge the following fees to your project fund code:

  • Piggyback blood draw on inpatient: $3.22
  • Inpatient blood draw:  $8.89
  • COVID inpatient blood draw: $14.56

 

A Conversation with Dr. Patrizia Cavazzoni

On Wednesday, September 29, from 3 PM —4 PM, the Duke School of Medicine will host a discussion and moderated Q&A with Dr. Patrizia Cavazzoni, the FDA’s director of the Center for Drug Evaluation and Research. Dr. Murali Doraiswamy from the Duke Department of Psychiatry & Behavioral Sciences, and the Duke Clinical Research Institute’s executive director, Dr. Adrian Hernandez, will join Dr. Cavazzoni for a  wide-ranging conversation centered around the past, present, and future landscape of pharmaceutical development, evaluation, safety, and regulatory science.

 

Attend this event via Zoom: https://duke.zoom.us/j/95759783411?pwd=T2hqS0ZWbzRnSFZvWFdnbW1mYmFTdz09

 

No registration is required.

 

 

IRIS/ONCORE UPDATES

 

Using an External IRB of Record? 

Consent forms for studies using an External IRB of Record (central IRB) are not formally approved by the Duke IRB.  In these situations, the consent form(s) will not push over into OnCore with the review and approval details. Instead, study teams must manually enter the consent information for each of the approved consents (adult/assent/parent consent etc.) each time a new consent is approved by the central IRB.  This includes any amendments involving the consent form and continuing reviews.

 

A few things to remember:

  • Protocol Management Access is required to add consents into OnCore. 
  • The tip sheet Adding Consent Information will help guide you through adding consents in OnCore. NOTE:  The consent details should be added under the corresponding IRB review in OnCore that the consent was submitted under in iRIS. 
  • All consents must be added into OnCore prior to enrolling the first participant so the necessary consent details will be available for subject registration. 

 

Managing Management Groups in OnCore

Effectively immediately, Tier Management Groups no longer need to be added in OnCore.

All COVID-related studies should continue to be identified by having the “COVID Study” management group added in addition to their primary management group:

 

 

Did You Know?  Viewing KSP Changes in iRIS

When you submit a KSP change in iRIS, the change will not be reflected until the next version of the protocol application.

If a study team has an amendment in process, the approved KSP changes will not be updated until the amendment has been approved.

One way study teams can view a current KSP list can be found in the Tip Sheet “How to Print Current Key Personnel in iRIS” on the DOCR iRIS Support page.

The link to the tip sheet is here, https://duke.app.box.com/s/q8antox35tnw3ipg58oylmka6vyuzelc.

 

 

DOCR NEWS

 

ClinicalTrials.gov Corner

As part of the study start-up process, DOCR reviews studies for ClinicalTrials.gov registration criteria.  The specific requirements for registration are listed below but all Investigators are encouraged to register any study on ClinicalTrials.gov to promote research transparency.  Please reach out to us at DOCR-CTGOV@dm.duke.edu if you have any questions or need any assistance with an upcoming or existing registration.

 

  1. Applicable Clinical Trials (ACTs) are required to register and report results per federal regulation. ACTs include trials of FDA-regulated drugs, biologics, or devices (other than Phase I drug and feasibility device studies). They must be registered prior to full institutional approval signoff in OnCore.
  2. NIH-funded clinical trials are required to register and report results per NIH policy. They must be registered prior to full institutional approval in OnCore.
  3. Federally-supported clinical trials are required to upload one consent form to a public website after enrollment is complete per the revised Common Rule. Per Duke Policy, these trials must be registered on ClinicalTrials.gov prior to full institutional approval signoff in OnCore.
  4. Qualifying Trials billing subject insurance must have an NCT# prior to full institutional approval signoff in OnCore.
  5. Prospective, interventional research that will be published in a journal following ICMJE guidelines should be registered prior to enrollment of the first participant.

 

Research Professionals Network:  How Can Research Staff Support Building Research Ready Communities

Thursday August 19th at 1:00 PM on Zoom

 

How Can Research Staff Support Building Research Ready Communities

This presentation will provide an overview of CEnR (Community Engaged Research) and principles of community engagement.  We will discuss the alignment of clinical research activities and community engagement practices and how research staff can become active participants in community engagement both as part of their research and within their individual circles of influence.

 

Speaker:  Sabrena Mervin-Blake, MS, CCRC

 

Zoom: https://duke.zoom.us/j/93994651242?pwd=N2hqRkRXQlJxaWJ4aUV2OThtTzF4UT09

 

Meeting ID: 939 9465 1242
Passcode: 443225
One tap mobile
+13017158592,,93994651242# US (Washington DC)
+13126266799,,93994651242# US (Chicago)

 

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

 

Onboarding Learning Plans Updated

The available Clinical Research Onboarding Learning Plans on the DOCR Onboarding Learning Plan webpage were recently updated with new materials and a link for new employees to register their use of the Plan for tracking purposes. If you are actively using these plans, be sure to download the newest version from Box! A few new courses are in development and the Plans will be updated again soon, so be sure to check back regularly for any updates.

 

There is also a new process for requesting the RPM/ARPM Onboarding Checklist. Rather than emailing WE-R Jobs, use the form linked on the Onboarding Learning Plan webpage under RPM/ARPM.

 

Feel free to direct any questions or comments about onboarding to Jessica Cranfill at Jessica.cranfill@duke.edu.

 

 

RECRUITMENT INNOVATION CORNER

The Nomination Form for the Engagement, Recruitment, & Retention Certificate Program is closing TODAY (8/11/21)!

Do you have an employee you were planning to nominate for the Engagement, Recruitment, and Retention Certificate Program? Today is the last day to submit your nominations for the upcoming Fall 2021 cohort! For more information about the program, check out the website.

 

In case you missed it: the purpose of the 6-month program is to develop experts in clinical research engagement, recruitment, and retention who can serve as a resource in clinical research units and divisions at Duke. Those who complete the program in its entirety (6 core courses and 3 electives) will receive a Duke Recruitment, Engagement, and Retention certificate and are encouraged to use that certificate as a career development tool to enhance applications for Tier Advancement. ​

 

Managers are invited to nominate employees who perform participant engagement, recruitment and retention activities whom they believe additional training would make them good resource in their units. If you are an employee who is interested in the program, please consult with your manager for nomination. ​

Nomination Form

All nominations are due TODAY (August 11, 2021) by 11:59pm

Want more information? Check out the program website

Program Flyer

 

Please direct any questions or intentions to submit (if you are not able to meet this deadline) to Jamie Roberts (Jamie.roberts@duke.edu) and Jessica Cranfill (Jessica.cranfill@duke.edu).

 

New Online Training Module – Using Social Media for Study Recruitment: Questions to Consider (Approx - 20min)

 

This new online module is now available in the LMS! This module was developed in collaboration with the RIC and DOCR and takes about 20 minutes to complete. The purpose of this online module is to describe the benefits of using social media for recruitment and provide an overview of questions to ask that can help determine whether study teams should use social media as a recruitment tool for studies in their portfolio. There are resources shared within this module that will help clinical research personnel decide whether social media is right for marking their research.

 

The module addresses the following learning objectives:

  1. Describe how social media is used for recruitment in research studies
  2. Identify questions to determine whether social media is right for a study
  3. Find policies and procedures related to using social media for recruitment at Duke

 

The content provides guidance to help develop the following WE-R clinical research competencies: Recruitment, Technology Use and Innovation

 

Link to course

 

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

 

 

DID YOU KNOW?

REDCap:  New Action Tag: @CALCTEXT

You can now use logic in the action tags.

 

@CALCTEXT evaluates logic that is provided in the @CALCTEXT() function and outputs the result as text, typically performed with the if(x,y,z) function.

 

For example, if age is used to determine eligibility for a study then @CALCTEXT(if([age]<18, ’Ineligible’,’Eligible’) would output whether a participant is eligible or not.

 

NOTE: It is important to realize that a field with @CALCTEXT will not be editable on the survey page or data entry form, and the field will function almost exactly like a normal calculated field, in which its value may get updated via a data import, when running Data Quality rule H, or in real-time during normal data entry on a form or survey. Also, it is possible to return the value as a number -e.g., @CALCTEXT(if([age] >= 18, 'adult', 5*[other_field])).

 

 

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 Dermatology Pathology CRU welcome Megan Griffin and Elizabeth Howington to the BRPC as Research Technicians!
  • The Dermatology Pathology CRU welcomes Connor Whatley as a Clinical Research Nurse Coordinator!
  • The School of Nursing CRU announces:
    • Ally Johnson has joined the group as a CRC.
    • Adam Benzekri and Marco Thimm-Kaiser are new Associates in Research.
    • Javier Martinez Rodriguez is a Clinical Research Specialist Sr. 

 

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.

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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