Duke Clinical Research Update December 16 2020

Wednesday, December 16, 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

 

NICHD Adverse Event, Unanticipated Problem, and Serious Adverse Event Reporting Guidance

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) recently released the following Guidance:  NICHD Adverse Event, Unanticipated Problem, and Serious Adverse Event Reporting Guidance.  This Guidance outlines new reporting requirements for those investigators receiving NICHD support.

 

The purpose of this Guide Notice is to notify the extramural community of NICHD's guidance for Adverse Event (AE) and Unanticipated Problems (UP) reporting for all research activities and contracts funded in whole or in part by the NICHD.

 

NICHD expects all clinical research to be conducted with a high standard of quality that assures the research question is answered in a reliable, valid, and unbiased manner, and that the rights and welfare of human subjects are protected. Starting with competing applications or newly started protocols for January FY21, the NICHD expects investigators to utilize the newly released NICHD Serious Adverse Events and Unanticipated Problems Guidance. 

 

For additional information and full text of this document:

 

 

Sponsored Accounts Required for Affiliate Access to REDCap

Starting January 1st, 2021 any new affiliates who need to access Duke’s REDCap system will require a sponsored account before they can be added to REDCap.

Affiliates are defined as individuals who are not recorded in a system of record, such as the Duke Human Resources system (SAP) or the Duke University student system (SISS). Affiliates can include collaborators at other research sites as well as visiting faculty, visiting scholars and post-docs, medical residents, and contractors.

  • Visit the Sponsored Guest site and follow the directions on the page to request a Guest Account. For the type of account please select a Research/Academic Collaborator, and only request a NetID.
    • We have a tip sheet available for you here.
  • Only Duke employees can sponsor an affiliate for an electronic identity (Duke Unique ID and NetID).
  • Requests will be processed on a first-come, first-served basis and can take up to three business days.
    • You can also check the status of your request on the same website.

 

Once your affiliate has a NetID then you can follow the process to have them set-up an account on REDCap and submit a request to add them to your project.

 

At this time, we will not require any existing affiliate users to transition to a Sponsored Account, but will plan to do that later.

 

Duke CTSA TL1 Applications Due January 19, 2021

The Duke CTSA TL1 fellowship provides two years of funded time to support the research training of outstanding junior scientists. We have particular interest in applicants who are interested in broadening their previous training to include a new category of research methodology (e.g., bench science trainees looking to gain training in translational or clinical research, or vice versa) and applicants looking to obtain training in data science methodology. However, research in these areas is not a requirement for award.

 

Applicants must be US citizens or resident aliens (Green Card), and should have no more than one prior year on a federal postdoctoral training grant. 

 

Up to two trainees may be awarded; 1-2 PhDs, and 0-1 MDs. PhD scholars will receive an NIH-scale postdoctoral stipend; MD scholars will receive a PGY-level-appropriate stipend. All awardees will receive tailored professional development support, and federally-designated training-related expenses including a travel allowance. 

 

MD program website: https://www.ctsi.duke.edu/TL1-physician-research-fellowship

PhD program website: https://www.ctsi.duke.edu/TL1-postdoc-training-program

 

Applications for both MDs and PhDs are due via Duke’s MyResearchProposal by Tuesday, January 19, 2021; awards will be offered in late February with an anticipated start day of July 1, 2021.

 

 

IRIS/ONCORE UPDATES

 

OnCore Minimum Footprint:  Protocol Type for Non-Oncology Studies

The Protocol Type field is a minimum footprint requirement that has been entered centrally for non-oncology protocols.  To facilitate efficient and accurate reporting moving forward this field should be filled in by study staff along with the other minimum footprint requirements. Note: This only applies to non-oncology studies. Protocol Type will continue to be entered by the CPC for studies in the oncology library.

 

iRIS/OnCore:  Consent Forms

Why do you need to add a Consent Category in iRIS? 

Please ensure you always select a consent category when submitting consent forms in iRIS.  A consent category must be selected in iRIS in order for the application approval details to push into OnCore (initial review, amendments and continuing reviews).  If the consent is missing a category type in iRIS, the associated review and approval details will NOT push into OnCore from iRIS.   If you notice missing IRB approval information in OnCore, contact OnCore@dm.duke.edu or submit a service now ticket for support. 

Image of iRIS category selection.

iRIS:  DUHS IRB Application Revision

There has been an addition to section 600 of the iRIS application where users complete CRU selection.  Language has been added to assist users with the selection of the Medicine CRU.  Please review and contact DOCR should you have additional questions regarding CRU selection.

 

Screen shot of Oversight Organization Selection screen

 

iRIS:  DUHS IRB Amendment Form Change

A change has been made which requires study teams to attach a revision to the DUHS Amendment form regardless of any modifications to the application itself.  In order for OnCore and iRIS to sync data properly, the application must be attached to the amendment. If your amendment does not include any changes to the application form, you are still required to add a revision (attachment) without making any changes to the application if unnecessary.  iRIS will then successfully submit the amendment to the IRB for review upon sign-off.  This change also satisfies several other technical requirements related to KP changes made during amendment submission and other workflow processes for the IRB.   

iRIS screen shot highlighting section 1.9 Revise the application to reflect the proposed changes.

 

iRIS screen shot of Select the application that you would like to attach and then click Save Attachment.

 

DOCR NEWS

 

Phlebotomy Competency for Research Classes for January to June 2021

The following Phlebotomy Competency for Research classes have been scheduled for the January – June 2021 time frame.

 

Phlebotomy Competency for Research

Thursday, January 14, 2021, 1:00 to 3:00 P.M.

Offering ID:  00154142

Registration Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106677

 

 

Phlebotomy Competency for Research

Thursday, February 11, 2021, 1:00 to 3:00 P.M.

Offering ID:  00154144

Registration Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106678

 

 

Phlebotomy Competency for Research

Thursday, March 11, 2021, 1:00 to 3:00 P.M.

Offering ID:  00154153

Registration Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106686

 

 

Phlebotomy Competency for Research

Thursday, April 15, 2021, 1:00 to 3:00 P.M.

Offering ID:  00154146

Registration Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106680

 

 

Phlebotomy Competency for Research

Thursday, May 13, 2021, 1:00 to 3:00 P.M.

Offering ID:  00154148

Registration Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106681

 

 

Phlebotomy Competency for Research

Thursday, June 10, 2021, 1:00 to 3:00 P.M.

Offering ID:  00154149

Registration Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106683

 

Urine Pregnancy Screening for Research Classes for January to June 2021

All of the Urine Pregnancy Screening for Research classes will be held in the DEPRU multipurpose room (Duke Clinic 3N, Room 3901A) and directions will be provided to registrants a few days prior to the scheduled class date.  Classes are set up to meet social distancing requirements.  For this reason we will not be able to accept walk-ins for class.  You must register via the Duke Learning Management System to attend.

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154008

Wednesday, January 6, 1:00-2:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106582

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154009

Wednesday, January 13, 3:00-4:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106583

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154010

Wednesday, January 27, 3:00-4:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106584

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154011

Wednesday, February 3, 1:00-2:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106585

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154012

Wednesday, February 10, 3:00-4:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106586

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154013

Wednesday, February 17, 1:00-2:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106587

 

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154014

Wednesday, February 24, 3:00-4:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106588

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154015

Wednesday, March 3, 1:00-2:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106589

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154016

Wednesday, March 10, 3:00-4:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106590

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154017

Wednesday, March 17, 1:00-2:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106591

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154018

Wednesday, March 24, 3:00-4:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106592

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154019

Wednesday, March 31, 1:00-2:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106593

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154020

Wednesday, April 7, 1:00-2:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106594

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154021

Wednesday, April 21, 1:00-2:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106595

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154022

Wednesday, May 5, 1:00-2:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106596

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154023

Wednesday, May 19, 1:00-2:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106597

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154024

Wednesday, June 16, 1:00-2:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106598

 

Urine Pregnancy Screening for Research

DOCR-RES-370

Offering ID: 00154025

Wednesday, June 30, 1:00-2:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000106599

 

 

RECRUITMENT INNOVATION CORNER

Goodbye 2020, Hello 2021

 

It’s easy to look back at 2020 and focus all of our attention on all the negative things that happened (and there were definitely plenty of them!). But for all the struggles, we’ve again shown our collective resilience and ability to adjust when necessary.  In our communities we’ve shared rolls of toilet paper and bottles of hand sanitizer, gone grocery shopping for our neighbors, adopted animals, and learned how to accessorize with masks!  We came together in ways that the world had not seen before.

 

Similarly, we showed that same sense of community, resilience and tenacity in our clinical research units. Studies were put on hold, efforts shifted, new studies opened up, and we all learned how to do remote research “on the fly” – essentially, we built airplanes while flying them at supersonic speeds with our hair on fire.  We learned how to better prioritize and become hyper-focused all while the world around us was rapidly changing as each new scientific discovery was made and each new economic impact was endured. In short, researchers became superheroes.

Cartoon image of super hero

As we move into 2021 we can’t afford to lose our stamina.  The pandemic will continue to affect everyone in research-whether it be because you are involved in COVID-19 studies or just talking through new safety protocols with potential participants. How we share information and tell stories about the work we do will become increasingly important. So, how can we best talk with people about clinical research during a pandemic?

 

 A recent survey of 1,100 people, including an oversampling of 300 African Americans to account for the significant racial health disparities seen in the pandemic, has shown that specific language resonates better with the public when talking about the pandemic. 

 

GOOD

  • The pandemic
  • Eliminate/eradicate/get rid of the virus
  • Social distancing
  • An effective and safe vaccine
  • Protocols
  • Face masks
  • Essential workers
  • Personal responsibility
  • A stay-at-home order
  • Policies that are based on facts

BAD

  • Mandate/orders/control
  • Facial coverings
  • Lockdown
  • science-based/data/medicine

Remember that research participants are people first, embedded in dynamic personal and family lives, and we are still in some very scary times.  It’s especially scary for people that don’t understand research and what it means to participate in a clinical trial.  In your choice of words and language, always be sure to practice empathy, understanding, and consideration for all.

 

Messaging should come in multiple different languages, cater to a fifth-grade reading level, and lean on community members to gain the trust of traditionally marginalized populations that have been hardest hit by the virus.1

As always, please Contact us for any of your research needs!  We can help you develop engaging eConsents, MyChart messages, social media marketing, websites, engagement letters, research notices, and more!  Our services are FREE and you can Email us at studyrecruitment@dm.duke.edu  if you have any questions!

                                          

1PatientEngagementHIT, part of the Xtelligent Healthcare Media network

 

Follow us on Facebook at Discover Duke Research.

 

 

DID YOU KNOW?

REDCap:  Did you know that Automated Survey Invitations (ASI) can be setup using a CSV file?

This is useful for projects that use a lot of ASI’s. For example, if you want to send your participants a survey every day for 100 days, you can easily copy and edit the message, conditions, and when to send the survey using the CSV. This is better than going into each invitation individually!   The ASI's can also be downloaded from one project and uploaded to another.

Screen shot shows the Upload or download Auto Invitations option in REDCap

 

Note: You can also do something similar with defining events and designating instruments to an event.

 

 

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 Medicine CRU WELCOMES New DOM CRU Team Members

  • Kieran McFarlane - Assistant Research Practice Manager - joined DOM CRU in December
  • Tiffani Reeves – CRC – joined Center for Aging in April
  • Brittney Broadnax – CRS, Sr – joined ID in August
  • Destiny Brewley – CRS, Sr – joined Pulmonary in August
  • Shelby Martindale – CRC – joined Pulmonary in August
  • Debra Turner – CRC – joined ID in October
  • Taylor Ardito – CRC – joined Pulmonary in October
  • Yen Lowder - CRC – joined Pulmonary in October
  • Olivia Cupelli - CRC – joined Pulmonary in November
  • Florence Briones – CRC – joined DMPI in November
  • Santos Bermejo – CRC – joined Pulmonary in December

 

The Department of Medicine CRU Congratulates DOM CRU Team Members

  • Ashley Pifer, ID, promoted to CRC, Sr
  • Dana Thompson transferred to Hematology and was promoted to CRC, Sr
  • Antoinette Santoro, Pulmonary, promoted to RPL
  • Dominick Bresson, Pulmonary, promoted to CRC
  • Justin Magin, Pulmonary, promoted to CRC

 

 

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