Duke Clinical Research Update July 21, 2021

Wednesday, July 21, 2021
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

 

Important Lab and Leave Update

Effective July 26, 2021, the Lab and Leave site at North Duke Street Clinic will be closing.  The last day for service at this location will be July 23, 2021.

 

Please remove this site from your list of Lab and Leave locations:

 

Duke Health Center at North Duke Street   Adult patients only

  • Address: 3116 North Duke Street
  • Telephone: 919-660-2200

 

Effective August 2, 2021, the Lab and Leave site at Children’s Specialty Service at Brier Creek will be closing.  The last day for service at this location will be July 30, 2021.

             

Please remove this site from your list of Lab and Leave locations:

 

Duke Children's Specialty Service of Brier Creek – Alm Street  Pediatric patients only

  • Address:  10211 Alm St. Suite 212, Raleigh
  • Telephone: 919-307-0170 (Option 8)

 

Effective September 1, 2021, the Lab and Leave site at Southpoint Clinic will be closing.  The last day for service at this site will be August 31, 2021.

 

Please remove this site from your list of Lab and Leave locations:

 

Duke Health Center at Southpoint   Adult patients only

  • Address: 6301 Herndon Road, Durham;  Across from Southpoint Mall
  • Telephone: 919-572-6095 (allow to ring after listening to all prompts)

 

As a reminder, the South Durham Clinic and the Brier Creek Clinic are NOT Lab and Leave locations.  Please do not direct patients to those sites.  Moving forward, we do not expect any additional changes to the remaining Lab and Leave locations.

 

Questions may be directed to Mary Smith at mary.r.smith@duke.edu

 

For additional information on the Lab and Leave process, see Lab and Leave Process for Clinical Research Labs Standard Operating Procedure.

 

DEPRU Services Request

The process to request DEPRU Services has been updated.  Note that DEPRU will be removed from the IRB as a Specialty Committee as this new process will not need DEPRU to review your study in the IRB

To request services from Duke Early Phase Clinical Research Unit (DEPRU), use the REDCap DEPRU-Services Request surveys:  https://redcap.duke.edu/redcap/surveys/?s=P3WAAD37AN

 

These surveys can be completed in 2 easy steps.  Soon after completion, you will receive a draft budget.

 

The link to the survey request can also be found on the DEPRU Webpage: https://medschool.duke.edu/research/clinical-and-translational-research/duke-office-clinical-research/clinical-research-resources-and-applications/duke-early-phase-clinical-research

 

See the DEPRU-Services Request Tip Sheet for detailed information on the process for requesting DEPRU Services.

 

 

DUHS IRB as Single IRB: Duke As A Site (DAAS) Workflow (iRIS, OnCore and eGRC)

For those multi-site studies that use DUHS IRB as the single IRB and Duke is one of the participating sites, DUHS IRB as Single IRB: Duke As A Site (DAAS), a workflow process (iRIS, OnCore and eGRC) has been outlined and can be found on the DCRI CRU Website.

 

Some Key Points to remember during this process that are included in the workflow are:

  • Non-Duke sites can move ahead with their  activities after DUHS IRB has approved the amendment to add their site to the sIRB protocol
  • sIRB PI comes over from iRIS with Principal Investigator role in OnCore. sIRB PI’s role needs to be changed to “sIRB PI” role in OnCore before the DAAS PI role is changed to “Principal Investigator” in OnCore.
  • DAAS PI comes over from iRIS with whatever role they were assigned in iRIS. DAAS PI’s role needs to be changed to “Principal Investigator” in OnCore.
  • DAAS CRU to hold off on RDSP signoff in OnCore until amendment to add Duke Site is approved.
  • IA in OnCore for Duke as a Site (DAAS) occurs after DUHS IRB has approved the amendment to add DAAS to the sIRB protocol.
  • Minimum Footprint in OnCore is the responsibility of DAAS

 

Questions regarding the DUHS IRB as Single IRB:  Duke as a Site workflow should be addressed to Simona Farcas and OnCore@dm.duke.edu

 

Return to Research (RTR) Updates and Announcements

The Duke University Health System (DUHS) recently released Guidelines for Re Opening Operations by Communicable Disease Risk.   Please become familiar with the important information on this document.  As communicated yesterday, the move to Tier 2 status has been postponed.

 

As Return to Research plans evolve, it is important to note that all safety measures regarding pre appointment screening, masking and eye protection are continued and remain unchanged.

 

Additional items to note include:

 

Effective now, Return to Research plans for Phase 3A - CRU approved are no longer required for approval. 

Phase 3B Return to Research plans that occur in community spaces or at a participant’s home still require approval.

    

Onsite personnel approval process through DOCR discontinued

  • It is no longer necessary to send names of onsite personnel to DOCR or to obtain an on-site approval letter prior to conducting research activities in-person.
  • Onsite training (Clinical Research Social Distancing and COVID Infection Prevention) and symptom monitoring is still required for new staff or staff coming onsite for the first time.  CRUs should confirm and keep the proof of training.
  • Basic science research buildings (e.g., MSRBs, GSRB, etc.) require coordinated approvals to gain access.  For clinical research personnel needing badge access to SOM research lab buildings to conduct research activities, the employee or their manager must complete an access request submitted through myRESEARCHhome. This process is only for laboratory personnel and those personnel in clinical research classifications who are requesting access to conduct research activities specifically in lab buildings.  All other personnel needing badge access to lab buildings or other locations should request access through their departmental business offices.

 

Space/Masking

  • If you are a vaccinated individual in office space with a closed door, a mask is not required. 
  • If there is potential contact with visitors, patients, or research participants such as hallways and other spaces where these individuals are located, a mask is required.
  • For non-vaccinated individuals, masks are required at all times.

 

Use of Davidson Conference Room 457

Beginning July 19th, the Davidson 457 Conference Room will no longer be available for use as touch down space and monitor visits.

 

 

IRIS/ONCORE UPDATES

 

Updated Study Closeout Checklist Now Available

Please remember that all subjects should be in an inactive status (Off Study, Not Eligible, Withdrawn) in both OnCore and Maestro Care prior to closing a study with the IRB.  The Study Closeout checklist has recently been modified to included additional clarification to help support participant status updates if needed.  You can review the updated version at this link. 

 

 

DOCR NEWS

 

Society for Clinical Research Sites (SCRS) Offers Online Modules that have been Mapped to WE-R Competencies

The Society for Clinical Research Sites (SCRS) offers a unified voice for the global clinical research site community.

 

The Duke Clinical Research Community is able to join SCRS free of charge.  Once logged into the site, Duke Community members are able to access 12 online modules that have been mapped to WE-R training competencies.

 

To create your account:

 

Once logged in, go to the Learning Campus tab and select Site Management Modules.  You now have access to 12 modules which outline basic components related to Principal Investigator oversight of clinical trials and the foundational concepts of Clinical Research in accordance with the ICH Guideline for Good Clinical Practice.  These modules allow site staff with less experience to become more familiar with conducting clinical research.

 

To see how the modules are mapped to WE-R competencies, go to the WE-R Competency Training page.

 

 

RECRUITMENT INNOVATION CORNER

Nominations are Open for the Engagement, Recruitment, & Retention Certificate Program!

Opening screen for the Recruitment Engagement Retention video

https://vimeo.com/429239669

There are limited spaces in the program, so don’t miss the opportunity to nominate your staff.

 

The CTSI Recruitment Innovation Center and DOCR would like to welcome managers to nominate employees for the upcoming cohort of the Engagement, Recruitment, and Retention Program.

 

The purpose of the program is to develop experts in these topics who can serve as a resource in clinical research units and divisions at Duke. Those who complete the program in its entirety 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.

 

The curriculum also features:

  • A diversity and inclusion lens throughout
  • Expert instruction in timely and requested topics
  • Engaging and thought-provoking material and interactions
  • Wiki access for continuous resource sharing among the cohort
  • Online pre-activities and in-class discussions
  • CEU credit hours for SOCRA and ACRP certifications

 

The program consists of an online pre-requisite course, six core classes, and three electives. Participants will choose from seven elective options. Anyone participating in the program can anticipate approximately 18 hours of commitment associated with the program over a 6 month period. Participants can expect no more than two classes each month from September 2021 – March 2022. The tentative course sequence is available in the program flyer.

 

Managers are invited to nominate employees who perform participant engagement, recruitment and retention activities and 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

 

The nomination form will close on August 11, 2021 at 11:59 PM

Want more information? Check out the program website.

 

The team facilitating this curriculum is collecting data to measure program effectiveness. Participants will be asked to complete self-assessments both before and after program completion to help with this effort. Students will also be asked to assess the instructors and course content to ensure continuous improvement of the program.

 

Please direct any questions to Jamie Roberts (Jamie.roberts@duke.edu) and Jessica Cranfill (Jessica.cranfill@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 Radiology CRU congratulates:

  • Aalanah Valentine on her promotion to CRC in our CRU
  • Kelly MacIntosh on her promotion to CRC in our CRU

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

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