Duke Clinical Research Update July 1 2020

Wednesday, July 1, 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, 1 PM, via WebEx

 

PACE Office Hours

Every other Tuesday, 1 PM, via WebEx.  Click for information.

 

RESEARCH COMMUNITY NEWS

 

Clinical Research Town Hall with Dr. Susanna Naggie, MD, Wednesday, July 1

Join Dr. Susanna Naggie, MD, as she presents this Clinical Research Town Hall, Wednesday, July 1, 3:00 PM – 4:00 PM via WebEx.

 

Topics to be covered include:

Metrics and current status of clinical research return
Phase III planning and timelines
Building reopening for clinical research
External monitoring on Duke premises
Ongoing COVID studies

 

Join this session via WebEx:

When it's time, join your Webex meeting here.

 

Meeting number (access code):

160 202 8960

Meeting password:

2RMvpkFhP85

 

Link:  https://dukemed.webex.com/dukemed/j.php?MTID=m8c9972e3767ba524403ed4cc6cfb0d40

 

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

 

DUHS Noncompliance Policy

The DUHS HRPP Noncompliance policy has been updated and posted to the IRB web site.  The policy has been revised:  1) to reflect the creation of IRB #9, the DUHS IRB’s new board dedicated solely to review of noncompliance issues, and 2) to allow all parties involved in noncompliance investigations the chance to submit written statements to the IRB.

 

Please visit the IRB web site to read the updated policy:  https://irb.duhs.duke.edu/policies-and-regulations/policies/non-compliance

 

Information Security Office Updates

Duke has seen an uptick in Zoom vandalism with highly offensive content.  Duke Zoom meeting hosts should review guidance at https://security.duke.edu for instructions on securing Zoom sessions.

 

The Duke Information Security Office (ISO) has recently updated our encryption policy and standard – available at https://dukeuniversity.policytech.com/docview/?docid=3618.  IT staff and those responsible for configuring or maintaining information systems should read the full documents.   ISO has also published a short encryption video to help general users understand their responsibilities around encryption: https://warpwire.duke.edu/w/69cDAA/

 

CAMRD Project Application Update

Starting July 1st 2020, new Center for Advanced Magnetic Resonance Development (CAMRD) project applications and renewals will be submitted through REDCap.  This will replace the current Word application that study teams send via email to CAMRD for review.  Approval notifications will continue to be emailed after Committee review. 

 

Please review the ‘Upcoming Changes in CAMRD PDF’ under the ‘Radiology Updates’ Research Wednesday presentation from 5/8/2019 for more detailed information about the changes.

 

On July 1st, you may visit our website to access the REDCap link: https://radiology.duke.edu/research/center/center-advanced-magnetic-resonance-development-camrd/

 

Please contact the CAMRD team via email with any questions: CAMRD-technologists.dm@duke.edu.

 

TIN Collaborative Webinar: Introducing the All of Us Researcher Workbench, Wednesday, July 1

The Trial Innovation Network (TIN) would like to invite you and your researchers to attend an upcoming TIN Collaborative Webinar:

Introducing the All of Us Researcher Workbench on Wednesday, July 1st at 12:00 pm EDT. 

The All of Us Research Program aims to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care by providing researchers access to one of the largest biomedical datasets of its kind.  During this session, we will introduce you to the All of Us Researcher Workbench and show how researchers use this platform to access and analyze All of Us data. We will also emphasize how interested researchers can apply to Beta test our platform and data.

This webinar is open to anyone who would like to attend.

Registration is on the TIN Events webpage

Please share with colleagues would might be interested in learning more!

 

Request for Proposals (RFP):  Management of Non-Communicable Diseases (NCD) for Health Care Providers

Date RFP Issued:  June 15, 2020

Geographic Scope:  United States, Canada, Japan, Europe

Clinical Area: Non-Communicable Diseases

Link to full RFP:  Management of Non-Communicable Diseases (NCD) for Health Care Providers

Application Due Date:  July 10, 2020

Specific Area of Interest:  It is our intention to support multiple grants focusing on either gap listed below or comprehensive grants that address both:

 

  • Continuing Professional Development / Medical Education Program that seeks practice and knowledge improvements initiative between experts and providers (specialists and non-specialists) around the world with access to the most up-to-date information and resources on screening for and preventing non-communicable diseases (NCDs). Component of the professional development/Medical Education program to needs to focus on leading causes of morbidity and mortality that will bridge gaps in knowledge and inform on advances in clinical practice.
  • Initiative towards Improvements in healthcare systems are paramount in effective management of NCDs. Today, patients are faced with fragmented systems, lack of coordination across HCPs, gaps in access to PCPs who have been adequately trained in NCDs, and little influence over their treatment.

 

Refer to complete details in the full RFP document. If you have questions regarding this RFP, please direct them in writing to Renee Yip (renee.yip@pfizer.com).

2020-2021 Health Disparities Research Curriculum:  Request for Applications

The Duke CTSA and the Center for Research to Advance Healthcare Equity (REACH Equity) are pleased to announce a call for applications for the Health Disparities Research Curriculum (HDRC).

 

HDRC is designed to increase knowledge and skill in the design and conduct of health disparities research.  The curriculum consists of didactic and interactive sessions every three weeks on Thursdays from 3:30 PM to 5:00 PM; September 2020 through June 2021. 

 

The curriculum addresses: 

  • Nomenclature and framework for approaching research involving health disparities
  • Contributors to health disparities
  • Role of implicit bias in disparities
  • Health disparities research methods across the translational spectrum
  • Conduct of health disparities research focused on the clinical encounter

 

For additional program information, syllabus and the application, please see: https://www.ctsi.duke.edu/dtmi-teams/education/duke-health-disparities-research-curriculum

 

If you’re interested in participating in the 2020-2021 curriculum, a brief online application must be submitted by August 17, 2020.   Acceptance into the HDRC curriculum will be determined based on capacity, commitment to conducting health disparities research, and the applicant's rationale for taking the course. Applicants will be notified of acceptance via email. 

 

HDRC uses the MyResearchProposal online application software.

  • To apply visit http://bit.ly/myresearchproposal, click on “Create New User” (or log in if you already have an account).
  • A step-by-step user’s guide for applying via the MyResearchProposal software is available - Please review this document.
  • Enter Access Code ‘CTSI’ then select the HDRC 2020-2021 opportunity and follow the instructions.
  • For any questions concerning MyResearchProposal passwords or system issues, please contact myresearchproposal@duke.edu.

 

For additional information or questions about HDRC, please contact:

Stephanie Molner, MSW

Stephanie.molner@duke.edu

919.656.3647

 

Clinical Research Training Program Accepting Applications

The program is now accepting applications for academic year 2020-2021. For a detailed description of the program, the course offerings, and a link to the online application, please visit the CRTP website at http://crtp.duke.edu.

 

This year CRTP is launching the Basic Science Research Track (BSRT), a customized curriculum designed for physician scientists and trainees leading to a Master of Health Sciences in Clinical Research Degree. 

 

The application deadline for priority review is May 15, 2020. Applications will be accepted through August 1, 2020.

 

 

iRIS/OnCore Updates

 

NEW OnCore Report:  Demographic Summary Accrual Report

Interested in a summary of your study enrollment demographics?  

 

A new customized report is available that allows you to pull this information across several protocols of interest.  A tip sheet has been developed for the Demographic Summary Accrual Report with more details on where to find and how to run the report.  It is also posted on the DOCR website at the 3 locations below. 

 

For Leadership
For Regulatory Coordinators
For Study Coordinators

 

 

DOCR NEWS

 

Phlebotomy Competency for Research WebEx Classes

The following Phlebotomy Competency for Research WebEx classes have been scheduled in the Duke Learning Management System:

 

Title:  Phlebotomy Competency for Research - DOCR

Date:  Thursday, July 16, 1 PM – 3 PM via WebEx – WebEx link will be sent to registrants on July 15

Course ID:  DOCR-RES-320

Offering ID:  00148774

Link: https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000102800

 

 

Title:  Phlebotomy Competency for Research - DOCR

Date:  Thursday, August 13, 2 PM – 4 PM, via WebEx – WebEx link will be sent to registrants on August 12

Course ID:  DOCR-RES-320

Offering ID:  00148775

Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000102801

 

Update to Coverage Analysis (CA) and Payment of Copayments & Deductibles Procedure

The “Coverage Analysis (CA) and Payment of Copayments & Deductibles” procedure has been updated to address the issue of split billing for bundled services.  This is particularly relevant to studies involving commercial drugs that are being administered at Duke.  The procedure now clarifies that drug administration charges cannot be routed differently from the charges for the drugs themselves—i.e., both must be billed to study, or both must be billed to patient/insurance.  Please note that this applies to commercial drugs only, not sponsor-supplied study drugs.  The addition to the procedure states:

 

“Duke will accept reasonable offers from the sponsor to pay for conventional or standard of care (SOC) items, diagnostic tests and procedures to comply with Medicare’s Secondary Payer (MSP) policy with the following exception: because of established billing/coding guidelines and claims edits set up by our institution as well as by insurance, certain combinations of services that are typically billed together (i.e., drugs and infusions and other such coding combinations) will not be split billed. In order to conform with standard billing and coding conventions, the charge assignment for these will be the same.”

 

The link to the updated procedure can be found here: https://duke.box.com/s/454q35xljhmg4j53xkq5exw342cvpsfs

 

 

RECRUITMENT INNOVATION CORNER

Engagement, Recruitment, & Retention Certificate Program: Nominations Open!

A new competency-based curriculum and certificate program

View a short video!

The Clinical and Translational Science Institute’s Recruitment Innovation Center has collaborated with DOCR to gather a team of experts across Duke and beyond to create a certificate program focused on engaging, recruiting, and retaining clinical research participants. 

 

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 ad 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
  • CEU credit hours for SOCRA and ACRP certifications
  • And an opportunity to evaluate the program and provide feedback to enhance it for future attendees

 

The program consists of five core classes and two electives. Participants will choose from six elective options. Anyone participating in the program can anticipate approximately 15 hours of commitment associated with the program over a 6 month period. No more than two classes will be held each month from September 2020 – February 2021. The tentative course schedule is available on our program flyer. ​

 

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 by August 3, 2020

Want more information? Check out the program website.​

 

 

The team facilitating this new curriculum will be collecting data to measure program effectiveness. Managers and participants will be asked to complete self and manager-scored 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). ​

 

 

DID YOU KNOW?

Did You Know that REDCap is NOT 21 CFR Part 11 Compliant?

REDCap is not 21 CFR Part 11 compliant, but DOCR can be contracted for assistance to meet compliance. Compliance must be met on a per project level. 21 CFR Part 11 also requires studies to validate the identity of the person providing an electronic signature, which may include a biometric method or two distinct identification components such as an identification code and password. Please consider if this will be possible for your project, and consult with DOCR if you have any questions before proceeding with REDCap for a project that must meet compliance, including as an EDC system or for the use of eConsent.

 

21 CFR Part 11 is the FDA's regulations for electronic records and electronic signatures.  Part 11 compliance may be needed if there is an intent to submit data from the study to FDA in support of a marketing application. In other words, if you are conducting a research study that is subject to the IND or IDE regulations, but you only intend to publish the findings and not submit the data to FDA, then compliance with 21 CFR Part 11 is typically not required. Compliance with Part 11 is strongly encourage if the data from the study will later be used to support a marketing application.

 

DOCR does not make a determinations if a project must meet Part 11 compliance.  ORAQ can assist study teams determine if Part 11 is required.

 

More information will be available in the coming weeks regarding 21 CFR Part 11.

 

 

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.

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

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