Duke Clinical Research Update August 5 2020

Wednesday, August 5, 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

 

Phase 3 Re-opening Updates

Phase 3 has been divided into 2 parts so that research can continue to open carefully and at a measured pace. On Monday, August 3rd, we will re-open Phase 3A, as described below. All studies and personnel will continue to require approvals before resuming any in-person activities. At this time, many Phase 3A plans can be reviewed and approved by the CRU. Each unit has worked closely with Vice Dean Naggie and DOCR and has a good understanding of how current DUHS and SoM requirements affect practices within your unit and participant populations.  Please submit all resumption plans to your CRU for discussion and consideration.  Because of current COVID case trends at Duke and within the local community, we are still focused on minimizing person density on campus. Please consider opportunities to utilize existing staff who are already approved to be on campus.  If this is not feasible, please submit a justification with your additional staff request to your CRU. 

 

At this time, the following types of studies can be considered for resuming in-person activities:

 

3A: Remaining Tier 2 & 3 on-premises activity

  • Reviewed and approved by CRUs: This includes the studies happening on Duke premises in buildings opened for clinical research and that require only personnel already approved to work on-site. An On-premise guidance document has been posted on the DOCR Website.
  • Submitted by each CRU to SoM via DOCR for review, discussion, and approval: This includes studies happening on Duke premises in sites not yet opened for clinical research, and justifications for additional on-site personnel. Please note, these studies cannot be approved until the locations have been opened and approved by other SOM offices for clinical research use.  However, submitting plans will help prioritize locations.

 

Phase 3B, includes research done off-Duke premises and in community spaces, such as community centers, parks, and patient homes.  These studies will remain postponed until local and state COVID-19 case incidence is decreasing for >14 days and consistent with low community transmission. Resumption of off-premises research will require significant planning. Please continue to create plans for these studies and to use your CRU and DOCR as resources for discussion.  An off-premises guidance document has been created to assist in your planning and in communicating expectations throughout your CRUs. 

 

Please note that the training required for all in-person research activity has been updated to include off-premises guidelines. Personnel already approved to be working on-site do not need to re-take this training.  However, if they plan to work in community setting after Phase 3B resumes, they may wish to review this updated training.  This training will replace the previous training as the requirement for any new personnel submitted in justifications for approval to work in-person.

 

Tips for Communicating with Patients while Wearing a Mask

In these times where face masks and physical distancing are necessary to reduce the spread of infection, patients with hearing loss (and even some with normal hearing) are experiencing increased difficulties understanding spoken language. Check out these tips that may help improve communication when a patient or caregiver is experiencing communication difficulty.

 

Basic Life Support (BLS) Format Redesign

The Basic Life Support (BLS) class format has been redesigned.  This redesign was necessary given Durham and Duke group size stipulations related to COVID-19.

 

There will no longer be biannual BLS blitzes, as this new process is now the standard for BLS delivery to the Duke community.

 

The Duke BLS class itself now consists of an online module consisting of videos followed by written text located in the Duke Learning Management System (LMS).

 

Once the learner has completed this online module and passed the end of module test, the LMS will allow them to register for the subsequent 1-hour skills validation (1 & 2 rescuer adult with AED, and 1 & 2 rescuer infant with BVM) at education (in all three hospitals).

 

The skills validation sessions consist of one instructor with six students and last about 45 minutes.  Health screenings will be conducted for participants prior to class.  Participants need to bring a mask to the skills validation session.  Gloves will be provided, and class equipment is sanitized by the course instructor after class.

 

Staff should register for the BLS session in LMS. 

 

LMS Course Name/Number:

 

Online Module:

BLS Update Online BLENDED:  BLSUPDBL2020
ACLS/BLS Update Online BLENDED:  ACLSBLSUPDBL2020
PALS Update Online BLENDED:  PALSUPDBL2020

 

In Person Skills Check:

BLS In Person Skills Check:  BLS_SKILLS
ACLS/BLS In Person Skills Check:  ACLSBLS_SKILLS
PALS In Person Skills Check:  PALS_SKILLS

 

Note for those needing to recertify:  The American Heart Association has endorsed a 120-day extension on all life support certification expirations until October.   Duke will align with this AHA endorsement.

 

 

Radiation Risk Statement Information for Duke Clinical Trial Study Teams

The following message is from Dr. Robert Reiman of the Radiation Safety Specialty Committee:

 

I am happy to report that since the beginning of April 2020, many of you have successfully used the “Radiation Risk Wizard” to create your study-specific radiation risk templates. The percentage of studies that the Radiation Safety Specialty Committee (RSSC) could return as “Approved” on the first submission has increased significantly compared to previous years. This is great, because it avoids unnecessary repeat trips through iRIS.

 

With the beginning of the new academic year, and possible staff re-assignments due to the Covid-19 issue, I thought that a review of institutional requirements regarding radiation use in clinical trials would be helpful.  Please take a few minutes to review the updated information on the “Overview” section of the Radiation Safety website. There are no changes in policies or procedures, but we’ve emphasized a few key points:

 

  • The radiation risk information supplied by study sponsors in their model consent forms almost never meets the Duke IRB and RSSC requirements for content and format. Please delete any sponsor-supplied radiation risk information from your draft Duke consent forms and use the Risk Statement Wizard on this site to create acceptable risk templates.

 

  • Radiation use in clinical trials is study-specific. There is no "one size fits all" radiation risk template, and "copy/pasting" radiation risk information from one study's consent form into the "Risks" section of another consent form prior to submission to the RSSC will usually result in a return of the study as "Not Approved".

 

Additionally, effective 5:00 PM on August 4, the web address for the “Radiation Risk Wizard” changed. 

 

The new address is:  https://lsw.duhs.duke.edu/radsafety/consents/

 

When you access the main page, it will look like this:

This picture shows the Radiation Wizard landing page

 

To get to the usual main page, just click the “Continue” button.  This change will be temporary and the link will be directed to the customary main page as soon as feasible.

 

Please update your shortcuts, “favorites”, bookmarks, etc. accordingly.

 

2020-2021 Health Disparities Research Curriculum:  Request for Applications

 

Image of Duke CTSI logo

Image of Reach Equity logo

 

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.  

 

Research Ethics and COVID-19: Lessons Learned and Future Considerations

Join us on August 18 for this one day online conference, which will address lessons learned and future considerations around COVID-19’s effect on the human subjects research enterprise including:

  • Vaccine research 
  • Biobanking
  • Informed consent
  • Re-opening research
  • Preparing your HRPP for post-pandemic era
  • Vulnerability
  • And more!

 

Attendees of this program can earn up to 17.5 of CE credit (if they watch all sessions live or on demand).

 

Certified IRB Professionals (CIPs®) can earn up to 17.5 credits in category two (online training and webinars) for participating in online meetings.

Learn More and Register

 

 

IRIS/ONCORE UPDATES

 

Procedure:  Forte eRegulatory (eReg) Binder Activation

A new procedure, Forte eRegulatory (eReg) Binder Activation, has been posted to the DOCR website.

 

This procedure outlines the necessary steps to activate an electronic regulatory binder in the Forte eRegulatory Management System (eReg).

 

For questions about eReg contact Susan.Natoli@duke.edu or Jessica.Houlihan@duke.edu

 

How do you add a Study Tier Management Group into OnCore Related to COVID-19? 

The INSTITUTIONAL APPROVAL NOTIFICATION includes the COVID UPDATE below with the instructions needed to take this action.   

 

**COVID UPDATE: Please make sure all studies have the COVID study or appropriate Essential Study Tier selected as a Management Group in PC Console >  Main > Management tab. Definitions for Tier 1, Tier 2, and Tier 3 Non-Essential studies can be found at the following link under the FAQs for Essential studies: https://research.duke.edu/covid-19-human-subjects-clinical-research  COVID studies do not need one of the Tier management groups. 

 

  • COVID Study = The study involves COVID-19 research
  • Tier 1 Essential Study = High Potential Direct Benefit
  • Tier 2 Essential Study = Moderate Potential Direct Benefit  
  • Tier 3 Non-essential Study = Primarily observational or behavioral studies, surveys, focus groups, retrospective studies, archival data/sample-based research studies.

Image of OnCore Tier Study Selection options

 

OR

Image of OnCore COVID study selection option

 

***  NOTE:  You must allow pop-ups to edit the Management Group

 

Upcoming iRIS Release 11.02.01 launching August 7th

The iRIS team is pleased to announce that on August 7th, Duke will upgrade to the most recent version of 11.02.01.  Official release notes will be posted to the DOCR website on August 7th. 

Users will also be able to find release notes by using the Help icon:

Image of iRIS help icon

 located in the iRIS header. 

 

 

DOCR NEWS

 

New Training Module on Informed Consent! 
Informed Consent Process and Procedures for Clinical Research

There is a new online course available that addresses the informed consent process. This new DOCR course is available in the LMS and takes about 30 minutes to complete.

 

Please note: This new course is intended to replace the old LMS module Screening and Consenting Subjects that has been required by the Duke IRB before consenting participants at Duke. If you have the Screening and Consenting Subjects course listed in onboarding materials, please replace it with the link listed below and the new title.

 

The course is designed to help clinical research study teams understand how to plan for informed consent, conduct the informed consent process, and document informed consent at Duke. The course provides guidance to help develop a baseline in the following WE-R clinical research competency:

 

  • Safety and Ethics: Consent Procedures

 

Link to course

 

Heads up! DOCR is also currently working on a course for those who are specifically responsible for developing the informed consent form (ICF). It will dive a little deeper into the consent form itself. Stay tuned!

 

Urine Pregnancy Screening for Research WebEx Classes Scheduled

The following Urine Pregnancy Screening for Research WebEx classes have been scheduled.  Class information and LMS registration links can be found below.

 

Urine Pregnancy Screening for Research via WebEx

DOCR-RES-370

Offering ID: 00150030

Tuesday, September 15, 3:00-4:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000103642

 

 

Urine Pregnancy Screening for Research via WebEx

DOCR-RES-370

Offering ID: 00150031

Thursday, October 15, 3:00-4:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000103643

 

 

Urine Pregnancy Screening for Research via WebEx

DOCR-RES-370

Offering ID: 00150032

Tuesday, November 17, 11:00 a.m.-12:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000103644

 

 

Urine Pregnancy Screening for Research via WebEx

DOCR-RES-370

Offering ID: 00150033

Thursday, December 10, 11:00 a.m.-12:00 p.m.

https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000103645

 

Research Professionals Network:  What You Should Know When Switching to eConsent

Many teams have had to move to eConsent in order to continue their studies during COVID-19.  Ceci Chamorro, a Manager, Information Systems with DOCR, will discuss how to quickly get started with eConsent in REDCap. She will discuss specific resources, where to find information to get started, and highlight the dos and do nots of eConsenting.  Ceci will also provide a brief overview of key considerations such as: sending the eConsent to the HIM group to be uploaded into the participant’s medical record, CFR Part 11 compliance, assent, LARs, and non-English consents.

Speaker: Ceci Chamorro

Thursday August 20th at 1:00 on Webex

WebEx: https://dukemed.webex.com/dukemed/j.php?MTID=m3ced334f2323744b28643a4e86d77e43

 

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

 

 

RECRUITMENT INNOVATION CORNER

Planning to Recruit from Primary Care Research?

Duke CTSI Primary Care Research Consortium logo

 

The Primary Care Research Consortium (PCRC), one of the components of the CTSI’s Research Networks and Recruitment Innovation Center, was established in 1996. PCRC is a primary care practice-based research network for academic, community, Veteran's Affairs, and managed-care practices within the Duke Health System and surrounding communities. PCRC includes more than 70 practices in nine counties in North Carolina, which represents more than 200 primary-care clinicians and over 500 clinical staff caring for more than 350,000 patients, with over 1.2 million encounters annually.

 

Our mission and goals are to operate a community-based research network in order to

  • Perform studies that will improve health care delivery and patient outcomes.
  • Provide educational opportunities for clinicians to maintain clinical skills and develop new skills in performing research.
  • Support clinician participation in clinical research through a central administrative office and trained study coordinators
  • Generate research to support the practice of evidence-based medicine

 

Please contact us at DukePCRC@duke.edu if you are interested in

  • Recruiting patient and provider research participants in the Primary Care setting,
  • Partnering with Primary Care investigators,
  • Joining the PCRC Research Advisory Board,
  • Receiving the quarterly PCRC newsletter, or
  • Getting input on your Primary Care research plans.

 

If you have a study that is actively enrolling and do not have it listed, but would like it to be, please don’t hesitate to reach out to the RIC to list it!  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, and more!

 

 

DID YOU KNOW?

Learn More about REDCap

Artwork with words 10,000 Projects

 

The use of REDCap continues to grow.  We just hit 10,000 REDCap Projects created!  The growth continues as faculty, staff, and students are using it to collect their research data securely.  REDCap has also been used for several administrative project as well.  REDCap is a HIPAA compliant, secure web application for building and managing online surveys and databases.

 

To celebrate, we have some REDCap swag for the requester of the 10,000 project.  Congratulations to Jennifer Grant, her project is Pro00101109 Consent Form - Aim R2c.

 

Learn more about by watching a brief video.  REDCap can be access at https://redcap.duke.edu and a practice project can be requested here.

 

Contact us at redcap-docr@duke.edu with any questions.

 

 

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 welcomes Noely Martinez Overby as our new Regulatory Coordinator. We are so excited to have her join our team!

 

 

PARTNER RESOURCES

DUHS Compliance Office

 

Picture of Duke South West Campus Building

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