Clinical Research Update - November 2018

Thursday, November 8, 2018
By Duke Office of Clinical Research (DOCR)

Research Community News
DOCR News
Did You Know?
Training Opportunities
Clinical Research Employee Highlights
Partner Resources


Research Community News

 

Responsible Conduct of Research (RCR) Training Requirement (Phase II) Update

The School of Medicine (SoM) Faculty and Staff Responsible Conduct of Research (RCR) program is expanding to offer more program options.

All Duke School of Medicine faculty and staff members engaged in research are now required to participate in RCR training on a routine, regular basis by completing:

  • One Online Self-Directed RCR course every 3 years

- AND -

  • One Collaborative Learning RCR course every 3 years

Online Self-Directed RCR programs currently available can be found on the SOM RCR 100 Program website.  Those persons who completed the RCR Self-Assessment or CITI RCR Course for the Phase I training deadline of June 30, 2018, have satisfied the Online Self-Directed RCR Course requirement.

More information about the Collaborative Learning RCR programs currently available and downloadable resources for leading an RCR discussion in your research unit can be found on the SOM RCR 200 Program website.  Those persons who have completed the RCR In-Person Workshop or attested to taking a Duke RCR course for the June 30, 2018 deadline, have satisfied the Collaborative Learning RCR Course requirement. 

Faculty and staff members engaged in research will receive emails annually with their current RCR training status and alerts before the deadline to complete each type of RCR training.  Faculty and staff members may check their RCR training status including all completed RCR courses through the Duke Learning Management System.  Please direct any questions about the SoM Faculty and Staff RCR Programs and RCR course completion to ASISTOffice@duke.edu or your departmental point of contact.  Click this link to find a list of points of contacts for departments.

We appreciate the continued support and feedback on the development and implementation of the SoM Faculty and Staff RCR program and look forward to working together to support our research community at all levels.

 

Process for Posting Actively Enrolling Studies on the Dukehealth.org Trial Information Pages (TIPs)

Researchers and study teams who would like to bring awareness of clinical research opportunities to our patients and community are encouraged to post their actively enrolling studies on the Dukehealth.org Trial Information Pages (TIPs).  Posting of study information to the TIPs will be facilitated through the SIP (Study Information Portal) Console in OnCore.  

In order to assist study teams with completing the SIP Console using language that is easy for the general public to understand, the Duke Office of Clinical Research (DOCR) has developed a SIP training module available in LMS.  Job aids and tip sheets are available and included in the module to assist the user.  We strongly encourage study teams to review the training module prior to completing the SIP console. Recruitment Innovation Center (RIC) staff will be available to support study teams with writing and reviewing study information to ensure appropriate formatting on the Duke TIPs.

  • Course Title:  OnCore Training:  Using the SIP Console
  • Course ID:  DOCR-ONCR-240
  • Offering ID:  00129901
  • Course Description:  Develop an understanding of the SIP Console in OnCore

Register for the Course

 

This e-learning course will help study team members gain confidence in using the SIP Console in OnCore and will also provide a basic understanding of the importance of incorporating language into research documents that ease public understanding of research studies.

If you have questions about posting studies or preparing language that is easy to understand, please contact the RIC at studyrecruitment@duke.edu or 919-681-5698.  If you have questions about the SIP training module, please contact DOCR-Training@duke.edu.

 

Clinical Research Competency Updates

Several Duke staff who participate in the WE-R initiative are members of the Joint Task Force (JTF) for Clinical Trial Competency.  The JTF, comprised of clinical research professionals from around the world, has worked to identify and define the skills required for clinical research professionals. The JTF met earlier this month and have posted several updates to the website's blog, as well as three new publications.

Learn more about Joint Task Force for Clinical Trial Competency Initiative.

Learn more about the MRCT Center's involvement with the Joint Task Force for Clinical Trial Competency.

 

The Office of Regulatory Affairs and Quality is Now Offering Training on IND and IDE Sponsor and Investigator Requirements in LMS

This training is available to anyone at Duke University who is interested in learning about sponsor and investigator requirements. The training takes approximately 1 hour to complete and is available in the Duke Learning Management System (LMS).

This training is required for all Duke Faculty who will hold an IND or IDE. However, sponsors previously trained by ORAQ will not be required to retake this training.

To learn more about access and registration for these training modules, please see the ORAQ website, or contact ORAQ directly at ORAQ@duke.edu.

 

Privacy

While there is always a need to understand your role with regard to protecting information assets with security controls and awareness, remember, it’s equally important to always ask the privacy questions up front.  Checking what you have and why, and do you still need it, and if not, properly destroy/dispose of it is good practice all around.  This serves to minimize what needs to be protected with IT controls and cyber awareness.  For more Privacy information visit https://oarc.duke.edu/privacy.

 

Project Baseline

The New York Times recently published an article about Project Baseline, highlighting Duke’s role in the groundbreaking clinical research study that Duke CTSI manages in Durham and Kannapolis.

 

MURDOCK Study

The MURDOCK Study and one of its nested subcohorts ­— Physical Performance Across the Lifespan, or PALS — were featured in the Charlotte Observer recently. The article includes study updates and interviews with Dr. Kristin Newby, principal investigator for the MURDOCK Study, and Dr. Miriam Morey, principal investigator for PALS, as well as quotes from participants and a short video taken at the Duke CTSI office in Kannapolis. 

 


DOCR News

 

Maestro Care Upgrade Training Toolkits Available

The Maestro Care upgrade was conducted on October 14th.  To assist the end users, Maestro Care Upgrade Training Toolkits can be found on the DOCR website.

Click here then go to System Updates to access the training toolkits.  Direct all questions and concerns to docr.help@dm.duke.edu

 

MC 100 Online Course Updated

The MC 100 online course has been updated!  Look for improved functionality as a result of this update.

New Course Title:  MC Clinical Research 100 E-Learning Module

ID:  DOCR-MC-480

Offering ID:  00129623

Contact DOCR-training@duke.edu with questions.

 

Ask the Experts:  Research Wednesdays November 14th

Do you have questions regarding clinical research at Duke or research workflows?  The Duke Office of Clinical Research is hosting an “Ask the Experts” session on November 14th from 1:10 PM – 2:00 PM in Duke North Hospital Lecture Room 2002.  Submit your questions prior to the event so we can make sure to have appropriate experts on hand to field your queries!

 

iRIS Office Hours Available

The Duke Office of Clinical Research will host Office Hours twice per month beginning in December.  Instructors will be available to assist end users with general questions regarding using the iRIS system to submit protocols to the DUHS IRB.  Please bring a laptop if possible and bring your protocol specific questions to the sessions.

Dates and locations for December are:

December 10, 11 AM – Noon, DMP2W93
December 17, 11 AM – Noon, DMP2W91

 

Clinical Research Appreciation Event Featured in Working@Duke

The 2018 Clinical Research Appreciation Event held in the Trent Semans Center Great Hall was a great success!  The event celebrated clinical research at Duke and connected Clinical Research resources and services with the research community and study teams who use them.  The event was also written up in Working at Duke and posted on the Working@Duke Facebook Page.  Be sure to read and like the article on Working@Duke! 

 


Did You Know?

 

 

A REDCap Project Can Be Built Offline Using the Data Dictionary?

The Data Dictionary is a specifically formatted CSV (comma delimited) file within which you may construct your project fields and afterward upload the file to commit the changes to your project.

In the Data Dictionary, new data collection instruments/surveys can be created or existing ones can be edited.  Using the Data Dictionary file may be more helpful if you will be adding a large number of fields for this project. View a 10-minute video about using the Data Dictionary here.

DOCR offers a REDCap:  Building in the Data Dictionary class.  You can register for the upcoming class in January here.

 


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

Detailed information about each offering and direct links to the offering are also available on the DOCR Course Listing.

 


Clinical Research Employee Highlights

 

  • The School of Nursing CRU welcomes Rita Masese, MBChB, MSc as a CRC.
  • The School of Nursing CRU welcomes Jacqueline Brown, MHA, MSL as a RPL.
  • The School of Nursing CRU welcomes Angel Garcia Aristi as a Clinical Research Specialist, Sr.
  • The Derm/Path CRU is pleased to welcome Olivia Kohrman, CRC Tier 2, to our group starting this month. 
  • The Duke Center for Onco-Primary Care would like to congratulate Renee Avecilla for obtaining her CCRP certification through SOCRA.

 

 


Partner Resources

 

 

DUHS Compliance Office Newsletter

Catch up on news from the DUHS Compliance Quarterly Newsletter.

Subscribe to the Clinical and Translational Science Institute (CTSI) Bi-Weekly Newsletter

Stay up to date on news, funding, and education opportunities in translational science at Duke by subscribing to CTSI UPDATES. Read past newsletters and subscribe at https://www.ctsi.duke.edu/news/newsletters.

 

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.