Reminder of NIH’s New Policy on Access to GSR
In November, 2018, the NIH announced revisions to its policy regarding data management procedures for GDS (Genomic Data Sharing). The revisions allow unrestricted access to GSR (Genomic Summary Results, previously referred to as ‘aggregate genomic data’) from most NIH-supported studies for health or research purposes. This includes dbGAP and other databases managed by NIH. The purpose of this change is to allow broader access to these databases in order to promote public benefit from the federal investment in genomics research.
While providing broader access, the NIH also acknowledges that it is possible that privacy risks related to broad access to GSR may be heightened for study populations from isolated geographic regions or with rare traits. For this reason, NIH has requested that investigators notify the NIH if databases with sensitive information should maintain controlled access. Please click the link below for instructions on how to submit this notice to NIH.
The deadline for notification is May 1, 2019. After that date, GSR may be provided through unrestricted access.
Please go to this link for complete information and instructions: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-023.html
Please contact Duke ORA for assistance with signatures on Institutional Certifications, per the current process.
FDA Form 1571 Instructions Updated
The U.S. Food and Drug Administration (FDA) recently released an update to the Form FDA 1571 instructions. This update further clarifies when Research or Commercial IND should be selected for Field 6B: IND Type and thus, when eCTD requirements will apply.
The instructions for Form FDA 1571 previously stated:
“Select Research IND if the product under investigation is not intended to be commercialized at a later date. Research INDs are generally sponsored by individual investigators, academic institutions and non-profit entities. May include INDs for emergency use and expanded access. (21 CFR 312.305 and 312.310)”
The Form instructions now include the following additional information regarding selection of the proper type of IND:
“When a sponsor that generally submits Research INDs, then submits either a Phase 2 or Phase 3 protocol, they should select “Commercial” (eCTD requirements will apply). However, when the sponsor believes the Phase 2 or Phase 3 protocol is still solely for research, the sponsor may submit a justification explaining their rationale in the cover letter, along with the protocol. If the FDA agrees, then the IND will remain a “Research” IND and the eCTD requirements will not apply. Note that in all cases, expanded access INDs and protocols should be marked as “Research” on the Form 1571 and are exempt from eCTD requirements.”
For more information, please visit the following resources:
- FDA Forms webpage
- Electronic Common Technical Document (eCTD)
- Expanded Access: Information for Industry
Recruitment and Engagement Policy Roll Out Schedule
The Recruitment and Engagement Policy Roll Out Schedule has been finalized. Thanks to all CRUs who responded and requested to participate in the various phases. Phased roll outs will occur as follows:
- Radiology and Ophthalmology
- Anesthesiology, Medicine, CTSI and Heart Center
- OB-GYN, Psychiatry, Family Medicine and Community Health (FMCH) and DHVI
- All remaining CRUs: DCRI, Dermatology/Pathology, Duke Early Phase Clinical Research Unit, Neurology, Neurosurgery, Oncology, Orthopaedic Surgery, Pediatrics, Population Health Sciences, School of Nursing, Surgery
Training on the new policy is required prior to submitting amendments to recruitment plans using these expanded recruitment options.
Training may be taken at any time and is available in the LMS at https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=dowbt000000000038365.
As you draft updated recruitment plans, remember that Maestro Care tools are available to assist with your research recruitment needs. These tools include the following:
- Custom reports to identify patients that meet your inclusion/exclusion criteria
- Custom columns for the patient schedule or patient list that display information about your study
- A Page, E-mail, and a Maestro Care In Basket Message to notify you of potential participants
- Direct contact with potential patients through MyChart Research Invitations (contact the Recruitment Innovation Center at firstname.lastname@example.org for assistance with drafting patient-facing language)
- Possibility of using a provider facing Research Recruitment Alert (Best Practice Alert – BPA).
For more details on any of these Maestro Care research recruitment and study conduct tools or to request someone talk with you about a specific project, please follow this link:
The Duke Clinical Trials Directory is Live
The Duke Clinical Trials Directory is live and getting more and more external views every day.
If you would like to have your study posted on the Directory, please follow the guidelines in the Study Information Portal (SIP) Training Module and Tip Sheets for adding content, then send an email to email@example.com with the PRO# to have the content reviewed and approved. A couple of things to note:
The Short Title is what appears in the Directory and should include 3-5 words that describe the study, not just the study ID, Sponsor or codes. For example:
- ABC123 (Metastatic HER2+ Breast Cancer)
- Pfizer XYZ456 (Stroke Prevention in AFib)
- INSPIRE Study (Vaccines for Infants and Toddlers)
- SMOKE (Smoking Cessation for Adolescents)
- COG12345 (drug’mib in Pediatric Sarcoma)
Updating the short title in OnCore does not require IRB approval or a return to iRIS – simply use the “update” function on the PC Console – Main page.
The Recruitment Innovation Center (RIC) has additional tools to help you complete your SIP content and is happy to provide presentations and other resources to your study teams and groups as needed.
New Reporting Tool Within Maestro Care: Slicer Dicer
SlicerDicer is a self-service cohort building tool within Maestro Care where study teams can see counts of patient populations. Study teams that have an approved Review Preparatory to Research (RPR) or an approved protocol with the DUHS IRB can view potential participants’ PHI for research purposes.
The SlicerDicer tooI is currently available to clinical providers and it will be rolled out to research users in a phased approach. It is already accessible to all CRCs with the Non-licensed Clinical Research Coordinator security template in Maestro Care. CRNCs with the Licensed Research Coordinator or ONCBCN Research security template will soon have access to the tool as well. Other research roles will have the opportunity to receive access as appropriate.
To see if you have SlicerDicer access, use the Chart Search box.
Here are links to useful SlicerDicer instructions
In addition, DOCR will host SlicerDicer office hours on Thursdays at 1:00 PM. Attend in person, Erwin Square Conference Room 1038 or join via WebEx using this link: Join WebEx Meeting
- Thursday, May 2, 1:00 PM – 2:00 PM
- Thursday, May 9, 1:00 PM – 2:00 PM
- Thursday, May 16, 1:00 PM – 2:00 PM
- Thursday, May 23, 1:00 PM – 2:00 PM
- Thursday, May 30, 1:00 PM – 2:00 PM
Find Funding with myRESEARCHhome
The Funding Opportunities widget is now available in myRESEARCHhome. This new tool recommends relevant internal and external funding opportunities based on your research profile. Opportunities can be sorted with filters, saved or removed with relevancy feedback, and shared with others. Recommendations are updated in real time as new funding cycles open. Experience the new widget and all myRESEARCHhome has to offer at mrh.duke.edu.
A Family-Centered Self-Management Program for Children with Sickle Cell Disease
The Darryl Smith and Gail Aiken Interdisciplinary Sickle Cell Colloquia will host a talk on: A Family-Centered Self-Management Program for Children with Sickle Cell Disease
Speaker: Shannon Phillips, PhD, RN, Assistant Professor College of Nursing Medical University of South Carolina
Thursday, May 2, 2019
4:00 PM -5:00 PM
Duke University School of Nursing, Room 1009
Registration is not required, so please join us
Research Town Hall: International Collaborations at Duke
Please join us for a Research Town Hall on May 6, 2:00 – 3:30 PM, in Trent Semans - Great Hall and be part of a discussion on developing, sustaining and managing international collaborations at Duke.
You can RSVP at the link.
The event is also posted on the Duke Events Calendar.
The Duke Research Town Hall Series is a recurring, engaging series developed to reinforce a strong research culture at Duke University. Monthly sessions will feature research best practices, research tools, and new research initiatives. If you have suggested topics, please contact the Duke Office of Scientific Integrity at firstname.lastname@example.org.
CTSI Grand Rounds: Duke Early Phase Clinical Research Unit (DEPRU)
Thursday, May 16th from 12:00 PM - 1:00 PM
Join the meeting via WebEx.
Please join us for the CTSI Virtual Grand Rounds on the Duke Early Phase Clinical Research Unit (DEPRU).
The Duke Clinical and Translational Science Institute (CTSI) Virtual Grand Rounds will be hosted and moderated by Dr. Ebony Boulware, Director of the CTSI, Vice Dean for Translational Sciences, and Associate Vice Chancellor for Translational Research.
REACH Equity Colloquium
The 2019 REACH Equity Colloquium, Understanding and Mitigating the Effects of Implicit Bias in Healthcare, will take place Friday, May 3, 2019, 8:30 AM – 3:00 PM, Great Hall, Trent Semans Center. For a list of speakers and to register: https://sites.duke.edu/reachequity/events-education/2019-colloquium/
Clinical Research Training Program Accepting Applications
The Clinical Research Training Program (CRTP) of the Duke University School of Medicine / Biostatistics and Bioinformatics Department provides academic training in the quantitative and methodological principles of clinical research. CRTP is designed primarily for faculty, fellows, and other health professionals. The program offers formal courses in research design, research management, medical genetics, comparative effectiveness, translational methodologies, and statistical analysis.
A degree option in the program leads to a Master of Health Sciences in Clinical Research, a professional degree awarded by the School of Medicine. An advanced degree in a clinical health science (or two years of medical school) from an accredited institution is a prerequisite for admission either as a degree candidate or as a non-degree participant. In addition, CRTP offers non-degree and certificate options for individuals interested in taking one or more courses.
The program is now accepting applications for the academic year 2019-2020. 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.mc.duke.edu. The application deadline for priority review is May 15, 2019. Applications will be accepted through August 1, 2019. On-line registration for fall term courses begin on July 8, and classes begin on August 26.
Summer Scholarly Writing Retreat
The Faculty Write Program is pleased to offer the 7th annual Summer Scholarly Writing Retreat, May 20 – 23, 9:00 AM – 5:00 PM, King’s Daughters Inn in Durham, NC. The retreat provides an immersive experience and includes time for writing, workshops on writing and project planning, and opportunities for feedback on works-in-progress. In workshops, writers learn powerful practices that can help them to incorporate their role as a writer among their many commitments. Each day includes both hands-on workshops and time to write independently in a comfortable, relaxed space. Learn practical skills about productive writing habits, make progress on a writing project, and participate in a writing community. Breakfast and lunch are provided. Space is limited to 25 participants. Cost: $250.
Learn more about faculty experiences in the summer retreat in the Duke News article At summer retreat, faculty brush up on their writing and faculty testimonials here. Questions? Contact email@example.com. Facilitators: Monique Dufour and Jennifer Ahern-Dodson
Registrations will be accepted through May 8 or until the retreat is full. To register, please complete this form and submit with payment (payment options are listed on form): 2019 Scholarly Writing Retreat.
CTSI Funding Opportunities Announced
Duke/NC State Translational Research Agreement (Deadline: May 2, 2019)
- Up to $25,000 per institution (Up to $50,000 total)
- Purpose: Develop inter-institutional collaborations for new investigator teams conducting novel clinical and translational research that applies or accelerates discovery into testing in clinical or population settings.
- More information and application details
CTSI Translational Accelerator Funding Agreements (Deadline: September 5, 2019)
- Up to $150,000
- Purpose: Support for cross-disciplinary scientific research addressing the development of therapies diagnostics, or devices applicable to human disease, clinical research trials (excluding Phase 2 and beyond), epidemiological studies, and/or community-based research.
- More information and application details
CTSI Transformative Funding Agreements (Deadline: September 5, 2019)
- Up to $500,000
- Purpose: Supporting the development of mature research with the potential to attract significant interest for external partnering, thus enabling and accelerating translation of research out of the academic environment.
- More information and application details
iRIS/OnCore Office Hours Available
The Duke Office of Clinical Research hosts iRIS/OnCore Office Hours twice per month. Instructors are available to assist end users with general questions regarding using the iRIS system to submit protocols to the DUHS IRB and use of the OnCore System. Please bring a laptop if possible along with your protocol specific questions to the sessions.
Dates and locations for May and June are:
- May 6, 11 AM – Noon, DMP 2W91
- May 20, 11 AM – Noon, DMP 2W91
- June 10, 11 AM – Noon, DMP 2W91
- June 17, 10:30 AM – 11:30 AM, DMP2W93
Do you perform Phlebotomy or Urine Pregnancy Screening for Research?
Phlebotomy Competency for Research (for first-time trainees) or Phlebotomy RENEWAL Competency for Research (for training subsequent to Phlebotomy Competency for Research) and Urine Pregnancy Screening for Research are annual training requirements for anyone who performs these procedures for research purposes and does not have credentials or a license that covers such procedures (i.e. Registered Nurse, Medical Technologist, Certified Phlebotomist, MD, PA, etc.). Log in to your Completed Learning in the Duke Learning Management System (LMS) to confirm that you have had the required training within the last calendar year. Both Phlebotomy for Research and Urine Pregnancy Screening are required courses with annual renewals.
Please use the following steps to check your training in LMS:
- Log into the LMS (https://lms.duhs.duke.edu/Saba/Web/Cloud)
- Select View Completed Learning
- Use a From search date that is one year prior to the current date and the set To date as the current date
- Select Search
- Review your transcript to ensure that you have had the applicable training within the last calendar year – Phlebotomy Competency for Research – DOCR, Phlebotomy RENEWAL Competency for Research – DOCR, and/or Urine Pregnancy Screening for Research – DOCR.
- Register yourself for any training that you may need to return to a compliant status.
If you need assistance checking your LMS transcript or registering for DOCR courses please do not hesitate to contact us at DOCR-Training@dm.duke.edu.
Email Address Change for eConsent in REDCap
If you are using eConsent in REDCap and have configured your project to automatically email a copy of the signed eConsent to the HIM group, please update your REDCap project to email to the following staff:
The email address has changed to send a PDF copy of the consent form from REDCap to the HIM group. Do not send PDFs to ROIfirstname.lastname@example.org.
Additional changes to the eConsent process will be coming soon. Contact us at email@example.com with any questions.
Role Transitions for Terry Ainsworth and Catee Mullen
Terry Ainsworth has transitioned to part-time retirement. Terry’s wealth of knowledge served both DOCR the clinical research community. Terry’s last day as a full time employee was Friday, April 12th. She returned on Monday, April 15th as a part-time (19 hours/week) staffer.
Catee Mullen started her new position as Director, Research Operations Monday, April 1st. In her new role, Catee serves as the single product manager of OnCore, leading both the operations and financials side, along with managing clinical research related support in start-up, conduct and closeout. Catee continues to be involved with SOMF clinical research finance activities until her replacement is in place.
How to Add Users to a REDCap Project
Do you need to request user rights for someone to access your REDCap project?
The link to request user rights is located on the main REDCap page. Once on the page, scroll down to the User Rights section and click on the link:
The link can also be accessed in your project.
On the left side under applications, click on the New User Rights/ Roles Request link:
Remember, an individual cannot request user rights to a project for themselves. Someone on the project needs to submit the request on their behalf.
Using Branching Logic in a Matrix Field
Branching logic can also be used in a matrix field. Even with in a matrix group, certain variables can be displayed/hidden based on specific selection(s) in other questions.
Branching logic in a matrix field is set up the same way branching is set up for other fields: select the Branching Logic button and then select the desired branching logic.
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.
The Department of Medicine CRU welcomes the following new employees:
- Amy Franklin, Sr. Regulatory Coordinator, DOM CRU
- Amir Hakim, CRC for Aging Center
- Usha Kadiyala, CRC for ID
- Matthew Kummerer, CRC for Pulmonary
- Catherine Kilday, CRC for Pulmonary
- Antoinette Santoro, CRC Sr. for Pulmonary
- Kay Johnson, CRS, Sr. for GI - NAFLD Research Program
- Magdi Elgasim, CRC for GI - NAFLD Research Program
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 firstname.lastname@example.org.