Notice of Privacy Practices Updated
The Duke University Health System (DUHS) has revised language in the Notice of Privacy Practices (NPP). The updated NPP went live on March 1st.
The Notice of Privacy Practices describes how medical information about Duke patients may be used and disclosed. The NPP also explains how patients can get access to this information.
Since the NPP is for Duke patients, study teams do not need to distribute the NPP to non-Duke patients or to Healthy Volunteers who are enrolling in their studies (unless they are assigned a medical record number for visit activity). Patients will be notified about the NPP according to DUHS policy.
Recruitment and Engagement Policy Update
To align with the revised NPP, the Recruitment and Engagement Policy posted to the DUHS IRB website March 1st. The policy is being rolled out in phases to CRUs beginning in March. This policy will allow study teams to engage patients through contacts including, but not limited to portal messages, mobile health devices, telephone, electronic surveys at clinic visits or hospital admissions, or directly via one or more clinicians. Any of these methods may be used to engage patients in research related to their health, if approved by the DUHS Institutional Review Board (IRB). The DUHS IRB will, in its review, consider the appropriateness of the recruitment methods in regard to the target population and the research objectives.
Training on the new policy is required of all Internal Key Personnel prior to submitting amendments to recruitment plans using these expanded recruitment options. In March recruitment amendments using the expanded options may be submitted by study teams in Radiology and Ophthalmology CRUs. In April, recruitment amendments using the expanded options may be submitted by study teams in Anesthesiology, Medicine, CTSI and Heart Center CRUs.
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....
The Duke Office of Clinical Research will work with CRU Leadership to finalize all phases of training in the next several weeks. Information learned during the rollout will help the IRB and DOCR determine how many CRUs can be phased in during each month.
Maestro Care Inpatient Build: Behavior Concern FYI Flag
To ensure a safe and secure environment for our patients, families and caregivers, Duke University Health System has approved a new visual indicator to alert you to patients with a history of aggressive or disruptive behavior. The Behavior Concern FYI flag may serve as an indicator for a variety of situations including a patient visitor’s aggression; therefore, staff members and caregivers should consult with their manager or the appropriate Charge Nurse to review the details prior to patient interaction.
When a staff member or provider feels threatened by a patient’s or visitor’s behavior, they should alert their manager or the appropriate Charge Nurse. If appropriate, an Operations Administrator or a member of Risk Management will initiate a new patient flag.
Duke Expanded Clinical Trial Definition Indicator in SPS
On February 22nd, new functionality regarding the Duke expanded clinical trial definition was put into production in SPS.
From a high level, the new Duke expanded clinical trial definition indicator will be displayed if the following conditions are true:
- Human Subjects = Yes
- Research does not meet the NIH definition of a Clinical Trial
- Proposal Prime Sponsor type is ‘Commercial’ or if a Proposal Prime Sponsor does not exist, the Proposal Sponsor type is ‘Commercial’
Please see screenshot below. The question mark icon, next to the question response, will display the new expanded definition for reference.
If you have any questions regarding the new Duke Expanded Clinical Trial Definition please contact ORC_Industry_Contracts@dm.duke.edu
ClinCard and eGRC SSN Exception Requests
In July 2018, we announced that CRUs with a ClinCard SOP did not need to submit eGRC SSN Exceptions when using the ClinCard for study subject payments. Any CRU utilizing ClinCard must now have an SOP in place (https://duke.box.com/s/qpbv9jphem7chwqv6e6zggre1yyyy9ps). To streamline SSN submissions in the eGRC, the OARC Compliance Office will not process ClinCard SSN Exception submissions after March 1, 2019. Other forms of subject payments (checks, other types of cards, etc.) and SSN use for non-payment purposes must still be submitted to the eGRC. In addition, OARC will begin administratively closing ClinCard entries in the eGRC SSN exception tables.
For more information regarding participant payments, please refer to the Duke General Accounting Procedures (GAP): Processing Payments to Research Participants (https://finance.duke.edu/accounting/gap/m200-420) or contact School of Medicine Finance at SOMFClinicalResearch@duke.edu.
Need a MRN in Maestro Care?
To request Registration/Medical Record Number for “new to Duke” participants in Maestro Care, please contact HIM via email, HimdataIntegrity@dm.duke.edu, or calling, 919-684-5525. Please provide the following information:
- Phone Number
Voluntary Exit Survey
In an effort to better understand the reasons behind transitions of our clinical research staff who either transfer to another department or leave Duke, Workforce Engagement and Resilience (WE-R) has implemented a voluntary exit survey (effective January 1, 2019). We have since updated the original process; effective immediately, this survey will be centrally administered by WERemail@example.com.
Clinical research leadership will alert their departmental HR manager when a clinical research employee in one of the WE-R job classifications is planning to leave Duke or transfer within Duke to another position. This notification will prompt departmental HR to send an email to WERfirstname.lastname@example.org containing the following information: a) staff members’ name, b) unique Duke ID number (DUID), c) CRU, division, or department, d) Duke email address, and e) planned date of departure from existing position.
We plan to share aggregate information with CRU RPMs and departmental Business and HR managers once sufficient data has been collected.
Alert: Duke Box
Duke Health Information Security Office (ISO) cautions staff to use extreme caution when setting Box sharing permissions to “people with this link” which effectively makes the Box file or folder publicly accessible.
For additional information: https://techcrunch.com/2019/03/11/data-leak-box-accounts/
April Research Town Hall
Please join us for a Research Town Hall on April 10th from 1:00 PM -3:00 PM entitled “Caring for Your Data: Data Management Resources at Duke.” Come learn about data management resources at Duke to help care for your data throughout the data life cycle! You can RSVP at the link.
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 ASIST (ASIST@duke.edu).
Investigational New Drug Application (IND) Forms: Updates and Best Practices
The Duke Office of Regulatory Affairs and Quality (ORAQ) will be hosting a one-hour workshop on IND forms. Forms FDA 1571, 1572 and 3674 will be reviewed, all of which are required for initial IND submissions for investigational drug studies. Recent changes in these forms will be emphasized and best practices will be reviewed. Discussion will be encouraged. This workshop is recommended for regulatory coordinators, study coordinators and anyone else who may be involved in the preparation of forms for IND submissions to the FDA.
Speaker: Daniel Tonkin, PhD, RAC
Monday, April 15
3:00 PM - 4:00 PM
Duke Medical Pavilion Room 2W96
Registration is required. Register at https://medschool.duke.edu/research/research-support-offices/office-regulatory-affairs-and-quality/education-and-training-opportunties
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/
NCBiotech Announces the New Translational Research Grant (TRG) Program
DEADLINE: Wednesday, March 13th (Noon)
The TRG program funds projects that explore potential commercial applications or initiate the early commercial development of university-held life science inventions. The technology must have the potential to solve a real world problem as a commercial product in the life science sector.
The goals of the TRG program are:
- Transform basic research discoveries into product-focused translational research development
- Generate data that addresses important product development milestones, addresses the concerns of potential licensees or investors, or otherwise de-risks the technology for a specific commercial application
- Enable strategic “go/no-go” decision-making regarding further technology development and/or pursuit of intellectual property protection
- Enable technology licensing efforts by the university
- Establish goal-oriented partnerships between university scientists, product development professionals, and key stakeholders
Proposals will be evaluated on the composition of the project team, including a project manager, and the setting of relevant, realistic, and achievable milestones during the product development tasks. See the guidelines for details.
Up to $100,000 may be requested for the technical and business development activities; an additional $10,000 supplement is available to support a project manager if one is not available through the applicant institution.
Applicants must be researchers employed by North Carolina-based universities or nonprofit research institutes. Technical projects may be conducted at awardee institutions or outsourced to contract research organizations.
Details on program requirements and application instructions are provided in the program guidelines available at www.ncbiotech.org/trg.
New CTSI Funding Opportunity
Duke/NCCU Collaborative Translational Research Awards (Mandatory LOI due: March 26, 2019)
- Up to $25,000 per institution ($50,000 total)
- Purpose: Develop inter-institutional collaborative research projects between Duke and North Carolina Central University researchers.
- More information and application details
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.
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 along with your protocol specific questions to the sessions.
Dates and locations for January and February are:
- April 8, 11 AM – Noon, DMP 2W91
April 22, 11 AM – Noon, DMP 2W91
There is a new External Module (EM) that will force Google reCaptcha on your public survey url. The EM is called REDCaptcha. REDCaptcha only works if the first form is a survey. Note, if using a multi-arm project with multiple public survey urls all will be protected. Optionally, you can configure custom instructions and error message text on a per-project basis (or leave blank for defaults).
When a participant clicks on the generic link, the following will display before redirecting to them to the survey:
In some cases, they may see one or two additional prompts before being redirected them to the survey:
If your first survey is a public survey and you have a generic link posted on a website, you may want to consider enabling this EM. The EM is discoverable and can be enable on under the External Modules link on the left hand side of a project.
Please contact us at email@example.com with any questions.
Maestro Care for Research
The Maestro Care for Research policy outlines support for Maestro Care for research studies that includes account access, recruitment options, but it also provides information about printing electronic health records.
“When a user requests the ability to print from Maestro and/or send information to a sponsor: Duke’s electronic medical records system, Maestro Care, is the only valid source for clinical data required for studies. Printed records or data extracted from the EMR cannot be used as source records, as they do not represent the first place that information was recorded. For this reason, Duke does not send printed records to outside parties or sponsors. Temporary access to Maestro Care can be granted to sponsor representatives for monitoring purposes.
Printed EMR data may be used by the Duke study team for internal processes or purposes, but it is the responsibility of the study team to protect the confidentiality of the information.”
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 Neurology CRU would like to welcome Kelsey Ling (CRC), McKenzie Luxmore (CRNC), and Lisa Harrison (CRNC).
- The Heart Center Central Cluster welcomes Ben O’Brien who started working with us as a CRS, Sr, on February 4th, 2019.
We have successfully completed the Tier Advancement cycle effective March 2019! We are sincerely grateful for all of the effort that the clinical research community has put into this important initiative!
Congratulations are in order for the following Clinical Research Coordinators, Clinical Research Nurse Coordinators, and Regulatory Coordinators for their professional advancement to Tier 2.
- Jason Boyle from Anesthesiology
- Peter Waweru from Anesthesiology
- Tamara Cannon from Anesthesiology
- Carrie Nowak from Heart Center
- Mary Summers from Heart Center
- Kathleen Coles from Medicine
- Julie Counts from Medicine
- Noely Martinez Overby from Medicine
- Shannon Tilley from Medicine
- Karen White-Tong from Neurology
- Ashley Pifer from Neurology
- Francisco Cordero from Oncology
- Samayra Siddiqui from Pediatrics
- Charlotte Stoute from Psychiatry
- Vicky Gandhi from Psychiatry
Congratulations are in order for the following Clinical Research Coordinators, Clinical Research Nurse Coordinators, and Regulatory Coordinators for their professional advancement to Tier 3.
- Sarah Maichle from CTSI
- Kristin Byrne from Medicine
- Debra Davis from Oncology
- Mihaela Stefanescu from Pediatrics
- Karen Cornett from Pediatrics
Congratulations are in order for the following Research Program Leaders for their professional advancement to Tier 2.
- Holly Hough from DOCR
- Ted Snyderman from DOCR
DUHS Compliance Office Newsletter
Catch up on news from the DUHS Compliance Quarterly Newsletter.
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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.