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Problems or Events that Require Prompt Reporting to the IRB Online Module Now Available
In response to audit findings regarding unreported study events to the DUHS IRB, the School of Medicine has developed an online training: Prompt Reporting to the IRB WBT - DOCR.
This 10 minute online module will walk you through protocol deviations and their counterparts protocol violations, adverse events and unanticipated problems, and the subsequent steps of reporting these events to the IRB.
By the end of this module, you will:
Recognize what constitutes a protocol deviation, violation, adverse event, and unanticipated problem
Recognize what events need to be reported to the IRB
Recall the reporting timeframe for these events
Attest to abiding by the policy requirements detailed in Problems or Events that Require Prompt Reporting to the IRB.
This module is required of all WE-R Clinical Research Professional job classifications.
If you are in a WE-R Clinical Research Professional job classification, you will be enrolled in this online course March 5th, 2020. When you have been enrolled, you will receive an email notification from the Duke LMS. To complete the course, click on the link provided in the email and launch the course from your In-Progress Learning.
Training must be complete by March 31st, 2020.
Reminder: CITI Single IRB (sIRB) Course Available to Duke Health CITI Users
Duke Health has acquired access to the CITI Single IRB (sIRB) Course for all Duke Health CITI users.
This course is a valuable resource for anyone working on a project involving an sIRB and is strongly recommended for anyone who is planning to request that Duke serve as the sIRB for their project. This course provides an overview of the use of Single IRBs in relation to the 2018 National Institutes of Health (NIH) policy requiring sIRB review for most human subjects research it conducts or supports, which significantly expanded the number of studies requiring sIRB review and anticipated.
For those interested in taking the sIRB module in CITI:
- Go to the CITI Program website: https://www.citiprogram.org
- Login to CITI correctly using the blue Log In button in the top right corner of the screen
- Select Log In Through My Institution
- Scroll to select Duke Health as your Institution
- Shibboleth authenticate with your NetID and password
Logging in via these steps will ensure that you will be able to access the sIRB training through your Duke Health CITI account.
To add the new course to your learning:
- Go to Institutional Courses
- Select the View Courses button next to Duke Health
- Scroll to the bottom of the page
- Under Learner Tools for Duke Health, select Add a Course
- Select Single IRB, then Next
This will add the course to your list of available CITI courses.
For additional information about the CITI Single IRB (sIRB) Course, visit https://about.citiprogram.org/en/blog/getting-ready-for-the-common-rule-single-irb-requirement/.
Additional information on how the sIRB Process has been implemented at Duke was conveyed during the February 12th Research Wednesdays session “The DUHS IRB in 2020.” Presenters Jody Power, Sharon Ellison, and Joe Austin updated the research community on the sIRB process for the SOM/SON:
As a follow-up to this session, a second set of slides has been posted to the DOCR Research Wednesdays website outlining the sIRB Process for DCRI. The difference in the sIRB process for DCRI is the need for a separate coordinating center protocol for DCRI since their operations are so large.
Optimize Your CITI Account for Training Success
You have the power to optimize your CITI account for training success!
Did you know that you have the power to update your CITI member information? Did you know that within the CITI program there are user tools that apply to all subscriber members to help you navigate your account? Did you know that you could set yourself up for success in CITI by knowing a few simple tips?
- What is CITI and why are we required to take CITI training?
The Collaborative Institutional Training Initiative (CITI) is web-based training for research with content developed by a national consortium of subject matter experts. Many institutions use CITI for their mandatory research training including Duke Health and Duke Campus.
You can find CITI training requirements in the policy Collaborative Institutional Training Initiative (CITI) Requirements for Duke Health Human Subjects Protection (HSP). The policy is easily accessible from the DOCR website at https://medschool.duke.edu/research/clinical-and-translational-research/duke-office-clinical-research/docr-policies-and-procedures
Duke Health CITI course requirements are:
- Basic Biomedical Research with GCP- a course consisting of multiple modules related to human research and Good Clinical Practices
- Vulnerable Subjects Research with Children
- Vulnerable Subjects Research with Prisoners
- Vulnerable Subjects Research with Pregnant Women, Fetuses, and Neonates
These modules are required for all Duke Researchers unless you meet one of the exceptions listed in the policy.
- Why is my CITI training not up to date in iRIS?
The iRIS application cannot recognize your CITI training information when your Net ID is NOT entered in a specific format. Without your updated information, iRIS will generate a “Training Validations Error” for you as KP on the study. This may cause your protocols to be delayed and your information must be entered manually.
- Log into CITI https://support.citiprogram.org
- Click the arrow next to your name
- Select Profiles
- Go to the field Email Address and enter the address in this format NetID@duke.edu
- How do I log into my CITI account?
If you have a Duke Net ID and password, logging into CITI is through Single Sign On (SSO). You do not need to log in through the CITI membership log in with your membership Username and Password.
- Go to: https://about.citiprogram.org/en/homepage/
- Click the link Log In Through My Institution
- Choose Duke Health from the Institutions List
- Enter your Net ID and Password
Please keep in mind that if you already have an account in CITI, you do not need to register again. As a Duke employee, use SSO.
Registering for another account creates what we call “Duplicate Accounts”.
- What are Duplicate CITI account?
Duplicate accounts occur when an existing member in CITI registers again under the same institution.
Each new registration results in a new membership number. Each account contains the training tied to that account.
Duplicate accounts often are the culprit when we see the following situations:
- I do not see all my training and I know I completed it?
- I am showing up on the delinquent training report and I took the course
- Variations of the same name show up for the same person (Mike Price, Mike E. Price, and Mike E Price, Jr) and the member information such as email address, DUID, net ID are the same.
Your accounts will need to be merged working with the CITI. DOCR CITI Administrators work with CITI to make sure all information is under one member account. Would you believe the record thus far is 12 different member numbers for one Duke member?
- How long will it take to complete the Duke Health CITI Courses?
The time it takes to complete your modules will vary from person to person. Most modules take about 10-20 minutes to complete according to CITI. You can exit and return where you left off at any time and with no restriction.
- When the need for additional help arises, whom should I contact?
DOCR is here to help you when there are questions about your Duke Health requirements. Please contact us for any issue related to Training errors or iRIS training issues. You may contact us at firstname.lastname@example.org, which will generate a Service-Now ticket, or you may enter a ticket directly at https://duke.service-now.com. Information is also available on the docr website under the CITI icon.
You may also contact CITI regarding issues regarding membership and specifics regarding the CITI program as an application. The Support link is available from your CITI screens.
As researchers at Duke Health, remember CITI training is required. There are things you can do to make this process easier for you and for the many staff members charged to administrate and assist you. Look for more CITI information to optimize your CITI knowledge in the next CR Update. You have the power to optimize your CITI account for success!
Maestro Care: Storyboard and Widescreen
The February 19th, 2020, Maestro Care upgrades included the new Storyboard functionality and widescreen view. You have probably already noticed that patient Maestro Care records have a different appearance as a result of these changes. For now, users are able to toggle Storyboard and Widescreen on and off. Although you can turn them off to revert to the way you are accustomed to seeing the screen, we would appreciate it if you would work with both settings toggled on to get used to the new appearance and to provide us with feedback regarding how well they work for you or if any of your normal functions appear to be missing. As of March 17th, the user’s ability to turn Storyboard off will end. If you have any questions or if functions appear to be missing please let us know.
Here is a link to instructions for turning Storyboard and Widescreen on and off:
OASIS Central Intake Mechanism
As we continue to build the research engagement capabilities within OASIS, we have discovered that a key component of creating a more effective and efficient process for IT related requests is a central intake mechanism. In today’s world, requests may be received by a number of different SOM/DHTS administrative support groups (ORA, ORC, ISO, DOCR, OASIS, etc.) and asking researchers to navigate across the groups or understand what information is critical to processing the requests has proved challenging. Therefore, we have decided that the creation of an intake form is a logical first step. The form will provide multiple benefits:
- Standard level of data collected regarding the request
- Single source of transparency across all requests
- Ability of all administrative departments involved to direct requests to universal starting point
Upon receipt of the completed form, a cross-departmental team will work with the requestor to triage and gather all necessary information and prepare the request for next steps (DHTS Demand, Contract Execution, Security Review, etc.)
Research Quality Management Program
The Research Quality Management Program is being implemented to promote best practices in research quality, data management, and accountability. Each Department/Center/Institute within Duke SOM has designated a Research Quality Team, comprised of a faculty Research Quality Officer and Lead Research Administrator within the unit. The program’s next milestone is June 30th. Each research faculty and research staff member will attest to the unit level Science Culture and Accountability Plan (SCAP). Reach out to the DOSI team at email@example.com with questions about the program or your unit’s Research Quality Team.
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.
OnCore Disease Category and the DUHS Clinical Trial Directory Page
The non-oncology disease categories for the Clinical Trials Directory on the DukeHealth website have been updated as follows. An oncology/non-oncology filter is slated to go live at the end of April.
For non-oncology studies, the category is selected under the Disease/Diagnosis section of the Treatment tab in OnCore. The RIC will update categories for all currently listed studies.
iRIS Update: CRU Reviewer Quick Guide
The iRIS CRU Reviewer Quick Guide has been updated.
This tip sheet describes the general process by which protocols are processed through Clinical Research Unit (CRU) Review in iRIS including:
- How to locate submissions
- How to assign an analyst/reviewers
- How to review
- How to complete the reviewer checklist
- How to see comments from all reviewers
- How to create a modification request/send mods to the study team
- How to review mods once study team has responded
- How the director completes final sign-off and either returns to the analyst or forwards to the IRB
Note that the process and order that a CRU uses to review protocols may vary from what is outlined in the tip sheet.
iRIS: Previously Created Initial Review and Amendment Forms Preventing Submissions
We have identified a system bug that we are vigorously working with the vendor to resolve. During the implementation of the Restriction to One Protocol Application feature in the latest Summer Release installation, it has been identified that draft Amendments and Initial Submission Packets are disallowing the creation of new forms where the application attachment is available (i.e.: Amendments, Protocol Application). The ability for users to delete certain draft forms has also been restricted and will require study teams to follow specific steps.
Users may receive an error when attempting to generate new Amendment forms. When this occurs, please do the following:
- Find the draft form in question by navigating to DUHS IRB Amendment Form > Identify the draft form> Select the box to far left> Delete Selected Form(s) in the top right corner of your screen.
- If you receive an error stating that the form cannot be deleted, STOP and submit a ServiceNow ticket, which can be accessed directly from the Help Icon within iRIS. (Note: Please always submit the protocol number and intended submission form) Once received, the iRIS technical team will submit the reported protocol to iMedRIS for clean-up.
iRIS Training Validation Error Update
Since the recent upgrade to the Summer Release of iRIS on January 17th, 2020, we have become aware of a system bug regarding training validations in iRIS. In the past, study teams have been able to easily identify specific individuals with non-compliant training. Since the latest release, the ability to quickly and easily identify specific training validation errors has been displaced.
While we continue to await a resolution from the vendor, study teams are encouraged to ensure that all study team members have compliant CITI training before adding them to studies. If training concerns are identified, please submit a Service Now ticket. Additionally, if you should encounter a training validation error during the submission of your protocol, please submit a Service Now ticket for immediate assistance where the iRIS team will identify each impacted user.
iRIS Tips and Tricks: Consent and Other Protocol Documents
We have received several reports concerning formatting issues within Consents and Other Protocol Documents. As a helpful tip, we recommend reducing the copy and paste functionality from outside websites into documents that will be uploaded into iRIS. Should you require the need to copy and paste images and other text, the recommendation is to copy and paste the content into the Notepad application, which will strip the metadata that causes the formatting issues when converted to PDF’s within iRIS.
iRIS Tip: How to Print Current Key Personnel
Often times study teams require the ability to print the current study personnel. Follow these steps to locate a print friendly option:
- Open your protocol from the All Protocol submissions panel
- Navigate to Protocol Management
- Select Protocol Summary/Profile- This page displays pertinent information regarding the study, including a comprehensive list of all current key personnel.
- Select the Print Friendly button located in the top right corner of the page and print.
Research Professionals Network: Introduction to Crucial Conversations
Thursday, March 5, 2020 at 1:00-2:00PM in Trent Semans Great Hall
This session will focus on an overview of the Crucial Conversations class that is offered through Duke’s Learning and Organization Development. We all face tense situations where saying the right thing is crucial. Whether you are approaching a supervisor who is breaking his or her own policies, critiquing a colleague’s work, or talking to a team member who isn’t keeping commitments, keeping the conversation productive can be very difficult. During this session, we will review some difficult situations that we encounter in research and discuss how to address them using some key elements of crucial conversations.
Speaker: Don Shortslef from Duke Human Resources
Light refreshments will be provided. Please use this link to register.
Clinical Trial Retention
Did you know that the average dropout rate across clinical trials is 30 percent!?1
Take a look at your study-how do your retention rates compare? Even though there has been an upward swing in recruitment, the benefits of participating in research studies has not translated to into the ability to retain patients.2
What are some reasons that these dropout rates are continuing to plague clinical trials?
- Inconvenient times or places
- Overwhelming number of visits
- Hard-to-understand informed consents which can lead to unclear expectations
- Lack of appreciation shown to participants (namely not calling them “Subjects!”)
- Fear and anxiety
- Mistrust in research
What can the RIC do to help you minimize your dropout rates?
- Create a patient-centered protocol design
- Present your study and study documents to our Patient Advisory Board (Comprised of solely Duke patients)
- Show you ways to give back to your patients and make them feel valued
- Offer 1:1 tailored training for new Duke Study Coordinators to teach better consenting practices
2 Ramsey, L. (2020). Recruitment Rates Rising, but Retention Rates Fall, According to New Study. Center Watch: https://www.centerwatch.com/articles/24543-recruitment-rates-rising-but-retention-rates-fall-according-to-new-study?utm_campaign=CWWeekly&utm_source=hs_email&utm_medium=email&utm_content=82772868&_hsenc=p2ANqtz-8S46M_p5aZzkJKmcm0BDckbgQ8BGcBYZc3lTeEWpFejh
REDCap: Downloading an Annotated PDF of the Data Dictionary Codebook
Did you know that you can now download an annotated PDF of the Data Dictionary Codebook?
Sample Annotated PDF:
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:
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.
We have successfully completed the Tier Advancement cycle effective March 2020! 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.
- Anthony DeVito from Psychiatry
- Bobbi Burwell from Psychiatry
- Bria Johnston from Surgery
- Brittany McDowell from Medicine
- Cara Mariani from OB/GYN
- Ebony Burns from School of Nursing
- Emily Maxfield from Oncology
- Emmalee Metzler from Anesthesiology
- Grace Jefferson from Pediatrics
- Jenna Goodwin from Oncology
- Jennifer Peters from Biomedical Engineering
- Jeryl Lockley from Surgery
- Jessica Shier from Medicine
- Jessica Summers from Psychiatry
- Lauren Bohannon from Oncology
- Lauren McGowan from Surgery
- Marco Reyes Martinez from Oncology
- Mark Ellison from Surgery
- Meagan Lew from Oncology
- Mitzi May from Oncology
- Nader Abraham from Surgery
- Nicole Pavlus from Medicine
- Stephanie Thera from Pediatrics
- Sydney Crane from Pediatrics
- Tiffani Reeves from Surgery
Congratulations are in order for the following Clinical Research Coordinators, Clinical Research Nurse Coordinators, and Regulatory Coordinators for their professional advancement to Tier 3.
- Dana Giangiacomo from Surgery
- Eli Morgan from Medicine
- Erin Arbuckle from Pediatrics
- Mary Atkinson from Surgery
- Mary Summers from Heart Center
- Megan Houpe from Oncology
- Nicole Walley from Pediatrics
- Omowunmi Olaleye from Anesthesiology
- Tamara Cannon from Anesthesiology
- Tyffany Coleman from Medicine
Congratulations are in order for the following Research Program Leaders for their professional advancement to Tier 2.
- Brian Small from Psychiatry
DUHS Compliance Office
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 firstname.lastname@example.org