october 2016 news for the research...
TRANSCRIPT
October 2016
News for the Research Community
Training Opportunities
Did You Know?
Clinical Research Employee Highlights
Partner Resources
News for the Research Community Annual DOCR Satisfaction Survey Results
The results of the annual DOCR satisfaction survey are available. The annual satisfaction survey polls the clinical research community regarding use, benefit, knowledge and courtesy of DOCR services and staff. These data are used in DOCR strategic planning to improve services to the research community in the future. This year’s survey was taken by a wide range of researchers in a variety of roles.
Who Responded to the Survey?
See what your colleagues had to say by reading the full survey results.
Congratulations to Elmer Balajonda, whose name was drawn as the winner of the iPad Mini for his participation in the survey!
Clinical Research Appreciation Day Tuesday, October 11th
The annual DOCR sponsored Clinical Research Appreciation Day will take place in the Trent Semans Center Great Hall. Highlights of the event include information tables from administrative offices and groups involved in clinical research at Duke, door prizes and great food. This event is a great way to network with others in the Clinical Research community, learn about groups and services available to clinical researchers, and be appreciated for the great work you do in clinical research at Duke. Please direct all questions and concerns to [email protected].
PC users: OPEN the attached iCalendar link to save the event to your Outlook calendar.
Mac users: a mac version is not available so mac users will need to add the date and time manually to your Outlook calendar.
UPDATED Maestro Care Clinical Research Billing Review Process (CRC) If You Work on Studies that Bill Through Maestro Care, Please Read!
A new Tip Sheet is posted on the wiki for the Clinical Research Review Billing Review Process. The updated process provides a step by step guide for CRC’s including generating the RSH005 report and performing the billing review activity. To further assist you, review and help sessions are available on Friday, Oct 7th and Oct 14th. Please consult the LMS for review session times. Walk-ins are welcome. The updated Tip sheet is available on the wiki
IRB Fees to Increase: Effective November 1, 2016
Effective November 1, 2016, IRB fees for the review of industry-sponsored protocols will increase to $2500 for initial review, $1000 for continuing review, and $750 for amendment review. The increase applies only to studies submitted in eIRB on or after November 1, 2016.
Fees are applied only to industry sponsored studies, and applied only to items that require full board review. No fees are charged for expedited or exempt IRB reviews. Please go to the IRB web site for more information regarding the planned fee increases:
https://irb.duhs.duke.edu/sites/irb.duhs.duke.edu/files/IRB%20Fees%209-30-2016.pdf
or
https://irb.duhs.duke.edu/about-us/fees
New Functionality in eIRB: Section 05 of IRB Application, Multi-Site Research
Study teams can now, at the time of their IRB Continuing Review, update any external (non-Duke) IRB approval documents that are located in Section 05 of their IRB application. At the time of Continuing Review, please upload any new or updated external IRB approvals, as applicable, and please edit the details in Section 05 accordingly. Talk with your IRB Specialist if you have questions.
IRB Updated Continuing Review Progress Report Template
The IRB has updated the continuing review progress report template. Please download the new template from the IRB website or from eIRB. All continuing reviews submitted beginning in November should use the new template. The primary change to the existing template end users will see is expanded instructions on how to add up total enrollment so that all enrollment numbers add up to equal total enrollment. Changes to the form are annotated in the document.
NIH Rules for Reporting Travel
New travel reporting requirements exist for all Duke faculty and staff who receive payments from a Public Health Service grant (NIH, CDC, AHRQ, Dept. of Defense, etc.). If you, your spouse (or spousal equivalent), or dependent children have sponsored travel paid by someone other
than Duke, you will need to report it to Duke. Travel paid by universities, medical centers, governments, and research institutes as sponsors does not need to be reported. Additionally, anything paid through Duke does not need to be reported. The federal government does require reporting of travel sponsored by foundations, professional societies, non-profits and for-profit companies. Sponsored travel may be reported at the following website: https://radapps.duke.edu/phs_travel. Questions should be directed to the Research Integrity Office at (919) 684-3121.
New Rules for ClinicalTrials.gov—Part 1 NIH
DHHS and the NIH have released a new regulation (Clinical Trials Registration and Results Information Submission, “the Final Rule”) and policy (NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information) that affect registration and results reporting for clinical trials. Both have an effective date of January 18, 2017.
What you need to know if you have NIH funding
All NIH funded interventional clinical trials [NIH definition of clinical trial – “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”] must be registered and have results submitted in ClinicalTrials.gov (previously this was encouraged).
The policy includes all interventional trials, including those that are not considered Applicable Clinical Trials (ACTs) such as behavioral, surgery, Phase I drug and device feasibility studies.
The policy applies to
o clinical trials funded in whole or part by the NIH (extramural, intramural, grants, and/or contracts) submitted on or after the effective date and
o new clinical trials added to competing renewals submitted on or after the effective date.
The timeframes for registration and submission of results information are the same as for ACTs.
o At Duke, registration must occur prior to institutional approval.
o Results, including adverse event information, must be submitted 1 year from the date the last patient was assessed for the primary outcome measure (even if data collection is ongoing for other outcome measures).
Next month we will review some of the changes to ClinicalTrials.gov
For more information: https://www.nih.gov/news-events/news-releases/hhs-take-steps-provide-more-information-about-clinical-trials-public
New to ClinicalTrials.gov? Sign up for the October 24th ClinicalTrials.gov Registration Class.
New CTSI Funding Opportunities
Submissions for the Duke/UNC CTSA Consortium Collaborative Translational Research (T1/T2) Pilot Grant (worth $50,000) are due Oct. 21. Submissions for the CTSI Translational Accelerator Award (worth $150,000) are due Nov. 2.
Faculty/Staff Effort Management for Clinical Research Studies Policy Available
A new Faculty/Staff Effort Management for Clinical Research Studies Policy has been posted on the duke finance website. This policy covers all University faculty and staff who provide effort in support of the clinical research mission at Duke University. The policy provides both guidelines and additional resources to appropriate effort during the budget/proposal development process and allocate effort appropriately throughout the life of the sponsored agreement to support accurate effort reporting in compliance with applicable federal regulations.
October is National Cyber Security Awareness Month
There are several opportunities for faculty and staff to participate in National Cyber Security Awareness Month. Learn IT will sponsor two lunch sessions:
LastPass: Three Features that will Simplify your Online Life (session description) o Presenter: Samantha Styles (Customer Service Success Manager, LastPass Enterprise) o Date: Wednesday, October 12 o Time: noon – 1:00 p.m. o Location: The Edge Workshop Room (1st floor Bostock Library)
Your $$$ or your data: Protecting yourself against ransomware (session description) o Presenter: John Straffin, Duke IT Security Office o Date: Wednesday, October 26 o Time: noon - 1:00 p.m. o Location: The Edge Workshop Room (1st floor Bostock Library)
Additionally, Duke faculty, staff and students can test their knowledge of ransomware and other phishing attacks by taking a short online quiz to be entered into a drawing for various technology prizes. Duke’s IT security offices also will hand out giveaways at campus events throughout the month with tips on how to protect yourself and your data online. For details, visit security.duke.edu.
Federal Trade Commission (FTC) Releases Data Breach Recovery and Prevention Video
The Federal Trade Commission (FTC) has released a step-by-step video to users whose personal information may have been exposed in a data breach. This video provides instruction on how to report an incident and develop a personal recovery plan after a data breach has occurred.
Scheduling Research Eye Exams
If eye exams are needed for your research projects, please contact the Ophthalmology CRU during the study start-up phase. Prior to study visits, a memorandum of understanding will be created that includes eye exam schedule, your Eye Center contact person, additional consent language, and the Maestro Care research charge router items. For additional information and assistance, please email Alexandra ‘Alli’ Bosquet at [email protected].
17th Annual ACRP Research Triangle Park Chapter Fall Conference
The ACRP Research Triangle Park Chapter will hold the 2016 Fall Conference titled “Fresh Perspectives on Recruitment, Regulations and Research”. The event will be held October 21 – 22, 2016 at the NC Biotechnology Center in Durham. For additional information, visit their website.
8th Annual REDCap Conference a Success
Duke hosted the 8th annual REDCap Conference on September 12th – 14th. The three-day event offered presentations, breakout sessions, and more by REDCap Consortium members. The event was a huge success which fostered collaboration among REDCap institutions and allowed for the highlighting of new and innovative uses of REDCap. For conference photos and details, see the DOCR website. Thanks to all those who volunteered to help make the event a success: Mary Beth Davis Surgery, Shelly Epps ISO, Mark Peedin DCI and DOCR Data Team members Joe McLean, Sue Budinger, Jeff Hawley, Jason Lones, Christine Deeter, Ceci Chamorro, Audrey Brown, Amanda Mazza, Matthew Small, Erik Churchill, Ashanti Ballard, Michael West, Ebony Burns, and also thanks to Cory Ennis and Denise Snyder!
Take Your Career to the Next Level: Join the Research Professionals Network!
This network provides an opportunity for research professionals to strengthen their role at Duke. The RPN's mission is to advocate for our members' research careers, provide options for formal and informal education, connect members with other professionals, and develop high standards in the research community. Interested research professionals can join our listserv at [email protected]. Please also email us with ideas, suggestions, and questions for future events. We’d like to hear from you!
Maestro Care Optimization Policies Available on the DOCR Website
Five new Maestro Care Optimization Policies are now available on the DOCR website:
Maestro Care Optimization Request Submission and Review Policy (7/13/2016) - This policy defines the process for submission and review of new proposals for optimization in Maestro Care.
Use of MyChart Questionnaires in Maestro Care (7/13/2016) - This policy describes the process for requesting and using MyChart questionnaires in Maestro Care.
Use of Retrieve Form for Data Capture (RFD) in Maestro Care (7/13/2016) - This policy describes the process for developing a REDCap database that incorporates RFD.
Use of Silent Alerts in Maestro Care (7/13/2016) - This policy describes the process for requesting and using silent alerts in Maestro Care research.
Use of SmartTools in Maestro Care (7/13/2016) - This policy describes the process for requesting and using SmartTools in Maestro Care.
Which Maestro Care Training Classes are Required for Your Role in Research?
Your role in research determines the template you are assigned. Your Research Practice Manager (RPM) or (ARPM) will request your template and submit a Profile Request Service Now ticket requesting your profile after training is documented as completed in LMS. Existing Research Templates are categorized by role.
Please note the following summary of Maestro Care Training Courses as a resource for registering for classes.
Maestro Care Clinical Research- View Only
DOCR Maestro Care Clinical Research 'View Only' Module (web based)
Required for staff requiring View Only Access-no editing or data entry
Module covers: o General Overview o Access to terminology o General navigation
Maestro Care Associating Patients to Studies
Instructor lead hands on workshop module teaches the process of (Enrolling) Associating Patients to No Bill Risk Studies
Course is taught weekly on Wednesdays in Seeley Mudd Room 104-D (1 hour)
Required for Staff who are responsible for Associating Patients with No Bill Risk Studies
Participants will learn to enroll patients in studies and will be provided best practice and tools for practical use
Maestro Care Clinical Research 100
Instructor led hands on workshop introduction and beginner module for Maestro Care CRC (not licensed) users
Course is taught weekly Wednesdays (2.5 hours)
This hands on class provides instruction for clinical researchers who are New to Duke or as a Clinical Research Refresher for existing clinical research staff
Research Dashboard and functions of the system are taught in a practical workflow oriented practical classroom session.
Course covers: o The Research Dashboard o Enrolling Patients in Studies o Order Management o Encounters-linking o Conducting and Documenting a Patients Study Visit o Navigating the In Patient Record- Chart Review
Maestro Care Oncology Beacon Clinical Research 100
Instructor led hands on workshop module for Maestro Care Oncology nurses (licensed)
Course is taught on weekly on Mondays in Seeley Mudd Room 104-D (2 hours)
Follow-up session is scheduled one on one at-elbow
This class was developed to: o Close gaps and include specifics for CRC oncology workflow o Develop targeted oncology-specific training for CRCs o Reduce number of training hours previously required as ambulatory training
Course covers: o The Research Dashboard o Enrolling Patients in Studies o Applying a Research Treatment Plan o Navigating and working with the Research treatment plan o Research Oncology workflow
Please feel free to contact [email protected] for questions and assistance. A complete list of training courses can be found in the DOCR Training Calendar at DOCR website.
DOCR Releases New On-Demand Web-Based Training Modules
The following newly released web-based training modules are available through the Duke Learning Management System (LMS):
Getting Full Institutional Approval – This module describes the CRU, DUHS IRB, and specialty committee reviews required to receive full institutional approval for a study at Duke. It describes the offices that are part of the review process and how to address any requested modifications. Finally, it reviews study activities that can begin before institutional approval.
Preparing the Study-Specific Documentation – This module describes the study-level documentation expected at Duke. It describes the regulatory binder, documents required for all studies, documents required for most studies, and documents that are required depending on the type of study. It discusses standard operating procedures. This module provides guidance for creating the binder or file, maintaining central files, and what should not be included in the documentation to be audit ready.
Screening and Consenting Subjects – This module describes how to determine the informed consent process for your specific study. It describes the consenting plan and consent form revisions. It provides specific regulatory guidance for who can provide consent for a subject to participate in a study including discussing assent, vulnerable populations, and the legally authorized representative. This module provides guidance for how to discuss the study and assess the potential subject to obtain consent and how to document informed consent. Finally, it discusses when the subject must re-consent and the screening process.
Monitoring and Reporting Safety – This module defines adverse event and serious adverse events. It provides specific guidance for documenting an event correctly. This module provides regulatory guidance for determining if an event is reportable under 45 CFR Part 46. In addition, it discusses what, when, and how to report events to the FDA, sponsor, funding agency, ClinicalTrials.gov, and the DUHS IRB.
Reporting Problems and Maintaining IRB Approval – This module defines the type of problems that must be reported to the IRB, how to report the problem, and the consequences of improper reporting. It discusses maintaining the key personnel list for a study. This module provides guidance for maintaining IRB approval and the continuing review process. It discusses handling amendments to the protocol and maintaining ClinicalTrial.gov study status.
Querying, Analyzing, and Closing Out the Data – This module provides guidance to prepare records for storage and retention. It discusses the query process, recognizing trends in data and queries, working with statisticians to analyze the data, and types of data sets. It provides guidance for de-identifying data and transferring data. It discusses locking and freezing the database.
You can find a link to each of the courses from the Available DOCR Training page on the DOCR website (link: https://medschool.duke.edu/research/clinical-and-translational-research/duke-office-clinical-research/policies-training-and-0). From the Duke LMS home page, you can select the Category link in the Catalog Search section of the home screen, then select DOCR. All available DOCR classes will be listed.
Training Opportunities Upcoming DOCR Training Offerings
DOCR training offerings are available in the Duke LMS. You have 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://vmw-lmsweb.duhs.duke.edu/SabaLogin
Detailed information about each offering and direct links to the offering are also available on the DOCR website. Following are the upcoming instructor-led DOCR offerings:
Title Dates Time
Research Wednesdays:
- Information Security Office: Cybersecurity Awareness Month
- Office of Audit, Risk and Compliance Updates
- Clinical Research Professionals: Results of Mapping at Duke Medicine
- Clinical Data Research Networks
October 12
October 26
November 9
November 16
1 PM – 2PM
Research Professionals Network:
- Duke’s Recruitment Innovation Core
- The New Face of CT.gov
October 13
November 17
1 PM – 2 PM
MC Clinical Research 100 October 12, 19, 26
November 2, 9, 16, 30 9 AM – Noon
MC Clinical Research 100 Oncology (Beacon) October 3, 10, 17, 24, 31
November 7, 14, 21, 28 11 AM – 1:30 PM
Updated MC Clinical Research Billing Review Process (CRC)
October 7
9 AM – 10 AM or
10 AM – 11 AM or
11 AM - Noon
Budget Development and Negotiation Training November 16 9 AM – 11 AM
ClinicalTrials.gov Introduction October 24 11 AM – 1 PM
ClinicalTrials.gov Practical Reporting November 7 Noon – 2 PM
Duke Human Research Training October 27 Noon – 2 PM
IRB Overview October 18
November 22 10 AM - Noon
Recruiting Regulations and Best Practices October 25 2 PM – 4 PM
REDCap: Exporting/Importing and Reports November 3 Noon – 1 PM
REDCap: Learning to Manage Surveys October 20 Noon – 1 PM
Research Database Design Principles October 27
November 17 Noon – 1 PM
Study Documentation Regulations and Best Practices November 14 1 PM – 3 PM
The Informed Consent Process November 8 11 AM – 1 PM
Urine Pregnancy Screening for Research October 25 Noon – 1 PM
Workshop: Creating SOPs October 6 Noon – 2 PM
Workshop: Start Building in REDCap October 27
November 17 1 PM – 3 PM
Did You Know? If a study sponsor offers to pay for an item or service—even if the item or service is considered standard of care—we should not reject their offer and choose to bill a third-party payer instead. To do so puts us out of compliance with CMS regulations. Medicare and other third-party payers should be considered the secondary payer to any sponsor funding. Most commercial health plans will not cover items and services that are the responsibility of another party, often called “third party” or “other party” payment exclusions. You can find more information about third-party coverage of research charges at the link below: https://medschool.duke.edu/research/clinical-and-translational-research/duke-office-clinical-research/irb-and-institutional-16.
Clinical Research Employee Highlights
Congratulations to Inneke Johnson (CRC 1) and Brenda Hardison (CTA 1) who recently joined the Heart Center CRU Cath Lab Research Cluster.
Please join the School of Nursing in welcoming Heather Adams to the Center for Nursing Research! Heather joined DUSON as an Assistant Research Practice Manager on September 15, 2016. She will be working with the Research Oversight and Compliance Core to provide research compliance and operationalization assistance with research programs.
Over the past few months the Ophthalmology CRU has grown with the addition of Alexandra ‘Alli’ Bosquet, David Nasrazadani, Malina Sexton and Victoria Germann joining our group.
Partner Resources DUHS Compliance Office Newsletter
Catch up on news from the DUHS Compliance Quarterly Newsletter.
Stay Abreast of the Newly Launched Duke Clinical and Translational Science Institute (CTSI)
The CTSI will continue to send out an email newsletter twice a month. View past newsletters and sign up for future ones at https://www.ctsi.duke.edu/news/newsletters or email [email protected].
To be added or removed from the distribution list for the DOCR Clinical Research Update newsletter, please contact the DOCR at [email protected].