Duke Clinical Research Update April 2 2020

Thursday, April 2, 2020
This image is the Duke Clinical Research Update Banner

 

 

 

 

 

 

 

 

 

SUPPORT OFFICE HOURS

REDCap Office Hours

Email redcap-docr@duke.edu to schedule a virtual session at one of the times indicated below.

Tuesdays 10 AM, virtual sessions
Wednesdays 10 AM, virtual sessions

Thursdays 2 PM, virtual sessions

Fridays 10 AM, virtual sessions

 

SlicerDicer Office Hours

Thursdays, 1 PM, via WebEx

 

PACE Office Hours

Every other Tuesday, 1 PM, via WebEx.  Click for information.

 

RESEARCH COMMUNITY NEWS

 

Classification of Essential Studies and Suspension of In-person Enrollment of Tier 2 (Moderate Impact) Essential Clinical Research Studies

As you are aware, the Duke University, Duke Health and Duke School of Medicine response to the COVID-19 pandemic is changing rapidly. To further classify essential studies, based on potential impact on the health and well-being of an individual, we are designating essential studies into 2 tiers (high-impact and moderate impact) as described below.  This will enable Duke to continue to appropriately match clinical research activities with the ongoing COVID19 response.

 

Based on the report by NC DHHS on Thursday March 19, 2020 of evidence of community transmission in the state, we believe it is important to alter in-person study visits for clinical research protocols balancing potential benefits and risks.

 

On Monday March 23, the Duke School of Medicine Clinical Research Administration will suspend in-person enrollment for Tier 2 Essential Clinical Research Studies. In addition, we ask research teams to continue converting study activities to virtual or remote/tele visits as much as possible.  Please also prepare contingency planning in the case all in-person follow-up study activities are suspended for Tier 2 Essential Studies.  

 

For Tier 1 Essential Clinical Research Studies, in-person enrollment and follow-up may continue, but we ask that research activities be converted to virtual or remote/tele visits as much as possible. Unless, direct engagement of a participant is needed to maintain integrity of the study and health of the participant (e.g. consent, investigational product delivery, or laboratory testing), we ask that all other visits be done remotely. 

 

All COVID-19 specific clinical research studies are considered Tier 1. We have a SOM COVID-19 Clinical Research Task Force coordinating efforts for these studies.

 

As per the Clinical Research Essential Study Policy enacted on Monday March 16, all in-person study activities for Tier 3, non-essential studies have been temporarily suspended until further notice.  While other research activities that can be done virtually or remotely will be able to continue, participant in-person visits will not be allowed.

 

Please review the IRB Policy titled “COVID-19 and Research at Duke” released on March 11, 2020 for further guidance on changes to research activities related to COVID-19. Please also reference the research.duke.edu FAQ list for questions regarding sponsor interactions and effort considerations related to this suspension of non-essential in-person study activities.

 

Please feel free to contact susanna.naggie@duke.edu for Clinical Research related questions.

 

 What defines an Essential Clinical Research Study?

 

An essential study as any study utilizing drugs, biologics, or devices that holds the prospect of direct benefit to the participant. Furthermore, any study involving therapeutic radiation would be considered essential. We have asked PI and CRUs to assess studies meeting this definition to identify those they believe must continue with in-person study activities due to the health and well-being of the participant. All other studies would be considered non-essential. 

 

Recall that for all non-essential studies, remote/virtual activities can continue as long as they don’t include in-person activities.

 

What defines a Tier 1 Essential Clinical Research Study?

 

Tier 1 – High Potential Direct Benefit to Research Participants

 

All clinical research protocols involving COVID-19 or clinical research protocols in which there is a high potential benefit for an individual’s survival or when alternative treatments are severely limited and there is a potential serious or immediate harm for an individual without participation in the protocol.

 

For example:

Clinical research protocols involving treatments for acute, life threatening health conditions (e.g. some treatment trials for cancers)

Clinical research protocols where stopping the intervention (e.g., some investigational drugs or vaccines or preventative drug regimens) could be harmful

What defines a Tier 2 Essential Clinical Research Study?

 

Tier 2- Moderate Potential Direct Benefit to Research Participants

 

Clinical research protocols that provide moderate potential benefit for an individual’s health or well-being over time which, if unavailable, may pose a long-term risk to the research participant.

 

For example:

Clinical research protocols evaluating treatments for chronic conditions (e.g., asthma, hypertension, depression, diabetes, HIV, fatty liver disease, etc.).

Clinical research protocols involving assessment of the safety or efficacy of an intervention in which, if stopped, the potential societal benefit of the science would be significantly and adversely impacted, for example where a research assessment (blood collection or imaging study) is only valuable if collected at a very specific time. This must be measured against the risk to participants, including the risk of exposure of COVID-19.

 

What defines a Tier 3 (non-essential) clinical research study?

Non-essential studies are primarily observational or behavioral studies, surveys, focus groups, retrospective studies, archival data/sample-based research studies. Non-essential studies may also be interventional studies that are not viewed as so critical to the health and well-being of the participant that it is worth the risk to the research staff and Duke Health community. If a PI or CRU believes a non-essential study needs to continue with in-person study activities, they will need to request this permission from Susanna Naggie and Adrian Hernandez. We must balance benefit to participants with risk to our research staff and the Duke Health community.

 

COVID-19 Response - IRB Personal Data Disclosure Forms

As a part of our COVID-19 response, many of our study visits are now taking place through alternative methods, such as telephone calls or virtual visits. Additionally, many of our staff are working remotely. This has presented some unique challenges when collecting and processing IRB Personal Data Disclosure forms. We have received multiple questions regarding alternative methods for the collection of signatures and the transmission of completed forms. We wanted to provide the following guidance as temporary measures to take during this time:

 

What is an acceptable method to obtain the participant’s signature when a visit occurs over the telephone or virtually?

  • For telephone and virtual visits, the study team staff may check the telephone visit box and write N/A in the subject signature line.  Document the details of the visit on the Personal Data Disclosure Form.

 

If study team members are working remotely, without access to a fax machine or copier/scanner, what is an acceptable method for signing and transmitting the document to the designated Approver?

  • Study team member signature
    • For study team staff that have access to electronic signatures through Adobe software, the use of electronic signature is acceptable.
    • For study team staff that do not have access to electronic signatures, staff may type their name and date using word processing software.
  • Transmission of the form to the department designated  person for processing, this may also be the ClinCard Approver  (no changes to current policy)
    • The study team may forward the IRB Personal Data Disclosure Form, within an encrypted, secure email, to the designated person for uploading to the Duke Protected Directory. Once completed and uploaded, the study team should immediately delete the attached IRB Personal Data Disclosure form from the email. There are two ways to send an encrypted secure email:
      • Type (secure) or [send secure] at the beginning of the subject line to encrypt the message
      • For users with Outlook 2010 or Outlook Web Access, click the Sensitive Electronic Information button or select this option from the menu.

 

 

We understand that this is a fluid situation and we may have to revise this guidance.

 

COVID-19 Funding Opportunities and Research Resources in myRESEARCHhome

 

This image shows the MRH COVID-19 Banner

Find important COVID-19 resources all in one place in myRESEARCHhome

  • Consolidated COVID-19 funding opportunities
  • Research FAQs
  • Help from the myRESEARCHnavigators for specific questions
  • Information & templates for notices to sponsors
  • Quickly notify Duke of COVID-19 related research and activities

 

Find all this and more at mrh.duke.edu

 

CRU Effort Sharing

For some teams, the transition to remote clinical research has been a challenge. While some are experiencing an increase in workload due to shifting to virtual and remote activities, others have a decrease in activity because they cannot perform their regular research duties.  The School of Medicine and DOCR are piloting an initiative that will allow CRUs and study teams to share effort of research staff (those with one of the 12 WE-R clinical research job codes), creating a more efficient workload balance and optimizing research budgets during this time.  Shared effort of clinical research staff will be covered by the project requesting assistance, and will involve a formal agreement between the two CRUs. If you are a RPM with staff effort to share or in need of extra effort to cover your portfolio of projects, you can make a request here:

 

 

If you are a staff member interested in participating in this initiative, please contact your manager or RPM to discuss the types of skills you have and the amount of time you have available. 

 

Medical and Graduate Assistance for Clinical Research Studies

Study teams who are interested in utilizing Medical and Graduate assistance for help with COVID-19 research projects can use the following link to request assistance:

https://redcap.duke.edu/redcap/surveys/?s=YN9NADX4W7

 

Medical and Graduate assistance is available for remote/virtual activities only.  No in-person or on-site research activities would be applicable for this effort.

 

Certain non-COVID research requests for Medical and Graduate assistance will also be considered.

 

Once the request for student assistance has been received, the Duke Office of Clinical Research will consult with the overseeing CRU regarding the request prior student placement.

 

Maestro Care Upgrade Postponed

The Maestro Care upgrade previously scheduled for April 19th has been postponed due to the COVID-19 pandemic.  A new date will be established and communicated as soon as possible.

 

Learning Health Systems Based Upon Outbreak Informatics

Presentation provided by Dr. Eric Perakslis

 

As the COVID-19 epidemic scales exponentially across the United States, calls for expended use of telehealth, innovative technology solutions and optimization of life-saving critical care hospital beds clearly highlight unmet needs in the American healthcare system. Dr. Perakslis will provide a wealth of insight on health systems, the use of informatics and technology during pandemic outbreaks.

 

Eric Perakslis, PhD is a Rubenstein Fellow at Duke University, Lecturer, Department of Biomedical Informatics at Harvard Medical School and Innovation Advisor to Médecins Sans Frontières. He has significant experience leading technology efforts in infectious disease outbreaks.

 

Date and Time

Wed, April 15, 2020

9:30 AM – 10:30 AM EDT

 

Register here

 

To participate in this WebEx go here

 

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.

 

 

IRIS/ONCORE UPDATES

 

Remote Data Clean Up activities for OnCore/Insights

Below is a list of data cleaning activities for OnCore and Insights which can be completed remotely.  The list is organized by CRC and Regulatory Coordinator roles.  Links to the appropriate tip sheets are also included.  

 

CRCs: 

  • CRC Tip Sheets here
  • Participant Data Clean up - Subject Searches: 
    • OnCore>Menu>Subjects>Subject Search * Customizable Search  
      • Suggestions:  Check the boxes in front of the follow fields:  Status, consent signed date, eligibility Verified date, Eligibility status, On Study Date, Off study Date (can also heck boxes for On Treatment, Treatment Arms, Off Treatment depending on OnCore calendar and anchor statuses), Protocol Status = Open to Accrual from date = 7/1/2016
        • If Consent Signed Date is blank, add the consent date (verbal approval to schedule and/or signed consent) OR follow the Deleting Subjects tip sheet to have the subject deleted from OnCore.  Subjects who have not consented should not be entered in OnCore
        • If a participant has a consent refused status submit a SN ticket to have those subjects deleted from OnCore and follow the Deleting subjects tip sheet for soft delete in MC if they were sent over at some point.
        • If Eligibility date/status is blank and subject went on study, add eligible status and date (default is date of consent) * Subject Eligibility Tip Sheet
        • Look for missing on study dates and remove on/off study dates where subject has an ineligible status
        • If On Study date is blank but an off study date is populated, either add an on study date OR remove the Off Study date.   If the subject was ineligible for the study, then no off study date would be entered. The last status should be Not Eligible * Updating Subject Status Tip Sheet
  • Enrollment log QC vs. OnCore
    • Verify Subject Registration Demographics * Tip Sheet
    • Fields below help support accurate Insights reporting
      • Subject Birth Date
      • Subject Ethnicity
      • Subject Gender
      • Subject Race
      • Subject ZIP
  • OnCore calendar approvals and outstanding active tasks in OnCore.  Ensure home screen is configured to include the “Active Tasks” and “Upcoming Tasks” widgets.  Click on the gear icon in the upper-right corner of your screen - Study Start-up Steps Tip Sheet
  • Outstanding Maestro Care order set or Beacon build approvals * Search e-mails from Phil Timmons or Angela Shatz pending your approval
  • CTgov updates (for those who may be record owners or on access list for current studies)

 

Regulatory Coordinators:  

  • Tip sheets here
  • Minimum footprint updates – fields below are critical for accurate Insights reporting.   
    • Accrual Duration and Accrual Goal
    • Study Status
    • Department
    • Management Group
    • Program Area (Oncology)
  • Staff list QC in OnCore vs. iRIS * ensure OnCore reflects approved KP in iRIS.  *** PI changes must be manually added. 
  • Study Status QC –
    • OnCore>Menu>Protocols>Protocol Search * Protocol Search Tip Sheet
    • Run a search including studies open to accrual, on hold and suspended.  Confirm and update statuses as needed.   
  • ClinicalTrials.gov updates (if record owners or on access list for current studies)
  • Outstanding active task clean-up in OnCore * Ensure home screen is configured to include the “Active Tasks” and “Upcoming Tasks” widgets.  You can do this by clicking on the gear icon in the upper-right corner of your screen. You can also view this task list via the “Status” tab in PC Console.  Study Start-up Steps Tip Sheet      

 

 

Documenting Virtual Visits in OnCore

For clinical research activities that can be done virtually, please document the Visit Description as Visit # -- Virtual Visit.

If additional information about the visit needs to be documented, please enter the information in the Clinical Comments section.

This image shows the Subject Visit Update screen in OnCore

 

 

REMEMBER: One of the following must be completed for all procedures in the Procedure section of the Subject Visit Update screen:

  • Procedure Date entered
  • Missed checked
  • N/A checked

If none of the above is completed, OnCore assumes that the procedure(s) has been done and the procedure(s) will show on the Financials Console which results in inaccurate billing to the Sponsor.

 

OnCore Added to Citrix Workspace

For those already working in Citrix with programs such as Maestro Care and SAP, a new pathway to open OnCore removes the need to also connect to the Duke Health VPN. The link has been added to the “Clinical Research Apps” folder for current active OnCore users, and launches via an “.ica” file to a virtual desktop like other Citrix applications. If you are having issues accessing the link, please contact the Research Support Desk for assistance.

This image shows the Clinical Research Apps folder on the Duke Health Website

 

 

 

Which iRIS KP Roles Flow Automatically into OnCore, and Which Don’t?

The iRIS to OnCore interface creates study records in OnCore that have been synced using the “Sync Data Over API” button in Section 700 of the DUHS IRB Application in iRIS. When pushed, an iRIS protocol’s Key Personnel list is automatically added to the OnCore protocol’s Staff tab, with a few exceptions. KP with the following Roles do NOT get synced to OnCore: Analyst, Computer Programmer, Collaborator, Grant Support Personnel, and Other. If personnel with one of these iRIS roles requires access to the protocol in OnCore, they will need to be manually added to the OnCore protocol by a Regulatory Coordinator.

 

In addition, recent testing has found that two roles in the IRB Application pick-list are not flowing to OnCore as expected: Study Coordinator and Pathologist/Lab Personnel. Instead of Study Coordinator, protocols should use the “Study Coordinator (CRC/CRNC/RPL)” role. Instead of Pathologist/Lab Personnel, protocols should use the “Pathologist”, “Laboratory Manager”, or “Laboratory Technician” roles. The iRIS team is working on a clean-up script to move existing personnel listed as Study Coordinator or Pathologist/Lab Personnel to these corresponding functioning roles, and then will remove them from the pick-list. A KSP Change Form from the study team will not be needed for this clean-up.

 

iRIS System Updates

Outstanding Issues

 

Previously Created Initial Review & Amendment Forms Preventing Submissions

 

Update: The iRIS technical team and Duke IRB office have identified a solution to this item which requires coordination and detailed clean-up with iMedRIS.  We will be communicating next steps for the entire research community in the near future.  We appreciate your patience as we coordinate these efforts on this high-priority issue.

 

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:

 

  1. 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. 
  2. If you receive an error stating that the form cannot be deleted, STOP and submit a Service Now 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. 

This image shows the iRIS My Workspaces banner

 

Bug Fixes

 

Training Validation Error

 

When a user is deemed to have invalid CITI training, a new pop-up window will appear displaying each user with invalid training (See image below).  Please continue to submit a Service Now ticket to include, the Protocol number and any listed user with invalid training.  The iRIS support team will validate all completed CITI training and resolve the error within iRIS.  Once you receive communication from the iRIS support team, please retract your submission and resend for PI sign-off. At that time, your submission will continue through the workflow for board processing. 

This image shows the iRIS training records failure screen

 

Form and Workflow Revisions

 

DUHS Continuing Review:

  1. Added "All study enrollment and subject involvement is complete but data analysis is ongoing" to the show/hide rule for the question "Do the consent forms need to be stamped for re-consent purposes?" The question will now become visible when a user selects "All study enrollment and subject involvement is complete but data analysis is ongoing" from the enrollment status radio buttons.
  2. Revised the subject accrual table rows with "a-h" designations for each line of the accrual table. 
  3. Added help text to the question header, "Please provide the following information on the number of SUBJECTS enrolled or the number of RECORDS accessed". The help text is "NOTE: Lines "d+e+f+g+h" in the Cumulative column should equal the total number enrolled indicated on line "a" in the Cumulative column."

 

DUHS IRB Application:

  1. Added form branching when the Trainee Research Away from Duke Protocol application type (Section 400) is selected. The form will now branch to the Oversight Organization section in order to collect information on CRU for these studies, as this data is a key driver in iRIS and needs to be populated for all studies.
  2. Added a new question to the Exempt Application pathway to ensure study teams are not using the application type to collect data in support of an FDA regulated drug/device/biologic.

 

DOCR NEWS

 

Study Documentation Refresher Series

Has it been a while since you’ve had a refresher on study documentation best practices and procedures? While there is a full training module on Study Documentation for those who are new to their role in Clinical Research, sometimes attending a whole course on a broad topic isn’t necessary. We broke the full course up into the below bite-sized pieces for anyone looking for a refresher on a specific concept! Use the links below to access the courses in the LMS. You can also find them anytime on the DOCR WE-R Training Page.

This 12 to 15 minute module discusses the importance of study documentation and how to navigate different governing authorities as it relates to study documentation.

This 20 to 25 minute module discusses what study level documentation is, how to maintain it, and resources for creating and maintaining a compliant regulatory binder. You’ll also learn what documents are required for different types of studies and the importance of SOPs.

This 15 to 20 minute module discusses what documents are “participant level” along with some specifics around informed consent, research data, and source data documentation. You’ll also learn how case report forms are used to report research data to the sponsor.

This 10 to 15 minute module discussed best practices for maintaining study documentation, proper practices for notation of changes, and when a note/memo to file might be required. You’ll also hear about when a protocol deviation would require both a Note/Memo to File and reporting to the IRB.

This 10 to 15 minute module discusses how documents are retained and stored for open and closed studies as well as how regulations inform document retention requirements. You’ll also learn tips on planning for document storage and retention.

 

 

RECRUITMENT INNOVATION CORNER

How to Maintain Participant Relationships During COVID-19

 

This graphic shows people holding hands helping one another

We are living in a very scary and uncertain time.  Two weeks ago Continuum Clinical conducted a study1 and said that 1/3rd of clinical trial sites expect the novel coronavirus (COVID-19) to have a “big or extremely big” impact on their ability to recruit patients and to keep those already enrolled compliant.   In addition, 39% of 170 U.S. clinical trial sites surveyed believe patients will be much less likely to enroll in new research trials. And 25% of the sites expect patients currently enrolled in a trial to be much less, or somewhat less, willing to continue their participation.

This picture shows a heart

This is why maintaining relationships with participants that are already enrolled in existing studies is extremely valuable right now.  You can maintain your relationships with participants through uplifting, supportive, encouraging and compassionate outreach during this unprecedented time.  Even though we don’t know how long this pandemic will last, putting some participants worries at bay would go a long way. Consider any of the following:

  • A quick phone call to check in and say you’re thinking of them, especially those you know may be isolated and alone
  • An personal email sent to them (not just a big chain email)
  • A letter in the mail with a real signature and hand-addressed envelope
  • An update about the study to know what has been disseminated so far
  • Notifications about new and upcoming COVID-19 studies they may be interested in

 

Any type of communication can convey that consider your participants as people and partners and not just “subjects.”  Keeping them involved and engaged in research even though we can’t conduct research as normal, will make them feel included and valued.  Remember, we can be together in social solidarity even while social distance keeps us physically apart.

We know much of recruitment is paused, but the RIC can still help you develop websites, engagement letters, research notices, and MORE!  Contact us for any of your research needs!

 

1 https://www.businesswire.com/news/home/20200316005858/en/Survey-COVID-19-Negatively-Impact-Clinical-Trial-Enrollment/

 

 

 

 

DID YOU KNOW?

REDCap Upgraded to v9.5

REDCap was recently upgraded to v9.5.

 

New functionality with this upgrade includes new Action Tags & new Smart Variables.  

 

Review a full list of new features 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

 

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.

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

This image shows the corner of a building on West Campus Duke

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