Duke Clinical Research Update April 15 2020

Wednesday, April 15, 2020

 

 

 

 

 

 

 

 

 

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

 

Key Points from FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic (March 2020)

The following information is a summary of the FDA guidance for your convenience. The full guidance contains ADDITIONAL FAQs, so please click the link above to see the full guidance.

Due to the COVID-19 pandemic, FDA recognizes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures. Top priorities for FDA-regulated studies are: assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity. Remember all changes to study design, consent platforms, drug delivery, etc. require submission of an Amendment to the IRB.

  • Participants must be kept informed of changes to the study & study visits that could impact them.
  • Sponsors may decide that the protection of participants’ safety, welfare, and rights is best served by continuing study participants in the trial per protocol or by discontinuing the administration of the investigational product. If the study cannot be properly conducted under the existing protocol, the sponsor may decide to stop ongoing recruitment or even withdraw trial participants.
  • Sponsors should evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment) could be used, and would be sufficient to assure the safety of participants.
  • COVID-19 screening procedures (like those required at DUHS) do not need to be reported as an amendment to the protocol, unless the sponsor plans to use the data collected as part of a new research objective.
  • Changes to the protocol to minimize or eliminate immediate hazards or to protect the life and well-being of research participants (e.g., to limit exposure to COVID-19) may be done without prior IRB approval or before filing an amendment to the IND or IDE. However, these changes must be reported to the IRB and FDA afterwards.
  • A listing of all participants affected by the COVID-19 related study disruption by unique subject number identifier and by investigational site, and a description of how and for how long the individual’s participation was altered, must be documented.
  • Missing protocol-specified information, such as missing study assessments or missing endpoints, should be fully documented in the case report form, including the relationship to COVID-19.
  • If scheduled visits at clinical sites will be significantly impacted, certain investigational products may be sent to participants using a secure delivery method. Consult with the Sponsor or FDA review divisions on plans for alternative administration of investigational products.
  • FDA will allow investigators to obtain a signed informed consent from a patient who is in isolation, by alternate methods such as electronic consent, telephone consent or video conference with the presence of an impartial witness, or a photograph of the signed informed consent document.
  • If the patient is unable to provide informed consent and there is a legally authorized representative (LAR), investigators must obtain consent from the participant’s LAR in accordance with 21 CFR 50.27(a).

This guidance has also been posted on the DUHS IRB website:  https://irb.duhs.duke.edu/node/4722

 

The Consent Process with Patients in Quarantine/Isolation

The IRB would like to particularly call your attention to the Q&A part of the guidance FDA issued on March 18, 2020 and updated on April 2, 2020 (see FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic at https://www.hhs.gov/ohrp/sites/default/files/fda-covid-guidance-2apr2020.pdf - PDF) because there is a Q&A that directly addresses the consent process with patients in quarantine/isolation. 

 

In the Guidance, this is Question 10.

 

Q10. How do I obtain a signed informed consent from a patient who is in isolation and the COVID-19 infection control policy would prevent us from removing a document signed by the patient from their hospital room?

FDA regulations generally require that the informed consent of a participant be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent (21 CFR 50.27(a)). In light of COVID-19 infection control measures, the following procedure would satisfy documentation of this requirement if the patient signing the informed consent is in COVID-19 isolation.7

 

  • If the technology is available, electronic methods of obtaining informed consent should be considered.8
  • When it is not possible to obtain informed consent electronically, the sponsor should consider taking the following steps:
  1. An unsigned consent form is provided to the patient by a heath care worker who has entered the room
  2. If direct communication with the patient in isolation is not feasible or safe, the investigator (or their designee) obtains the patient’s phone number and arranges a three-way call or video conference with the patient, an impartial witness, and if desired and feasible, additional participants requested by the patient, (e.g. next of kin)
  3. To ensure that patients are approached in a consistent fashion, a standard process should be used that will accomplish the following:
  • Identification of who is on the call
  • Review of the informed consent with the patient by the investigator (or their designee) and response to any questions the patient may have Confirmation by the witness that the patient’s questions have been answered
  • Confirmation by the investigator that the patient is willing to participate in the trial and sign the informed consent document while the witness is listening on the phone
  • Verbal confirmation by the patient that they would like to participate in the trial and that they have signed and dated the informed consent document that is in their possession.

 

If the signed informed consent document cannot be collected from the patient’s location and included in the study records, FDA considers the following two options acceptable to provide documentation that the patient signed the informed consent document:

 

  • Attestations by the witness who participated in the call and by the investigator that the patient confirmed that they agreed to participate in the study and signed the informed consent

OR

  • A photograph of the informed consent document with attestation by the person entering the photograph into the study record that states how that photograph was obtained and that it is a photograph of the informed consent signed by the patient.

 

A copy of the informed consent document signed by the investigator and witness should be placed in the patient’s trial source documents, with a notation by the investigator of how the consent was obtained, e.g. telephone. The trial record at the investigational site should document how it was confirmed that the patient signed the consent form (i.e., either using attestation by the witness and investigator or the photograph of the signed consent). The note should include a statement of why the informed consent document signed by the patient was not retained, e.g., due to contamination of the document by infectious material.

If the patient is unable to provide informed consent and there is a legally authorized representative, investigators must obtain consent from the participant’s legally authorized representative in accordance with 21 CFR 50.27(a).

 

7 The procedures suggested do not apply to informed consent being obtained under 21 CFR 50.23 – (Exception from general requirements) or 21 CFR 50.24 (Exception from informed consent requirements for emergency research).

8 See Guidance for institutional review boards, investigators, and sponsors Use of Electronic Informed Consent In Clinical Investigations (December 2016), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-informed-consent-clinical-investigations-questions-and-answers .

 

Upcoming Research Administration Town Hall—Thursday, April 16, 2020

Please join us for the next virtual Research Administration Town Hall this Thursday, April 16.  We will cover the latest updates on COVID-19 (including planned enhancements to compensation tracking while in remote status and revisions to the COVID-19 research registry, among other topics). There will also be Q&A. Please note that attendees will need to register for this event, using the password provided below.

This session will be recorded for those who are unable to attend in person or have technical difficulties and will be posted to the coronavirus.research.duke.edu site when available.

 

Research Administration Town Hall – No. 3
April 16, 2020; 4:00 PM - 5:30 PM

WebLink: https://dukeuniversity.webex.com/dukeuniversity/onstage/g.php?MTID=ed5b9029319e448e0685083c48269d60e

Event Number: 478 572 115

Password: R-COVID

Call-in toll number: (US/Canada) 1-650-479-3207

Access code: 478 572 115

 

Slides and recordings from the first two Research Administration Town Hall are available here.

 

COVID-19 Research Dashboard in myRESEARCHhome

A new dashboard in myRESEARCHhome consolidates important forms, resources, and services to help you:

  • Develop your COVID-19 research
  • Manage your current research remotely
  • Get help and information

 

Visit the new COVID-19 Research Dashboard 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:

 

Need staff effort: https://redcap.duke.edu/redcap/surveys/?s=ARADRT8JD9
Have extra staff effort: https://redcap.duke.edu/redcap/surveys/?s=XXN9JFFTLD

 

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. 

 

Duke Privacy

Along with the need to focus on protecting information assets with security controls and awareness, it is equally important to ask the privacy questions up front.  Understanding what data constitutes personally identifiable information (PII) and sensitive information is the first best-step. Duke Privacy has created a web page comprised of resources that illustrate best practices for the safeguarding and proper handling of PII and confidential information. Visit https://oarc.duke.edu/privacy/privacy-training-and-best-practices.

 

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

 

Protocol Status Updates in OnCore Due to COVID-19

Is your study and/or enrollment temporarily on hold due to COVID-19 restrictions?  See a few scenarios below for how to update your Protocol Status in OnCore. 

 

SCENARIO 1:  ON-HOLD:  Protocol received Institutional Approval but had NOT YET Opened to Accrual

 

  • PC Console > Select Protocol > Status tab
  • * If you see the Submit, Clear or Close buttons, you are in update mode.  Select the Close button to exit the update mode so the available status buttons will become visible.
  • Select On Hold

This image shows the OnCore PC Console.

 

  • Enter the Status Date > Initiator > and select COVID-19 as the Reason from available list.

This image shows the OnCore PC Console

This image shows the OnCore PC Console On Hold Status

  • The protocol status is now ON-HOLD.
  • Once restrictions are lifted and you are ready to open the study to accrual – select Off HOLD

 

SCENARIO 2:  SUSPENDED:  Protocol previously Open to Accrual but enrollment is temporarily on hold due to COVID-19.  Study will RESUME enrollment once restrictions lifted

 

  • PC Console > Select Protocol > Status tab
  • * If you see the Submit, Clear or Close buttons, you are in update mode.  Select the Close button to exit the update mode so the available status buttons will become visible.

This image shows the OnCore PC Console

 

  • Select Suspend
  • Enter the Status Date > Initiator > and select COVID-19 as the Reason from list

This image shows the OnCore PC Console

 

  • The protocol status is now suspended.
  • Once restrictions are lifted and you are ready to open the study to accrual – select OPEN
    • NOTE:  If the undo suspend button is selected, the suspend status will NOT appear in the protocol status summary. The undo suspend button should only be selected if the suspended status was selected in error.  

This image shows the OnCore PC Console.

SCENARIO 3:  CLOSED TO ACCRUAL:  Protocol previously Opened to Accrual and Enrollment is being permanently closed due to COVID-19 AND WILL NOT RESUME once restrictions lifted

 

  • PC Console > Select Protocol > Status tab
  • * If you see the Submit, Clear or Close buttons, you are in update mode.  Select the Close button to exit the update mode so the available status buttons will become visible.
  • Select Closed to Accrual

This image shows the OnCore PC Console Closed to Accrual button.

  • Enter the Status Date > Initiator > and select COVID-19 as the Reason from list

This image shows the OnCore PC Console.

 

Participant Status Updates in OnCore Due to COVID-19

Do you have any research participants who went Off Treatment or Off Study due to COVID-19? 

 

COVID-19 is now an available reason to select when updating participant statuses to “off treatment” or “off study.”

This image shows the OnCore Subject Console.

 

iRIS:  Indicating a Study that was Previously Enrolling Participants is On-Hold

Are you preparing a continuing review submission for a study that was previously enrolling participants but is now temporarily on-hold? 

 

  • Indicate that the current study enrollment status is OPEN for enrollment of new subjects. 

This image shows the iRIS Study Enrollment Status radio buttons.

 

  • Explain that study enrollment is on hold due to staffing issues, IP availability, sponsor request, funding challenges etc. within the study progress narrative (section 5.1). 

This image shows Section 5.0 Study Progress in the iRIS System.

 

 

 

DOCR NEWS

 

Research Wednesdays Series Ongoing with WebEx

The Research Wednesdays Series is going strong with a new WebEx format.

 

Upcoming topics for the series can be found on the DOCR Website and WebEx meeting information is emailed to the DOCR list serve the Monday prior to the session.

This image shows the Scheduled Topics section of the Research Wednesdays website.

 

Did you miss a session or want to refer to some of the material presented in a session?  You can view past presentations and access presentation slides in the Research Wednesdays archive.

 

If you are not subscribed to the DOCR list server, send an email to docr.help@dm.duke.edu and request to be added.

 

 

 

RECRUITMENT INNOVATION CORNER

#ResearchSupportsTheFrontLine

 

This is a stock image of a scientist.

We all know that research provides important information about disease trends and risk factors, treatment outcomes, public health interventions, patterns of care, health care costs and utilization.  Research is what allows us to understand and learn more about the novel coronavirus that is plaguing the world and turning lives inside out. Research is what is going to allow us to heal from COVID-19 and prevent it in the future.

This is a stock image of people.

This hashtag represents all of you working in research, supporting the fight against COVID-19 by

  • Bolstering our frontline healthcare workers
  • Learning how to work from home, sometimes with new and interesting colleagues!
  • Learning how to wear and work in PPE
  • Working on COVID-19 studies
  • Writing COVID-19 research proposals and grants 
  • Donating supplies from your studies
  • Sewing masks for frontline HCWs
  • Educating your children, family, friends, and community

 

Whatever you are doing, YOU, the Duke Research Community, are supporting our frontline healthcare workers.  Thank you, Duke Research Community!

 Now, let’s get these hashtags trending:

  • #ResearchSupportsTheFrontLine
  • #HealthCareHeroes
  • #UnsungHeroes
  • #WeApplaud
  • #FlattenTheCurve
  • #SupportTheScrubs
  • #ClapForOurHCWs
  • #HeartsForHCWs

 

 

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.

 

 

CLINICAL RESEARCH EMPLOYEE HIGHLIGHTS

  • The Children’s Clinical Research Unit welcomes APRMs Michelle Griffin and Joan Wilson and CRC Marcus Layer who serves in our CORE coordinator pool.
    • Michelle comes to us from Duke Hospital and Emergency Medicine and Joan from Pediatric Division of AI and Pulmonary.
    • Marcus comes to us from UNC Hemophilia and Thrombosis Center.
  • The Radiology CRU
    • Welcomes Melody Torain, CRC to our CRU team.
    • Congratulates Jennifer Korzekwinski in her promotion to Clinical Research Coordinator Sr. with our CRU team.
    • Welcomes Anne Boyd, CRC to our CRU team.
  • DCI Oncology CRU and Gynecologic Oncology research program welcomes Geoffrey Richardson as Clinical Research Coordinator beginning April 1st.

 

 

PARTNER RESOURCES

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 docr.help@dm.duke.edu