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CCI COVID-19 Resources for Virtual Visits, IRB amendments, IDS Changes

We would first like to thank you for your flexibility with the CCI and research community as we navigate these unprecedented times. As we all know this situation is rapidly evolving and changing, on a daily basis. Our email on 3/16/20 notified you that we have closed down all CCI ambulatory/inpatient locations except for the Clinical Trials Hub (CTH). The reduction in locations allows us to divert staffing resources and minimize the amount of on-site staff. However, in accordance with Partners policy we remain open and available at this time for therapeutic studies with direct patient benefit. If study teams and visits remain on site an exemption form was due yesterday to BWH Research Management.

We ask that investigators who qualify for these exemptions still take this time to explore all additional avenues available to them to conduct their research visits before submitting an Overbook, to use the CTH resources so we may continue to preserve minimal staffing numbers. It is imperative that we reduce the number of visits, participants, and staff hours during this extraordinary situation. We have compiled a list of resources for you below, to help you with decision making during this time and ask that you review these options in accordance with your study protocols and explore these options before scheduling visits.

Virtual Visits

We encourage all investigators to consider whether their visits can in fact be completed virtually. If the entire visit cannot be done, consider if part of the visit can be done virtually to minimize the time the participant must spend at the CTH. The hospital has many remote collaboration tools including but not limited to: Windstream, InterCall, Skype for Business, Microsoft Teams, WebEx, or Zoom. For more information on gaining access to these tools, please visit: Gaining Access to Collaboration Tools.

Additionally, to conduct a virtual visit by telephone and continue documentation in EPIC including but not limited to chart notes, smartphrases, encounters, and billing purposes, please visit: EPIC Tip Sheet for Telephone Visits.

IRB Amendment changes for virtual visits—see attachment for Policy on Conduct of Human Research Activities during COVID-19, part B “Working with the IRB”

Not all studies require an amendment change for changing in-person visits to virtual or remote visits. If the approved procedures to be conducted at that visit can be done remotely without compromising the safety of the research participant or the scientific validity of the study, this would be considered minor deviation and would not require prior approval by the IRB. However, if there are procedures that cannot be conducted because an in-person visit cannot occur AND those procedures impact the safety of the participant or the scientific validity of the study, this should be submitted to IRB for approval as described above. The Partners IRB help desk is still operating, can contact at: IRB@partners.org

Mailing of Study Drugs

At this time the IDS pharmacy will not be making any changes to their staffing or hours. The Brigham and Women’s Hospital Pharmacy Department is not licensed as a mail order (non-resident) pharmacy and thus will not be able to mail new supplies of IP to subjects. However, study teams may coordinate their own mailing and courier services of study drugs and continue to send medication orders and prescriptions to the IDS pharmacy and pick up the drug from pharmacy. This comes with study teams taking on liability and it would be up to the sponsor to approve, pay for, and potentially coordinate (if the study team isn’t doing it) the transportation of drug from BWH to a patient via a mail/courier service.  We encourage investigators to consider this as an avenue for their studies if applicable. Please contact your IDS pharmacist or email the IDS Pharmacy directly at BWHRXIDS@partners.org.

There are some changes that IDS has made in response to the COVID-19 outbreak. Please see attachment for details regarding IDS Pharmacy Changes, IDS Planned monitoring visits, and mailing of IP.

For investigators looking to schedule future visits (after 8 weeks) or trying to cancel their current visits that do not meet the therapeutic guidelines threshold, please submit an Overbook request. We will do our best to follow up with your requests for future visits in a timely fashion to help continue the flow of research scheduling. For any questions or concerns, please email us at CCI@bwh.harvard.edu.

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