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Q. If we decide to put our study on hold for now, do we need to make any changes to the status in CRMS?
No. If the IRB makes any changes, they will interface with CRMS. There is no need to make changes to the study status in CRMS.
Q. Should I let CRBC know if we change the location or method of services in my study? (For example, moving to the CRU, Green Spring Station or Telehealth)
Yes. CRBC staff will make a note of the changes to the conduct of the study and whether or not we expect to see charges for the services. Please remember to follow IRB guidance before any changes (see links below).
Q. What should I do if my research participants need to get blood drawn or labs in an outside lab?
It depends. If the order is placed in Epic, the research billing workflow should still work. However, if the participant goes to an outside lab, you need to arrange with that lab to receive a bill if the services rendered are billable to research per PRA,
Q. Who can I talk to if I have questions regarding the billing of my research participants during this time?
You can contact Liza Rodriguez, Associate Director, Clinical Research Billing Compliance by email at erodri13@jhmi.edu.
Q. Do I need to do anything “special” for telehealth visits?
Telehealth visits should follow the research billing workflows in Epic. However, please document a) the reason for the visit, b) what was done, c) the visit point on the study timeline and d) total time of the visit.
Johns Hopkins School of Medicine IRB guidance: https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information.html/
Johns Hopkins Institute for Clinical and Translational Research (ICTR) Information: https://ictr.johnshopkins.edu/coronavirus
U.S. Food and Drug Administration (FDA )Guidance: https://ictr.johnshopkins.edu/coronavirus/fda-guidance-on-conduct-of-clinical-trials-of-medical-products-during-the-covid-19-pandemic/
Center for Medicare & Medicaid Services (CMS)
CMS Billing & Coding Guidance:
Office of the Inspector General of Health and Human Services (OIG)
https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/policy-telehealth-2020.pdf
Last Updated October 29, 2020 101:30 a.m.
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