Clinical Research Unit (CRU) Utilization during the COVID-19 Pandemic
Posted by: cwill137 on: September 8, 2020 | Print This Page
- Only research that has approval to start may schedule visits in the CRU. Do not schedule a visit for your study until you have IRB approval to begin/resume your study.
- Before you start scheduling visits for your study, email your letter from the IRB approving the resumption of your study to Shernice Madison at email@example.com. A short “re-boot meeting” will be scheduled between the CRU and the study team to go over any changes to your study. Shernice will assist with this.
- When you schedule your visit in CRU online, add a comment in the “note” section with the date of your IRB approval to resume your research. Without this, your visit will be rejected.
- Participant visits must be entered in CRU-online at least 48 hours in advance of appointment. You will receive confirmation within 48 hours after you submit your request. You will not be allowed to see your participant in the CRU unless you have a confirmation email from us.
- For last minute scheduling requests (i.e. less than 48 hours prior to visit), contact CRU staff to schedule appointment.
- Any EPIC appointment that is made by study team staff must also be entered in CRU-online and receive a CRU confirmation.
- Advise participants about visitor restrictions, face coverings policy, need for physical distancing and hand hygiene- see most up to date guidelines here: https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_ambulatory_clinic_guidance.pdf
- Participants must receive a COVID Risk Sheet during consent process or before their CRU visit if they are already consented: https://www.hopkinsmedicine.org/institutional_review_board/news/covid19_information.html/research_participant_covid19_risk_information_documents.html
- Participants must have COVID risk screening conducted by the study team at the time they are given an appointment and the day before or before leaving home to come to the appointment. Use the most recent JHMI standards: (PLEASE CHECK THIS SITE DAILY FOR CHANGES)
Telephone Pre-screen Flow
EPIC screening documentation workflow: https://livejohnshopkins.sharepoint.com/sites/epictraining/Epic%20Training%20Dropbox%20DocLib/ID%20Screening%20-%20How%20to%20Conduct%20and%20Complete%20the%20Infectious%20Disease%20Screening.pdf
- Entrances and available parking are limited and must be explained to participants https://www.hopkinsmedicine.org/coronavirus/index.html#patient-visitor-alerts For JH Adult Unit (Blalock 3) map go to https://ictr.johnshopkins.edu/coronavirus/planning-for-restart/ scroll to “Communication with Participants” to find pdf map. (PCRU map is unchanged and Bayview parking and entrances are unchanged.)
- All providers and staff must wear appropriate face coverings: surgical facemasks and face shields at a minimum. https://intranet.insidehopkinsmedicine.org/heic/_docs/2019-nCoV_ppe_ambulatory_recommendations.pdf
- Obtaining PPE will be the responsibility of the study team. https://ictr.johnshopkins.edu/coronavirus/planning-for-restart/ scroll to PPE section.
- Participants must wear face covering – cloth mask permitted
- Adhere to 6-foot distance between participants and staff or between staff and other staff – when feasible. Limit number of staff in clinic.
- No visitors for adult participants will be permitted, with the exceptions that one caregiver may accompany a participants with a disability and a pediatric participant may have one parent/guardian. (For Pediatric CRU visits, family members who are not within the household will not be permitted). All COVID screening, masking, distancing etc. apply to visitors as well.
- To reduce waiting room volume, immediate rooming after check in will be enforced when feasible.
- Study staff should arrive in the clinic at least 5 minutes before the participant’s scheduled appointment time. Do not wait for CRU staff to advise you of your participant’s arrival.
- Rooms will be cleaned by CRU staff with Sani – Cloth wipes after each patient. (Desk, exam table-if used, chairs.) Computer surfaces will be wiped (keyboard, mouse, screen) if used.
Institutional policies and guidelines have to be followed for these procedures. See the links below: