The Education & Research Foundation, Inc. COVID-19 Site Precautions

Updated 06DEC2021

Site Operations:

  • The site is open Monday through Friday for in person and virtual study visits.
  • Access to site is limited to staff, investigators, study subjects and specific critical vendors and clients.
  • ERF staff will report to the office for study visits, whether virtual or in person.

Study Visits:

  • For in person study visits, the following precautions will be taken:
    • Subjects will be notified in advance that no one is to accompany them to their study appointments (with the exception of a parent or guardian accompanying a minor subject). Any visitors coming to the study visit with the subject will be asked to wait outside.
    • All subjects will wear a mask during their study visit. (Bandanas or other loose-fitting facial coverings will not be acceptable.) If a subject arrives without an acceptable mask, one will be provided by ERF. 
    • Upon arrival at the site and prior to entry to the clinical space, health screening questions may be asked. Each subject’s temperature will be taken. Those with a fever (99.5 deg F or higher registered on the forehead with a touchless thermometer or 100.4 deg. F or higher with an oral thermometer) and/or reporting possible COVID-19 exposure will be rescheduled for a later date. If subject is well and not an exposure risk, the study visit will proceed. 
    • Shaking hands and/or other unnecessary physical contact between subjects and site staff will not be allowed.
    • Social distancing (minimum of 6 feet) will be followed between staff and subjects as much as possible.
    • When close contact between staff and subjects is required, the number of staff members in contact with each subject will be minimized as much as possible. and close contact for longer than 10 minutes will be avoided when possible.
    • Masks will be worn by all site staff in the clinic area and lobby when subjects are in house. Gloves, gowns, goggles and face shields will also be available for use.
    • Study staff will wash hands for 20 seconds or use hand sanitizer before and after each subject contact.
    • The exam rooms will be sanitized after each subject.
  • Certain subject visits may be conducted virtually or via phone call, if sponsor permits. The method of virtual visits will be documented in the subject files.

Cleaning and Disinfecting:

  • Study areas will be sanitized after each subject visit, including all surfaces, chairs, equipment, faucet handles, door handles, light switches, clip boards and pens.
  • All communal door handles, light switches, surfaces, tables, chairs, etc., will be wiped down as needed throughout the day. Examples are front desk, waiting areas, hallways, bathrooms, etc.

Pre-Study Site Visits (PSSV) and Study Initiation Visits (SIV):

  • Virtual or in-person PSSV’s and SIV’s are allowed.
  • ERF can offer virtual tours of the site via Skype or Facetime.
  • Visiting sponsor or CRO personnel will be screened for COVID-19 symptoms and exposure risk upon arrival, and will be required to follow ERF’s masking, social distancing and other safety protocols while at the site.

Monitoring Visits:

  • Remote Monitoring Visits (RMV) or in-person monitoring visits are allowed.
  • Visiting monitors will be screened for COVID-19 symptoms and exposure risk upon arrival, and will be required to follow ERF’s masking, social distancing and other safety protocols while at the site.

COVID-19 Exposure Notification:

  • If an ERF employee tests positive for COVID-19, management will inform any coworkers, study subjects or site visitors who had close contact with the employee from 2 days prior to the test date or 2 days prior to symptom onset (whichever is earlier) through the time the employee begins self-isolation. Management will maintain the confidentiality of the COVID-19 positive employee to the extent possible.

Additional ERF Staff Precautions and Guidance:

(updated to reflect 100% of ERF staff reaching fully-vaccinated status)

 

  • All staff members will wear a mask in the clinic areas and the lobby when subjects are in house. Masking is not required of fully-vaccinated staff in the office area at any time, or in the clinic areas or lobby when no subjects are in house.
  • Management may require COVID-19 testing for employees on a case-by-case basis.
  • If management is notified of a study subject or site visitor who has tested positive for COVID-19, study staff, study subjects and/or site visitors who had close contact with that person within 2 days of the test date and/or symptom onset may be notified, while maintaining the confidentiality of the person to the extent possible.

 

Alexis Chantal, President

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cobb dermatology proud supporters of education and research foundation lynchburg vasociet for clinical reserch site education research foundationwomen business enterprise education research foundation 

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Phone: (434) 847-8400
Fax: (434) 846-1707

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Location:
2095 Langhorne Road
Lynchburg, Virignia 24501

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