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

Updated 20OCT2022

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:
  • All subjects will have an option to wear a mask during their study visit.
  • Upon arrival at the site and prior to entry to the clinical space, health screening questions may be asked. Those reporting possible COVID-19 exposure or current COVID-19 symptoms will be rescheduled for a later date. If the 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 be minimized.
  • 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.
  • Masks will be optional for all 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 practice good hand hygiene between subject encounters.
  • The exam rooms will be sanitized after each subject.
  • Any staff member with COVID-19 exposure or signs/symptoms of COVID-19 will be asked to remain home or use appropriate source control based on current CDC guidelines.

• 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:

• 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)

• 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.

Sue Foster, Assistant Director