Purpose:
List clear guidelines, which must be followed to Assessing COVID-19 Status, Symptoms and/or Risk Factors

All procedures will adhere strictly to GCP guidelines. Guidelines are subject to change based on any new updates from the CDC, WHO, and/or FDA.

Procedure(s):
To ensure all subjects have been properly assessed for COVID-19, symptoms, and/or risk factors, the following procedures include but are not limited to:

a) Site staff will contact the subject the business day prior to their appointment to confirm the following:

i) Have they experienced any symptoms of COVID-19 (i.e. Fever, Cough, Shortness of Breath, Chills, Repeated shaking with Chills, Muscle Pain, Headache, Sore Throat, loss of taste or smell, etc) within the last two weeks?

ii) Have they been exposed to anyone who has exhibited symptoms of COVID-19 (i.e. Fever, Cough, Shortness of Breath, Chills, Repeated shaking with Chills, Muscle Pain, Headache, Sore Throat, loss of taste or smell, etc) within the past two weeks?

If the subject responds “No” to both of those questions, the subject’s appointment is confirmed for a Face-to-Face visit.

b) Site staff will instruct the subject prior to their appointment that they are required to have a mask (if unvaccinated) or facial covering while completing a COVID-19 questionnaire and temperature check. Site staff (Investigators, Raters, Study Coordinators, Lab Technicians, Front Office staff, Research Assistants, Onsite Monitors/CRA’s, etc) will be required to wear a mask or facial covering while meeting with a patient at the patients request.

i) If the subject presents with a fever, the subject is immediately asked to leave, and the adverse event is documented appropriately per the protocol. The exam room is disinfected using Cavi Wipes and Lysol Spray, pillowcases and exam table paper is removed and bagged, all equipment in the room is sanitized and the room is then decommissioned until the next business day.

ii) If the subject does not present with a fever, all protocol procedures (including but not limited to Informed Consent, Vital Signs, ECG’s, Blood Draws, Patient Reported Outcomes, Rating Assessments, IP accountability and administration, etc) are completed in the exam room. Social distancing is maintained in the exam room between the subject and employee. The patient may request staff members to wear a mask if needed.

1) If a protocol requires the use of a tablet, the tablet is wiped down after every user. Subjects and/or Employees are required to wash hands for at least 20 seconds with soap and water prior to and after using the tablet.

iii) Exam rooms are cleaned with Cavi Wipes and Lysol Spray between each subject. New pillowcases are applied on each pillow and new table paper is applied to the exam table. All ECG cords/machines are wiped down, blood pressure cuff is sanitized with Lysol, thermometers are wiped down, etc.

c) Staff and subjects are advised to maintain social distance while walking in the halls or in the lobby. To ensure proper distance between subjects while in the lobby, two thirds of the chairs have been removed. The subject will remain in the exam room but if for any reason they are required to wait in the lobby, subjects are to remain seated in the same seat until asked to move to the exam room.

i) After use of any chairs in the lobby, the furniture is sanitized with Lysol Spray and Cavi Wipes.

ii) The site limits the quantity of subjects waiting in the lobby to no more than four subjects at any given time.

d) Frequent proper hand washing is highly encouraged to all site staff and subjects while onsite. Hand Sanitation stations have been placed throughout the entire office.

Updated: March 31, 2022.