Business Continuity Plan for COVID-19 Outbreak

As a company dedicated to being a trusted partner in creating a world of safer drugs, Spaulding Clinical Research is following recommended clinical trial and workplace strategies outlined by the FDA, Centers for Disease Control and Prevention (CDC), as well as state and local health authorities to safeguard against COVID-19.

The following actions have been taken to maintain the safety of our employees and study participants:

• Thorough phone screening of study participants to prevent symptomatic participants from entering the clinic
  • Phone screen script developed to screen out people with the highest risk of infection
  • Notice to all employees and participants with appointments to not present to clinic if they have any pre-specified symptoms
• All staff, vendors, monitors, and study participants entering the clinic will complete a triage process which includes temperature screening and a questionnaire on travel, contacts, signs, and symptoms
• Enhanced social distancing for participants and employees during all study activity
  • Beds more than six feet apart
  • Community areas set up to assist in distancing: lines placed on floors in waiting areas, additional waiting areas opened, common areas reconfigured to allow greater distancing
  • Clinical staff will work remotely when able; all office staff will work remotely with a slow return to the office in small groups over a 1–2 month period, following state and national guidance
• Designated building spaces for confined versus non-confined participants; participants checking in for confinement will flow through separated areas from participants coming in and out for screening and outpatient visits
  • Isolation rooms set up to segregate participants that develop any symptoms of concern while housed in the unit
  • Designated staff for confined participants versus non-confined participants
• Enhanced disinfecting measures have been put in place specifically for COVID-19
  • Additional cleaning procedures for staff at work sites, equipment, etc. (increased frequency to decrease risk of spreading infection)
• Hand sanitation stations added to key locations; this will not replace, but be in addition to, our current handwashing policies
• Personal protective equipment requirements
  • All staff and participants to wear surgical masks when within six feet of each other during all study activity
  • Masks, gloves, goggles, and gown to be worn during triage procedures
  • Glove use will continue per our bloodborne pathogen training and policies which require glove changes between every participant
• Testing for COVID-19 will be done, if deemed necessary, for suspected cases of COVID-19 through Quest Diagnostics
  • This applies to anyone who is in confinement that exhibits symptoms of COVID-19. After moving to isolation, the investigator may elect to send a nasal swab sample to Quest Diagnostics. A supply of swabs have been reserved for these scenarios.
• Only healthy populations will be considered for screening and enrollment at this time; all immunosuppressant trials, and those requiring renal or hepatic impaired subjects or elderly participants, have been suspended until further notice
• Bed occupancy in the 200-bed campus will be significantly limited in May 2020 to allow for social distancing measures
• Screening and check-in groups will be limited to 10 participants at a time to allow for six feet of distance to be kept during this process
• Spaulding Clinical is currently exempt from the State of Wisconsin Safer at Home Order since it is classified as an essential business; the unit will continue to operate with the implemented safety precautions as described above