Dear SOM Clinical Research Community,
As follow-up to the message below, we would like to clarify that clinical research monitors working with all SOM studies are expected to comply with the new UNC Health policy requiring COVID vaccination, regardless of the monitor’s primary onsite work location. For example, if the monitor of a study led by a SOM Investigator will work in an administrative space of Bioinformatics, they would still be expected to comply with the UNCH vaccination policy.
We hope that this clarification eases uncertainties related to determining what policies apply based on primary work locations and addresses monitors who may enter multiple locations during a visit.
If you have any questions or concerns related to this new policy, please let us know.
Sincerely,
SOM CRSO & UNCH ORSC
Research Colleagues:
As valued partners of UNC Health and its affiliates, clinical research monitors are expected to remain in compliance with certain UNC Health safety requirements while visiting or working at any UNC Health facility.
A recent revision to UNC Health’s immunization requirements now includes COVID-19 vaccinations. Effective fourteen (14) days from today, April 12, 2022, the COVID-19 immunization requirement shall apply for research monitors who visit or work at designated UNC Health facilities (Exhibit A, attached), including the IDS Pharmacy. Research monitors must attest to a complete COVID-19 vaccination (e.g., both doses if receiving a two-dose vaccine) before visiting and/or working at a designated UNC Health facility. This requirement may be amended from time to time at the discretion of UNC Health. See COVID-19 Immunization of Healthcare Personnel.
Research monitors must attest to being fully vaccinated prior to visiting any UNC Health facility. Use of a mask is not an acceptable alternative to receiving the COVID-19 vaccine. For research monitors who are not vaccinated or who have been exempted from vaccination by their employer, the only alternatives are to send a delegate/substitute or to conduct the work remotely with assistance from the site-based study team. In addition, research monitors should reschedule their visits to UNC Health facilities if they have symptoms of an infectious disease or exposure to communicable diseases per UNC Health policy. Research monitors with signs or symptoms of an infectious disease or exposure to communicable diseases should be cleared by their occupational health department or local physician before visiting or working at UNC Health facilities.
Research monitors must certify their compliance with UNC Health’s COVID-19 immunization requirement by completing the online forms at the links provided by their research contact before scheduling any on site visit. There are no exceptions to this policy. Research monitors will be required to attest to their vaccination status each time they visit a designated UNC Health facility. Immunization records should be maintained by the research monitor’s employer.
The vaccination attestation will be accompanied by an electronic Confidentiality Statement which can be completed online for your convenience.
Once a research monitor has completed the online forms, the study contact initiating the process will receive email notifications for tracking purposes and to allow planning for the associated visit. For trials involving investigational drugs, you must forward PDF of the attestation to the IDS pharmacy at UNCIDS@unchealth.unc.edu. Research monitors will not be allowed to access the IDS during their visits if they do not have an attestation on file for that visit. The email notification for the Confidentiality Statement will also include a copy of the completed form in PDF format which may be filed or distributed as needed to facilitate visit requirements.
Sample content with the required links for the online forms can be found in Exhibit B (attached). You may modify this language as preferred.
Thank you for ensuring the safety of UNC Health patients, families, guests and staff.
Sincerely,
UNCH ORSC and SOM CRSO