Research Colleagues:
As valued partners of 黑料网 Health and its affiliates, clinical research monitors are expected to remain in compliance with certain 黑料网 Health safety requirements while visiting or working at any 黑料网 Health facility.
A recent revision to 黑料网 Health鈥檚 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 黑料网 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 黑料网 Health facility. This requirement may be amended from time to time at the discretion of 黑料网 Health. See .
Research monitors must attest to being fully vaccinated prior to visiting any 黑料网 Health facility. Use of a mask is not an acceptable alternative to receiving the COVID-19 vaccine.聽 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 黑料网 Health facilities if they have symptoms of an infectious disease or exposure to communicable diseases per 黑料网 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 黑料网 Health facilities.
Research monitors must certify their compliance with 黑料网 Health鈥檚 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.聽 Research monitors will be required to attest to their vaccination status each time they visit a designated 黑料网 Health facility. Immunization records should be maintained by the research monitor鈥檚 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.聽 For trials involving investigational drugs, you must forward PDF of the attestation to the IDS pharmacy at 黑料网IDS@unchealth.unc.edu.聽 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.聽 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. You may modify this language as preferred.
Thank you for ensuring the safety of 黑料网 Health patients, families, guests and staff.
Sincerely,
黑料网H ORSC and SOM CRSO