Page 183 - CHST Research Administration eBook 2 of 2 (Q4 2021)
P. 183
To: Clinical Research Staff
From: ResearchAdministration
Date: 10/1/2020
Re: Updated guidance for a mandatory onsite research sponsor representative visit
Children’s Health is committed to protecting our employees and patients from inadvertent exposuretoCOVID-19(coronavirus). Wehaveupdatedtheriskmitigationplanforclinical research visitors (e.g., sponsor representatives, monitors, CROs, etc.):
1) Sitevisitsshouldbeconductedvirtuallywheneverpossible.
2) Ifthevisitcannotbeconductedvirtuallyorpostponed,wewillevaluateeachrequeston
a case-by-case basis.
3) Remote/virtualvisitsarerequiredunlessanexceptionhasbeengrantedbyResearch
Administration.
4) Routinescreeningattheentrance,masksrequirementsandsocialdistancingmeasures
are mandatory.
5) Thenumberofmeetingattendeeswillbelimitedtoensure6-footsocialdistancecanbe
maintained (maximum of 10 attendees or as meeting room accommodates for social
distancing requirements)
6) Ifrequired,onestudyteammembermayescortthesponsorrepresentativetothelab
and pharmacy.
7) Sponsorrepresentativeswillnotbeallowedinpatientcareareas.
8) Meetingroomwillbecleanedwithdisinfectantwipesafteruse(e.g.,wipedownmeeting
table and door handles).
9) Sponsorrepresentativewillnotbeallowedonsiteuntilthisrequestandsponsorpre-
screening form has been received and approved.
If the sponsor representative visit cannot be conducted virtually or postponed, the Principal Investigator/Coordinator is to complete this form and submit to Deborah.town@childrens.com. You will be notified within 5 business days if the request is approved.
NAME of individual completing form: Study Title:
IRB#:
Velos#:
Date of onsite visit: Purpose for onsite visit:
Reason why the visit can’t be conducted virtually: attach documentation from sponsor disallowing remote/virtual visit
Location of onsite meeting:
List the names/roles of those who need to be physically present in the meeting:
