FAQs for Clinical Research During the Coronavirus Pandemic - UPDATED

UPDATED April 19, 2022

Please see the April 19, 2022, update of the CHOP Research Institute FAQs for Clinical Research During the Coronavirus Pandemic. For important frequently asked research questions related to clinical research during the pandemic. All clinical research may continue operating, and staffing capacity for research buildings remains at 100 percent.

The major changes to the FAQs are:

• The Subject Checklist is no longer required, but should serve as a guide for screening subjects coming to campus
• A positive screen on the checklist does not mean that a visit must be cancelled, but rather, a positive screen means that a determination should be escalated to the principal investigator or a physician-level team member to determine if the risk of potential exposure outweighs the benefit of the onsite visit. If bringing in a subject/parent who screens positive, the research team needs to ensure that research staff are comfortable with the visit, that research staff have access to and are donning appropriate PPE, and that all units/teams where the subject will be seen are comfortable accommodating the visit.
• A limited number of N95 masks are available for research teams at no cost and can be requested by emailing ClinResearchQuestions@chop.edu
• SARS-CoV2 positive subjects/parents can be consented in person, as long as the research team member performing the consent dons the appropriate PPE and is comfortable conducting in person consent.

Please refer to the "PI Protocol Checklist & Return to Clinical Research at CHOP" and the updated "Subject Research Checklist" as additional resources. A patient-family handout "Research During COVID-19: Information for Families" is also available. A "Study Monitor/Trainer Onsite Visit Checklist" is designed as a tool for study team use when scheduling study monitor/trainer visits.

For questions related to the staged return to clinical research, please contact the Clinical Research Support Office Leadership Team at ClinResearchQuestions@chop.edu.