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We are committed to helping advance COVID-19 studies quickly and effectively.COVID-19 RESOURCES & UPDATES

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On-Site Visits

A sponsor representative may need to visit a site due to various reasons including monitoring, investigational product reconciliation, site CoinJoin feasibility, initiation, or close-out visits. If a sponsor representative must come on-site, procedures should be put in place to protect all stakeholders, including participants, frontline workers and the industry representative.

 

  • Tab IconConsiderations and Best Practices
  • Tab IconResources

Considerations

  • Institutions should look to minimize the number of visits from industry sponsor representatives and look to perform as many visit activities virtually if possible.
  • In some cases, on-site visits may still be required. For example, in the following cases:
    • “For cause” audit or inspection
    • Work requires a physical presence, and no remote solution is available
  • REBs may show flexibility in allowing a transition to virtual consults.  Ensure study documentation and communication supports this approach.
  • Sites may adopt self-governance strategies (i.e., quality management processes) as part of a risk-based monitoring strategy to reduce the number of sites visits required by the sponsor (see Transcelerate link for strategies).
  • Some industry sponsors have started accepting pictures or video proof of reconciliation activities.
  • Video vignettes or real-time video conferencing of the site may be useful to allow sponsors to observe and evaluate facilities, process, etc. without entering the facility.
  • Innovative solutions may be considered such as using technology like Google Glasses, automated pill counter with photo of count, video recording of task, or smart bottles.
  • Direct to participant shipping may be an option for some investigational clinical trial products.

Best Practices

  • Create a registry and screening process for all on-site visitors. Example of screening questions for the representative attending the on-site visit:
    • Resides in Canada;
    • Has not travelled outside of Canada in the last 14 days;
    • Has not had a positive COVID test in the past 2 weeks, and is symptom free;
    • Follows all local, provincial and national travel guidelines regarding restrictions and quarantine;
    • Will be screened at the entrance before entry at the hospital;
    • Will be required to wear a mask or face covering;
    • Will be required to sanitize hands.
  • Limit on-site presence by:
    • Minimizing time spent on-site to only perform the necessary tasks
    • Limiting interaction with others and maintain physical distance
    • Avoiding travel through clinical areas
  • Contact tracing data should be gathered for all who come on site, including staff.
  • PI or delegate may act as site host, and will be responsible to:
    • Submit necessary requests for an on-site visit
    • Confirm travel history
  • On the day of the visit:
    • Provide the screening supervisor with your PI/ delegate contact info, monitor’s name, company, purpose of the visit and approximate time of arrival.
    • Meet the study monitor at the door and escort to the space.
    • Clean and sanitize high touch surfaces between users .
    • Escort monitor to the door when the visit is completed.
  • Communicate the institutional policy for external visitors broadly (i.e., to all relevant departments).
  • Clearly communicate the correct location, site, and entrances to be used for each vendor, sponsor, and research participant.
  • If new technology solutions are adopted, communicate its availability and provide training on the technology to research staff.
  • Use a standardized communication method such as SBAR to communicate all changes to contract tracing and screening requirements (see resources for template).
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