Table 2.

Conducting phase site engagement activities for multi-site clinical trials.

Activity	Study Role Target	Conventional Approach	Novel Approach	Evaluation Criteria
Refresher Training	•CRCs •Site PIs •Data Managers •Regulatory Specialists •Supervisors/Research Managers	Not required	•Designed for new site personnel to address staff turnover •Gather site feedback to help tailor future trainings	•Attendance •Change in accrual or compliance rates before and after training
Site Visit	•CRCs •Site PIs •Medical Directors •Research Nurses •Data Managers •Regulatory Specialists •Supervisors/Research Managers	Not generally required	PI and/or Project Manager meet with site study personnel in-person, discuss progress, and troubleshoot challenges	•Number of site visits •Change in accrual or compliance rates before and after visit
Monthly Newsletters	•CRCs •Site PIs •Research nurses •Advocacy partners •Stakeholders •Supervisors/Research Managers	Not required	•Provide study updates •Recognize site study personnel •Disseminate new research •Feature new sites and/or site personnel •Highlight advocacy resources and events that site teams can share with patients •Give call-to-actions	•Email open rate and click-through rate •Follow-up actions on call-to-action items •Number of times newsletter features were forwarded
Monthly Group Calls	•CRCs •Site PIs •Research Nurses •Data Managers •Physics team •Regulatory Specialists •Supervisors/Research Managers	•Site members share study updates and reminders •Periodic calls to train staff on protocol modifications	•Shared learning opportunity to troubleshoot challenges and streamline workflow •Individual sites lead discussion on areas of expertise •Disseminate lessons learned back to site teams	•Attendance •Frequency of bi-directional discussion vs. one-way instruction •Number of shared lessons or resources
Individual Site Calls	•CRCs •Site PIs •Supervisors/research managers	Not required	•Hold calls with site PIs and at least one CRC from each site •Summary of findings provided back to sites through in-person meetings, monthly calls, and tip-sheets	•Attendance on calls •Number of calls held •Number of follow-up calls needed to expand on identified opportunities or challenges
Acts of Gratitude	•Site PIs •CRCs •Advocacy Partners •Stakeholders •Executive committee •Physics team •Adjudicators •Reviewers •Any other supporting staff	•Thank you letters •Presentation of formal awards •Inclusion in “acknowledgement section” of publications	•Formally addressed thank you letters •Monthly recognition emails •Newsletter feature •Social media feature	•Number of letters, cards, emails, and awards given