Transition from On-Site to Remote Site Initiation Activities
Year of Publication
Harris, Jacklyn; Chaney, Kayla; Salazar, Dagmar; Ward, Anthony; Shmueli-Blumberg, Dikla
Society of Clinical Research Associates (SOCRA)
COVID-19; remote monitoring; site initiation; site monitoring
The National Institute on Drug Abuse National Drug Abuse Treatment Clinical Trial Network (NIDA NDAT CTN) Clinical Coordinating Center (CCC) supports many study operational facets for multi-site substance use treatment clinical trials including clinical monitoring, which has traditionally been conducted utilizing a combination of remote and on-site procedures. Due to the COVID-19 pandemic and safety-related restrictions conduct of on-site monitoring visits have not been feasible for many trials. Therefore, the CCC developed a series of alternative remote processes to continue to support conduct of site initiation visits (SIVs) to assess sites’ readiness to begin implementing the study. To increase consistency and efficiency in multi-site clinical trials, it is critical to conduct SIV pre-visit preparation with each site prior to the conduct of a SIV. This preparation begins with the development of the study specific Site Readiness for Endorsement Checklist (SRC). The CCC maintains an SRC template that identifies all the required elements a site must have in place for study start-up. During COVID, the SRC was revised to include new requirements to better enable remote monitoring. The SRC is distributed to study sites during the pre-implementation study period. Each site is then required to submit the SRC weekly to the CCC to review site progress and to provide feedback to support completion of the tasks. Traditionally and prior to COVID, once the site completes most requirements included in the SRC, the CCC schedules and conducts the onsite SIV. However due to restrictions (i.e., travel) imposed by COVID, all SIVs have had to be conducted remotely. Therefore, to further accommodate preparation for the SIV, the CCC introduced the conduct of a remote pre-SIV meeting with the research staff to review the expectations for the SIV. As there are multiple components of the SIV , including review of the regulatory binder, and monitoring of supplies and investigational product (IP) it became essential to conduct a remote pre-SIV meeting with research staff to coordinate the logistics for conducting the SIV remotely. In some cases, during the pre-SIV meeting research staff discussed limitations with allowing video conferencing due to facility restrictions which led to the need for further flexibility, coordination, and planning all in advance of the SIV, thus avoiding rescheduling the SIV all together and avoiding delay with study launch. This process has been incorporated into the monitoring plan for site initiation for all of NIDA CTN studies since March 2020 when COVID-19 restrictions caused the CCC to shift to exclusively conducting remote monitoring visits. The CCC has successfully conducted 89 remote SIVs from March 2020 to date. Flexibility and innovation have allowed for multi-center substance use treatment clinical trials to be launched despite the constantly evolving situation and restrictions imposed by COVID. The SRC and Pre-SIV meeting are useful tools to ensure sites are aware of expectations and requirements for initiation in a remote setting. In the future, the project may explore automated options to track pre-implementation milestones.